With AbbVie’s megablockbuster Humira set to face an onslaught of biosimilars next year, industry watchers have long circled 2023 as the year of the major pharma patent cliff. But this year’s slate of top losses of exclusivity covers sizable brands worth more than $17 billion in annual sales.
When Bristol Myers Squibb inked its $74 billion deal to buy Celgene back in early 2019, the timing of generics to blockbuster multiple myeloma drug Revlimid loomed as one major uncertainty for the deal. Now, the $12 billion brand is set to face some of its first copycats within weeks. It’s looking to be the industry’s biggest loss of exclusivity since Pfizer’s Lipitor, which peaked at $13 billion in annual sales.
But, unfortunately for AbbVie, Revlimid will only hold that distinction for a year. AbbVie’s megabrand Humira, which generates around $20 billion annually, is set to tumble next year as a host of generics vie for market share.
For BMS, the copycat pain won’t end there. The company also expects generics to its chemotherapy drug Abraxane, which pulled in $898 million in the U.S. last year starting in late March.
Aside from BMS, AbbVie is losing U.S. exclusivity on a pair of eye drugs in 2022. Restasis, a drug inherited in its Allergan buyout, is facing new copycats from Viatris after that company’s FDA generic approval last month. And Combigan, another former Allergan med, is facing a key patent expiration in April.
BMS and AbbVie won’t be alone in facing 2022 copycat pain. Among other big brands set to face off against generics are Eli Lilly’s blockbuster cancer med Alimta, UCB’s lucrative seizure medicine Vimpat, Roche’s eye drug Lucentis and Takeda’s multiple myeloma drug Velcade.
In researching this report, the Fierce Pharma team relied on company filings, FDA records and our own archives. The team also utilized outside projections such as those from OptumRx (PDF), Healthgrades and GoodRx.
We hope you enjoy reading about the top U.S. losses of exclusivity for 2022, and please reach out with any thoughts. To read our prior versions of the report, follow these links for 2021, 2020 and 2019.
1. Revlimid
Disease: Multiple myeloma
2021 U.S. sales: $8.7 billion
Generic entry: March 2022
Few efforts to extend a drug’s exclusivity have received as much negative attention as Celgene and Bristol Myers Squibb’s defense of megablockbuster blood cancer treatment Revlimid.
In 2020, Congress took Celgene and BMS to task after a probe found the companies raised prices on Revlimid more than 20 times to hit aggressive sales targets. Once priced at $215 per pill, Revlimid now goes for $870 before rebates and discounts, the probe found. Lawmakers concluded the company’s tactics were “anti-competitive” yet all within the laws of the land Congress controls.
The pricing and patenting strategy has helped reap enormous rewards for BMS, which bought out Celgene for $74 billion in 2019, the same year Revlimid’s original patent expired. Here’s why the companies worked so hard to extend their exclusivity: In 2020, Revlimid brought in $12.1 billion in sales. Last year, its sales reached (PDF) $12.8 billion.
But after years of patent litigation and settlements, Revlimid’s days are numbered as generic versions of the treatment are nearing the key U.S. market. In February, Sandoz and Stada Arzneimittel revealed that launches of their generic versions of Revlimid are underway in Europe. This month, generics are set to reach the U.S.
This is hardly unbridled competition, however. Among the companies set to launch in the U.S., BMS has agreements in place that will limit how much product they can sell. On Monday, Teva said it had launched the first Revlimid generic.
For example, Natco Pharma of India, which gained FDA approval for its generic in May of last year, agreed to hold off its launch until this month. For their launch, Natco and its U.S. marketing partner Arrow will produce only a small amount—described as a mid-single-digit percentage of Revlimid’s monthly volume. Over time, that percentage increases, reaching 33% of Revlimid’s volume by March 2025. Then, on Jan. 31, 2026, the limitations end.
Other generics manufacturers—including Alvogen of New Jersey and Sun Pharma, Zydus Cadila, Cipla and Dr. Reddy’s Laboratories of India—have similar agreements in place with BMS. Alvogen already has launched a Revlimid generic in a few select European countries. In September of last year, Apotex launched a Revlimid generic in Canada.
The settlements came after Celgene survived a patent challenge from Dr. Reddy’s. The decision allowed Celgene to extend its exclusivity and make advantageous deals with the generics makers that will help slow the erosion of Revlimid’s sales.
The introduction of generics usually puts downward pressure on prices. But limited-volume deals such as these will not impact prices as much.
Any discussion of Revlimid and its loss of exclusivity must include its sidecar multiple myeloma treatment Pomalyst, which was developed from the same drug, Thalomid, and thus had the same patent life, due for expiration this year.
But, relying on similar patents BMS erected to protect the risk evaluation and mitigation system which governs the distribution of Revlimid, Pomalyst appears to be free from challenges. Many generics makers initially challenged Pomalyst’s patents, including Mylan and Breckenridge, which worked out settlements with BMS.
“As it relates to U.S. IP for Pomalyst, we are pleased that there is now no outstanding litigation,” David Elkins, BMS’ chief financial officer, said during the company’s fourth-quarter earnings call. “We don’t expect generic entry in the U.S. market prior to the first quarter of 2026.”
Pomalyst, which is used as a third-line treatment if Revlimid fails, generated sales of $3.33 billion last year.
BMS has projected sales of Revlimid to reach between $9.5 billion and $10 billion this year. The company then expects sales to drop between $2 billion and $2.5 billion each year afterward. With the drop in Revlimid sales, BMS sees low single-digit growth this year.
BMS tried to allay investors’ fears in January when it said it had the wherewithal to sustain the loss of Revlimid revenue. Blood thinner Eliquis and immuno-oncology standouts Opdivo and Yervoy will generate added growth of $8 billion to $10 billion annually, CEO Giovanni Caforio said. The company expects an additional $10 billion to $13 billion in annual sales to come from recent and expected launches, which include anemia drug Reblozyl, CAR-T therapy Breyanzi and psoriasis candidate deucravacitinib.
Samsung Bioepis won approval after a phase 3 AMD trial in nine counties going head-to-head with Lucentis showed Byooviz performed comparably and with the same safety profile.
At least four other biosimilars are in development for Lucentis. Another South Korean company, Chong Kun Dang, has completed a phase 3 trial and filed for regulatory approval in its country of its version of Lucentis.
Xbrane Biopharma of Sweden has completed a phase 3 trial of its candidate, Xlucane, and in September of last year filed for approval in Europe. Xbrane will file in the U.S. in this quarter, the company said in its quarterly earnings report. Xbrane is partnering on the biosimilar with Stada Arzneimittel of Germany and Bausch & Lomb.
Coherus BioSciences of California and Bioeq of Switzerland are partnering on Lucentis biosimilar Cimerli, which was developed by Formycon of Germany. In October, the FDA accepted Bioeq’s application for approval and it is “progressing well” toward the target action date in August of this year, CEO Denny Lanfear said on the company’s earnings call. Their plan is to launch sometime in the second half of the year.
Lupin of India also has a Lucentis copycat in phase 3 testing, with hopes of a submission to the FDA in the first quarter of 2023 and a potential launch a year later.
Some of the big players on the biosimilar scene—including Pfizer, Sandoz, Celltrion and Biocon—were believed to have some initial interest in developing a Lucentis biosimilar but recently have not revealed plans for a program.
Roche hasn’t stood idly by as Lucentis loses its exclusivity. In January of this year, the company won approval for Vabysmo, which it hopes will be better suited to compete with Eyela as it requires as few as three injections per year as opposed to six.
Additionally, in October of last year, Genentech gained a nod for Susvimo, an eye implant system which needs to be refilled every six months. The company also is working on expanding that duration to every nine months and on adding indications for the treatment.
Another player that factors into the competition is Novartis’ Beovu, which was approved in October 2019 and is considered a blockbuster in waiting. But between the pandemic and some newfound safety concerns, the treatment has struggled to get a foothold.
Given the similarity in the effectiveness of Lucentis and Eylea, the introduction of biosimilars for the former could also cut into Eylea’s sales.
Several major companies, including Samsung Bioepis, are developing biosimilars for when Eylea’s patent protection ends. According to Regeneron’s 2021 Securities and Exchange Commission K-10 filing, that happens in the U.S. in 2023 and in Europe in 2025, though there are several other Eylea patents—for formulation, manufacture and methods of treatment—which expire as late as 2032.
The launching of biosimilars for Eylea would, of course, further cut into sales of Lucentis and its biosimilar knockoffs.
3. Vimpat
2021 U.S. sales: $1.27 billion
Disease: Partial-onset seizures
Potential generic entry: March 2022
With its anti-epileptic drug Vimpat set to face generic competition in March, UCB kicked off 2022’s biopharma dealmaking with a $1.9 billion acquisition of rare epilepsy drug developer Zogenix. The deal, expected to close in the second quarter, will allow UCB to get its hands on Fintepla, an FDA-approved treatment for rare types of epilepsy with blockbuster potential.
Fintepla is especially needed given the delayed approval of UCB’s next potential cash cow, the plaque psoriasis treatment Bimzelx (bimekizumab). The FDA was originally due to issue a verdict on Bimzelx in mid-October, but the regulator had to delay its decision thanks to pandemic-related travel restrictions that kept it from inspecting European manufacturing facilities.
UCB is counting on Bimzelx’s launch, plus a trio of growth products—Briviact, Nayzilam, Evenity—to “more than compensate the impact of the [loss of exclusivity] for Vimpat next year and Cimzia in 2024,” Sandrine Dufour, executive vice president and chief financial officer at UCB, said on a call with investors last year.
Thanks to a 2018 decision from the Court of Appeals for the Federal Circuit, Vimpat has protection on a key U.S. patent until March of this year. UCB predicted the drug would generate peak sales of 1.5 billion euros in 2021–going out with a bang in its last full year of exclusivity.
On that projection, the company delivered. Vimpat posted 1.55 billion euros ($1.74 billion) in global sales last year, with 1.13 billion euros ($1.27 billion) coming from the U.S.
As for potential copycats at the gates, India’s Aurobindo Pharma snagged tentative approval for its Vimpat generic, also known as lacosamide, way back in 2015. Generics compatriot Zydus Cadila also won a tentative green light for its lacosamide tablets in 2019, according to FDA records.
Meanwhile, UCB is bracing for the arrival of Neupro generics this year. UCB lost a bit to enforce a reformulation patent on the Parkinson’s disease drug in April. UCB appealed, but pending that appeal, Actavis may launch a generic version of Neupro, the company said in its 2021 half-year earnings report.
Last year, Neupro generated 95 million euros ($106 million) in the U.S. and 307 million euros ($344 million) globally.
4. Alimta
2021 U.S. sales: $1.23 billion
Diseases: Malignant pleural mesothelioma and nonsquamous non-small cell lung cancer
Generic entry: February 2022
Eli Lilly is growing primarily thanks to its newer offerings these days, but the entry of Alimta generics this year may herald a “rapid and severe decline in revenue” for the aging cancer med, the company warned in a 2020 securities filing.
The first copycat came from Eagle Pharmaceuticals in February. Eagle announced a limited generic launch in February, and it has the rights to an “uncapped” market entry April 1. Other generic drugmakers, for their part, will need to wait until May, when the last of Alimta’s patents lapse in the U.S.
Alimta’s so-called “vitamin regimen patent” runs out in May, potentially opening the gates for generic rivals from Viatris and Apotex. Back in 2017, Lilly’s intellectual property helped fend off Teva Pharmaceutical. The patent covers the cancer med’s use alongside vitamin B therapy.
Alimta can cause potentially fatal side effects when taken without vitamins. Lilly has argued that its work to find a solution warranted an IP shield, while competitors seeking to launch knockoff versions, like Teva, have argued adding vitamins was a next logical step.
Lilly’s protectiveness over Alimta makes sense; the drugmaker knows its loss of exclusivity is going to hurt. The arrival of U.S. generics “will cause a rapid and severe decline in revenue” and have a material adverse effect on our consolidated results of operations and cash flows,” the company said in its 2020 10-K securities filing.
Alimta delivered $2.06 billion in global 2021 sales, a 12% decline from the prior year. In the U.S., the drug posted $1.23 billion in 2021 sales, a 2% decline.
The med has already fallen from a 2014 peak of $2.7 billion following the onslaught of generics abroad, but, in more recent years, the drug has been revived as part of a combination therapy with Merck’s Keytruda in non-small cell lung cancer.
Alimta is approved to treat advanced non-small cell lung cancer and mesothelioma.
5. Restasis
2021 U.S. sales: $1.23 billion
Disease: Ocular inflammation associated with keratoconjunctivitis sicca
Generic entry: February 2022
Give Allergan credit. Its attempt to shield Restasis from generic competition by licensing it to the Saint Regis Mohawk Tribe took enormous chutzpah.
The outside-the-box ploy—back in September 2017—ultimately failed to extend the patent protection of the dry eye medicine. But it will live on as an outlandish example of the extremes biopharmaceutical companies will go to extend their monopolies and milk as much as they can from their cash cows.
Despite that setback, it still has taken more than four years for generic competition to finally become a reality for Restasis, which now is under the umbrella of AbbVie following the company's 2019 acquisition of Allergan.
Competition could have arrived years ago in the U.S., but generics makers have not been able to get a copycat across the FDA finish line.
Then, in early February, Viatris subsidiary Mylan gained approval for its generic. In announcing the nod, Viatris CEO Rajiv Malik referred to the decadelong effort to both develop the generic and to “remove all barriers to entry.”
“We are also proud to add another first to our growing list of industry-setting scientific achievements in bringing to market complex and difficult-to-manufacture products,” Malik said in the release.
Viatris launched its copycat product Feb. 3, according to a posting from OptumRx.
The FDA helped Mylan develop the treatment through its Generic Drug User Fee Amendments Science and Research Program. Upon the approval, the U.S. regulator cited the difficulty of developing generics with a “complex active ingredient formulation or route of delivery.”
The FDA effort to help companies develop a generic for Restasis dates to 2012. A year later, hoping to facilitate the effort as it related to Restasis generics, the FDA dropped the requirement that copycat formulations would have to be tested on humans rather than in a lab to determine their bioequivalence.
Nine generics makers sought approval for their versions of Restasis before Mylan’s breakthrough, according to Evercore ISI. Among those in the mix were Akorn, Amneal, Teva and Pfizer’s InnoPharma.
The green light came as a surprise to AbbVie. On the morning the generic was approved, the company said—in quoting its sales estimate for Restasis in 2022—that it didn’t expect generic competition in the first half of 2022.
Sales of Restasis have leveled off since the drug reached its peak in 2017, when it generated $1.41 billion. In those days, it was assumed that the treatment would continue to grow its sales, exceeding the $2 billion mark by 2021.
But branded competition from Novartis’ Xiidra has forced price reductions for Restasis and lessened its demand. Sales sunk all the way to $787 million in 2020, when the pandemic played a big role in the slump, but U.S. revenues rebounded to $1.23 billion in 2021.
With just one generic lined up so far, it’s uncertain what kind of competition it will pose.
“If there is one generic, they are probably going to price it, MSRP-wise, relatively similarly to the branded medication,” Francis Mah, M.D., told Healio News. “I don’t know that it is going to make a huge impact.”
6. Velcade
2021 U.S. sales: $920 million
Diseases: Multiple myeloma and mantle cell lymphoma
Generic entry: March 2022
Even after Fresenius Kabi released its injectable version of bortezomib back in 2018, the branded, subcutaneous drug from Takeda has been churning in big sales. But Velcade’s lucrative run is nearly at its end in the U.S.
In its third-quarter fiscal year 2021 results, Takeda said it expects “at least one” rival to launch in its current fiscal year, which ends this month. The drug, used to treat certain blood cancers, generated about $920 million in the U.S. last year, Takeda said in filings.
Velcade’s long stretch of generating big sales is ending after the company scored a major victory in defense of the drug back in 2017. At the time, an appeals court said a lower court erred in striking down a key patent, extending the drug’s patent protections into this year. Before that win, Takeda had been publicly bracing for generics.
Now, with patents and exclusivity running out, it appears a host of generics companies are lining up to take a run at the big Velcade U.S. market. Companies such as Novartis’ Sandoz, Accord Healthcare, Fresenius Kabi and others have won tentative generic approvals, according to FDA records.
As those companies line up with their tentative approvals, Takeda’s patents are running out: Velcade’s last remaining patents and exclusivity expire this year, according to the FDA’s Orange Book.
Velcade is nearing generic competition just as Takeda is looking to launch new meds in a bid for growth. But those efforts took a hit late last year when one of its top prospects, Eohilia for eosinophilic esophagitis, received an FDA rejection. Then, in reporting quarterly results in early February, Takeda said it opted to abandon the prospect.
As for Velcade, the drug has been facing some U.S. competition from Fresenius Kabi since that company launched a lyophilized powder for intravenous injection version back in 2018. On Takeda’s Velcade website, the company says the branded drug is given intravenously or subcutaneously one or two times per week.
In Takeda’s most recent quarterly results, the company said the drug generated 81.8 billion yen ($710 million) in the U.S. in the nine months leading up to Dec. 31, a 13.3% increase from the same period during its 2020 fiscal year. In the first three months of 2021, Velcade pulled in 24.1 billion yen ($210 million) in the U.S.
. Vasostrict
2021 sales: $901 million
Disease: Diabetes insipidus
Generic entry: January 2022
Endo International’s blood pressure drug Vasostrict reaped $901 million in 2021, making it the company’s top-selling med.
While Vasostrict is now past the end of its exclusive market life, the med has snagged a second wind recently as a crucial therapy for COVID-19 patients in critical care. Still, that hasn’t stopped Eagle Pharmaceuticals’ generic vasopressin from taking flight.
In January, Eagle announced the launch of its copycat in the U.S. market along with a coveted 180 days of marketing exclusivity. Eagle’s generic won its green light from the FDA in December, some three and a half months after the U.S. District Court for the District of Delaware ruled Eagle’s product didn’t infringe patents owned by Endo unit Par Pharmaceutical, Eagle noted in a release.
Since Eagle's launch, "additional competing alternatives have entered the market, including an authorized generic," Endo said in a recent Securities and Exchange Commission filing. "The degree of generic and/or other competition facing this segment is expected to increase in the future," the company added. In other words, expect sales to fall—fast.
In the last three months of 2021, meanwhile, Vasostrict ginned up nearly $225 million for Endo, taking its full-year haul to $901.74 million, a 15% increase from 2020. Endo chalked up those gains to additional Vasostrict revenues “primarily due to hospitalizations associated with COVID-19.”
During its earnings presentation last fall, Endo pointed out that Vasostrict comprised roughly 70% of third-quarter revenues from its sterile injectables business. At the time, the company flagged “potential for loss of exclusivity in early 2022.”
Over the past three years, Vasostrict "accounted for 30%, 27% and 18% of our 2021, 2020 and 2019 net revenues, respectively," Endo added in its 10-K.
To offset the Vasostrict generics squeeze, Endo is banking on established Dupuytren's contracture med Xiaflex and up-and-comer cellulite treatment Qwo. Xiaflex, which treats a condition that affects the connective tissue beneath the skin of the palm, made $432 million in 2021. Endo has yet to break out Qwo sales in its earnings.
On the pandemic front, Endo in November said its Par Sterile Products unit would supply vials of Vasostrict to healthcare providers through Premier’s Premier ProRx program. That was part of a bid to keep supplies afloat for a critical care med used in “some of the most acute cases of COVID-19,” the company said at the time.
Eagle isn’t the only company waiting in the wings with Vasostrict copycats. Amphastar Pharmaceuticals and Regent have also snared approvals for their generic vasopressin products, according to the FDA.
8. Abraxane
2021 U.S. sales: $898 million
Diseases: Breast cancer, non-small cell lung cancer, pancreatic cancer
Potential generic entry: March 2022
Bristol Myers Squibb’s chemotherapy Abraxane reaped blockbuster sales in 2021, but the drug is set to face its first generic rival in the U.S. come the end of March–which will nearly halve revenues on the drug, BMS has predicted.
At the end of this month, BMS expects generics to launch in the U.S., the company said in its recent 10-K annual filing (PDF) with the Securities and Exchange Commission. That’s based on settlements the company has reached with generic players.
Teva, Hikma and Fresenius Kabi are among the generics companies with FDA approvals, according to agency records.
Elsewhere, Abraxane generics are on the market in Europe. BMS isn’t expecting loss of exclusivity on the drug in Japan until 2023. The IP protection there is based on a method-of-use patent, BMS said.
For 2021, the drug generated about $1.18 billion, down about 5% from the $1.25 billion it made in 2020. In the U.S., the med pulled down sales of $898 million last year.
The chemotherapy represents one of two major losses of exclusivity BMS is bracing for this year, alongside the company’s megablockbuster Revlimid. The company expects to generate worldwide sales of $47 billion for 2022, with about $10.5 billion of that pinned to Abraxane and Revlimid sales.
Still, it’s Revlimid that will be doing much of the heavy lifting as Abraxane is only expected to contribute about $500 million to that $10.5 billion haul, BMS said in a fourth-quarter earnings report.
Elsewhere, Abraxane won’t be able to depend on sales from China anymore, either. BMS and Celgene in October alerted partner BeiGene they were yanking Abraxane’s China rights from a basket licensing deal Celgene signed in 2017. The termination will take effect 180 days from the notice, a BMS spokesperson told Fierce Pharma at the time.
9. Pradaxa
2021 U.S. sales: $550 million (IQVIA estimate)
Diseases: Atrial fibrillation, deep vein thrombosis, pulmonary embolism
Potential generic entry: June 2022
Boehringer Ingelheim’s anticoagulant Pradaxa has managed to retain its market exclusivity longer than some industry watchers had anticipated, but now the drug could be coming up against 2022 generics.
After its original FDA approval in 2010, Pradaxa is inching toward the end of its exclusive life. Hetero Labs (PDF) and Alkem Labs (PDF) have won FDA approvals for their copycats, according to agency records, but can’t launch until Boehringer’s '380 patent on Pradaxa expires. That’s set to occur in June, according to the FDA’s Orange Book.
Meanwhile, Boehringer has a range of other patents that run through this decade and even 2031. In their FDA applications, Hetero and Alkem said their generics wouldn’t infringe Boehringer patents. Nonetheless, Boehringer took the companies to court over alleged infringement of the '380 patent.
In the Hetero case, a court filing from June 2016 shows the companies “agreed to terms and conditions representing a negotiated settlement” that enjoins the generic drug company or any affiliated entities from launching its product “through and until” the expiration of the patent. That expiration, again, occurs in June, according to FDA records.
A filing in the Alkem case shows a similar result. In a July 2016 outcome, the court wrote that Alkem agreed that the patent is “valid and enforceable.”
Aside from Hetero and Alkem, Glenmark, Teva, Alembic, Dr. Reddy’s and Viatris’ Mylan have scored tentative FDA approvals, according to agency records. Teva and Breckenridge Pharmaceuticals entered deals enjoining them from launching their potential copycats before the expiration of the '380 patents, court records show.
Court proceedings involving a host of other generics companies are still playing out, according to records.
Previously, experts at GoodRx said Pradaxa could face generics starting in September 2021, indicating the drug has been able to evade generics longer than some market watchers had expected.
For their part, in a fourth-quarter industry update (PDF), experts at OptumRx said they're expecting Pradaxa generics in the second quarter of 2022.
Boehringer didn’t break out half-year sales of the drug, and it hasn’t yet reported full-year 2021 sales. But, in 2020, the company said the drug generated 1.49 billion euros, which was “marginally short of the previous year’s result.” Still, the drug “remains one of Boehringer Ingelheim’s strongest revenue contributors,” the company said at the time.
When Glenmark won tentative FDA approval for its generic version of the drug in late 2020, the company said the size of Pradaxa’s U.S. market is $550 million annually, citing IQVIA data.
In response to questions about the company’s expectations for generics, a Boehringer spokesperson said it “cannot comment regarding the approval of another company’s product.”
“While we cannot speak to the specifics of products being developed or launched by other companies, we believe it is important for patients to have safe and effective treatment options, including Pradaxa,” the spokesperson added.
10. Combigan
2021 U.S. sales: $373 million
Disease: Glaucoma
Generic entry: January 2022
While AbbVie inherited a range of big-selling medicines in its 2020 Allergan buyout, the company also got its hands on two eye meds set to face near-term generic competition. Now, it seems both are set to take the patent cliff tumble in 2022.
The situation around Restasis, the larger of the two brands, was detailed in profile No. 5 in this report. As for the other, Combigan, it’s already facing some copycat competition following Apotex’s recent launch.
Jan. 19, Apotex said it launched the first-to-market Combigan authorized generic in the U.S. The AbbVie brand, which is the most-dispensed glaucoma brand in the U.S., pulled in $373 million in the key market last year. Combigan won its FDA approval way back in 2007.
As for other generics players, Sandoz, Akorn and HiTech Pharma are among the companies with tentative generic approvals, according to FDA records. All patents on the drug run out in April, the FDA’s Orange Book says.
Before AbbVie acquired Allergan, the latter company had sued a range of generics companies for alleged Combigan patent infringement. Based on a quarterly filing from 2015, it appears Apotex’s recent launch was the result of a settlement the company entered with Allergan in April of that year. Hi-Tech Pharma also has a settlement with Allergan, according to the filing.
In Allergan’s case against Sandoz and Alcon, a district court in 2018 granted a preliminary injunction prohibiting the generics launches until after the patents expire. The following year, an appeals court upheld the decision.
For AbbVie, the loss of around $400 million in U.S. sales is hardly the company’s top concern. Next year, the company faces U.S. biosimilars to its immunology megablockbuster Humira, which last year cleared $20 billion in global sales for the first time. To help fill the revenue hole, the company is counting on new launches Skyrizi and Rinvoq to generate $15 billion combined by 2025.
https://www.fiercepharma.com/special-reports/top-10-drugs-losing-us-exclusivity-2022
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