When Amgen bought marketing rights to psoriasis pill Otezla for $13.4 billion two years ago, the company was likely counting on not having to compete against early generics. And now, thanks to a win in court, Amgen appears poised to enjoy several more years of exclusivity in the key U.S. market.
After facing legal challenges from generics makers Sandoz and Zydus Pharmaceuticals, Amgen's patent portfolio on the blockbuster medicine has held up in court. With the win and pending potential appeals, Amgen's drug should be free from having to face those competitors until early 2028.
Before the trial, Novartis' Sandoz unit admitted that its Otezla generic infringed a range of patents that expire between 2023 and 2034. For its part, Zydus admitted that its copycat infringes some of the same patents but not a key one that expires in 2023.
With that, the trial was centered on the issue of whether Zyduss generic infringes a 2023 patent, Amgen said Tuesday. After reviewing the arguments, the U.S. District Court for the District of New Jersey upheld four patents but ruled against Amgen on some claims in a 2034 patent.
RELATED: Amgen's psoriasis pill Otezla thrives amid pandemic against injectable rivals
Thats a big win for the branded drugmaker, which picked up Otezla from Celgene before that company sold to Bristol Myers Squibb in 2019s largest biopharma M&A deal.
Still, a Novartis spokesperson said Sandoz is "pleased" with the ruling as it "held as invalid a key 2034-expiring Amgen patent covering specific dosage regimens for treating psoriasis" with the drug. The ruling "enables Sandoz to launch our generic apremilast product in the US in 2028, 6 years prior to the expiry date of the latest-expiring Amgen patent asserted in litigation," Novartis' spokesperson said.
Since taking over Otezla marketing, Amgen has generated some hefty sales with its new med. Thanks to the drugs oral mode of delivery, it has succeeded against injectable rivals during the pandemic. During a conference call last summer, Amgens executive vice president of global commercial operations Murdo Gordon said that more patients started on the medicine during the first few months of the pandemic than those who started on Otezlas psoriasis rivals. That came despite the fact that COVID-19 caused a decline in new patient starts across the treatment class.
Overall for 2020, the drug generated $2.2 billion. In the first half of the 2021, sales declined 5% in part thanks to lower prices, but the drug continued to maintain first-line share leadership in psoriasis, the company said.
RELATED: Under-pressure Amgen insists Otezla can withstand Bristol Myers' forthcoming psoriasis rival
While it appears Amgen won't have to worry about generics right away, the company's key med could face forthcoming competition from Bristol Myers Squibb's TYK2 inhibitor deucravacitinib, an oral med that has outperformed Otezla in head-to-head trials. Even amid that potential competition, Amgen and analysts believe the company can still succeed in mild to moderate patients.
Editor's note: This story was updated with a statement from Novartis.
- What is Psoriasis? (Part 1 of 3) | HealthiNation - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Psoriasis Treatment - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Psoriasis (Understanding Disease: Dermatology) - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- I'm Just Like You - Kids and Psoriasis - 2011 Trailer - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Psoriasis And Me - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Psoriasis?..... - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Natural Treatment For Psoriasis - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- psoriasis / eczema diet help skin care advice [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- plaque psoriasis picture m3b - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Restless Legs, Arthritis, and Psoriasis Gone Going Gluten Free - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Vitamin D can Cure Psoriasis - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Reversing Psoriasis With Green Smoothies - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Effectively Treat Psoriasis [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Scalp Treatment for Psoriasis - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Scalp Psoriasis - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- How To Treat Psoriasis - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Research and Markets: Global Psoriasis Drug Pipeline Capsule - 2012 Update [Last Updated On: September 18th, 2012] [Originally Added On: September 18th, 2012]
- Press Release [Last Updated On: September 19th, 2012] [Originally Added On: September 19th, 2012]
- $1.8 million grant supports investigation of psoriasis link to cardiovascular disease [Last Updated On: September 20th, 2012] [Originally Added On: September 20th, 2012]
- $1.8M Grant Supports Investigation of Psoriasis Link to CVD [Last Updated On: September 20th, 2012] [Originally Added On: September 20th, 2012]
- Kiwi Company Provides Scalp Relief For Coeliac Community [Last Updated On: September 20th, 2012] [Originally Added On: September 20th, 2012]
- Community News: Sept. 28 paper [Last Updated On: September 27th, 2012] [Originally Added On: September 27th, 2012]
- Novartis Psoriasis Drug Shows Promising Results [Last Updated On: September 28th, 2012] [Originally Added On: September 28th, 2012]
- Novartis data show AIN457 significantly reduced signs and symptoms in patients with hard-to-treat moderate-to-severe ... [Last Updated On: September 28th, 2012] [Originally Added On: September 28th, 2012]
- International Study Highlights Need to Support Patients With Psoriasis Suffering Feelings of Isolation, Stigmatisation ... [Last Updated On: September 30th, 2012] [Originally Added On: September 30th, 2012]
- Research and Markets: Psoriasis (Event Driven) [Last Updated On: September 30th, 2012] [Originally Added On: September 30th, 2012]
- Stiefel receives US FDA approval of Sorilux™ Foam, 0.005% for topical treatment of plaque psoriasis of the scalp [Last Updated On: September 30th, 2012] [Originally Added On: September 30th, 2012]
- Many options for psoriasis treatments [Last Updated On: October 1st, 2012] [Originally Added On: October 1st, 2012]
- Study: Psoriasis patients more prone to diabetes [Last Updated On: October 2nd, 2012] [Originally Added On: October 2nd, 2012]
- Novartis Progresses with AIN457 [Last Updated On: October 2nd, 2012] [Originally Added On: October 2nd, 2012]
- Gum disease linked to psoriasis: study [Last Updated On: October 5th, 2012] [Originally Added On: October 5th, 2012]
- Gum disease linked to psoriasis: Taiwanese study [Last Updated On: October 5th, 2012] [Originally Added On: October 5th, 2012]
- Study: People with gum disease 54% more likely to develop psoriasis [Last Updated On: October 5th, 2012] [Originally Added On: October 5th, 2012]
- Large menu of treatments for psoriasis [Last Updated On: October 6th, 2012] [Originally Added On: October 6th, 2012]
- Psoriasis Free For Life Guide for Natural Psoriasis Treatment Now Available [Last Updated On: October 7th, 2012] [Originally Added On: October 7th, 2012]
- Interim Analysis Supports Continuation of Can-Fite's Phase 2/3 Psoriasis Clinical Study with CF101 [Last Updated On: October 10th, 2012] [Originally Added On: October 10th, 2012]
- Research and Markets: Key Findings from Treatment Algorithms: Psoriasis [Last Updated On: October 10th, 2012] [Originally Added On: October 10th, 2012]
- Research and Markets: Psoriasis - Thought Leader Panel 2012 - A Summary of Persepectives from 6 Key Opinion Leaders [Last Updated On: October 11th, 2012] [Originally Added On: October 11th, 2012]
- People with severe psoriasis nearly twice at risk for diabetes [Last Updated On: October 15th, 2012] [Originally Added On: October 15th, 2012]
- Idera Pharmaceuticals Announces Completion of Patient Enrollment in Phase 2 Trial of IMO-3100 in Patients with Psoriasis [Last Updated On: October 15th, 2012] [Originally Added On: October 15th, 2012]
- Psoriasis nearly doubles diabetes risk [Last Updated On: October 16th, 2012] [Originally Added On: October 16th, 2012]
- Rise in number of Pakistanis suffering from psoriasis [Last Updated On: October 16th, 2012] [Originally Added On: October 16th, 2012]
- Psoriasis Remedies Book Teaches How to Get Rid of Psoriasis [Last Updated On: October 17th, 2012] [Originally Added On: October 17th, 2012]
- Psoriasis Patients Twice As Likely To Develop Diabetes [Last Updated On: October 17th, 2012] [Originally Added On: October 17th, 2012]
- Idera Pharma: Itching For Touch Up... [Last Updated On: October 17th, 2012] [Originally Added On: October 17th, 2012]
- Psoriasis Mandate Results Released to Mark World Psoriasis Day [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Psoriasis Care Failing Patients [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- UK Survey Calls for Further Education to Help Eliminate Common Misconceptions About Psoriasis [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- International Federation of Psoriasis Associations: Put Psoriasis on the Agenda Now! [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Analysis links psoriasis, diabetes [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Psoriasis isn't skin deep [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Lake Consumer Products Announces Innovative New MG217® Psoriasis Treatment Cream that's Unlike Anything Else on the ... [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Psoriasis and Heart Disease: It's More Than Skin Deep - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- I'm back - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Purifying Lotion - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Dr stephen ferguson ND PhD psoriasis cured - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- NATURES ANTIBIOTIC - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- DIY Face Scrub Natural [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Psoriasis Free For Life E-book... - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Buy: Psoriasis Free For Life Ebook - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Ahava Liquid Salt review by Paola Bassanese Energya Ltd - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Psoriasis Free For Life Ebook - Download - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Psoriasis Free For Life Ebook - Web Link - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Vampire Transformation! - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Evans Dermatology Evans GA - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Psoriasis Treatment Discovery Could Cure Psoriasis New Book Claims [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- My life with Psoriasis - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Johns Creek Dermatology and Family Medicine Practice Profile - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Radio Psoriasis 2 - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Joel Schlessinger MD Visits the Avene Hydrotherapy Center - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Radio Psoriasis - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Skin Salvation and Psoriasis - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Can Psoriasis Treatment Cause Hair Lost? - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Healed from Multiple Sclerosis and psoriasis! RELOAD from thedurianKing - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Psoriasis Natural Treatment - Psoriasis Cure - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- psoriasis getting cure in acupuncture-indian accu touch - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Psoriasis Interview 18010154 - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Psoriasis does not spread by touch - Skin experts - Tv9 - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Psoriasis presentation - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Home Remedies for Scalp Psoriasis - Cure Psoriasis without Medication - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]