Otezla Xr Patent Expiration

Otezla Xr is a drug owned by Amgen Inc. It is protected by 4 US drug patents filed in 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 27, 2042. Details of Otezla Xr's patents and their expiration are given in the table below.

Filter patents by

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US7427638 (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione:, and methods of synthesis and compositions thereof
Feb, 2028

(2 years from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11752129 NA
May, 2042

(16 years from now)

Active
US11969409 NA
May, 2042

(16 years from now)

Active
US10092541 Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast
May, 2034

(8 years from now)

Active

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Several oppositions have been filed on Otezla Xr's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Otezla Xr's generic, the next section provides detailed information on ongoing and past EP oppositions related to Otezla Xr patents.

Otezla Xr's Oppositions Filed in EPO

Otezla Xr has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 26, 2010, by Ratiopharm Gmbh. This opposition was filed on patent number EP03721414A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP10162667A Mar, 2020 Galenicum Health S.L.U. Revoked
EP10162667A Feb, 2020 Hoffman Eitle Patent- und Rechtsanwälte Partnerschaftsgesellschaft mbB Revoked
EP10162667A Feb, 2020 Zentiva k.s. Revoked
EP10162667A Feb, 2020 Hexal AG Revoked
EP10162667A Feb, 2020 Wuesthoff & Wuesthoff Patentanwälte PartG mbB Revoked
EP15177140A Oct, 2019 KRKA, d.d., Novo mesto Granted and Under Opposition
EP15177140A Oct, 2019 Galenicum Health S.L.U. Granted and Under Opposition
EP15177140A Oct, 2019 Zentiva k.s. Granted and Under Opposition
EP15177140A Oct, 2019 Cipla Ltd Granted and Under Opposition
EP15177140A Oct, 2019 STADA Arzneimittel AG Granted and Under Opposition
EP15177140A Oct, 2019 Alfred E. Tiefenbacher (GmbH & Co. KG) Granted and Under Opposition
EP15177140A Oct, 2019 Dr. Reddy's Laboratories Limited Granted and Under Opposition
EP15177140A Oct, 2019 Hexal AG Granted and Under Opposition
EP15177140A Oct, 2019 Sanovel Ilaç Sanayi Ve Ticaret Anonim Sirketi Granted and Under Opposition
EP15177140A Oct, 2019 Química Sintética, S.A. Granted and Under Opposition
EP15177140A Oct, 2019 ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. Granted and Under Opposition
EP15177140A Oct, 2019 Generics (UK) Ltd Granted and Under Opposition
EP15177140A Oct, 2019 Accord Healthcare Ltd Granted and Under Opposition
EP15177140A Oct, 2019 Hoffman Eitle Patent- und Rechtsanwälte Partnerschaftsgesellschaft mbB Granted and Under Opposition
EP15177140A Oct, 2019 Teva Pharmaceutical Industries Ltd Granted and Under Opposition
EP10162653A Feb, 2018 ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. Revoked
EP09003138A Jul, 2017 Accord Healthcare Revoked
EP03721414A May, 2010 Ratiopharm GmbH Revoked


US patents provide insights into the exclusivity only within the United States, but Otezla Xr is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Otezla Xr's family patents as well as insights into ongoing legal events on those patents.

Otezla Xr's Family Patents

Otezla Xr has patent protection in a total of 24 countries. It's US patent count contributes only to 28.6% of its total global patent coverage. 6 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Otezla Xr.

Family Patents

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Generic Launch

Generic Release Date:

Otezla Xr's generic launch date based on the expiry of its last outstanding patent is estimated to be May 27, 2042 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Otezla Xr Generic API suppliers:

Apremilast is the generic name for the brand Otezla Xr. 14 different companies have already filed for the generic of Otezla Xr, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Otezla Xr's generic

Alternative Brands for Otezla Xr

There are several other brand drugs in the same treatment category and using the same active ingredient (Apremilast) as Otezla Xr. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Amgen Inc
Otezla

(uses Apremilast)

used for treating psoriatic arthritis and plaque psoriasis with dosage titration and inhibiting PDE4.

Apart from brand drugs containing the same ingredient, some generics have also been filed for Apremilast, Otezla Xr's active ingredient. Check the complete list of approved generic manufacturers for Otezla Xr





About Otezla Xr

Otezla Xr is a drug owned by Amgen Inc. Otezla Xr uses Apremilast as an active ingredient. Otezla Xr was launched by Amgen Inc in 2025.

Approval Date:

Otezla Xr was approved by FDA for market use on 29 August, 2025.

Active Ingredient:

Otezla Xr uses Apremilast as the active ingredient. Check out other Drugs and Companies using Apremilast ingredient

Dosage:

Otezla Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
75MG TABLET, EXTENDED RELEASE Prescription ORAL