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.
| 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 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
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 |
| |||
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 |