Otezla is a drug owned by Amgen Inc. It is protected by 15 US drug patents filed from 2014 to 2024. Out of these, 6 drug patents are active and 9 have expired. Otezla's patents will be open to challenges from 20 January, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 29, 2034. Details of Otezla'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 |
| US7893101 | Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions thereof, and uses thereof |
Dec, 2023
(1 year, 5 months ago) |
Expired
|
| US6020358 | Substituted phenethylsulfones and method of reducing TNFα levels |
Oct, 2018
(6 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US10092541 (Pediatric) | Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast |
Nov, 2034
(9 years from now) | Active |
|
US9872854 (Pediatric) | Methods for the treatment of psoriatic arthritis using apremilast |
Nov, 2034
(9 years from now) | Active |
| US10092541 | Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast |
May, 2034
(9 years from now) | Active |
| US9872854 | Methods for the treatment of psoriatic arthritis using apremilast |
May, 2034
(9 years from now) | Active |
|
US7427638 (Pediatric) | (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione:, and methods of synthesis and compositions thereof |
Aug, 2028
(3 years from now) | Active |
| US8455536 | Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline 1,3-dione |
Mar, 2023
(2 years ago) |
Expired
|
| US8802717 | Methods of treating arthritic conditions using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline 1,3-dione |
Mar, 2023
(2 years ago) |
Expired
|
| US7208516 | Methods of the treatment of psoriatic arthritis using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione |
Mar, 2023
(2 years ago) |
Expired
|
| US7659302 | Methods of using (+)-2-[1-(3-ethoxy-4 methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione |
Mar, 2023
(2 years ago) |
Expired
|
| US9018243 | Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions thereof, and uses thereof |
Mar, 2023
(2 years ago) |
Expired
|
| US6962940 | (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione: methods of using and compositions thereof |
Mar, 2023
(2 years ago) |
Expired
|
| US9724330 | Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione |
Mar, 2023
(2 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Otezla's patents.
Latest Legal Activities on Otezla's Patents
Given below is the list of recent legal activities going on the following patents of Otezla.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Sep, 2022 | US9018243 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Jul, 2022 | US7893101 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Mar, 2022 | US10092541 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 Jan, 2022 | US8802717 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 28 Jul, 2021 | US7659302 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Jul, 2021 | US9872854 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 Sep, 2020 | US9724330 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Sep, 2020 | US8455536 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 17 Mar, 2020 | US7427638 |
| Post Issue Communication - Certificate of Correction | 27 Nov, 2018 | US10092541 |
FDA has granted several exclusivities to Otezla. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Otezla, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Otezla.
Exclusivity Information
Otezla holds 9 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Otezla's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-694) | Sep 23, 2017 |
| New Chemical Entity Exclusivity(NCE) | Mar 21, 2019 |
| New Indication(I-803) | Jul 19, 2022 |
| M(M-257) | Apr 10, 2023 |
| New Indication(I-884) | Dec 20, 2024 |
| Orphan Drug Exclusivity(ODE-248) | Jul 19, 2026 |
| M(M-299) | Jul 20, 2026 |
| Pediatric Exclusivity(PED) | Jan 20, 2027 |
| New Patient Population(NPP) | Apr 25, 2027 |
Several oppositions have been filed on Otezla'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's generic, the next section provides detailed information on ongoing and past EP oppositions related to Otezla patents.
Otezla's Oppositions Filed in EPO
Otezla 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 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's family patents as well as insights into ongoing legal events on those patents.
Otezla's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Otezla's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 29, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Otezla Generic API suppliers:
Apremilast is the generic name for the brand Otezla. 13 different companies have already filed for the generic of Otezla, 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's generic
How can I launch a generic of Otezla before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Otezla's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Otezla's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Otezla -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg, 20 mg and 30 mg | 22 Mar, 2018 | 10 | 17 Feb, 2021 | 29 May, 2034 | Eligible |
About Otezla
Otezla is a drug owned by Amgen Inc. It is used for treating psoriatic arthritis and plaque psoriasis with dosage titration and inhibiting PDE4. Otezla uses Apremilast as an active ingredient. Otezla was launched by Amgen Inc in 2014.
Approval Date:
Otezla was approved by FDA for market use on 21 March, 2014.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Otezla is 21 March, 2014, its NCE-1 date is estimated to be 20 January, 2026.
Active Ingredient:
Otezla uses Apremilast as the active ingredient. Check out other Drugs and Companies using Apremilast ingredient
Treatment:
Otezla is used for treating psoriatic arthritis and plaque psoriasis with dosage titration and inhibiting PDE4.
Dosage:
Otezla is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 30MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |
| 20MG | TABLET | Prescription | ORAL |