OTEZLA XR Drug Patent Profile
Which patents cover Otezla Xr, and what generic alternatives are available?
Otezla Xr is a drug marketed by Amgen Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in OTEZLA XR is apremilast. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the apremilast profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Otezla Xr
A generic version of OTEZLA XR was approved as apremilast by ALKEM LABS LTD on September 21st, 2021.
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Questions you can ask:
- What is the 5 year forecast for OTEZLA XR?
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- What is Average Wholesale Price for OTEZLA XR?
Summary for OTEZLA XR
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 51 |
| Drug Prices: | Drug price information for OTEZLA XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OTEZLA XR |
| DailyMed Link: | OTEZLA XR at DailyMed |
Recent Clinical Trials for OTEZLA XR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| SFA Therapeutics | PHASE2 |
| Amgen | Early Phase 1 |
| Wake Forest University Health Sciences | Early Phase 1 |
Pharmacology for OTEZLA XR
| Drug Class | Phosphodiesterase 4 Inhibitor |
| Mechanism of Action | Phosphodiesterase 4 Inhibitors |
Paragraph IV (Patent) Challenges for OTEZLA XR
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| OTEZLA XR | Extended-release Tablets | apremilast | 75 mg | 210745 | 1 | 2026-08-24 |
US Patents and Regulatory Information for OTEZLA XR
OTEZLA XR is protected by nine US patents and four FDA Regulatory Exclusivities.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amgen Inc | OTEZLA XR | apremilast | TABLET, EXTENDED RELEASE;ORAL | 210745-001 | Aug 29, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Amgen Inc | OTEZLA XR | apremilast | TABLET, EXTENDED RELEASE;ORAL | 210745-001 | Aug 29, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Amgen Inc | OTEZLA XR | apremilast | TABLET, EXTENDED RELEASE;ORAL | 210745-001 | Aug 29, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Amgen Inc | OTEZLA XR | apremilast | TABLET, EXTENDED RELEASE;ORAL | 210745-001 | Aug 29, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Amgen Inc | OTEZLA XR | apremilast | TABLET, EXTENDED RELEASE;ORAL | 210745-001 | Aug 29, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Amgen Inc | OTEZLA XR | apremilast | TABLET, EXTENDED RELEASE;ORAL | 210745-001 | Aug 29, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for OTEZLA XR
See the table below for patents covering OTEZLA XR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 3188745 | ⤷ Start Trial | |
| World Intellectual Property Organization (WIPO) | 2016025686 | ⤷ Start Trial | |
| Argentina | 125988 | FORMULACIONES DE APREMILAST | ⤷ Start Trial |
| Australia | 2022280939 | FORMULATIONS OF APREMILAST | ⤷ Start Trial |
| Brazil | 112023024564 | Formulações de apremilast | ⤷ Start Trial |
| Canada | 3216640 | FORMULATIONS D'APREMILAST (FORMULATIONS OF APREMILAST) | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OTEZLA XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2962690 | 300994 | Netherlands | ⤷ Start Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
| 2962690 | LUC00125 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/14/981 20150116 |
| 2962690 | 122019000070 | Germany | ⤷ Start Trial | PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 20150115 |
| 2962690 | CA 2019 00033 | Denmark | ⤷ Start Trial | PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116 |
| 2962690 | 2019C/008 | Belgium | ⤷ Start Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION |
| 2962690 | 37/2019 | Austria | ⤷ Start Trial | PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 (MITTEILUNG) 20150116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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