OTEZLA Drug Patent Profile
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Which patents cover Otezla, and what generic alternatives are available?
Otezla is a drug marketed by Amgen Inc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has ninety patent family members in twenty-four countries.
The generic ingredient in OTEZLA is apremilast. There are twenty-eight drug master file entries 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
A generic version of OTEZLA was approved as apremilast by ALKEM LABS LTD on September 21st, 2021.
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Summary for OTEZLA
| International Patents: | 90 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 85 |
| Clinical Trials: | 50 |
| Patent Applications: | 755 |
| Drug Prices: | Drug price information for OTEZLA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OTEZLA |
| What excipients (inactive ingredients) are in OTEZLA? | OTEZLA excipients list |
| DailyMed Link: | OTEZLA at DailyMed |
Recent Clinical Trials for OTEZLA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Amgen | Early Phase 1 |
| Wake Forest University Health Sciences | Early Phase 1 |
| Robert Micheletti | Phase 2 |
Pharmacology for OTEZLA
| Drug Class | Phosphodiesterase 4 Inhibitor |
| Mechanism of Action | Phosphodiesterase 4 Inhibitors |
Paragraph IV (Patent) Challenges for OTEZLA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| OTEZLA | Tablets | apremilast | 10 mg, 20 mg and 30 mg | 205437 | 11 | 2018-03-22 |
US Patents and Regulatory Information for OTEZLA
OTEZLA is protected by three US patents and seven FDA Regulatory Exclusivities.
Patents protecting OTEZLA
Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
(+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminois- oindoline-1,3-dione:, and methods of synthesis and compositions thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods for the treatment of psoriatic arthritis using apremilast
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting OTEZLA
TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
Exclusivity Expiration: ⤷ Sign Up
REVISIONS TO THE LABELING TO INCLUDE DATA FOR SUBJECTS WITH MILD TO MODERATE PLAQUE PSORIASIS, AND TO ALLOW FOR AN EXPANSION OF THE INDICATION
Exclusivity Expiration: ⤷ Sign Up
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
CLINICAL STUDY INFORMATION ADDED TO THE LABEL ABOUT THE TREATMENT OF MODERATE TO SEVERE GENITAL PSORIASIS
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for OTEZLA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for OTEZLA
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Amgen Europe BV | Otezla | apremilast | EMEA/H/C/003746 Psoriatic arthritisOtezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.PsoriasisOtezla is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA). |
Authorised | no | no | no | 2015-01-15 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for OTEZLA
See the table below for patents covering OTEZLA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 101683334 | (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione: methods of using and compositions thereof | ⤷ Sign Up |
| Hungary | S1900032 | ⤷ Sign Up | |
| Australia | 2014235273 | Treatment of psoriatic arthritis using apremilast | ⤷ Sign Up |
| Spain | 2742729 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OTEZLA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2962690 | C 2019 032 | Romania | ⤷ Sign Up | PRODUCT NAME: APREMILAST SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/14/981; DATE OF NATIONAL AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/981; DATE OF FIRST AUTHORISATION IN EEA: 20150115 |
| 2962690 | CA 2019 00033 | Denmark | ⤷ Sign Up | PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116 |
| 2962690 | SPC/GB19/045 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/14/981/001(NI) 20150116; UK EU/1/14/981/002(NI) 20150116; UK EU/1/14/981/003(NI) 20150116; UK PLGB 50412/0006 20150116; UK PLGB 50412/0007 20150116 |
| 2962690 | LUC00125 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/14/981 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. 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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