OTEZLA Drug Patent Profile
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When do Otezla patents expire, and when can generic versions of Otezla launch?
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.
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: | 49 |
Patent Applications: | 925 |
Formulation / Manufacturing: | see details |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for OTEZLA
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 | 10 | 2018-03-22 |
US Patents and Regulatory Information for OTEZLA
OTEZLA is protected by five US patents and three FDA Regulatory Exclusivities.
Patents protecting OTEZLA
Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PSORIASIS USING A DOSAGE TITRATION SCHEDULE
Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE USING A DOSAGE TITRATION SCHEDULE
(+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminois- oindoline-1,3-dione:, and methods of synthesis and compositions thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods for the treatment of psoriatic arthritis using apremilast
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PSORIATIC ARTHRITIS USING A DOSAGE TITRATION SCHEDULE
Methods for the treatment of psoriatic arthritis using apremilast
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PSORIATIC ARTHRITIS WITH APREMILAST USING A DOSAGE TITRATION SCHEDULE AND A SECOND ACTIVE AGENT
FDA Regulatory Exclusivity protecting OTEZLA
TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
Exclusivity Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
CLINICAL STUDY INFORMATION ADDED TO THE LABEL ABOUT THE TREATMENT OF MODERATE TO SEVERE GENITAL PSORIASIS
Exclusivity Expiration: ⤷ Try a Trial
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 | 205437-001 | Mar 21, 2014 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 | 205437-001 | Mar 21, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Australia | 756308 | ⤷ Try a Trial | |
Hong Kong | 1103224 | ⤷ Try a Trial | |
Japan | 2015013893 | (+)−2−[1−(3−エトキシ−4−メトキシフェニル)−2−メチルスルホニルエチル]−4−アセチルアミノイソインドリン−1,3−ジオン、その使用方法及び組成物 ((+)-2-[1-(3-ETHOXY-4-METHOXYPHENYL)-2-METHYLSULFONYLETHYL]-4-ACETYLAMINOISOINDOLINE-1,3-DIONE, METHODS OF USING THE SAME, AND COMPOSITIONS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OTEZLA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2962690 | 132019000000096 | Italy | ⤷ Try a Trial | PRODUCT NAME: APREMILAST(OTEZLA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/981, 20150116 |
2962690 | C02962690/01 | Switzerland | ⤷ Try a Trial | VERTRETERLOESCHUNG |
2962690 | 37/2019 | Austria | ⤷ Try a 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 |