ADAPALENE Drug Patent Profile
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When do Adapalene patents expire, and when can generic versions of Adapalene launch?
Adapalene is a drug marketed by Fougera Pharms, Actavis Mid Atlantic, Alembic, Encube Ethicals, Glenmark Generics, P And L, Taro, Call Inc, Actavis Labs Ut Inc, Encube, Glenmark Pharms Ltd, Padagis Israel, and Zydus Pharms. and is included in twenty NDAs.
The generic ingredient in ADAPALENE is adapalene; benzoyl peroxide. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Adapalene
A generic version of ADAPALENE was approved as adapalene; benzoyl peroxide by PADAGIS ISRAEL on January 23rd, 2018.
Summary for ADAPALENE
| US Patents: | 0 |
| Applicants: | 13 |
| NDAs: | 20 |
| Finished Product Suppliers / Packagers: | 34 |
| Raw Ingredient (Bulk) Api Vendors: | 142 |
| Clinical Trials: | 81 |
| Patent Applications: | 4,663 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ADAPALENE |
| Drug Sales Revenues: | Drug sales revenues for ADAPALENE |
| What excipients (inactive ingredients) are in ADAPALENE? | ADAPALENE excipients list |
| DailyMed Link: | ADAPALENE at DailyMed |
Recent Clinical Trials for ADAPALENE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mansoura University | Phase 2 |
| University of Oklahoma | Phase 3 |
| Dr.dr.Irma Bernadette, SpKK (K) | Phase 1 |
Pharmacology for ADAPALENE
| Drug Class | Retinoid |
Medical Subject Heading (MeSH) Categories for ADAPALENE
Anatomical Therapeutic Chemical (ATC) Classes for ADAPALENE
US Patents and Regulatory Information for ADAPALENE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fougera Pharms | ADAPALENE | adapalene | CREAM;TOPICAL | 090824-001 | Jun 30, 2010 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Taro | ADAPALENE AND BENZOYL PEROXIDE | adapalene; benzoyl peroxide | GEL;TOPICAL | 206959-001 | Jan 24, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Taro | ADAPALENE | adapalene | GEL;TOPICAL | 215940-001 | Jan 14, 2022 | OTC | No | No | ⤷ 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 |
