ADAPALENE - Generic Drug Details
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What are the generic drug sources for adapalene and what is the scope of patent protection?
Adapalene
is the generic ingredient in six branded drugs marketed by Fougera Pharms, Galderma Labs Lp, Actavis Mid Atlantic, Alembic, Encube Ethicals, Glenmark Pharms Inc, P And L, Taro, Call Inc, Actavis Labs Ut Inc, Encube, Glenmark Pharms Ltd, Padagis Israel, Zydus Pharms, Galderma Labs, and Bausch, and is included in twenty-eight NDAs. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Adapalene has fifty-six patent family members in twenty-two countries.
There are twelve drug master file entries for adapalene. Forty suppliers are listed for this compound.
Summary for ADAPALENE
International Patents: | 56 |
US Patents: | 15 |
Tradenames: | 6 |
Applicants: | 16 |
NDAs: | 28 |
Drug Master File Entries: | 12 |
Finished Product Suppliers / Packagers: | 40 |
Raw Ingredient (Bulk) Api Vendors: | 142 |
Clinical Trials: | 82 |
Drug Prices: | Drug price trends 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 |
---|---|
HITEC-Institute of Medical Sciences | N/A |
Mansoura University | Phase 2 |
University of Oklahoma | Phase 3 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Galderma Labs Lp | DIFFERIN | adapalene | LOTION;TOPICAL | 022502-001 | Mar 17, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Call Inc | ADAPALENE | adapalene | SOLUTION;TOPICAL | 203981-001 | Sep 23, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Bausch | CABTREO | adapalene; benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 216632-001 | Oct 20, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 ADAPALENE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Galderma Labs Lp | DIFFERIN | adapalene | CREAM;TOPICAL | 020748-001 | May 26, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Galderma Labs Lp | DIFFERIN | adapalene | SOLUTION;TOPICAL | 020338-001 | May 31, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ADAPALENE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 1109307 | ⤷ Sign Up | |
Japan | 5722598 | ⤷ Sign Up | |
Poland | 216763 | ⤷ Sign Up | |
European Patent Office | 1532974 | Composition comprenant de l'acide 6-[3-(1-adamantyl)-4-méthoxyphényl]-2-naphthanoique pour le traitement de troubles dermatologiques (Composition comprising 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ADAPALENE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1458369 | SPC/GB10/005 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111 |
1458369 | 132008901685368 | Italy | ⤷ Sign Up | PRODUCT NAME: ADAPALENE E BENZOILE PEROSSIDO(EPIDUO); AUTHORISATION NUMBER(S) AND DATE(S): 40440, 20071218;DA 038261018/M A 038261057/M, 20080618 |
1458369 | 08C0024 | France | ⤷ Sign Up | PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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