Adapalene - Generic Drug Details
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What are the generic sources for adapalene and what is the scope of freedom to operate?
Adapalene
is the generic ingredient in five branded drugs marketed by Fougera Pharms, Galderma Labs Lp, Actavis Mid Atlantic, Aleor Dermaceuticals, Encube Ethicals, Glenmark Generics, P And L, Taro, Taro Pharms, Call Inc, Actavis Labs Ut Inc, Encube, Glenmark Pharms Ltd, Padagis Israel, Zydus Pharms, and Galderma Labs, and is included in twenty-seven NDAs. There are twenty-four 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. Twenty-six suppliers are listed for this compound.
Summary for adapalene
International Patents: | 56 |
US Patents: | 24 |
Tradenames: | 5 |
Applicants: | 16 |
NDAs: | 27 |
Drug Master File Entries: | 12 |
Finished Product Suppliers / Packagers: | 26 |
Raw Ingredient (Bulk) Api Vendors: | 139 |
Clinical Trials: | 79 |
Patent Applications: | 6,252 |
Formulation / Manufacturing: | see details |
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 |
---|---|
University of Oklahoma | Phase 3 |
Dr.dr.Irma Bernadette, SpKK (K) | Phase 1 |
Jonathan M Towarnicki | Early 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
P And L | ADAPALENE | adapalene | GEL;TOPICAL | 090962-001 | Jun 2, 2010 | OTC | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Glenmark Pharms Ltd | ADAPALENE AND BENZOYL PEROXIDE | adapalene; benzoyl peroxide | GEL;TOPICAL | 208108-001 | Nov 8, 2019 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 | CREAM;TOPICAL | 020748-001 | May 26, 2000 | See Plans and Pricing | See Plans and Pricing |
Galderma Labs Lp | DIFFERIN | adapalene | SOLUTION;TOPICAL | 020338-001 | May 31, 1996 | See Plans and Pricing | See Plans and Pricing |
Galderma Labs Lp | DIFFERIN | adapalene | CREAM;TOPICAL | 020748-001 | May 26, 2000 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for adapalene
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
France | 2890861 | COMPOSITIONS COMPRENANT AU MOINS UN DERIVE DE L'ACIDE NAPHTOIQUE ET AU MOINS UN COMPOSE DE TYPE POLYMERES DE POLYURETHANES OU DES DERIVES DE CELUI-CI, LEURS PROCEDE DE PREPARATION, ET LEUR UTILISATION (Composition, useful to treat and/or prevent e.g. dermatological diseases, acne necrotic, acne neonatorum, comprises naphthoic acid derivative and polyurethane type polymer) | See Plans and Pricing |
Russian Federation | 2008114840 | КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ПО МЕНЬШЕЙ МЕРЕ ОДНО ПРОИЗВОДНОЕ НАФТОЕВОЙ КИСЛОТЫ И ПО МЕНЬШЕЙ МЕРЕ ОДНО СОЕДИНЕНИЕ ТИПА ПОЛИУРЕТАНОВОГО ПОЛИМЕРА ИЛИ ЕГО ПРОИЗВОДНОЕ, СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ | See Plans and Pricing |
Poland | 372317 | Zastosowanie kwasu 6-[3-(1-adamantylo)-4-metoksyfenylo]-2-naftalenokarboksylowego (USE OF ADAPALENE FOR THE TREATMENT OF DERMATOLOGICAL DISORDERS) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for adapalene
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1458369 | 132008901685368 | Italy | See Plans and Pricing | PRODUCT NAME: ADAPALENE E BENZOILE PEROSSIDO(EPIDUO); AUTHORISATION NUMBER(S) AND DATE(S): 40440, 20071218;DA 038261018/M A 038261057/M, 20080618 |
1458369 | SPC/GB10/005 | United Kingdom | See Plans and Pricing | PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111 |
1458369 | 08C0024 | France | See Plans and Pricing | 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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