DrugPatentWatch Database Preview
ADAPALENE - Generic Drug Details
» See Plans and Pricing
What are the generic drug sources for adapalene and what is the scope of patent protection?
Adapalene
is the generic ingredient in five branded drugs marketed by Fougera Pharms, Galderma Labs Lp, Actavis Mid Atlantic, Aleor Dermaceuticals, Glenmark Generics, P And L, Taro, Tolmar, Call Inc, Glenmark Pharms Ltd, Perrigo Uk Finco, and Galderma Labs, and is included in twenty-two 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-five patent family members in twenty-two countries.
There are twelve drug master file entries for adapalene. Twenty-one suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for ADAPALENE
International Patents: | 55 |
US Patents: | 24 |
Tradenames: | 5 |
Applicants: | 12 |
NDAs: | 22 |
Drug Master File Entries: | 12 |
Suppliers / Packagers: | 21 |
Bulk Api Vendors: | 125 |
Clinical Trials: | 70 |
Patent Applications: | 6,212 |
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 |
---|---|
Aurobindo Pharma Ltd | Phase 3 |
Assiut University | Phase 4 |
Foamix Ltd. | Phase 2 |
Generic filers with tentative approvals for ADAPALENE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 0.3%;2.5% | GEL; TOPICAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for ADAPALENE
Drug Class | Retinoid |
Medical Subject Heading (MeSH) Categories 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 | EPIDUO FORTE | adapalene; benzoyl peroxide | GEL;TOPICAL | 207917-001 | Jul 15, 2015 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Galderma Labs Lp | DIFFERIN | adapalene | SOLUTION;TOPICAL | 020338-001 | May 31, 1996 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Galderma Labs | EPIDUO FORTE | adapalene; benzoyl peroxide | GEL;TOPICAL | 207917-001 | Jul 15, 2015 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
Call Inc | ADAPALENE | adapalene | SOLUTION;TOPICAL | 204593-001 | Jan 5, 2016 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Galderma Labs | EPIDUO FORTE | adapalene; benzoyl peroxide | GEL;TOPICAL | 207917-001 | Jul 15, 2015 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 ADAPALENE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Galderma Labs Lp | DIFFERIN | adapalene | SOLUTION;TOPICAL | 020338-001 | May 31, 1996 | Start Trial | Start Trial |
Galderma Labs Lp | DIFFERIN | adapalene | CREAM;TOPICAL | 020748-001 | May 26, 2000 | Start Trial | Start Trial |
Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | Start Trial | Start Trial |
Galderma Labs Lp | DIFFERIN | adapalene | SOLUTION;TOPICAL | 020338-001 | May 31, 1996 | Start Trial | Start Trial |
Galderma Labs Lp | DIFFERIN | adapalene | CREAM;TOPICAL | 020748-001 | May 26, 2000 | Start Trial | Start Trial |
Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ADAPALENE
Country | Patent Number | Estimated Expiration |
---|---|---|
Russian Federation | 2377981 | Start Trial |
European Patent Office | 1933827 | Start Trial |
Slovenia | 1485080 | Start Trial |
Poland | 372317 | Start Trial |
Japan | 2009508843 | Start Trial |
South Korea | 20080050579 | Start Trial |
European Patent Office | 1485080 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ADAPALENE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1458369 | 132008901685368 | Italy | Start Trial | 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 | Start Trial | PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218 |
1458369 | SPC/GB10/005 | United Kingdom | Start Trial | PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:






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.