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Adapalene; benzoyl peroxide - Generic Drug Details
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What are the generic sources for adapalene; benzoyl peroxide and what is the scope of patent protection?
Adapalene; benzoyl peroxide
is the generic ingredient in three branded drugs marketed by Actavis Mid Atlantic, Glenmark Pharms Ltd, Perrigo Uk Finco, Taro, Tolmar, Galderma Labs Lp, and Galderma Labs, and is included in eight NDAs. There are sixteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Adapalene; benzoyl peroxide has one hundred and twenty-two patent family members in twenty-seven countries.
There are twelve drug master file entries for adapalene; benzoyl peroxide. Six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for adapalene; benzoyl peroxide
| International Patents: | 122 |
| US Patents: | 16 |
| Tradenames: | 3 |
| Applicants: | 7 |
| NDAs: | 8 |
| Drug Master File Entries: | 12 |
| Suppliers / Packagers: | 6 |
| Clinical Trials: | 38 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for adapalene; benzoyl peroxide |
| DailyMed Link: | adapalene; benzoyl peroxide at DailyMed |
Recent Clinical Trials for adapalene; benzoyl peroxide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mahidol University | Phase 2 |
| Beiersdorf | Phase 2 |
| New York University School of Medicine | N/A |
Generic filers with tentative approvals for ADAPALENE; BENZOYL PEROXIDE
| 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; benzoyl peroxide
| Drug Class | Retinoid |
Paragraph IV (Patent) Challenges for ADAPALENE; BENZOYL PEROXIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| EPIDUO FORTE | GEL;TOPICAL | adapalene; benzoyl peroxide | 207917 | 2016-05-04 |
| EPIDUO | GEL;TOPICAL | adapalene; benzoyl peroxide | 022320 | 2011-12-30 |
US Patents and Regulatory Information for adapalene; benzoyl peroxide
| 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 | Y | 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 | 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 | EPIDUO FORTE | adapalene; benzoyl peroxide | GEL;TOPICAL | 207917-001 | Jul 15, 2015 | AB | RX | Yes | Yes | Start Trial | Start Trial | 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; benzoyl peroxide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | Start Trial | Start Trial |
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for adapalene; benzoyl peroxide
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hungary | 230439 | Start Trial |
| Slovenia | 2114392 | Start Trial |
| Russian Federation | 2009104949 | Start Trial |
| Germany | 60325379 | Start Trial |
| World Intellectual Property Organization (WIPO) | 03055472 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for adapalene; benzoyl peroxide
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1458369 | SPC/GB10/005 | United Kingdom | Start Trial | PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111 |
| 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 | SZ 31/2008 | Austria | Start Trial | PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID |
| 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 | 122008000041 | Germany | Start Trial | PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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