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DIFFERIN Drug Profile
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» See Plans and PricingWhich patents cover Differin, and when can generic versions of Differin launch?
Differin is a drug marketed by Galderma Labs Lp and is included in five NDAs. There are nine patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-five patent family members in twenty-two countries.
The generic ingredient in DIFFERIN is adapalene. There are twelve drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the adapalene profile page.
US ANDA Litigation and Generic Entry Outlook for Differin
A generic version of DIFFERIN was approved as adapalene by P AND L on June 2nd, 2010.
Summary for DIFFERIN
| International Patents: | 55 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 5 |
| Suppliers / Packagers: | 5 |
| Bulk Api Vendors: | 115 |
| Clinical Trials: | 20 |
| Patent Applications: | 2,409 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DIFFERIN |
| Drug Sales Revenues: | Drug sales revenues for DIFFERIN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DIFFERIN |
| DailyMed Link: | DIFFERIN at DailyMed |
Recent Clinical Trials for DIFFERIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Aurobindo Pharma Ltd | Phase 3 |
| Aleor Dermaceuticals Limited | Phase 3 |
| Catawba Research, LLC | Phase 3 |
Pharmacology for DIFFERIN
| Drug Class | Retinoid |
US Patents and Regulatory Information for DIFFERIN
| 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 | CREAM;TOPICAL | 020748-001 | May 26, 2000 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | 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 Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | 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 DIFFERIN
| 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 | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DIFFERIN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Greece | 860948 | Start Trial |
| Russian Federation | 2004130308 | Start Trial |
| Australia | 4796190 | Start Trial |
| Denmark | 162286 | Start Trial |
| South Africa | 200405853 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DIFFERIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 0199636 | 300209 | Netherlands | Start Trial | 300209, 20060411, EXPIRES: 20070702 |
| 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 | 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 |
