DIFFERIN Drug Patent Profile
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Which 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-six 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-seven suppliers are listed for this compound. Additional details are available on the adapalene profile page.
DrugPatentWatch® 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: | 56 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 142 |
| Clinical Trials: | 22 |
| Patent Applications: | 5,059 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DIFFERIN |
| Drug Sales Revenues: | Drug sales revenues for DIFFERIN |
| What excipients (inactive ingredients) are in DIFFERIN? | DIFFERIN excipients list |
| DailyMed Link: | DIFFERIN at DailyMed |
Recent Clinical Trials for DIFFERIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bausch Health Americas, Inc. | Early Phase 1 |
| Wake Forest University Health Sciences | Early Phase 1 |
| Aurobindo Pharma Ltd | Phase 3 |
Pharmacology for DIFFERIN
| Drug Class | Retinoid |
Anatomical Therapeutic Chemical (ATC) Classes for DIFFERIN
US Patents and Regulatory Information for DIFFERIN
DIFFERIN is protected by nine US patents.
Patents protecting DIFFERIN
Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS
Pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphtoic acid for the treatment of dermatological disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACNE
Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACNE
Cosmetic/dermatological compositions comprising naphthoic acid compounds and polyurethane polymers
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACNE
Cosmetic/dermatological compositions comprising naphtholic acid compounds and polyurethane polymers
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACNE
Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACNE
Cosmetic/dermatological compositions comprising naphthoic acid compounds and polyurethane polymers
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACNE
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Galderma Labs Lp | DIFFERIN | adapalene | SOLUTION;TOPICAL | 020338-001 | May 31, 1996 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 020380-002 | Jul 8, 2016 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Galderma Labs Lp | DIFFERIN | adapalene | CREAM;TOPICAL | 020748-001 | May 26, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Galderma Labs Lp | DIFFERIN | adapalene | SOLUTION;TOPICAL | 020338-001 | May 31, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DIFFERIN
See the table below for patents covering DIFFERIN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 60325379 | ⤷ Try a Trial | |
| South Korea | 101007161 | ⤷ Try a Trial | |
| France | 2837101 | UTILISATION DE L'ACIDE 6-[1-ADAMANTYL)-4-METHOXYPHENYL]-2- NAPHTHOIQUE POUR LE TRAITEMENT DE DESORDRES DERMATOLOGIQUES | ⤷ Try a Trial |
| Russian Federation | 2421216 | 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 (COMPOSITIONS CONTAINING AT LEAST ONE NAPHTHOIC ACID DERIVATIVE AND AT LEAST ONE COMPOUND OF POLYURETHANE POLYMER OR ITS DERIVATIVE, METHODS OF PRODUCING AND APPLYING THEREOF) | ⤷ Try a Trial |
| Denmark | 172070 | ⤷ Try a Trial | |
| Australia | 638223 | ⤷ Try a Trial | |
| Japan | H0830015 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DIFFERIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1458369 | SPC/GB10/005 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111 |
| 1458369 | 08C0024 | France | ⤷ Try a 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 | ⤷ Try a Trial | 300209, 20060411, EXPIRES: 20070702 |
| 1458369 | 132008901685368 | Italy | ⤷ Try a Trial | PRODUCT NAME: ADAPALENE E BENZOILE PEROSSIDO(EPIDUO); AUTHORISATION NUMBER(S) AND DATE(S): 40440, 20071218;DA 038261018/M A 038261057/M, 20080618 |
| >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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