Tretinoin - Generic Drug Details
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What are the generic sources for tretinoin and what is the scope of freedom to operate?
Tretinoin
is the generic ingredient in ten branded drugs marketed by Anchen Pharms, Barr Labs Inc, Glenmark Pharms Ltd, Cheplapharm, Mylan Pharms Inc, Valeant Pharms North, Bausch, Valeant Bermuda, Allergan, Padagis Us, Taro, Zo Skin Health, Dow Pharm, Mylan, Valeant Intl, Encube, Teva Pharms, and Wockhardt, and is included in thirty-four NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Tretinoin has six patent family members in six countries.
There are twenty-six drug master file entries for tretinoin. Twenty-two suppliers are listed for this compound.
Summary for tretinoin
International Patents: | 6 |
US Patents: | 2 |
Tradenames: | 10 |
Applicants: | 18 |
NDAs: | 34 |
Drug Master File Entries: | 26 |
Finished Product Suppliers / Packagers: | 22 |
Raw Ingredient (Bulk) Api Vendors: | 140 |
Clinical Trials: | 117 |
Patent Applications: | 6,020 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for tretinoin |
Drug Sales Revenues: | Drug sales revenues for tretinoin |
What excipients (inactive ingredients) are in tretinoin? | tretinoin excipients list |
DailyMed Link: | tretinoin at DailyMed |
Recent Clinical Trials for tretinoin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Montefiore Medical Center | N/A |
Merete Haedersdal | Phase 2 |
University Hospital Inselspital, Berne | N/A |
Pharmacology for tretinoin
Drug Class | Retinoid |
Medical Subject Heading (MeSH) Categories for tretinoin
Paragraph IV (Patent) Challenges for TRETINOIN
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
RETIN-A-MICRO | Gel | tretinoin | 0.04% | 020475 | 1 | 2010-12-20 |
RETIN-A-MICRO | Gel | tretinoin | 0.1% | 020475 | 1 | 2010-07-08 |
US Patents and Regulatory Information for tretinoin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Padagis Us | TRETINOIN | tretinoin | GEL;TOPICAL | 075589-001 | Jun 11, 2002 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Bausch | RETIN-A-MICRO | tretinoin | GEL;TOPICAL | 020475-004 | Oct 23, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Padagis Us | TRETINOIN | tretinoin | CREAM;TOPICAL | 075264-001 | Dec 24, 1998 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Valeant Pharms North | RENOVA | tretinoin | CREAM;TOPICAL | 019963-001 | Dec 29, 1995 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Padagis Us | TRETINOIN | tretinoin | CREAM;TOPICAL | 075265-001 | Dec 24, 1998 | AB1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mylan | AVITA | tretinoin | GEL;TOPICAL | 020400-001 | Jan 29, 1998 | DISCN | No | No | ⤷ 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 tretinoin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bausch | RETIN-A MICRO | tretinoin | GEL;TOPICAL | 020475-001 | Feb 7, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Bausch | RETIN-A MICRO | tretinoin | GEL;TOPICAL | 020475-001 | Feb 7, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Valeant Pharms North | RENOVA | tretinoin | CREAM;TOPICAL | 019963-001 | Dec 29, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Valeant Pharms North | RENOVA | tretinoin | CREAM;TOPICAL | 019963-001 | Dec 29, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Valeant Pharms North | RENOVA | tretinoin | CREAM;TOPICAL | 021108-001 | Aug 31, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Bausch | RETIN-A-MICRO | tretinoin | GEL;TOPICAL | 020475-003 | Jan 28, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for tretinoin
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 2020010381 | COMPOSICIONES FARMACÉUTICAS TÓPICAS PARA TRATAR ENFERMEDADES CUTÁNEAS. (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS.) | ⤷ Try a Trial |
Brazil | 112020020431 | composições farmacêuticas tópicas para tratamento de condições de pele | ⤷ Try a Trial |
European Patent Office | 3773641 | COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINÉES À TRAITER DES AFFECTIONS CUTANÉES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS) | ⤷ Try a Trial |
Argentina | 114730 | COMPOSICIONES FARMACÉUTICAS TÓPICAS PARA TRATAR CONDICIONES EN LA PIEL, KIT Y MÉTODO DE TRATAMIENTO | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2019195697 | ⤷ Try a Trial | |
Canada | 3095937 | COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINEES A TRAITER DES AFFECTIONS CUTANEES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for tretinoin
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1304992 | 122013000081 | Germany | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322 |
1304992 | CR 2013 00053 | Denmark | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322 |
1304992 | 2013C/060 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506 |
0617614 | C300043 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011 |
1304992 | PA2013025 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323 |
1304992 | SPC/GB13/061 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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