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Last Updated: October 26, 2021

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TRETINOIN - Generic Drug Details

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What are the generic drug sources for tretinoin and what is the scope of freedom to operate?

Tretinoin is the generic ingredient in nine branded drugs marketed by Anchen Pharms, Barr Labs Inc, Glenmark Pharms Ltd, Cheplapharm, Mylan Pharms Inc, Valeant Pharms North, Valeant Bermuda, Allergan, Padagis Us, Taro Pharms, Zo Skin Health, Dow Pharm, Mylan, Valeant Intl, Teva Pharms, and Wockhardt, and is included in thirty-two NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tretinoin has five patent family members in five countries.

There are twenty-six drug master file entries for tretinoin. Nineteen suppliers are listed for this compound.

Drug Prices for TRETINOIN

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Drug Sales Revenue Trends for TRETINOIN

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Recent Clinical Trials for TRETINOIN

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SponsorPhase
Dr.dr.Irma Bernadette, SpKK (K)N/A
Dwight OwenPhase 1
Medical Research CouncilPhase 2

See all TRETINOIN clinical trials

Pharmacology for TRETINOIN
Drug ClassRetinoid
Medical Subject Heading (MeSH) Categories for TRETINOIN
Paragraph IV (Patent) Challenges for TRETINOIN
Tradename Dosage Ingredient NDA Submissiondate
RETIN-A-MICRO GEL;TOPICAL tretinoin 020475 2010-12-20
RETIN-A MICRO GEL;TOPICAL tretinoin 020475 2010-12-20
RETIN-A-MICRO GEL;TOPICAL tretinoin 020475 2010-07-08
RETIN-A MICRO GEL;TOPICAL tretinoin 020475 2010-07-08
RETIN-A GEL;TOPICAL tretinoin 017579

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 075529-001 Feb 22, 2000 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan AVITA tretinoin GEL;TOPICAL 020400-001 Jan 29, 1998 BT RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Valeant Intl RETIN-A tretinoin SWAB;TOPICAL 016921-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan TRETINOIN tretinoin GEL;TOPICAL 207955-001 Aug 13, 2015 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Padagis Us TRETINOIN tretinoin GEL;TOPICAL 075589-001 Jun 11, 2002 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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
Valeant Intl RETIN-A tretinoin GEL;TOPICAL 017579-002 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
Valeant Intl RETIN-A tretinoin GEL;TOPICAL 017955-001 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
Dow Pharm ALTRENO tretinoin LOTION;TOPICAL 209353-001 Aug 23, 2018 ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan Pharms Inc AVITA tretinoin CREAM;TOPICAL 020404-003 Jan 14, 1997 ⤷  Free Forever Trial ⤷  Free Forever Trial
Valeant Intl RETIN-A tretinoin SOLUTION;TOPICAL 016921-001 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for TRETINOIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 C01304992/01 Switzerland ⤷  Free Forever Trial PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992 122013000081 Germany ⤷  Free Forever Trial PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
0617614 C300043 Netherlands ⤷  Free Forever Trial PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
1304992 1390049-3 Sweden ⤷  Free Forever Trial PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
0617614 2001/009 Ireland ⤷  Free Forever Trial PRODUCT NAME: PANRETIN-ALITRETINOIN
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
Baxter
Medtronic
AstraZeneca
McKinsey

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