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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Baxter
Farmers Insurance
Fuji
Federal Trade Commission
Healthtrust
QuintilesIMS
Covington
AstraZeneca

Generated: July 17, 2018

DrugPatentWatch Database Preview

Clindamycin phosphate; tretinoin - Generic Drug Details

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What are the generic sources for clindamycin phosphate; tretinoin and what is the scope of clindamycin phosphate; tretinoin patent protection?

Clindamycin phosphate; tretinoin
is the generic ingredient in three branded drugs marketed by Actavis Mid Atlantic, Aqua Pharms Llc, and Medicis, and is included in three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Clindamycin phosphate; tretinoin has thirty-four patent family members in twenty-two countries.

There are fifty-five drug master file entries for clindamycin phosphate; tretinoin. Four suppliers are listed for this compound.
Summary for clindamycin phosphate; tretinoin
Pharmacology for clindamycin phosphate; tretinoin

US Patents and Regulatory Information for clindamycin phosphate; tretinoin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aqua Pharms Llc VELTIN clindamycin phosphate; tretinoin GEL;TOPICAL 050803-001 Jul 16, 2010 BX RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Mid Atlantic CLINDAMYCIN PHOSPHATE AND TRETINOIN clindamycin phosphate; tretinoin GEL;TOPICAL 202564-001 Jun 12, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Medicis ZIANA clindamycin phosphate; tretinoin GEL;TOPICAL 050802-001 Nov 7, 2006 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for clindamycin phosphate; tretinoin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Aqua Pharms Llc VELTIN clindamycin phosphate; tretinoin GEL;TOPICAL 050803-001 Jul 16, 2010 ➤ Sign Up ➤ Sign Up
Medicis ZIANA clindamycin phosphate; tretinoin GEL;TOPICAL 050802-001 Nov 7, 2006 ➤ Sign Up ➤ Sign Up
Medicis ZIANA clindamycin phosphate; tretinoin GEL;TOPICAL 050802-001 Nov 7, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for clindamycin phosphate; tretinoin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,517,847 Topical gel delivery system ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for clindamycin phosphate; tretinoin

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013025 Lithuania ➤ Sign Up 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
13/044 Ireland ➤ Sign Up PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
2013 00053 Denmark ➤ Sign Up PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
2013025,C1304992 Lithuania ➤ Sign Up PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Healthtrust
Argus Health
Cantor Fitzgerald
UBS
US Army
Merck
Daiichi Sankyo
Federal Trade Commission

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