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Clindamycin phosphate; tretinoin - Generic Drug Details

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Clindamycin phosphate; tretinoin is the generic ingredient in three branded drugs marketed by Medicis, Aqua Pharms Llc, and Actavis Mid Atlantic, 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.

This ingredient has twenty-seven patent family members in twenty-two countries.

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

Summary for Generic Name: clindamycin phosphate; tretinoin

Tradenames:3
Patents:1
Applicants:3
NDAs:3
Drug Master File Entries: see list52
Suppliers / Packaging: see list4
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: clindamycin phosphate; tretinoin

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aqua Pharms Llc
VELTIN
clindamycin phosphate; tretinoin
GEL;TOPICAL050803-001Jul 16, 2010RXYes► subscribe► subscribe
Actavis Mid Atlantic
CLINDAMYCIN PHOSPHATE AND TRETINOIN
clindamycin phosphate; tretinoin
GEL;TOPICAL202564-001Jun 12, 2015RXNo► subscribe► subscribe
Medicis
ZIANA
clindamycin phosphate; tretinoin
GEL;TOPICAL050802-001Nov 7, 2006RXYes6,387,383► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: clindamycin phosphate; tretinoin

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medicis
ZIANA
clindamycin phosphate; tretinoin
GEL;TOPICAL050802-001Nov 7, 20065,721,275► subscribe
Aqua Pharms Llc
VELTIN
clindamycin phosphate; tretinoin
GEL;TOPICAL050803-001Jul 16, 20105,690,923► subscribe
Medicis
ZIANA
clindamycin phosphate; tretinoin
GEL;TOPICAL050802-001Nov 7, 2006RE41134► subscribe
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Non-Orange Book Patents for Generic Ingredient: 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► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: clindamycin phosphate; tretinoin

Country Document Number Estimated Expiration
Austria429922► subscribe
Spain2437321► subscribe
Denmark2052714► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: CLINDAMYCIN PHOSPHATE; TRETINOIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013025,C1304992Lithuania► subscribePRODUCT 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
401Luxembourg► subscribePRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
2013025Lithuania► subscribePRODUCT 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
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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 verifification 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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