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CLINDAGEL Drug Profile

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Clindagel is a drug marketed by Precision Dermat and is included in one NDA. It is available from one supplier. There is one patent protecting this drug.

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

The generic ingredient in CLINDAGEL is clindamycin phosphate. There are fifty-two drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.

Summary for Tradename: CLINDAGEL

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: CLINDAGEL

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Precision Dermat
CLINDAGEL
clindamycin phosphate
GEL;TOPICAL050782-001Nov 27, 2000RXYes6,387,383► subscribeY ► subscribe
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Non-Orange Book Patents for Tradename: CLINDAGEL

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 Tradename: CLINDAGEL

Country Document Number Estimated Expiration
Brazil0113247► subscribe
Argentina030093► subscribe
Australia2001279002► 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: CLINDAGEL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992/01Switzerland► subscribePRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
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
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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