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Clindamycin phosphate - Generic Drug Details

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Clindamycin phosphate is the generic ingredient in sixteen branded drugs marketed by Alvogen Inc, Watson Labs, Pharmacia And Upjohn, Delcor Asset Corp, Wockhardt, Loch, Eurohlth Intl Sarl, West-ward Pharms Int, Bristol Myers Squibb, Sagent Pharms, Ingenus Pharms Llc, Sagent Strides, G And W Labs Inc, Marsam Pharms Llc, Versapharm, Solopak, Abbvie, Igi Labs Inc, Paddock Llc, Vintage Pharms, Abraxis Pharm, Perrigo, Fougera Pharms, Teva Parenteral, Boca Pharma Llc, Fresenius Kabi Usa, Akorn Inc, Baxter Hlthcare, Perrigo New York, Fougera, Bedford, Precision Dermat, Taro Pharm Inds, Perrigo Uk Finco, Sandoz Inc, Perrigo Pharma Intl, Medicis, Aqua Pharms Llc, and Actavis Mid Atlantic, and is included in sixty-four NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and ten patent family members in thirty-six countries.

There are fifty-two drug master file entries for clindamycin phosphate. Thirty-one suppliers are listed for this compound.

Summary for Generic Name: clindamycin phosphate

Tradenames:16
Patents:6
Applicants:39
NDAs:64
Drug Master File Entries: see list52
Suppliers / Packaging: see list31
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: clindamycin phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn
CLEOCIN T
clindamycin phosphate
GEL;TOPICAL050615-001Jan 7, 1987RXYes► subscribe► subscribe
Marsam Pharms Llc
CLINDAMYCIN PHOSPHATE
clindamycin phosphate
INJECTABLE;INJECTION062913-001Oct 20, 1988DISCNNo► subscribe► subscribe
Pharmacia And Upjohn
CLEOCIN
clindamycin phosphate
SUPPOSITORY;VAGINAL050767-001Aug 13, 1999RXYes6,495,157► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: clindamycin phosphate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Perrigo Pharma Intl
CLINDESSE
clindamycin phosphate
CREAM;VAGINAL050793-001Nov 30, 20045,266,329► subscribe
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Non-Orange Book Patents for Generic Ingredient: clindamycin phosphate

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
8,586,008Pharmaceutical foam► subscribe
6,416,778 Pharmaceutical preparations and methods for their regional administration► subscribe
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

Country Document Number Estimated Expiration
Austria429922► subscribe
World Intellectual Property Organization (WIPO)9832422► subscribe
Canada2378572► 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
401Luxembourg► subscribePRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
90049-3Sweden► subscribePRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
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
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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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