CLINDESSE Drug Patent Profile

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When do Clindesse patents expire, and when can generic versions of Clindesse launch?

Clindesse is a drug marketed by Padagis Us and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in CLINDESSE is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Clindesse

A generic version of CLINDESSE was approved as clindamycin phosphate by ALMAJECT on July 24^th, 1987.

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Summary for CLINDESSE

International Patents:	22
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	1
Patent Applications:	2,341
Drug Prices:	Drug price information for CLINDESSE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLINDESSE
What excipients (inactive ingredients) are in CLINDESSE?	CLINDESSE excipients list
DailyMed Link:	CLINDESSE at DailyMed

Drug patent expirations by year for CLINDESSE

Recent Clinical Trials for CLINDESSE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Watson Laboratories, Inc.	Phase 3
Actavis Inc.	Phase 3

See all CLINDESSE clinical trials

Pharmacology for CLINDESSE

Drug Class	Lincosamide Antibacterial
Physiological Effect	Decreased Sebaceous Gland Activity Neuromuscular Blockade

Paragraph IV (Patent) Challenges for CLINDESSE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CLINDESSE	Vaginal Cream	clindamycin phosphate	2%	050793	1	2015-02-05

US Patents and Regulatory Information for CLINDESSE

CLINDESSE is protected by one US patents.

Patents protecting CLINDESSE

Pharmaceutical delivery system
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING BACTERIAL VAGINOSIS

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004		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

Expired US Patents for CLINDESSE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for CLINDESSE

See the table below for patents covering CLINDESSE around the world.

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Country	Patent Number	Title	Estimated Expiration
Brazil	PI0414500	formulação farmacêutica composição para tratar uma infecção vaginal, e, métodos para tratar uma infecção vaginal, para estabilizar uma formulação de clindamicina, para tratar ou prevenir uma recorrência de uma infecção vaginal em uma paciente e para tratar condições vaginais	⤷ Sign Up
Canada	2635992	MEDICAMENT UTILISE PAR VOIE TOPIQUE (MEDICAMENT FOR TOPICAL USE)	⤷ Sign Up
Argentina	039037	UN SISTEMA DE LIBERACION DE UNA DROGA VAGINAL CON UN PH ESENCIALMENTE NEUTRO Y UN METODO PARA TRATAR UNA ENFERMEDAD VAGINAL QUE COMPRENDE DICHO SISTEMA	⤷ Sign Up
Japan	2519029		⤷ Sign Up
Peru	20070974	COMPOSICION FARMACEUTICA QUE COMPRENDE AGENTES DUALES	⤷ Sign Up
China	101045034	Bioadhesive drug delivery system	⤷ Sign Up
Italy	MI20021660	SISTEMA DI SOMMINISTRAZIONE DI FARMACO BIOADESIVO	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CLINDESSE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	122013000081	Germany	⤷ Sign Up	PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992	SPC/GB13/061	United Kingdom	⤷ Sign Up	PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992	2013/044	Ireland	⤷ Sign Up	PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992	PA2013025,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
1304992	2013C/060	Belgium	⤷ Sign Up	PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992	C01304992/01	Switzerland	⤷ Sign Up	PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992	92401	Luxembourg	⤷ Sign Up	PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description