CLINDAMYCIN PHOSPHATE - Generic Drug Details

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

Clindamycin phosphate is the generic ingredient in eighteen branded drugs marketed by Glenmark Pharms Ltd, Padagis Israel, Taro, Norvium Bioscience, Pfizer, Fougera Pharms, Padagis Us, Bausch, Alembic, Amneal, Encube, Quagen, Solaris Pharma Corp, Zydus Lifesciences, Organon Llc, Pharmacia And Upjohn, Abraxis Pharm, Almaject, Bedford, Bristol Myers Squibb, Fresenius Kabi Usa, Hikma, Igi Labs Inc, Loch, Marsam Pharms Llc, Rising, Sagent Pharms Inc, Solopak, Teva Parenteral, Watson Labs, Baxter Hlthcare Corp, Sandoz Inc, Abbott Labs, Baxter Hlthcare, Boca Pharma Llc, Chartwell Rx, Encube Ethicals, Endo Operations, Fougera Pharms Inc, G And W Labs Inc, Novast Labs, Pai Holdings Pharm, Taro Pharm Inds, Vintage Pharms, Xttrium Labs Inc, Epic Pharma Llc, Actavis Mid Atlantic, and Almirall, and is included in ninety-one NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Clindamycin phosphate has sixty-four patent family members in twenty-five countries.

There are twenty-five drug master file entries for clindamycin phosphate. Twenty-nine suppliers are listed for this compound.

Summary for CLINDAMYCIN PHOSPHATE

International Patents:	64
US Patents:	4
Tradenames:	18
Applicants:	48
NDAs:	91
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	30
Patent Applications:	3,581
Drug Prices:	Drug price trends for CLINDAMYCIN PHOSPHATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLINDAMYCIN PHOSPHATE
What excipients (inactive ingredients) are in CLINDAMYCIN PHOSPHATE?	CLINDAMYCIN PHOSPHATE excipients list
DailyMed Link:	CLINDAMYCIN PHOSPHATE at DailyMed

See drug prices for CLINDAMYCIN PHOSPHATE

Recent Clinical Trials for CLINDAMYCIN PHOSPHATE

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

Sponsor	Phase
Daré Bioscience, Inc.	Phase 1
Memorial Sloan Kettering Cancer Center	Phase 2
Daré Bioscience, Inc.	Phase 3

See all CLINDAMYCIN PHOSPHATE clinical trials

Pharmacology for CLINDAMYCIN PHOSPHATE

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

Paragraph IV (Patent) Challenges for CLINDAMYCIN PHOSPHATE

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 CLINDAMYCIN PHOSPHATE

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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
Pfizer	CLEOCIN	clindamycin phosphate	SWAB;TOPICAL	050537-002	Feb 22, 1994		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006	AB1	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%	clindamycin phosphate	INJECTABLE;INJECTION	214401-002	Apr 5, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Almaject	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	INJECTABLE;INJECTION	062800-001	Jul 24, 1987	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	INJECTABLE;INJECTION	063079-001	Mar 5, 1990		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	GEL;TOPICAL	214668-001	Aug 5, 2022	AB2	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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 CLINDAMYCIN PHOSPHATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norvium Bioscience	EVOCLIN	clindamycin phosphate	AEROSOL, FOAM;TOPICAL	050801-001	Oct 22, 2004	⤷ Sign Up	⤷ Sign Up
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Bausch	CLINDAGEL	clindamycin phosphate	GEL;TOPICAL	050782-001	Nov 27, 2000	⤷ Sign Up	⤷ Sign Up
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Pfizer	CLEOCIN	clindamycin phosphate	SUPPOSITORY;VAGINAL	050767-001	Aug 13, 1999	⤷ 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 CLINDAMYCIN PHOSPHATE

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Country	Patent Number	Title	Estimated Expiration
Brazil	PI0620905	uso de uma composição farmacêutica, composição farmacêutica e sistema de distribuição antibacteriano e antifúngico vaginal	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2007079390		⤷ Sign Up
Malaysia	144021	PHARMACEUTICAL DELIVERY SYSTEM	⤷ Sign Up
Poland	3324938		⤷ Sign Up
European Patent Office	1968545	MEDICAMENT UTILISE PAR VOIE TOPIQUE (MEDICAMENT FOR TOPICAL USE)	⤷ Sign Up
Japan	2007505927		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CLINDAMYCIN PHOSPHATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	C300617	Netherlands	⤷ Sign Up	PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
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	2013C/060	Belgium	⤷ Sign Up	PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992	2013/044	Ireland	⤷ Sign Up	PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992	CR 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
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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