Clindamycin phosphate - Generic Drug Details
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What are the generic sources for clindamycin phosphate and what is the scope of freedom to operate?
Clindamycin phosphate
is the generic ingredient in eighteen branded drugs marketed by Glenmark Pharms Ltd, Padagis Israel, Taro, Mylan, Pfizer, Fougera Pharms, Padagis Us, Bausch, Amneal, Encube, 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, 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 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. Thirty suppliers are listed for this compound.
Summary for clindamycin phosphate
International Patents: | 64 |
US Patents: | 4 |
Tradenames: | 18 |
Applicants: | 45 |
NDAs: | 90 |
Drug Master File Entries: | 25 |
Finished Product Suppliers / Packagers: | 30 |
Raw Ingredient (Bulk) Api Vendors: | 58 |
Clinical Trials: | 30 |
Patent Applications: | 3,861 |
Formulation / Manufacturing: | see details |
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 |
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 |
Pharmacology for clindamycin phosphate
Drug Class | Lincosamide Antibacterial |
Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Anatomical Therapeutic Chemical (ATC) Classes for clindamycin phosphate
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sandoz Inc | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | clindamycin phosphate | INJECTABLE;INJECTION | 201692-003 | May 31, 2012 | AP | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sagent Pharms Inc | CLINDAMYCIN PHOSPHATE | clindamycin phosphate | INJECTABLE;INJECTION | 090108-001 | Sep 30, 2011 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Abbott Labs | CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER | clindamycin phosphate | INJECTABLE;INJECTION | 065027-001 | Jun 29, 2001 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Pfizer | CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER | clindamycin phosphate | INJECTABLE;INJECTION | 050639-001 | Aug 30, 1989 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novast Labs | CLINDAMYCIN PHOSPHATE | clindamycin phosphate | SOLUTION;TOPICAL | 064108-001 | Sep 27, 1996 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Encube | CLINDAMYCIN PHOSPHATE | clindamycin phosphate | LOTION;TOPICAL | 215607-001 | Jan 18, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | CLEOCIN | clindamycin phosphate | SUPPOSITORY;VAGINAL | 050767-001 | Aug 13, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Padagis Us | CLINDESSE | clindamycin phosphate | CREAM;VAGINAL | 050793-001 | Nov 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Mylan | EVOCLIN | clindamycin phosphate | AEROSOL, FOAM;TOPICAL | 050801-001 | Oct 22, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Bausch | CLINDAGEL | clindamycin phosphate | GEL;TOPICAL | 050782-001 | Nov 27, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Padagis Us | CLINDESSE | clindamycin phosphate | CREAM;VAGINAL | 050793-001 | Nov 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Padagis Us | CLINDESSE | clindamycin phosphate | CREAM;VAGINAL | 050793-001 | Nov 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for clindamycin phosphate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
New Zealand | 541526 | Clindamycin phosphate foam | ⤷ Try a Trial |
Eurasian Patent Organization | 014372 | ПЕНА НА ОСНОВЕ ФОСФАТА КЛИНДАМИЦИНА (CLINDAMYCIN PHOSPHATE FOAM) | ⤷ Try a Trial |
Japan | 2007505927 | ⤷ Try a Trial | |
Serbia | 20050557 | KLINDAMICIN FOSFAT U OBLIKU PENE (CLINDAMYCIN PHOSPHATE FOAM) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2005027807 | ⤷ Try a Trial | |
Japan | 2009522361 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for clindamycin phosphate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1304992 | C300617 | Netherlands | ⤷ Try a Trial | 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 | C01304992/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014 |
1304992 | 2013/044 | Ireland | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322 |
1304992 | 2013C/060 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506 |
1304992 | 92401 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE |
1304992 | 122013000081 | Germany | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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