Clindesse Drug Patent Profile
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When do Clindesse patents expire, and what generic alternatives are available?
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. Thirty 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 24th, 1987.
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: | 2,548 |
Formulation / Manufacturing: | see details |
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 |
Recent Clinical Trials for Clindesse
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Actavis Inc. | Phase 3 |
Watson Laboratories, Inc. | Phase 3 |
Pharmacology for Clindesse
Drug Class | Lincosamide Antibacterial |
Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Anatomical Therapeutic Chemical (ATC) Classes for Clindesse
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING BACTERIAL VAGINOSIS
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 Clindesse
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 |
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 Clindesse
See the table below for patents covering Clindesse around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 3584523 | ⤷ Try a Trial | |
European Patent Office | 2316424 | ⤷ Try a Trial | |
Japan | 2003286193 | BIOADHESIVE DRUG DELIVERY SYSTEM | ⤷ Try a Trial |
Portugal | 977555 | ⤷ Try a Trial | |
Eurasian Patent Organization | 200870154 | ЛЕКАРСТВЕННОЕ СРЕДСТВО ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ | ⤷ Try a Trial |
South Korea | 20080091794 | MEDICAMENT FOR TOPICAL USE | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Clindesse
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1304992 | CR 2013 00053 | Denmark | ⤷ Try a Trial | 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 | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624 |
1304992 | 92401 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE |
1304992 | 2013/044 | Ireland | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322 |
1304992 | PA2013025,C1304992 | Lithuania | ⤷ Try a Trial | 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 | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |