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 24th, 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 |
Recent Clinical Trials for clindesse
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Watson Laboratories, Inc. | Phase 3 |
Actavis Inc. | Phase 3 |
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
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
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.
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 |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for clindesse
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |