CLINDESSE Drug Patent Profile
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Which patents cover Clindesse, 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. 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 |
---|---|
Watson Laboratories, Inc. | Phase 3 |
Actavis 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 |
---|---|---|---|
Australia | 5922798 | ⤷ Try a Trial | |
Argentina | 058897 | MEDICAMENTO PARA USO TOPICO | ⤷ Try a Trial |
European Patent Office | 1494630 | SYSTEME BIOADHESIF D'ADMINISTRATION DE MEDICAMENTS (BIOADHESIVE DRUG DELIVERY SYSTEM) | ⤷ Try a Trial |
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 | ⤷ Try a Trial |
Australia | 2003218233 | BIOADHESIVE DRUG DELIVERY SYSTEM | ⤷ Try a Trial |
Japan | 2001511773 | ⤷ Try a Trial | |
Argentina | 047108 | FORMULACION FARMACEUTICA PARA TRATAR AFECCIONES VAGINALES EN HUMANOS, COMPOSICION PARA TRATAR UNA INFECCION VAGINAL Y METODO PARA TRATAR DICHA INFECCION VAGINAL | ⤷ 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 | 2013/044 | Ireland | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322 |
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 | 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 | 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 | 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 |
1304992 | C01304992/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |