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 are two patents protecting this drug and one Paragraph IV challenge.
This drug has forty-four patent family members in twenty-one countries.
The generic ingredient in CLINDESSE is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Thirty-one 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: | 44 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 49 |
| Clinical Trials: | 1 |
| Patent Applications: | 2,952 |
| 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 |
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 two US patents.
Patents protecting CLINDESSE
Bioadhesive drug delivery system
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING BACTERIAL VAGINOSIS
Pharmaceutical delivery system
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Padagis Us | CLINDESSE | clindamycin phosphate | CREAM;VAGINAL | 050793-001 | Nov 30, 2004 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| >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 | See Plans and Pricing | See Plans and Pricing |
| Padagis Us | CLINDESSE | clindamycin phosphate | CREAM;VAGINAL | 050793-001 | Nov 30, 2004 | See Plans and Pricing | See Plans and Pricing |
| >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 |
|---|---|---|---|
| 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 | See Plans and Pricing |
| European Patent Office | 0977555 | PREPARATIONS PHARMACEUTIQUES ET PROCEDES PERMETTANT DE LES ADMINISTRER LOCALEMENT (PHARMACEUTICAL PREPARATIONS AND METHODS FOR THEIR REGIONAL ADMINISTRATION) | See Plans and Pricing |
| World Intellectual Property Organization (WIPO) | 9832422 | See Plans and Pricing | |
| European Patent Office | 0244405 | VAGINAL DELIVERY SYSTEMS | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CLINDESSE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1304992 | PA2013025,C1304992 | Lithuania | See Plans and Pricing | 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 | 2013/044 | Ireland | See Plans and Pricing | PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322 |
| 1304992 | C300617 | Netherlands | See Plans and Pricing | 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 | See Plans and Pricing | 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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