CLINDESSE Drug Patent Profile
✉ Email this page to a colleague
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-three 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: | 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 two US patents.
Patents protecting CLINDESSE
Bioadhesive drug delivery system
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING BACTERIAL VAGINOSIS
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 | |||
| 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 |
|---|---|---|---|
| Russian Federation | 2320322 | БИОАДГЕЗИВНАЯ СИСТЕМА ДОСТАВКИ ЛЕКАРСТВ (BIOADHESIVE SYSTEM FOR DELIVERING MEDICINAL PREPARATIONS) | ⤷ Try a Trial |
| Portugal | 977555 | ⤷ Try a Trial | |
| Australia | 5922798 | ⤷ Try a Trial | |
| Canada | 2278541 | PREPARATIONS PHARMACEUTIQUES ET PROCEDES PERMETTANT DE LES ADMINISTRER LOCALEMENT (PHARMACEUTICAL PREPARATIONS AND METHODS FOR THEIR REGIONAL ADMINISTRATION) | ⤷ Try a Trial |
| Japan | S63501563 | ⤷ Try a Trial | |
| Australia | 2006332519 | 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 | 2013C/060 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506 |
| 1304992 | C01304992/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014 |
| 1304992 | 92401 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE |
| 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 | 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 | 2013/044 | Ireland | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2023 - 2024
NCE-1 Patent Challenge Dates 2023 - 2024
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - HIPAA-ready chat for life sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
