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CLINDESSE Drug Profile
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» See Plans and PricingWhen do Clindesse patents expire, and when can generic versions of Clindesse launch?
Clindesse is a drug marketed by Perrigo Pharma Intl 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. Twenty-seven suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
US ANDA Litigation and Generic Entry Outlook for Clindesse
A generic version of CLINDESSE was approved as clindamycin phosphate by ALVOGEN INC on July 24th, 1987.
Summary for CLINDESSE
| International Patents: | 44 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 41 |
| Clinical Trials: | 1 |
| Patent Applications: | 1,273 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CLINDESSE |
| Drug Sales Revenues: | Drug sales revenues for CLINDESSE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CLINDESSE |
| 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 |
Paragraph IV (Patent) Challenges for CLINDESSE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CLINDESSE | CREAM;VAGINAL | clindamycin phosphate | 050793 | 2015-02-05 |
US Patents and Regulatory Information for CLINDESSE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Perrigo Pharma Intl | CLINDESSE | clindamycin phosphate | CREAM;VAGINAL | 050793-001 | Nov 30, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Perrigo Pharma Intl | CLINDESSE | clindamycin phosphate | CREAM;VAGINAL | 050793-001 | Nov 30, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 |
|---|---|---|---|---|---|---|---|
| Perrigo Pharma Intl | CLINDESSE | clindamycin phosphate | CREAM;VAGINAL | 050793-001 | Nov 30, 2004 | Start Trial | Start Trial |
| Perrigo Pharma Intl | CLINDESSE | clindamycin phosphate | CREAM;VAGINAL | 050793-001 | Nov 30, 2004 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CLINDESSE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 102854 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2005027807 | Start Trial |
| Australia | 2004274000 | Start Trial |
| Canada | 2540129 | Start Trial |
| Hungary | 0203102 | Start Trial |
| China | 102048689 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CLINDESSE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1304992 | PA2013025,C1304992 | Lithuania | Start 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 | Start 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 | SPC/GB13/061 | United Kingdom | Start Trial | PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624 |
| 1304992 | 2013/044 | Ireland | Start Trial | PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322 |
| 1304992 | 92401 | Luxembourg | Start Trial | PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE |
| 1304992 | CR 2013 00053 | Denmark | Start Trial | PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
