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CLINDAGEL Drug Profile
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When do Clindagel patents expire, and what generic alternatives are available?
Clindagel is a drug marketed by Bausch and is included in one NDA. There is one patent protecting this drug.
This drug has thirty-four patent family members in twenty-two countries.
The generic ingredient in CLINDAGEL is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
US ANDA Litigation and Generic Entry Outlook for Clindagel
A generic version of CLINDAGEL was approved as clindamycin phosphate by ALVOGEN on July 24th, 1987.
Summary for CLINDAGEL
| International Patents: | 34 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 47 |
| Clinical Trials: | 1 |
| Patent Applications: | 2,724 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CLINDAGEL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CLINDAGEL |
| What excipients (inactive ingredients) are in CLINDAGEL? | CLINDAGEL excipients list |
| DailyMed Link: | CLINDAGEL at DailyMed |
Recent Clinical Trials for CLINDAGEL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Stiefel, a GSK Company | Phase 1 |
| GlaxoSmithKline | Phase 1 |
Pharmacology for CLINDAGEL
| Drug Class | Lincosamide Antibacterial |
| Physiological Effect | Decreased Sebaceous Gland Activity |
US Patents and Regulatory Information for CLINDAGEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch | CLINDAGEL | clindamycin phosphate | GEL;TOPICAL | 050782-001 | Nov 27, 2000 | BT | 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 CLINDAGEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch | CLINDAGEL | clindamycin phosphate | GEL;TOPICAL | 050782-001 | Nov 27, 2000 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CLINDAGEL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1125847 | Start Trial |
| China | 1460013 | Start Trial |
| Spain | 2437321 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0211683 | Start Trial |
| South Korea | 100840169 | Start Trial |
| Germany | 60138549 | Start Trial |
| Slovenia | 1304992 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CLINDAGEL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 132013902214376 | Italy | Start Trial | PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718 |
| 1304992 | C01304992/01 | Switzerland | Start Trial | PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014 |
| 1304992 | 1390049-3 | Sweden | Start Trial | PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322 |
| 1304992 | 474 | Finland | Start Trial | |
| 1304992 | C300617 | Netherlands | Start 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 | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
