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CLEOCIN Drug Profile
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Which patents cover Cleocin, and when can generic versions of Cleocin launch?
Cleocin is a drug marketed by Pharmacia And Upjohn and is included in fourteen NDAs. There is one patent protecting this drug.
This drug has twenty-four patent family members in twenty-two countries.
The generic ingredient in CLEOCIN is clindamycin palmitate hydrochloride. There are fifty-five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the clindamycin palmitate hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Cleocin
A generic version of CLEOCIN was approved as clindamycin palmitate hydrochloride by PADDOCK LABS LLC on July 7th, 2010.
Summary for CLEOCIN
| International Patents: | 24 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 14 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 102 |
| Clinical Trials: | 9 |
| Patent Applications: | 1,215 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CLEOCIN |
| What excipients (inactive ingredients) are in CLEOCIN? | CLEOCIN excipients list |
| DailyMed Link: | CLEOCIN at DailyMed |
Recent Clinical Trials for CLEOCIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Roswell Park Cancer Institute | Phase 4 |
| National Cancer Institute (NCI) | Phase 4 |
| Tianjin Medical University Cancer Institute and Hospital | N/A |
Pharmacology for CLEOCIN
| Drug Class | Lincosamide Antibacterial |
| Physiological Effect | Decreased Sebaceous Gland Activity |
US Patents and Regulatory Information for CLEOCIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pharmacia And Upjohn | CLEOCIN | clindamycin hydrochloride | CAPSULE;ORAL | 061809-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Pharmacia And Upjohn | CLEOCIN T | clindamycin phosphate | GEL;TOPICAL | 050615-001 | Jan 7, 1987 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Pharmacia And Upjohn | CLEOCIN | clindamycin phosphate | SUPPOSITORY;VAGINAL | 050767-001 | Aug 13, 1999 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Pharmacia And Upjohn | CLEOCIN | clindamycin phosphate | CREAM;VAGINAL | 050680-002 | Mar 2, 1998 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Pharmacia And Upjohn | CLEOCIN PHOSPHATE | clindamycin phosphate | INJECTABLE;INJECTION | 061839-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | 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 CLEOCIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pharmacia And Upjohn | CLEOCIN | clindamycin phosphate | SUPPOSITORY;VAGINAL | 050767-001 | Aug 13, 1999 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CLEOCIN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| El Salvador | 2001000138 | Start Trial |
| Denmark | 1200065 | Start Trial |
| Slovenia | 1200065 | Start Trial |
| Hong Kong | 1047538 | Start Trial |
| Spain | 2207532 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CLEOCIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1304992 | 2013C/060 | Belgium | Start Trial | PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506 |
| 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 |
| 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 | 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 | 2013/044 | Ireland | Start Trial | PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
