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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. Thirty-two 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 INC on January 25th, 2020.
Summary for CLINDAGEL
| International Patents: | 34 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 40 |
| Clinical Trials: | 1 |
| Patent Applications: | 1,273 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CLINDAGEL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CLINDAGEL |
| DailyMed Link: | CLINDAGEL at DailyMed |
Recent Clinical Trials for CLINDAGEL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| GlaxoSmithKline | Phase 1 |
| Stiefel, a GSK Company | Phase 1 |
Recent Litigation for CLINDAGEL
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Bayer Healthcare Pharmaceuticals, Inc. v. River's Edge Pharmaceuticals, LLC | 2011-05-19 |
| Medicis Pharmaceutical Corporation v. Actavis Mid Atlantic LLC | 2011-05-11 |
| Medicis Pharmaceutical Corporation v. Acella Pharmaceuticals, LLC | 2010-08-19 |
Pharmacology for CLINDAGEL
| Drug Class | Lincosamide Antibacterial |
| Physiological Effect | Decreased Sebaceous Gland Activity |
Synonyms for CLINDAGEL
| (2S-trans)-Methyl 7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2-pyrrolidinyl)carbonyl]amino]-1-thio-L-threo-.alpha.-D-galacto-octopyranoside 2-(dihydrogen phosphate) |
| [(2R,3R,4S,5R,6R)-6-[(1S,2S)-2-chloro-1-[[(2S,4R)-1-methyl-4-propyl-pyrrolidine-2-carbonyl]amino]propyl]-4,5-dihydroxy-2-methylsulfanyl-tetrahydropyran-3-yl] dihydrogen phosphate |
| [(2R,3R,4S,5R,6R)-6-[(1S,2S)-2-chloro-1-[[(2S,4R)-1-methyl-4-propylpyrrolidine-2-carbonyl]amino]propyl]-4,5-dihydroxy-2-methylsulfanyloxan-3-yl] dihydrogen phosphate |
| [(2R,3R,4S,5R,6R)-6-[(1S,2S)-2-chloro-1-{[(2S,4R)-1-methyl-4-propylpyrrolidin-2-yl]formamido}propyl]-4,5-dihydroxy-2-(methylsulfanyl)oxan-3-yl]oxyphosphonic acid |
| 24729-96-2 |
| 7(S)-Chloro-7-deoxylincomycin 2-phosphate |
| AB01566857_01 |
| AC1L9EKE |
| AKOS008901431 |
| API0002056 |
| AS-12554 |
| AX8019646 |
| BDBM241975 |
| BRD-K27771035-001-02-5 |
| C11728 |
| C18H34ClN2O8PS |
| CAS-24729-96-2 |
| CHEMBL3184512 |
| Cleocin phosphate |
| CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER |
| Cleocin T |
| Clinda-Derm |
| Clindamax |
| Clindamycin (phosphate) |
| Clindamycin 2-dihydrogen phosphate |
| Clindamycin 2-phosphate |
| Clindamycin dihydrogenphosphat |
| Clindamycin injection |
| Clindamycin phosphate |
| Clindamycin phosphate (JP17/USP) |
| Clindamycin phosphate [USAN:JAN] |
| Clindamycin phosphate [USAN:USP:JAN] |
| CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% |
| CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER |
| Clindamycin-2-dihydrogenphosphat |
| CLINDAMYCIN-2-PHOSPHATE |
| Clindesse |
| Clindets |
| CS-4620 |
| D01073 |
| Dalacin P |
| Dalacin T |
| Dalacin-S (TN) |
| DSSTox_CID_28603 |
| DSSTox_GSID_48677 |
| DSSTox_RID_82873 |
| DTXSID1048677 |
| EH6D7113I8 |
| EINECS 246-433-0 |
| Evoclin (TN) |
| HY-B1064 |
| L-threo-alpha-D-galacto-Octapyranoside, methyl 7-chloro-6,7,8-trideoxy-6-(((1-methyl-4-propyl-2-pyrrolidinyl)carbonyl)amino)-1-thio-, 2-(dihydrogen phosphate), (2S-trans)- |
| L-threo-alpha-D-galacto-Octopyranoside, methyl 7-chloro-6,7,8-trideoxy-6-(((1-methyl-4-propyl-2-pyrrolidinyl)carbonyl)amino)-1-thio-, 2-(dihydrogen phosphate), (2S-trans)- |
| LS-98133 |
| Methyl (2S-trans)-7-chloro-6,7,8-trideoxy-6-(((1-methyl-4-propyl-2-pyrrolidinyl)carbonyl)amino)-1-thio-L-threo-alpha-D-galacto-octopyranoside, 2-(dihydrogen phosphate) |
| Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2- pyrrolidinecarboxamido)-1-thio-L-threo-alpha-D-galacto-octopyranoside 2-(dihydrogen phosphate) |
| Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-alpha-D-galacto-octopyranoside 2-(dihydrogen phosphate) |
| MFCD07793328 |
| MolPort-015-163-859 |
| NCGC00163494-01 |
| NCGC00166320-01 |
| NCGC00386379-01 |
| PubChem5913 |
| s2048 |
| SCHEMBL37148 |
| SR-01000872581 |
| SR-01000872581-1 |
| ST24046358 |
| Tox21_113055 |
| Tox21_113410 |
| U 28508 |
| U-28,508 |
| U-28508 |
| UFUVLHLTWXBHGZ-MGZQPHGTSA-N |
| UNII-EH6D7113I8 |
| ZINC4102185 |
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 |
International Patents for CLINDAGEL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 2052714 | Start Trial |
| Brazil | 0113247 | Start Trial |
| Argentina | 030093 | Start Trial |
| Spain | 2326955 | Start Trial |
| European Patent Office | 2052714 | Start Trial |
| China | 101305982 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CLINDAGEL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 2013C/060 | Belgium | Start Trial | PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506 |
| 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 | C01304992/01 | Switzerland | Start Trial | PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014 |
| 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 | PA2013025 | Lithuania | Start Trial | PRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
