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Clobetasol propionate - Generic Drug Details
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What are the generic sources for clobetasol propionate and what is the scope of freedom to operate?
Clobetasol propionate
is the generic ingredient in eleven branded drugs marketed by Glenmark Pharms Ltd, Ingenus Pharms Llc, Perrigo Israel, Perrigo Uk Finco, Taro, Mylan, Acp Nimble, Amneal Pharms Llc, Fougera Pharms Inc, Glenmark Pharms, Lupin Ltd, Rising, Teligent Pharma Inc, Teva Pharms Usa, Xiromed, Zydus Pharms, Fougera Pharms, Novast Labs, Hi Tech Pharma, Encore Dermat, Perrigo Co, Actavis Mid Atlantic, Hi Tech, Galderma Labs Lp, Aleor Dermaceuticals, Novel Labs Inc, Galderma Labs, Macleods Pharms Ltd, Saptalis Pharms, Tolmar, Wockhardt Bio Ag, Akorn, Apotex Inc, and Paddock Llc, and is included in eighty-one NDAs. There are eleven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Clobetasol propionate has one hundred patent family members in twenty-seven countries.
There are fourteen drug master file entries for clobetasol propionate. Forty-eight suppliers are listed for this compound.
Summary for clobetasol propionate
| International Patents: | 100 |
| US Patents: | 11 |
| Tradenames: | 11 |
| Applicants: | 34 |
| NDAs: | 81 |
| Drug Master File Entries: | 14 |
| Suppliers / Packagers: | 48 |
| Bulk Api Vendors: | 63 |
| Clinical Trials: | 48 |
| Patent Applications: | 6,463 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for clobetasol propionate |
| Drug Sales Revenues: | Drug sales revenues for clobetasol propionate |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for clobetasol propionate |
| DailyMed Link: | clobetasol propionate at DailyMed |
Recent Clinical Trials for clobetasol propionate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Association pour la Recherche Clinique et Immunologique | N/A |
| Beni-Suef University | Phase 1 |
| Dermtreat | Phase 2 |
Recent Litigation for clobetasol propionate
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Galderma Laboratories LP v. Akorn Inc | 2016-04-14 |
| Delcor Asset Corporation v. Taro Pharmaceutical Industries, Ltd. | 2016-03-01 |
| Galderma Laboratories LP v. Teligent Inc | 2015-12-04 |
Pharmacology for clobetasol propionate
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for clobetasol propionate
Synonyms for clobetasol propionate
| (11b,16b)-21-Chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione |
| [(8S,9R,10S,11S,13S,14S,16S,17R)-17-(2-chloroacetyl)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate |
| 122C467 |
| 21-chloro-9-fluoro-11 beta-hydroxy-16 beta-methylpregna-1,4-diene-3,20-dione 17-propionate |
| 21-Chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione (11beta,16beta)- |
| 21-Chloro-9-fluoro-11b,17-dihydroxy-16b-methylpregna-1,4-diene-3,20-dione 17-propionate |
| 21-chloro-9-fluoro-11beta-hydroxy-16beta-methyl-3,20-dioxopregna-1,4-dien-17-yl propanoate |
| 21-Chloro-9-fluoro-11beta-hydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17-propionate |
| 21-Chloro-9-fluoro-11beta,17-dihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17-propionate |
| 21-Chloro-9alpha-fluoro-11beta,17alpha-dihydroxy-16beta-methyl-1,4-pregnadiene-3,20-dione 17-Propionate |
| 25122-46-7 |
| 779619577M |
| AB00383081_11 |
| AB00383081-10 |
| AB1009262 |
| AC-17990 |
| AC1L1OG9 |
| AC1Q3T8C |
| AKOS015951278 |
| AMOT0927 |
| AN-14318 |
| AS-12555 |
| BCP04125 |
| BCP0726000094 |
| BCP9000539 |
| BDBM39347 |
| BRD-K10799896-001-10-6 |
| BRD-K10799896-001-26-2 |
| Butavate |
| C-22667 |
| C25H32ClFO5 |
| CAS-25122-46-7 |
| CC-25914 |
| CCG-220781 |
| CCI 4725 |
| CCI-4725 |
| CGP 9555 |
| CGP9555 pound>> CCl 4725 pound>>CGP 9555 pound>> CCl4725 pound>>CGP-9555 pound>> CCl-4725 |
| CHEBI:31414 |
| CHEMBL1159650 |
| cid_32798 |
| Clarelux |
| Clobesol |
| Clobestasol propionate |
| clobetasol 17-propanoate |
| Clobetasol 17-propionate |
| Clobetasol for peak identification, European Pharmacopoeia (EP) Reference Standard |
| CLOBETASOL PROPIONATE (EMOLLIENT) |
| Clobetasol propionate (JP17/USP) |
| Clobetasol propionate [USAN:JAN] |
| Clobetasol propionate [USAN:USP:JAN] |
| Clobetasol propionate E |
| Clobetasol propionate gel |
| Clobetasol propionate, analytical standard |
| Clobetasol propionate, European Pharmacopoeia (EP) Reference Standard |
| Clobetasol Propionate, Pharmaceutical Secondary Standard; Certified Reference Material |
| Clobetasol propionate, United States Pharmacopeia (USP) Reference Standard |
| Clobetasole propionate |
| Clobetasolpropionat mikron. |
| Clobetasolpropionate |
| Clobex |
| Cormax |
| Cormax (TN) |
| CPD000058745 |
| CS-2594 |
| D01272 |
| DB01013 |
| Dermoval |
| Dermovate |
| Dermoxinale |
| DSSTox_CID_25907 |
| DSSTox_GSID_45907 |
| DSSTox_RID_81219 |
| DTXSID6045907 |
| EBD6220 |
| EINECS 246-634-3 |
| Embeline |
| Embeline E |
| GR 2/925 |
| GTPL7062 |
| HMS2090A04 |
| HMS2230H08 |
| HMS3259A10 |
| HMS3714M04 |
| HY-13600 |
| Impoyz |
| LS-118433 |
| MFCD00058499 |
| MLS000028708 |
| MLS001076345 |
| NC00551 |
| NCGC00023373-03 |
| NCGC00023373-04 |
| NCGC00095078-01 |
| Olux |
| Olux E |
| OLUX FOAM |
| Olux-E |
| Opera_ID_1470 |
| Pregna-1,4-diene-3,20-dione, 21-chloro-9-fluoro-11-beta,17-dihydroxy-16-beta-methyl-, 17-propionate |
| Pregna-1,4-diene-3,20-dione, 21-chloro-9-fluoro-11-beta,17-dihydroxy-16-beta-methyl-,17-propionate |
| Pregna-1,4-diene-3,20-dione, 21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-, (11beta,16beta)- |
| Propionic acid clobetasol |
| s2584 |
| SCHEMBL3997 |
| SMR000058745 |
| SR-01000000280 |
| SR-01000000280-4 |
| Temovate |
| Temovate E |
| Tox21_111414 |
| Tox21_111414_1 |
| UNII-779619577M |
| Yugofin |
| ZINC3977767 |
Paragraph IV (Patent) Challenges for CLOBETASOL PROPIONATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| OLUX E | AEROSOL, FOAM;TOPICAL | clobetasol propionate | 022013 | 2010-02-25 |
| CLOBEX | SPRAY;TOPICAL | clobetasol propionate | 021835 | 2008-09-29 |
| CLOBEX | SHAMPOO;TOPICAL | clobetasol propionate | 021644 | 2008-01-09 |
| CLOBEX | LOTION;TOPICAL | clobetasol propionate | 021535 | 2006-03-27 |
| OLUX | AEROSOL, FOAM;TOPICAL | clobetasol propionate | 021142 | 2005-06-27 |
US Patents and Regulatory Information for clobetasol propionate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus Pharms | CLOBETASOL PROPIONATE | clobetasol propionate | SPRAY;TOPICAL | 206378-001 | Feb 16, 2017 | AT | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Actavis Mid Atlantic | CLOBETASOL PROPIONATE | clobetasol propionate | OINTMENT;TOPICAL | 074128-001 | Aug 3, 1994 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Zydus Pharms | CLOBETASOL PROPIONATE | clobetasol propionate | LOTION;TOPICAL | 205249-001 | Sep 24, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Hi Tech | CLOBETASOL PROPIONATE | clobetasol propionate | SHAMPOO;TOPICAL | 209871-001 | Oct 27, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Taro | CLOBETASOL PROPIONATE | clobetasol propionate | SOLUTION;TOPICAL | 075224-001 | Nov 16, 1998 | AT | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Teligent Pharma Inc | CLOBETASOL PROPIONATE | clobetasol propionate | GEL;TOPICAL | 208881-001 | Mar 6, 2017 | AB | RX | 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 clobetasol propionate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Galderma Labs | CLOBEX | clobetasol propionate | SHAMPOO;TOPICAL | 021644-001 | Feb 5, 2004 | Start Trial | Start Trial |
| Fougera Pharms | TEMOVATE | clobetasol propionate | OINTMENT;TOPICAL | 019323-001 | Dec 27, 1985 | Start Trial | Start Trial |
| Mylan | OLUX | clobetasol propionate | AEROSOL, FOAM;TOPICAL | 021142-001 | May 26, 2000 | Start Trial | Start Trial |
| Fougera Pharms | TEMOVATE | clobetasol propionate | SOLUTION;TOPICAL | 019966-001 | Feb 22, 1990 | Start Trial | Start Trial |
| Galderma Labs | CLOBEX | clobetasol propionate | SHAMPOO;TOPICAL | 021644-001 | Feb 5, 2004 | Start Trial | Start Trial |
| Fougera Pharms | TEMOVATE | clobetasol propionate | CREAM;TOPICAL | 019322-001 | Dec 27, 1985 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for clobetasol propionate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 69928253 | Start Trial |
| Poland | 344365 | Start Trial |
| China | 107872972 | Start Trial |
| Japan | 2005298518 | Start Trial |
| Japan | 2002518311 | Start Trial |
| Russian Federation | 2001101891 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.