Clobetasol propionate - Generic Drug Details
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What are the generic drug sources for clobetasol propionate and what is the scope of patent protection?
Clobetasol propionate
is the generic ingredient in twelve branded drugs marketed by Alembic, Glenmark Pharms Ltd, Novast Labs, Padagis Israel, Taro, Mylan, Amneal, Aurobindo Pharma Usa, Chartwell Rx, Cosette, Encube, Fougera Pharms Inc, Glenmark Pharms, Lupin Ltd, Pai Holdings Pharm, Rising, Teva Pharms Usa, Torrent, Xiromed, Zydus Pharms, Ani Pharms, Fougera Pharms, Hikma, Primus Pharms, Padagis Us, Actavis Mid Atlantic, Epic Pharma Llc, Zydus Lifesciences, Galderma Labs Lp, Macleods Pharms Ltd, Novel Labs Inc, Galderma Labs, Prinston Inc, Quagen, Saptalis Pharms, Wockhardt Bio Ag, Akorn, and Apotex, and is included in ninety-six NDAs. There are six patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Clobetasol propionate has forty-eight patent family members in twenty-two countries.
There are eleven drug master file entries for clobetasol propionate. Thirty-nine suppliers are listed for this compound.
Summary for clobetasol propionate
| International Patents: | 48 |
| US Patents: | 6 |
| Tradenames: | 12 |
| Applicants: | 38 |
| NDAs: | 96 |
| Drug Master File Entries: | 11 |
| Finished Product Suppliers / Packagers: | 39 |
| Raw Ingredient (Bulk) Api Vendors: | 80 |
| Clinical Trials: | 66 |
| Patent Applications: | 6,045 |
| 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 |
| What excipients (inactive ingredients) are in clobetasol propionate? | clobetasol propionate excipients list |
| DailyMed Link: | clobetasol propionate at DailyMed |
Recent Clinical Trials for clobetasol propionate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Monitor CRO | Phase 2 |
| GEN İlaç ve Sağlık Ürünleri A.Ş. | Phase 2 |
| Combined Military Hospital Abbottabad | Phase 1 |
Pharmacology for clobetasol propionate
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for clobetasol propionate
Paragraph IV (Patent) Challenges for CLOBETASOL PROPIONATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| IMPOYZ | Cream | clobetasol propionate | 0.025% | 209483 | 1 | 2019-12-06 |
| OLUX E | Emulsion Foam | clobetasol propionate | 0.05% | 022013 | 1 | 2010-02-25 |
| CLOBEX | Spray | clobetasol propionate | 0.05% | 021835 | 1 | 2008-09-29 |
| CLOBEX | Topical Shampoo | clobetasol propionate | 0.05% | 021644 | 1 | 2008-01-09 |
| CLOBEX | Lotion | clobetasol propionate | 0.05% | 021535 | 1 | 2006-03-27 |
| OLUX | Topical Foam | clobetasol propionate | 0.05% | 021142 | 1 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Taro | CLOBETASOL PROPIONATE (EMOLLIENT) | clobetasol propionate | CREAM;TOPICAL | 075633-001 | May 17, 2000 | AB2 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Pai Holdings Pharm | CLOBETASOL PROPIONATE | clobetasol propionate | CREAM;TOPICAL | 209974-001 | Apr 17, 2018 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan | OLUX E | clobetasol propionate | AEROSOL, FOAM;TOPICAL | 022013-001 | Jan 12, 2007 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Galderma Labs Lp | CLOBEX | clobetasol propionate | LOTION;TOPICAL | 021535-001 | Jul 24, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| Mylan | OLUX E | clobetasol propionate | AEROSOL, FOAM;TOPICAL | 022013-001 | Jan 12, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for clobetasol propionate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 2017011521 | COMPOSICIONES TOPICAS QUE COMPRENDEN UN CORTICOSTEROIDE. (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID.) | ⤷ Try a Trial |
| Spain | 2429040 | ⤷ Try a Trial | |
| New Zealand | 735341 | Topical compositions comprising a corticosteroid | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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