CLOBETASOL PROPIONATE Drug Patent Profile
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When do Clobetasol Propionate patents expire, and when can generic versions of Clobetasol Propionate launch?
Clobetasol Propionate is a drug marketed by Alembic, Glenmark Pharms Ltd, Novast Labs, Padagis Israel, Taro, 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, Fougera Pharms, Padagis Us, Actavis Mid Atlantic, Epic Pharma Llc, Zydus Lifesciences, Macleods Pharms Ltd, Novel Labs Inc, Hikma, Prinston Inc, Quagen, Saptalis Pharms, Wockhardt Bio Ag, Akorn, Apotex, Formosa, and Ani Pharms. and is included in eighty-one NDAs. There are two patents protecting this drug.
This drug has twenty-three patent family members in seventeen countries.
The generic ingredient in CLOBETASOL PROPIONATE is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Clobetasol Propionate
A generic version of CLOBETASOL PROPIONATE was approved as clobetasol propionate by COSETTE on February 16th, 1994.
Summary for CLOBETASOL PROPIONATE
| International Patents: | 23 |
| US Patents: | 2 |
| Applicants: | 35 |
| NDAs: | 81 |
| Finished Product Suppliers / Packagers: | 37 |
| Raw Ingredient (Bulk) Api Vendors: | 80 |
| Clinical Trials: | 66 |
| Patent Applications: | 4,524 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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 |
See drug prices for CLOBETASOL PROPIONATE
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
Anatomical Therapeutic Chemical (ATC) Classes 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
CLOBETASOL PROPIONATE is protected by two US patents and one FDA Regulatory Exclusivity.
Patents protecting CLOBETASOL PROPIONATE
Aqueous suspension agent containing glucocorticosteroid nanoparticles
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INFLAMMATION
FDA Regulatory Exclusivity protecting CLOBETASOL PROPIONATE
NEW PRODUCT
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glenmark Pharms | CLOBETASOL PROPIONATE | clobetasol propionate | SPRAY;TOPICAL | 209004-001 | Mar 26, 2018 | AT | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Fougera Pharms | CLOBETASOL PROPIONATE | clobetasol propionate | OINTMENT;TOPICAL | 074407-001 | Feb 23, 1996 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Pai Holdings Pharm | CLOBETASOL PROPIONATE | clobetasol propionate | LOTION;TOPICAL | 208667-001 | Nov 29, 2016 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
International Patents for CLOBETASOL PROPIONATE
See the table below for patents covering CLOBETASOL PROPIONATE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Brazil | 112017024000 | suspensão aquosa contendo nano partículas de glucocorticosteroide | ⤷ Try a Trial |
| Canada | 2985171 | AGENT AQUEUX DE SUSPENSION COMPRENANT DES NANOPARTICULES DE GLUCOCORTICOSTEROIDE (AQUEOUS SUSPENSION CONTAINING NANOPARTICLES OF GLUCOCORTICOSTEROID) | ⤷ Try a Trial |
| South Korea | 102268710 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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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