CLOBEX Drug Patent Profile
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Which patents cover Clobex, and what generic alternatives are available?
Clobex is a drug marketed by Galderma Labs Lp and Galderma Labs and is included in three NDAs. There is one patent protecting this drug and three Paragraph IV challenges.
This drug has thirty-two patent family members in twenty-one countries.
The generic ingredient in CLOBEX is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Clobex
A generic version of CLOBEX was approved as clobetasol propionate by COSETTE on February 16th, 1994.
Summary for CLOBEX
| International Patents: | 32 |
| US Patents: | 1 |
| Applicants: | 2 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 78 |
| Clinical Trials: | 14 |
| Patent Applications: | 4,965 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CLOBEX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CLOBEX |
| What excipients (inactive ingredients) are in CLOBEX? | CLOBEX excipients list |
| DailyMed Link: | CLOBEX at DailyMed |
Recent Clinical Trials for CLOBEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Drug Delivery Solutions Ltd. (part of MC2 Therapeutics) | Phase 1 |
| MC2 Therapeutics | Phase 1 |
| University of California, San Francisco | Phase 4 |
Pharmacology for CLOBEX
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for CLOBEX
Paragraph IV (Patent) Challenges for CLOBEX
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| 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 |
US Patents and Regulatory Information for CLOBEX
CLOBEX is protected by one US patents.
Patents protecting CLOBEX
Foaming compositions for hair care
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF SCALP PSORIASIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | CLOBEX | clobetasol propionate | LOTION;TOPICAL | 021535-001 | Jul 24, 2003 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Galderma Labs | CLOBEX | clobetasol propionate | SHAMPOO;TOPICAL | 021644-001 | Feb 5, 2004 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Galderma Labs Lp | CLOBEX | clobetasol propionate | SPRAY;TOPICAL | 021835-001 | Oct 27, 2005 | AT | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for CLOBEX
| 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 |
| Galderma Labs Lp | CLOBEX | clobetasol propionate | SPRAY;TOPICAL | 021835-001 | Oct 27, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CLOBEX
See the table below for patents covering CLOBEX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 753735 | ⤷ Try a Trial | |
| Netherlands | 300225 | ⤷ Try a Trial | |
| Hong Kong | 1089956 | ⤷ 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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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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