BRYHALI Drug Patent Profile
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Which patents cover Bryhali, and what generic alternatives are available?
Bryhali is a drug marketed by Bausch and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-six patent family members in nineteen countries.
The generic ingredient in BRYHALI is halobetasol propionate. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Bryhali
A generic version of BRYHALI was approved as halobetasol propionate by FOUGERA PHARMS on December 16th, 2004.
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Questions you can ask:
- What is the 5 year forecast for BRYHALI?
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- What is Average Wholesale Price for BRYHALI?
Summary for BRYHALI
| International Patents: | 26 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 49 |
| Clinical Trials: | 1 |
| Drug Prices: | Drug price information for BRYHALI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BRYHALI |
| What excipients (inactive ingredients) are in BRYHALI? | BRYHALI excipients list |
| DailyMed Link: | BRYHALI at DailyMed |
Recent Clinical Trials for BRYHALI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Icahn School of Medicine at Mount Sinai | Phase 3 |
| Bausch Health Americas, Inc. | Phase 3 |
Pharmacology for BRYHALI
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Paragraph IV (Patent) Challenges for BRYHALI
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BRYHALI | Lotion | halobetasol propionate | 0.01% | 209355 | 1 | 2019-05-15 |
US Patents and Regulatory Information for BRYHALI
BRYHALI is protected by six US patents.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch | BRYHALI | halobetasol propionate | LOTION;TOPICAL | 209355-001 | Nov 6, 2018 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Bausch | BRYHALI | halobetasol propionate | LOTION;TOPICAL | 209355-001 | Nov 6, 2018 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Bausch | BRYHALI | halobetasol propionate | LOTION;TOPICAL | 209355-001 | Nov 6, 2018 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bausch | BRYHALI | halobetasol propionate | LOTION;TOPICAL | 209355-001 | Nov 6, 2018 | RX | Yes | Yes | ⤷ 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 BRYHALI
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch | BRYHALI | halobetasol propionate | LOTION;TOPICAL | 209355-001 | Nov 6, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BRYHALI
See the table below for patents covering BRYHALI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2011345240 | ⤷ Start Trial | |
| Brazil | 112013012476 | ⤷ Start Trial | |
| Canada | 2817524 | ⤷ Start Trial | |
| Canada | 3055328 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BRYHALI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 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 |
| 1304992 | 1390049-3 | Sweden | ⤷ Start Trial | PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322 |
| 1304992 | 92401 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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