bryhali Drug Patent Profile
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Which patents cover Bryhali, and when can generic versions of Bryhali launch?
Bryhali is a drug marketed by Bausch and is included in one NDA. There are three 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?
- What are the global sales for bryhali?
- What is Average Wholesale Price for bryhali?
Summary for bryhali
International Patents: | 26 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 49 |
Clinical Trials: | 1 |
Patent Applications: | 4,752 |
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 |
![bryhali drug patent expirations Drug patent expirations by year for bryhali](/p/graph/s/t/bryhali-patent-expirations.png)
![Drug Prices for bryhali](/p/graph/drug-price/bryhali.png)
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 three US patents.
Patents protecting bryhali
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
Pharmaceutical formulations containing corticosteroids for topical administration
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Bausch | BRYHALI | halobetasol propionate | LOTION;TOPICAL | 209355-001 | Nov 6, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bausch | BRYHALI | halobetasol propionate | LOTION;TOPICAL | 209355-001 | Nov 6, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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 | ⤷ Sign Up | ⤷ Sign Up |
>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 | 2001279002 | ⤷ Sign Up | |
Portugal | 2052714 | ⤷ Sign Up | |
Cyprus | 1109189 | ⤷ Sign Up | |
European Patent Office | 4233838 | FORMULATIONS PHARMACEUTIQUES CONTENANT DES CORTICOSTÉROÏDES POUR ADMINISTRATION TOPIQUE (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION) | ⤷ Sign Up |
Japan | 2013542990 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for bryhali
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1304992 | 92401 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE |
1304992 | SPC/GB13/061 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624 |
1304992 | 474 | Finland | ⤷ Sign Up | |
1304992 | 2013/044 | Ireland | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322 |
1304992 | PA2013025 | Lithuania | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |