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BRYHALI Drug Profile
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When do Bryhali patents expire, 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.
This drug has fifty-one patent family members in twenty-three countries.
The generic ingredient in BRYHALI is halobetasol propionate. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.
US ANDA Litigation and Generic Entry Outlook for Bryhali
A generic version of BRYHALI was approved as halobetasol propionate by FOUGERA PHARMS on January 18th, 2020.
Summary for BRYHALI
| International Patents: | 51 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Drug Prices: | Drug price information for BRYHALI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BRYHALI |
| DailyMed Link: | BRYHALI at DailyMed |
Recent Litigation for BRYHALI
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| BAUSCH HEALTH IRELAND LIMITED v. GLENMARK PHARMACEUTICALS LIMITED | 2019-06-28 |
Pharmacology for BRYHALI
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Paragraph IV (Patent) Challenges for BRYHALI
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BRYHALI | LOTION;TOPICAL | halobetasol propionate | 209355 | 2019-05-15 |
US Patents and Regulatory Information for BRYHALI
| 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 | 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 | Y | Start 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 BRYHALI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1114646 | Start Trial |
| Canada | 2417646 | Start Trial |
| Spain | 2326955 | Start Trial |
| Spain | 2437321 | Start Trial |
| Luxembourg | 92401 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BRYHALI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 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 | C01304992/01 | Switzerland | Start Trial | PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014 |
| 1304992 | 474 | Finland | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
