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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 two patents protecting this drug and one Paragraph IV challenge.
This drug has eighteen patent family members in twelve countries.
The generic ingredient in BRYHALI is halobetasol propionate. There are nine drug master file entries for this compound. Twelve 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.
Summary for BRYHALI
| International Patents: | 18 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 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 |
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
BRYHALI is protected by two US patents and one FDA Regulatory Exclusivity.
Patents protecting BRYHALI
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
Pharmaceutical formulations containing corticosteroids for topical administration
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
FDA Regulatory Exclusivity protecting BRYHALI
NEW PRODUCT
Exclusivity Expiration: ⤷ Try it Free
| 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 | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Bausch | BRYHALI | halobetasol propionate | LOTION;TOPICAL | 209355-001 | Nov 6, 2018 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Bausch | BRYHALI | halobetasol propionate | LOTION;TOPICAL | 209355-001 | Nov 6, 2018 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| >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 | ⤷ Try it Free | ⤷ Try it Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BRYHALI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 7900201 | ⤷ Try it Free |
| Portugal | 2052714 | ⤷ Try it Free |
| Japan | 4988129 | ⤷ Try it Free |
| China | 1460013 | ⤷ Try it Free |
| Poland | 360589 | ⤷ Try it Free |
| Israel | 226398 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BRYHALI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1304992 | SPC/GB13/061 | United Kingdom | ⤷ Try it Free | PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624 |
| 1304992 | PA2013025,C1304992 | Lithuania | ⤷ Try it Free | PRODUCT NAME: CLINDAMYCINUM + 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 | PA2013025 | Lithuania | ⤷ Try it Free | 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 | 92401 | Luxembourg | ⤷ Try it Free | PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE |
| 1304992 | 132013902214376 | Italy | ⤷ Try it Free | PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718 |
| 1304992 | 2013C/060 | Belgium | ⤷ Try it Free | PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
