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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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 |
| 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 |
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.
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
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 | 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 | ⤷ Sign Up | ||||
| 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 | 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 |
|---|---|---|---|
| Brazil | 0113247 | ⤷ Sign Up | |
| Denmark | 1304992 | ⤷ Sign Up | |
| Japan | 4988129 | ⤷ Sign Up | |
| Austria | 429922 | ⤷ Sign Up | |
| China | 103228281 | Pharmaceutical formulations containing corticosteroids for topical administration | ⤷ Sign Up |
| Australia | 7900201 | ⤷ Sign Up | |
| Israel | 226398 | פורמולציות רקחייות המכילות קורטיקוסטראוידים למתן על העור (Pharmaceutical formulations containing corticosteroids for topical administration) | ⤷ 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 | 122013000081 | Germany | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322 |
| 1304992 | 474 | Finland | ⤷ Sign Up | |
| 1304992 | PA2013025,C1304992 | Lithuania | ⤷ Sign Up | 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 | C01304992/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014 |
| 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 |
| 1304992 | 1390049-3 | Sweden | ⤷ Sign Up | PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322 |
| 1304992 | 132013902214376 | Italy | ⤷ Sign Up | PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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