BREKIYA (AUTOINJECTOR) Drug Patent Profile
When do Brekiya (autoinjector) patents expire, and what generic alternatives are available?
Brekiya (autoinjector) is a drug marketed by Amneal and is included in one NDA. There are eight patents protecting this drug.
The generic ingredient in BREKIYA (AUTOINJECTOR) is dihydroergotamine mesylate. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dihydroergotamine mesylate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Brekiya (autoinjector)
A generic version of BREKIYA (AUTOINJECTOR) was approved as dihydroergotamine mesylate by HIKMA on June 9th, 2003.
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Questions you can ask:
- What is the 5 year forecast for BREKIYA (AUTOINJECTOR)?
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- What is Average Wholesale Price for BREKIYA (AUTOINJECTOR)?
Summary for BREKIYA (AUTOINJECTOR)
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| DailyMed Link: | BREKIYA (AUTOINJECTOR) at DailyMed |
-patent-expirations.png "BREKIYA (AUTOINJECTOR) drug patent expirations")
Pharmacology for BREKIYA (AUTOINJECTOR)
| Drug Class | Ergotamine Derivative |
US Patents and Regulatory Information for BREKIYA (AUTOINJECTOR)
BREKIYA (AUTOINJECTOR) is protected by eleven US patents.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal | BREKIYA (AUTOINJECTOR) | dihydroergotamine mesylate | SOLUTION;SUBCUTANEOUS | 215400-001 | May 14, 2025 | RX | Yes | Yes | 11,819,501 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Amneal | BREKIYA (AUTOINJECTOR) | dihydroergotamine mesylate | SOLUTION;SUBCUTANEOUS | 215400-001 | May 14, 2025 | RX | Yes | Yes | 10,532,049 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Amneal | BREKIYA (AUTOINJECTOR) | dihydroergotamine mesylate | SOLUTION;SUBCUTANEOUS | 215400-001 | May 14, 2025 | RX | Yes | Yes | 12,533,351 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Amneal | BREKIYA (AUTOINJECTOR) | dihydroergotamine mesylate | SOLUTION;SUBCUTANEOUS | 215400-001 | May 14, 2025 | RX | Yes | Yes | 12,329,749 | ⤷ 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 BREKIYA (AUTOINJECTOR)
See the table below for patents covering BREKIYA (AUTOINJECTOR) around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 3826614 | FORME POSOLOGIQUE UNITAIRE PARENTÉRALE DE DIHYDROERGOTAMINE (A PARENTERAL UNIT DOSAGE FORM OF DIHYDROERGOTAMINE) | ⤷ Start Trial |
| World Intellectual Property Organization (WIPO) | 2020044367 | ⤷ Start Trial | |
| European Patent Office | 3826614 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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. 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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