FIRAZYR Drug Patent Profile
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Which patents cover Firazyr, and when can generic versions of Firazyr launch?
Firazyr is a drug marketed by Takeda Pharms Usa and is included in one NDA.
The generic ingredient in FIRAZYR is icatibant acetate. There are thirteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the icatibant acetate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Firazyr
A generic version of FIRAZYR was approved as icatibant acetate by TEVA PHARMS USA on July 15th, 2019.
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Summary for FIRAZYR
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 74 |
Clinical Trials: | 9 |
Patent Applications: | 326 |
Drug Prices: | Drug price information for FIRAZYR |
What excipients (inactive ingredients) are in FIRAZYR? | FIRAZYR excipients list |
DailyMed Link: | FIRAZYR at DailyMed |
Recent Clinical Trials for FIRAZYR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sebastian Videla | Phase 2 |
University of Southern California | Phase 2 |
Georgetown University | Phase 2 |
Pharmacology for FIRAZYR
Drug Class | Bradykinin B2 Receptor Antagonist |
Mechanism of Action | Bradykinin B2 Receptor Antagonists |
Paragraph IV (Patent) Challenges for FIRAZYR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
FIRAZYR | Injection | icatibant acetate | 10 mg/mL | 022150 | 2 | 2015-08-25 |
US Patents and Regulatory Information for FIRAZYR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Takeda Pharms Usa | FIRAZYR | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 022150-001 | Aug 25, 2011 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 FIRAZYR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | FIRAZYR | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 022150-001 | Aug 25, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FIRAZYR
See the table below for patents covering FIRAZYR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 4013270 | ⤷ Sign Up | |
Hungary | 210712 | ⤷ Sign Up | |
Israel | 91298 | Peptides having bradykinin antagonist action, their preparation and use | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FIRAZYR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0370453 | 91499 | Luxembourg | ⤷ Sign Up | 91499, EXPIRES: 20141121 |
0370453 | C300359 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ICATIBANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, BIJ VOORKEUR ICATIBANTACETAAT; REGISTRATION NO/DATE: EU/1/048/461/001 20080711 |
0370453 | SPC/GB09/002 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ICATIBANT, OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF, INCLUDING ICATIBANT ACETATE; REGISTERED: UK EU/1/08/461/001 20080711 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |