Firazyr Drug Patent Profile
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Which patents cover Firazyr, and what generic alternatives are available?
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. Ten 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.
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: | 330 |
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 |
Main Line Health | Phase 2 |
University of Colorado, Denver | Phase 2 |
Pharmacology for Firazyr
Drug Class | Bradykinin B2 Receptor Antagonist |
Mechanism of Action | Bradykinin B2 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for Firazyr
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Canada | 2041268 | PEPTIDES AYANT UNE ACTION ANTAGONISTE DE LA BRADYKININ (PEPTIDES WITH A BRADYKININ-ANTAGONISTIC ACTION) | ⤷ Try a Trial |
Germany | 122008000066 | ⤷ Try a Trial | |
China | 1042918 | ⤷ Try a Trial | |
Portugal | 94982 | PROCESSO PARA A PREPARACAO DE PEPTIDOS COM ACCAO ANTAGONISTA CONTRA BRADIQUININA E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM | ⤷ Try a Trial |
Czech Republic | 280682 | Peptidy s bradykinin-antagonistickým účinkem, způsob jejich výroby, jejich použití a farmaceu tický prostředek tyto peptidy obsahující (PEPTIDES EXHIBITING BRADYKININ-ANTAGONISTIC EFFECT, PROCESS FOR THEIR PREPARATION, THEIR APPLICATION AND PHARMACEUTICAL CONTAINING SAID PEPTIDES) | ⤷ Try a Trial |
>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 | ⤷ Try a Trial | 91499, EXPIRES: 20141121 |
0370453 | 51/2008 | Austria | ⤷ Try a Trial | PRODUCT NAME: ICATIBANT, WAHLWEISE IN FORM EINES PHYSIOLOGISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ICATIBANT-ACETAT; REGISTRATION NO/DATE: EU/1/08/461/001 20080711 |
0370453 | SPC/GB09/002 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ICATIBANT, OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF, INCLUDING ICATIBANT ACETATE; REGISTERED: UK EU/1/08/461/001 20080711 |
0370453 | 300359 | Netherlands | ⤷ Try a Trial | 300359, 20091121, EXPIRES: 20141120 |
0370453 | C300359 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ICATIBANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, BIJ VOORKEUR ICATIBANTACETAAT; REGISTRATION NO/DATE: EU/1/048/461/001 20080711 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |