ICATIBANT ACETATE - Generic Drug Details
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What are the generic sources for icatibant acetate and what is the scope of patent protection?
Icatibant acetate
is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa, Alembic, Cipla, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Glenmark Pharms Ltd, Jiangsu Hansoh Pharm, Nang Kuang Pharm Co, Teva Pharms Usa, and Wilshire Pharms Inc, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.There are thirteen drug master file entries for icatibant acetate. Eleven suppliers are listed for this compound.
Summary for ICATIBANT ACETATE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 11 |
NDAs: | 11 |
Drug Master File Entries: | 13 |
Finished Product Suppliers / Packagers: | 11 |
Raw Ingredient (Bulk) Api Vendors: | 14 |
Patent Applications: | 39 |
What excipients (inactive ingredients) are in ICATIBANT ACETATE? | ICATIBANT ACETATE excipients list |
DailyMed Link: | ICATIBANT ACETATE at DailyMed |
Pharmacology for ICATIBANT ACETATE
Drug Class | Bradykinin B2 Receptor Antagonist |
Mechanism of Action | Bradykinin B2 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for ICATIBANT ACETATE
Paragraph IV (Patent) Challenges for ICATIBANT ACETATE
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 ICATIBANT ACETATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glenmark Pharms Ltd | ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 213222-001 | May 21, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Takeda Pharms Usa | FIRAZYR | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 022150-001 | Aug 25, 2011 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Wilshire Pharms Inc | ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 211501-001 | Sep 1, 2020 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Eugia Pharma | ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 213521-001 | Aug 14, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Dr Reddys | ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 213054-001 | Oct 5, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Nang Kuang Pharm Co | ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 212081-001 | Dec 16, 2020 | AP | RX | No | No | ⤷ 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 ICATIBANT ACETATE
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 |
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