icatibant acetate - Profile
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What are the generic drug 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, Caplin, Cipla, 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.Summary for icatibant acetate
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 11 |
| NDAs: | 11 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | FIRAZYR | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 022150-001 | Aug 25, 2011 | AP | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Alembic | ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 213773-001 | Jun 14, 2024 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Caplin | ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 213054-001 | Oct 5, 2020 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Cipla | ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 212446-001 | Jul 13, 2020 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 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 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
