ICATIBANT ACETATE Drug Patent Profile
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Which patents cover Icatibant Acetate, and what generic alternatives are available?
Icatibant Acetate is a drug marketed by 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 ten NDAs.
The generic ingredient in ICATIBANT ACETATE 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 Icatibant Acetate
A generic version of ICATIBANT ACETATE was approved as icatibant acetate by TEVA PHARMS USA on July 15th, 2019.
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Questions you can ask:
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Summary for ICATIBANT ACETATE
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 10 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 14 |
| Patent Applications: | 22 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic | ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 213773-001 | Jun 14, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Jiangsu Hansoh Pharm | ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 211021-001 | Mar 9, 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 | |||
| 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 | |||
| Cipla | ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 212446-001 | Jul 13, 2020 | 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 | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
