ICATIBANT ACETATE Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Icatibant Acetate, and what generic alternatives are available?
Icatibant Acetate is a drug marketed by Cipla, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Glenmark Pharms Ltd, Jiangsu Hansoh Pharm, Nang Kuang Pharm Co, Slayback Pharma Llc, and Teva Pharms Usa. and is included in nine NDAs.
The generic ingredient in ICATIBANT ACETATE 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 Icatibant Acetate
A generic version of ICATIBANT ACETATE was approved as icatibant acetate by TEVA PHARMS USA on July 15th, 2019.
Summary for ICATIBANT ACETATE
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 9 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cipla | ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 212446-001 | Jul 13, 2020 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Nang Kuang Pharm Co | ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 212081-001 | Dec 16, 2020 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Fresenius Kabi Usa | ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 208317-001 | Jun 18, 2020 | AP | RX | No | No | ⤷ 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 |
