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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wilshire Pharms Inc | ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 211501-001 | Sep 1, 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 | ||||
| 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 | |||
| Fresenius Kabi Usa | ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 208317-001 | Jun 18, 2020 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alembic | ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 213773-001 | Jun 14, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 210118-001 | Jul 15, 2019 | 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 | |||
| >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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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