Tirofiban hydrochloride - Generic Drug Details
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What are the generic drug sources for tirofiban hydrochloride and what is the scope of patent protection?
Tirofiban hydrochloride
is the generic ingredient in two branded drugs marketed by Medicure, Eugia Pharma, Gland Pharma Ltd, and Nexus, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for tirofiban hydrochloride. Four suppliers are listed for this compound.
Summary for tirofiban hydrochloride
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 4 |
NDAs: | 5 |
Drug Master File Entries: | 4 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 128 |
Clinical Trials: | 54 |
Patent Applications: | 2,138 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tirofiban hydrochloride |
What excipients (inactive ingredients) are in tirofiban hydrochloride? | tirofiban hydrochloride excipients list |
DailyMed Link: | tirofiban hydrochloride at DailyMed |
Recent Clinical Trials for tirofiban hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
The First Affiliated Hospital of University of Science and Technology of China | Phase 3 |
Pharmaron (Chengdu) Clinical Services Co., Ltd. | Phase 3 |
Peking Union Medical College Hospital | Phase 3 |
Pharmacology for tirofiban hydrochloride
Drug Class | Platelet Aggregation Inhibitor |
Physiological Effect | Decreased Platelet Aggregation |
Anatomical Therapeutic Chemical (ATC) Classes for tirofiban hydrochloride
Paragraph IV (Patent) Challenges for TIROFIBAN HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
AGGRASTAT | Injection | tirofiban hydrochloride | 5 mg/100 mL | 020913 | 1 | 2019-08-29 |
AGGRASTAT | Injection | tirofiban hydrochloride | 12.5 mg/250 mL | 020913 | 1 | 2018-10-03 |
US Patents and Regulatory Information for tirofiban hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Nexus | TIROFIBAN HYDROCHLORIDE | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 213947-001 | Feb 7, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Gland Pharma Ltd | TIROFIBAN HYDROCHLORIDE | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 206888-001 | Apr 8, 2021 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INJECTION | 020912-002 | Aug 31, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Eugia Pharma | TIROFIBAN HYDROCHLORIDE | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 216379-001 | May 1, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Eugia Pharma | TIROFIBAN HYDROCHLORIDE | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 216379-002 | May 1, 2023 | 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 tirofiban hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-001 | May 14, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020912-001 | May 14, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-003 | Apr 20, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-003 | Apr 20, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-001 | May 14, 1998 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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