TIROFIBAN HYDROCHLORIDE Drug Patent Profile
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Which patents cover Tirofiban Hydrochloride, and when can generic versions of Tirofiban Hydrochloride launch?
Tirofiban Hydrochloride is a drug marketed by Eugia Pharma, Gland Pharma Ltd, and Nexus. and is included in three NDAs.
The generic ingredient in TIROFIBAN HYDROCHLORIDE is tirofiban hydrochloride. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the tirofiban hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tirofiban Hydrochloride
A generic version of TIROFIBAN HYDROCHLORIDE was approved as tirofiban hydrochloride by GLAND PHARMA LTD on April 8th, 2021.
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Summary for TIROFIBAN HYDROCHLORIDE
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eugia Pharma | TIROFIBAN HYDROCHLORIDE | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 216379-001 | May 1, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Nexus | TIROFIBAN HYDROCHLORIDE | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 213947-001 | Feb 7, 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 | |||
| Gland Pharma Ltd | TIROFIBAN HYDROCHLORIDE | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 206888-001 | Apr 8, 2021 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Nexus | TIROFIBAN HYDROCHLORIDE | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 213947-002 | Jul 24, 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 |
