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 |
| Peking Union Medical College Hospital | Phase 3 |
| Pharmaron (Chengdu) Clinical Services Co., Ltd. | 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 | 216379-002 | May 1, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-002 | May 17, 2002 | AP | RX | Yes | 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 | |||
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-001 | May 14, 1998 | DISCN | 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 | |||
| Gland Pharma Ltd | TIROFIBAN HYDROCHLORIDE | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 206888-001 | Apr 8, 2021 | 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;INJECTION | 020912-002 | Aug 31, 2016 | ⤷ 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 | 020913-002 | May 17, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-002 | May 17, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020912-001 | May 14, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020912-001 | May 14, 1998 | ⤷ 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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