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Tirofiban hydrochloride - Generic Drug Details
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What are the generic sources for tirofiban hydrochloride and what is the scope of freedom to operate?
Tirofiban hydrochloride
is the generic ingredient in one branded drug marketed by Medicure and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Tirofiban hydrochloride has five patent family members in five countries.
There are four drug master file entries for tirofiban hydrochloride. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for tirofiban hydrochloride
| International Patents: | 5 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 4 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 106 |
| Clinical Trials: | 44 |
| Patent Applications: | 1,505 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tirofiban hydrochloride |
| DailyMed Link: | tirofiban hydrochloride at DailyMed |
Recent Clinical Trials for tirofiban hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fondazione "Un Cuore per Milano" - a no profit foundation | Phase 2 |
| University of Milan | Phase 2 |
| Assiut University | Phase 1/Phase 2 |
Generic filers with tentative approvals for TIROFIBAN HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | INJECTABLE;INJECTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for tirofiban hydrochloride
| Drug Class | Platelet Aggregation Inhibitor |
| Physiological Effect | Decreased Platelet Aggregation |
Paragraph IV (Patent) Challenges for TIROFIBAN HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| AGGRASTAT | INJECTABLE;INJECTION | tirofiban hydrochloride | 020913 | 2019-08-29 |
| AGGRASTAT | INJECTABLE;INJECTION | tirofiban hydrochloride | 020913 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INJECTION | 020912-002 | Aug 31, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020912-001 | May 14, 1998 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020913-002 | May 17, 2002 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020913-001 | May 14, 1998 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| >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 | INJECTABLE;INJECTION | 020913-001 | May 14, 1998 | Start Trial | Start Trial |
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INJECTION | 020912-002 | Aug 31, 2016 | Start Trial | Start Trial |
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020913-003 | Apr 20, 2000 | Start Trial | Start Trial |
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020912-001 | May 14, 1998 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for tirofiban hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2005532306 | Start Trial |
| World Intellectual Property Organization (WIPO) | 03092767 | Start Trial |
| Australia | 2003234596 | Start Trial |
| European Patent Office | 1503753 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for tirofiban hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0478363 | C990040 | Netherlands | Start Trial | PRODUCT NAME: TIROFIBAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF EEN HYDRAAT, IN HET BIJZONDER TIROFIBANHY- DROCHLORIDE MONOHYDRAAT; NATL REGISTRATION NO/DATE: RVG 23380-1 19990707; FIRST REGISTRATION: DE 42618.00.00-01 19980630 |
| 0478363 | SPC/GB99/042 | United Kingdom | Start Trial | PRODUCT NAME: TIROFIBAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE HYDROCHLORIDE; REGISTERED: LI 54761 19980528; CH 54761 19980528; DE 42618.00.00 19980630; DE 42618.00.01 19980630; DE 42620.00.00 19980630; DE 42620.00.01 19980630; UK PL 00025/0375 19990715; UK PL 00025/0376 19990715 |
| 0478363 | 48/1999 | Austria | Start Trial | PRODUCT NAME: TIROFIBAN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: 1-23140 UND 1-23141 19990714; FIRST REGISTRATION: LI IKS-NR 54761 19980528 |
| 0478363 | 2000C/002 | Belgium | Start Trial | PRODUCT NAME: TIROFIBANUM HYDROCHLORIDUM (EQ. TIROFIBAN); NAT. REGISTRATION NO/DATE: 922 IS 191 F 12 19990906; FIRST REGISTRATION: CH 54761 19980528 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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