DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 020913
The generic ingredient in AGGRASTAT is tirofiban hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tirofiban hydrochloride profile page.
Summary for 020913
Tradename: | AGGRASTAT |
Applicant: | Medicure |
Ingredient: | tirofiban hydrochloride |
Patents: | 2 |
Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 020913
Generic Entry Date for 020913*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;INJECTION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 020913
Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 020913
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020913 | NDA | Medicure International Inc | 25208-002 | 25208-002-02 | 1 CONTAINER in 1 CARTON (25208-002-02) > 250 mL in 1 CONTAINER |
AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020913 | NDA | Medicure International Inc | 25208-002 | 25208-002-03 | 1 VIAL, GLASS in 1 CARTON (25208-002-03) > 100 mL in 1 VIAL, GLASS |
Paragraph IV (Patent) Challenges for 020913
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
AGGRASTAT | INJECTABLE;INJECTION | tirofiban hydrochloride | 020913 | 2019-08-29 |
AGGRASTAT | INJECTABLE;INJECTION | tirofiban hydrochloride | 020913 | 2018-10-03 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) | ||||
Approval Date: | May 14, 1998 | TE: | RLD: | No | |||||
Patent: | Start Trial | Patent Expiration: | Jan 29, 2019 | Product Flag? | Substance Flag? | Delist Request? | |||
Patent: | Start Trial | Patent Expiration: | May 1, 2023 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | A DOSING REGIMEN OF AGGRASTAT (TIROFIBAN HYDROCHLORIDE)(25MCG/KG FOLLOWED BY 0.15MCG/KG/MIN INFUSION) TO REDUCE THE RATE OF THROMBOTIC CORONARY EVENTS ASSOCIATED WITH ACUTE CORONARY SYNDROME (ACS) IN PATIENTS WITH NON-ST ELEVATION ACS |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) | ||||
Approval Date: | May 17, 2002 | TE: | RLD: | Yes | |||||
Patent: | Start Trial | Patent Expiration: | Jan 29, 2019 | Product Flag? | Substance Flag? | Delist Request? |
Expired US Patents for NDA 020913
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020913-003 | Apr 20, 2000 | Start Trial | Start Trial |
Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020913-001 | May 14, 1998 | 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 | 020913-001 | May 14, 1998 | Start Trial | Start Trial |
Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020913-002 | May 17, 2002 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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