AGGRASTAT Drug Patent Profile
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Which patents cover Aggrastat, and when can generic versions of Aggrastat launch?
Aggrastat is a drug marketed by Medicure and is included in two NDAs. There is one patent protecting this drug and two Paragraph IV challenges.
This drug has five patent family members in five countries.
The generic ingredient in AGGRASTAT is tirofiban hydrochloride. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tirofiban hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Aggrastat
A generic version of AGGRASTAT was approved as tirofiban hydrochloride by GLAND PHARMA LTD on April 8th, 2021.
Summary for AGGRASTAT
International Patents: | 5 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 66 |
Clinical Trials: | 13 |
Patent Applications: | 5,386 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for AGGRASTAT |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AGGRASTAT |
What excipients (inactive ingredients) are in AGGRASTAT? | AGGRASTAT excipients list |
DailyMed Link: | AGGRASTAT at DailyMed |


Recent Clinical Trials for AGGRASTAT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Iowa | Phase 1/Phase 2 |
David Hasan | Phase 1/Phase 2 |
University Hospital Inselspital, Berne | Phase 4 |
Pharmacology for AGGRASTAT
Drug Class | Platelet Aggregation Inhibitor |
Physiological Effect | Decreased Platelet Aggregation |
Anatomical Therapeutic Chemical (ATC) Classes for AGGRASTAT
Paragraph IV (Patent) Challenges for AGGRASTAT
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 AGGRASTAT
AGGRASTAT is protected by one US patents.
Patents protecting AGGRASTAT
Method for inhibiting platelet aggregation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
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 | INJECTABLE;INJECTION | 020912-001 | May 14, 1998 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-003 | Apr 20, 2000 | AP | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INJECTION | 020912-002 | Aug 31, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-002 | May 17, 2002 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-001 | May 14, 1998 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 AGGRASTAT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-002 | May 17, 2002 | See Plans and Pricing | See Plans and Pricing |
Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INJECTION | 020912-002 | Aug 31, 2016 | See Plans and Pricing | See Plans and Pricing |
Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-001 | May 14, 1998 | See Plans and Pricing | See Plans and Pricing |
Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020912-001 | May 14, 1998 | See Plans and Pricing | See Plans and Pricing |
Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-003 | Apr 20, 2000 | See Plans and Pricing | See Plans and Pricing |
Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-003 | Apr 20, 2000 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AGGRASTAT
See the table below for patents covering AGGRASTAT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2483929 | METHODE PERMETTANT D'INHIBER L'AGREGATION PLAQUETTAIRE (A METHOD FOR INHIBITING PLATELET AGGREGATION) | See Plans and Pricing |
Russian Federation | 2116296 | SULFONAMIDE DERIVATIVES, PHARMACEUTICAL COMPOSITION BASED ON THEREOF, METHOD OF INHIBITION OF FIBRIN EFFECT AND A METHOD OF TREATMENT OF MAMMALIAN WITH THROMBOSIS | See Plans and Pricing |
China | 1200676 | See Plans and Pricing | |
Singapore | 63636 | Novel sulfonamide fibrinogen receptor antagonists | See Plans and Pricing |
Australia | 740941 | See Plans and Pricing | |
Slovakia | 282353 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AGGRASTAT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0478363 | C990040 | Netherlands | See Plans and Pricing | 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 | 2000C/002 | Belgium | See Plans and Pricing | PRODUCT NAME: TIROFIBANUM HYDROCHLORIDUM (EQ. TIROFIBAN); NAT. REGISTRATION NO/DATE: 922 IS 191 F 12 19990906; FIRST REGISTRATION: CH 54761 19980528 |
0478363 | SPC/GB99/042 | United Kingdom | See Plans and Pricing | 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 | See Plans and Pricing | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |