AGGRASTAT Drug Patent Profile
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When do Aggrastat patents expire, and what generic alternatives are available?
Aggrastat is a drug marketed by Medicure and is included in two NDAs.
The generic ingredient in AGGRASTAT is tirofiban hydrochloride. There are four drug master file entries for this compound. Four 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
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 71 |
| Clinical Trials: | 13 |
| Patent Applications: | 4,299 |
| 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
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-003 | Apr 20, 2000 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INJECTION | 020912-002 | Aug 31, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 AGGRASTAT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020912-001 | May 14, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020912-001 | May 14, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-002 | May 17, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| Israel | 99540 | Sulfonamide fibrinogen receptor antagonists and pharmaceutical compositions containing them | ⤷ Try a Trial |
| Canada | 2052073 | ANTAGONISTES DES RECEPTEURS DE LA FIBRINOGENE A BASE DE SULFAMIDES (SULFONAMIDE FIBRINOGEN RECEPTOR ANTAGONISTS) | ⤷ Try a Trial |
| Japan | 2002501936 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AGGRASTAT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0478363 | 48/1999 | Austria | ⤷ Try a 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 | C990040 | Netherlands | ⤷ Try a 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 | 2000C/002 | Belgium | ⤷ Try a 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 |
Make Better Decisions: Try a trial or see plans & pricing
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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