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. 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
| International Patents: | 5 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 70 |
| Clinical Trials: | 13 |
| Patent Applications: | 4,300 |
| 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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ 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 | ||||
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-002 | May 17, 2002 | AP | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-001 | May 14, 1998 | DISCN | No | No | ⤷ 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 | SOLUTION;INTRAVENOUS | 020913-001 | May 14, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-003 | Apr 20, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-002 | May 17, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INJECTION | 020912-002 | Aug 31, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020912-001 | May 14, 1998 | ⤷ 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 |
|---|---|---|---|
| European Patent Office | 1503753 | METHODE PERMETTANT D'INHIBER L'AGREGATION PLAQUETTAIRE (A METHOD FOR INHIBITING PLATELET AGGREGATION) | ⤷ Try a Trial |
| Colombia | 4770960 | COMPOSICIONES ANTAGONISTAS RECEPTORAS DE BUTILSULFONILAMINO FIBRINOGENO PARA INHIBIR LA AGREGACION DE PLAQUETAS | ⤷ Try a Trial |
| Australia | 655436 | ⤷ Try a Trial | |
| New Zealand | 323134 | Pharmaceutical compositions containing platelet aggregation inhibitors | ⤷ Try a Trial |
| Malaysia | 116837 | COMPOSITIONS FOR INHIBITING PLATELET AGGREGATION | ⤷ 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 | 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 | SPC/GB99/042 | United Kingdom | ⤷ Try a 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 | ⤷ 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 | 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 |
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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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