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Tirofiban hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for tirofiban hydrochloride?

Tirofiban hydrochloride is the generic ingredient in one branded drug marketed by Medicure and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tirofiban hydrochloride has fifty-nine patent family members in thirty-five countries.

There are three drug master file entries for tirofiban hydrochloride. One supplier is listed for this compound.

Summary for Generic Name: tirofiban hydrochloride

Tradenames:1
Patents:6
Applicants:1
NDAs:2
Drug Master File Entries: see list3
Suppliers / Packagers: see list1
Bulk Api Vendors: see list89
Clinical Trials: see list1,004
Patent Applications: see list6,092
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:tirofiban hydrochloride at DailyMed

Pharmacology for Ingredient: tirofiban hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medicure
AGGRASTAT
tirofiban hydrochloride
INJECTABLE;INJECTION020913-003Apr 20, 2000RXYesYes6,136,794► Subscribe ► Subscribe
Medicure
AGGRASTAT
tirofiban hydrochloride
INJECTABLE;INJECTION020913-002May 17, 2002RXYesNo6,770,660► Subscribe ► Subscribe
Medicure
AGGRASTAT
tirofiban hydrochloride
SOLUTION;INJECTION020912-002Aug 31, 2016RXYesYes5,972,967► SubscribeY ► Subscribe
Medicure
AGGRASTAT
tirofiban hydrochloride
INJECTABLE;INJECTION020913-001May 14, 1998DISCNNoNo5,978,698► Subscribe ► Subscribe
Medicure
AGGRASTAT
tirofiban hydrochloride
INJECTABLE;INJECTION020912-001May 14, 1998DISCNNoNo5,965,581► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: tirofiban hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medicure
AGGRASTAT
tirofiban hydrochloride
INJECTABLE;INJECTION020913-003Apr 20, 20005,972,967► Subscribe
Medicure
AGGRASTAT
tirofiban hydrochloride
INJECTABLE;INJECTION020913-003Apr 20, 20005,733,919► Subscribe
Medicure
AGGRASTAT
tirofiban hydrochloride
INJECTABLE;INJECTION020913-002May 17, 20025,658,929► Subscribe
Medicure
AGGRASTAT
tirofiban hydrochloride
INJECTABLE;INJECTION020912-001May 14, 19985,292,756► Subscribe
Medicure
AGGRASTAT
tirofiban hydrochloride
INJECTABLE;INJECTION020913-003Apr 20, 20005,880,136► Subscribe
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International Patent Family for Ingredient: tirofiban hydrochloride

Country Document Number Estimated Expiration
Cyprus2292► Subscribe
Portugal859634► Subscribe
Mexico9803275► Subscribe
Turkey9800716► Subscribe
Japan2002501936► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TIROFIBAN HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90040Netherlands► SubscribePRODUCT 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
C/GB99/042United Kingdom► SubscribePRODUCT 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
00C/002Belgium► SubscribePRODUCT NAME: TIROFIBANUM HYDROCHLORIDUM (EQ. TIROFIBAN); NAT. REGISTRATION NO/DATE: 922 IS 191 F 12 19990906; FIRST REGISTRATION: CH 54761 19980528
/1999Austria► SubscribePRODUCT 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
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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 verifification 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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