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Eptifibatide - Generic Drug Details

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Eptifibatide is the generic ingredient in two branded drugs marketed by Schering, Aurobindo Pharma Ltd, and Teva Pharms Usa, and is included in four NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-six patent family members in sixteen countries.

There are thirteen drug master file entries for eptifibatide. Four suppliers are listed for this compound.

Summary for Generic Name: eptifibatide

Tradenames:2
Patents:1
Applicants:3
NDAs:4
Drug Master File Entries: see list13
Suppliers / Packaging: see list4
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: eptifibatide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa
EPTIFIBATIDE
eptifibatide
INJECTABLE;INJECTION091555-001Jun 5, 2015DISCNNo► subscribe► subscribe
Schering
INTEGRILIN
eptifibatide
INJECTABLE;INJECTION020718-002May 18, 1998RXYes5,807,825► subscribe ► subscribe
Aurobindo Pharma Ltd
EPTIFIBATIDE
eptifibatide
INJECTABLE;INJECTION206127-002Dec 8, 2015RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: eptifibatide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering
INTEGRILIN
eptifibatide
INJECTABLE;INJECTION020718-001May 18, 19985,686,570► subscribe
Schering
INTEGRILIN
eptifibatide
INJECTABLE;INJECTION020718-001May 18, 19985,968,902► subscribe
Schering
INTEGRILIN
eptifibatide
INJECTABLE;INJECTION020718-002May 18, 19985,968,902► subscribe
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Non-Orange Book Patents for Generic Ingredient: eptifibatide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,344,783 Platelet aggregation inhibitors► subscribe
5,770,564 Platelet aggregation inhibitors► subscribe
5,318,899 Platelet aggregation inhibitors► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: eptifibatide

Country Document Number Estimated Expiration
Norway304267► subscribe
Norway982249► subscribe
Norway312965► 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: EPTIFIBATIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90043Netherlands► subscribePRODUCT NAME: EPTIFIBATIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NAT. REGISTRATION NO/DATE: EU/1/99/109/001 - EU/1/99/109/002 19990701; FIRST REGISTRATION: CH 54050, 54054 19970227
/1999Austria► subscribePRODUCT NAME: EPTIFIBATID ODER PHARMAZEUTISCH ANNEHMBARE SALZE HIEVON; NAT. REGISTRATION NO/DATE: EU/1/99/109/001 EU/1/99/109/002 19990701; FIRST REGISTRATION: LI 54050 UND 54054 19970227
C/GB99/046United Kingdom► subscribePRODUCT NAME: EPTIFIBATIDE OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: CH 54054 19970227; CH 54050 19970227; UK EU/1/99/109/001 19990701; UK EU/1/99/109/002 19990701
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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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