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Pegaptanib sodium - Generic Drug Details

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Pegaptanib sodium is the generic ingredient in one branded drug marketed by Valeant Pharms Llc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has three hundred and sixty-seven patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for Generic Name: pegaptanib sodium

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: 0
Suppliers / Packaging: see list1

Pharmacology for Ingredient: pegaptanib sodium

Clinical Trials for: pegaptanib sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms Llc
MACUGEN
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 2004RXYes5,932,462<disabled>Y <disabled>
Valeant Pharms Llc
MACUGEN
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 2004RXYes6,011,020<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: pegaptanib sodium

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms Llc
MACUGEN
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 20046,113,906<disabled>
Valeant Pharms Llc
MACUGEN
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 20045,919,455<disabled>
Valeant Pharms Llc
MACUGEN
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 20046,051,698<disabled>
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Non-Orange Book Patents for Generic Ingredient: pegaptanib sodium

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
6,465,189 Systematic evolution of ligands by exponential enrichment: blended selex<disabled in preview>
7,087,735Bivalent binding molecules of 7 transmembrane G protein-coupled receptors<disabled in preview>
5,972,599 High affinity nucleic acid ligands of cytokines<disabled in preview>
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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: pegaptanib sodium

Country Document Number Estimated Expiration
European Patent Office2241635<disabled in preview>
World Intellectual Property Organization (WIPO)9622383<disabled in preview>
Japan2005065701<disabled in preview>
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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: PEGAPTANIB SODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0957929/01Switzerland<disabled>PRODUCT NAME: PEGAPTANIB; REGISTRATION NUMBER/DATE: SWISSMEDIC 57459 15.02.2006
C024/2006Ireland<disabled>SPC024/2006:, EXPIRES: 20210130
0234Netherlands<disabled>300234, 20171017, EXPIRES: 20210130
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