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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, 20045,919,455<disabled>
Valeant Pharms Llc
MACUGEN
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 20046,113,906<disabled>
Valeant Pharms Llc
MACUGEN
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 20046,426,335<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
6,610,841 Nucleotide-based prodrugs<disabled in preview>
5,789,160 Parallel selex<disabled in preview>
6,261,774 Truncation selex method<disabled in preview>
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International Patent Family for Ingredient: pegaptanib sodium

Country Document Number Estimated Expiration
European Patent Office0823914<disabled in preview>
Canada2360748<disabled in preview>
Australia6147096<disabled in preview>
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Supplementary Protection Certificates for Tradename: PEGAPTANIB SODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C024/2006Ireland<disabled>SPC024/2006:, EXPIRES: 20210130
C0021France<disabled>PRODUCT NAME: PEGAPTANIB EN PARTICULIER SOUS FORME DE SON SEL DE SODIUM; REGISTRATION NO/DATE IN FRANCE: EU/1/05/325/001 DU 20060131; REGISTRATION NO/DATE AT EEC: EU/1/05/325/001 DU 20060131
0234Netherlands<disabled>300234, 20171017, EXPIRES: 20210130
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