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Pegaptanib sodium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for pegaptanib sodium?

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 / Packagers: see list1
Clinical Trials: see list927
Drug Prices:see low prices
DailyMed Link:pegaptanib sodium at DailyMed

Pharmacology for Ingredient: pegaptanib sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms Llc
MACUGEN
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 2004RXYesYes5,932,462► SubscribeY ► Subscribe
Valeant Pharms Llc
MACUGEN
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 2004RXYesYes6,011,020► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: pegaptanib sodium

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► Subscribe
Valeant Pharms Llc
MACUGEN
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 20046,113,906► Subscribe
Valeant Pharms Llc
MACUGEN
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 20046,147,204► Subscribe
Valeant Pharms Llc
MACUGEN
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 20046,426,335► Subscribe
Valeant Pharms Llc
MACUGEN
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 20046,051,698► Subscribe
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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
8,546,493Multi-armed, monofunctional, and hydrolytically stable derivatives of poly(ethylene glycol) and related polymers for modification of surfaces and molecules► Subscribe
5,670,637 Nucleic acid ligands► Subscribe
5,637,461 Ligands of HIV-1 TAT protein► Subscribe
6,465,189 Systematic evolution of ligands by exponential enrichment: blended selex► Subscribe
5,726,017 High affinity HIV-1 gag nucleic acid ligands► 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: pegaptanib sodium

Country Document Number Estimated Expiration
Canada2535449► Subscribe
JapanH09502354► Subscribe
Australia3149595► Subscribe
Australia5670796► Subscribe
Estonia200200051► 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: PEGAPTANIB SODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2006004,C0957929Lithuania► SubscribePRODUCT NAME: PEGAPTANIBUM; REGISTRATION NO/DATE: EU/1/05/325/001 20060131
0957929/01Switzerland► SubscribePRODUCT NAME: PEGAPTANIB; REGISTRATION NUMBER/DATE: SWISSMEDIC 57459 15.02.2006
C024/2006Ireland► SubscribeSPC024/2006:, EXPIRES: 20210130
C0021France► SubscribePRODUCT 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
2006004Lithuania► SubscribePRODUCT NAME: PEGAPTANIBUM; REG. NO/DATE: EU/1/05/325/001 20060131
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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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