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Details for Generic Name: pegaptanib sodium

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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 three 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

Drug Master File Entries: 0
Suppliers / Packaging: see list1

Pharmacology for Ingredient: pegaptanib sodium

Clinical Trials for: pegaptanib sodium

Study To Evaluate Safety And Tolerability Of Pegaptanib Sodium In Patients With Diabetic Macular Edema
Status: Completed Condition: Anti- VGF Inhibitor; Diabetic Macular Edema; Diabetic Retinopathy

The Effect of Macugen in Patients With Chronic, Post-Operative Cystoid Macular Edema
Status: Terminated Condition: Cystoid Macular Edema

Evaluation of Macugen Treatment of Macular Edema Due to Branch Retinal Vein Occlusion
Status: Completed Condition: Branch Retinal Vein Occlusion

Macugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-PDRS ED)
Status: Active, not recruiting Condition: Proliferative Diabetic Retinopathy

A Study of the Safety, Tolerability, and Efficacy of IVT Pre-op 0.3mg Pegaptanib Sodium Versus Sham, for Management of Tractional Retinal Detachment and Vitreous Hemorrhage With Proliferative Diabetic Retinopathy
Status: Withdrawn Condition: Proliferative Diabetic Retinopathy

Intravitreal Macugen for Ischaemic Diabetic Macular Oedema
Status: Completed Condition: Diabetic Macular Oedema

A Single-Center Trial of Intravitreous Injections of Macugen (Pegaptanib Sodium) Given at Least 7 Days Before Vitrectomy Secondary To Tractional Retinal Detachment in Proliferative Diabetic Retinopathy
Status: Completed Condition: PDR

Effect of Macugen(Pegaptanib)on Surgical Outcomes and VEGF Levels in Diabetic Patients With PDR (Diabetic Retinopathy or CSDME (Macular Edema)
Status: Completed Condition: Proliferative Diabetic Retinopathy; Diabetic Macular Edema

Pegaptanib for Retinal Edema Secondary to Diabetic Vascular Disease(Preserve) Study
Status: Completed Condition: Diabetic Macular Edema

A Pilot Study for the Treatment of Iris Neovascularization With Macugen
Status: Completed Condition: Iris Neovascularization; Diabetic Retinopathy

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms Llc
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 2004RXYes5,932,462<disabled>Y <disabled>
Valeant Pharms Llc
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 2004RXYes6,011,020<disabled>Y <disabled>
Valeant Pharms Llc
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 2004RXYes6,051,698<disabled>Y <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
5,811,533 High-affinity oligonucleotide ligands to vascular endothelial growth factor (VEGF)<disabled in preview>
5,674,685 High affinity PDGF nucleic acid ligands<disabled in preview>
6,001,577 Systematic evolution of ligands by exponential enrichment: photoselection of nucleic acid ligands and solution selex<disabled in preview>
5,789,160 Parallel selex<disabled in preview>
5,476,766 Ligands of thrombin<disabled in preview>
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International Patent Family for Ingredient: pegaptanib sodium

Country Document Number Publication Date
Japan2003505111Feb 12, 2003
European Patent Office0533838Dec 03, 1997
JapanH08252100Oct 01, 1996
Russian Federation2198931Feb 20, 2003
Canada2645735Nov 07, 1996
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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