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Profile for Tradename: MACUGEN

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Macugen is a drug marketed by Valeant Pharms Llc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug.

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

The generic ingredient in MACUGEN is pegaptanib sodium. One supplier is listed for this compound. Additional details are available on the pegaptanib sodium profile page.

Summary for Tradename: MACUGEN

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: MACUGEN

Clinical Trials for: MACUGEN

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

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

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

A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration In Real Life.
Status: Completed Condition: Exudative Age-related Macular Degeneration

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

Subretinal Macugen® for Neovascular Age-Related Macular Degeneration
Status: Recruiting Condition: Age-related Macular Degeneration

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

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

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

Continuation of Previous Study to Gather More Data on Effect of Macugen on the Corneal Endothelium
Status: Recruiting Condition: Age-Related Macular Degeneration; Retinal Vein Occlusion; Diabetic Macular Edema

Courtesy of ClinicalTrials.org
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
MACUGEN
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 2004RXYes6,051,698<disabled>Y<disabled>
Valeant Pharms Llc
MACUGEN
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 2004RXYes6,011,020<disabled>Y<disabled>
Valeant Pharms Llc
MACUGEN
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 2004RXYes5,932,462<disabled>Y<disabled>
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Non-Orange Book Patents for Tradename: MACUGEN

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
6,261,774 Truncation selex method<disabled in preview>
5,731,424 High affinity TGF.beta. nucleic acid ligands and inhibitors<disabled in preview>
5,670,637 Nucleic acid ligands<disabled in preview>
7,094,535Nucleic acid ligands to integrins<disabled in preview>
6,762,290 High affinity vascular endothelial growth factor (VEGF) receptor nucleic acid ligands and inhibitors<disabled in preview>
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International Patent Family for Tradename: MACUGEN

Country Document Number Publication Date
World Intellectual Property Organization (WIPO)9530775Nov 16, 1995
Australia781234May 12, 2005
World Intellectual Property Organization (WIPO)0052207Oct 25, 2001
European Patent Office1203007May 08, 2002
Australia3604700Sep 21, 2000
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ISSN: 2162-2639

Preferred citation:

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

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