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Profile for Tradename: LUMIGAN

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Lumigan is a drug marketed by Allergan and is included in two NDAs. It is available from two suppliers. There are eleven patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-five patent family members in twenty-four countries.

The generic ingredient in LUMIGAN is bimatoprost. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the bimatoprost profile page.

Summary for Tradename: LUMIGAN

Patents:11
Applicants:1
NDAs:2
Suppliers / Packagers: see list8

Pharmacology for Tradename: LUMIGAN

Ingredient-typeProstaglandins
Drug ClassProstaglandin Analog

Clinical Trials for: LUMIGAN

Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01 % and Lumigan® 0.03% Unit Dose
Status: Recruiting Condition: Primary Open Angle Glaucoma; Ocular Hypertension

Eyelash Growth From Application of Bimatoprost in Gel Suspension to the Base of the Eyelashes
Status: Completed Condition: Hypertrichosis

Efficacy Study of Latanoprost and Bimatoprost Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata
Status: Completed Condition: Alopecia Areata

An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®
Status: Completed Condition: Glaucoma; Ocular Hypertension

The Effects of Xalatan, Travatan and Lumigan on Skin Pigmentation Near the Eye
Status: Active, not recruiting Condition: Glaucoma; Periocular Skin Pigmentation Changes

Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan®
Status: Completed Condition: Glaucoma; Ocular Hypertension

Assessment of Intraocular Pressure (IOP) Control in Subjects With Open-Angle Glaucoma or Ocular Hypertension Treated With Travoprost 0.004% (TRAVATAN® Z) or Bimatoprost 0.01% (LUMIGAN®)
Status: Completed Condition: Glaucoma; Ocular Hypertension; Open-Angle Glaucoma

Comparison of Latanoprost With Travoprost and Bimatoprost in Patients With Elevated IOP. A 12-Weeks, Masked Evaluator, Phase IV Multi-Center Study in the US
Status: Completed Condition: Glaucoma; Ocular Hypertension

A Study of Lumigan® 0.01% in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Status: Completed Condition: Glaucoma, Open-Angle; Ocular Hypertension

Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Status: Active, not recruiting Condition: Glaucoma; Ocular Hypertension

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
Allergan
LUMIGAN
bimatoprost
SOLUTION/DROPS;OPHTHALMIC022184-001Aug 31, 2010RXYes5,688,819<disabled><disabled>
Allergan
LUMIGAN
bimatoprost
SOLUTION/DROPS;OPHTHALMIC022184-001Aug 31, 2010RXYes8,524,777<disabled><disabled>
Allergan
LUMIGAN
bimatoprost
SOLUTION/DROPS;OPHTHALMIC022184-001Aug 31, 2010RXYes8,278,353<disabled>Y<disabled>
Allergan
LUMIGAN
bimatoprost
SOLUTION/DROPS;OPHTHALMIC022184-001Aug 31, 2010RXYes8,772,338<disabled>Y<disabled>
Allergan
LUMIGAN
bimatoprost
SOLUTION/DROPS;OPHTHALMIC022184-001Aug 31, 2010RXYes8,299,118<disabled><disabled>
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Paragraph IV activity for: LUMIGAN

Drugname Dosage Strength RLD Submissiondate
bimatoprostOphthalmic Solution0.01%Lumigan4/5/2011
bimatoprostOphthalmic Solution0.03%Lumigan12/22/2008

Non-Orange Book Patents for Tradename: LUMIGAN

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
6,204,287 Cyclopentane heptan(ene)oic acid, 2-heteroarylalkenyl derivatives as therapeutic agents<disabled in preview>
6,037,364 Cyclopentane heptan(ene)oic acid, 2-heteroarylalkenyl derivatives as therapeutic agents<disabled in preview>
5,352,708 Non-acidic cyclopentane heptanoic acid, 2-cycloalkyl or arylalkyl derivatives as therapeutic agents<disabled in preview>
6,310,087 Cyclopentane heptan(ene)oic acid, 2-heteroarylalkenyl derivatives as therapeutic agents<disabled in preview>
5,972,991 Cyclopentane heptan(ene) oic acid, 2-heteroarylalkenyl derivatives as therapeutic agents<disabled in preview>
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International Patent Family for Tradename: LUMIGAN

Country Document Number Publication Date
Canada2585691Sep 28, 2006
Japan3681068Aug 10, 2005
JapanH11505802May 25, 1999
Russian Federation2007133919Apr 27, 2009
Norway20074390Oct 15, 2007
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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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