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Profile for Tradename: ELIGARD

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Eligard is a drug marketed by Tolmar Therap and is included in four NDAs. It is available from two suppliers. There are three patents protecting this drug.

This drug has sixty-one patent family members in twenty-six countries.

The generic ingredient in ELIGARD is leuprolide acetate. There are nineteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

Summary for Tradename: ELIGARD

Patents:3
Applicants:1
NDAs:4
Suppliers / Packagers: see list12

Clinical Trials for: ELIGARD

Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer
Status: Active, not recruiting Condition: Prostate Cancer

Evaluate Recovery of Testosterone for Patients Using Eligard
Status: Completed Condition: Prostate Cancer

A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty
Status: Completed Condition: Puberty, Precocious

Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty
Status: Completed Condition: Precocious; Leuprolide Acetate; Luteinizing Hormone (LH); Gonadotrophin-releasing Hormone Agonist (GnRHa); Tanner Staging; Depot Formulation; Suppression of LH; Central Precocious Puberty (CPP); Gonadotrophin-releasing Hormone (GnRH); Lupron; GnRH Analog; Pediatrics Central Precocious Puberty

A Study of Leuprolide to Treat Prostate Cancer
Status: Completed Condition: Prostate Cancer

Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
Status: Active, not recruiting Condition: Prostate Cancer

Observational, Non-interventional, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients
Status: Completed Condition: Prostate Cancer

A Study in Patients With Metastatic Prostate Cancer to Assess How the Drug Eligard®, Affects Certain Markers in Blood and Urine, Which Are Indicators for the Disease
Status: Recruiting Condition: Metastatic Prostate Cancer

A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD
Status: Completed Condition: Prostate Cancer

Melanoma Vaccine With Peptides and Leuprolide
Status: Completed Condition: Melanoma

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
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021343-001Jan 23, 2002RXYes6,565,874<disabled>Y<disabled>
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021488-001Feb 13, 2003RXYes6,565,874<disabled>Y<disabled>
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379-001Jul 24, 2002RXYes6,565,874<disabled>Y<disabled>
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021731-001Dec 14, 2004RXYes6,626,870<disabled>Y<disabled>
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021488-001Feb 13, 2003RXYes6,773,714<disabled>Y<disabled>
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Non-Orange Book Patents for Tradename: ELIGARD

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
8,486,455Polymeric delivery formulations of leuprolide with improved efficacy<disabled in preview>
6,143,314 Controlled release liquid delivery compositions with low initial drug burst<disabled in preview>
8,840,916Sustained release polymer<disabled in preview>
8,470,359Sustained release polymer<disabled in preview>
6,630,155 Controlled release liquid delivery compositions with low initial drug burst<disabled in preview>
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International Patent Family for Tradename: ELIGARD

Country Document Number Publication Date
New Zealand525210Oct 29, 2004
Slovenia1322286Oct 31, 2005
Poland361671Oct 04, 2004
Slovakia5152003Oct 07, 2003
Denmark1126822May 10, 2004
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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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