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Dow
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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021488

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NDA 021488 describes ELIGARD, which is a drug marketed by Tolmar Therap and is included in four NDAs. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the ELIGARD profile page.

The generic ingredient in ELIGARD is leuprolide acetate. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 021488
Tradename:ELIGARD
Applicant:Tolmar Therap
Ingredient:leuprolide acetate
Patents:8
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021488
Suppliers and Packaging for NDA: 021488
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021488 NDA TOLMAR PHARMACEUTICALS INC. 62935-302 N 62935-302-30
ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021488 NDA TOLMAR PHARMACEUTICALS INC. 62935-303 N 62935-303-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength30MG/VIAL
Approval Date:Feb 13, 2003TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 28, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING CANCER
Patent:➤ Try a Free TrialPatent Expiration:Mar 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Oct 28, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING CANCER

Expired US Patents for NDA 021488

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021488-001 Feb 13, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021488-001 Feb 13, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021488-001 Feb 13, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021488-001 Feb 13, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Express Scripts
Colorcon
QuintilesIMS
Citi
Deloitte
Federal Trade Commission
Daiichi Sankyo
McKesson

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