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Last Updated: September 28, 2020

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ELIGARD KIT Drug Profile

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Which patents cover Eligard Kit, and what generic alternatives are available?

Eligard Kit is a drug marketed by Tolmar Therap and is included in four NDAs. There are five patents protecting this drug.

This drug has seventy-nine patent family members in twenty-six countries.

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

US ANDA Litigation and Generic Entry Outlook for Eligard Kit

A generic version of ELIGARD KIT was approved as leuprolide acetate by SANDOZ on August 4th, 1998.

  Start Trial

Summary for ELIGARD KIT
International Patents:79
US Patents:5
Applicants:1
NDAs:4
Suppliers / Packagers: 1
Clinical Trials: 27
Formulation / Manufacturing:see details
DailyMed Link:ELIGARD KIT at DailyMed
Drug patent expirations by year for ELIGARD KIT
Recent Clinical Trials for ELIGARD KIT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
ECOG-ACRIN Cancer Research GroupPhase 3
SanofiPhase 2
Luis SouhamiPhase 2

See all ELIGARD KIT clinical trials

US Patents and Regulatory Information for ELIGARD KIT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021343-001 Jan 23, 2002 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021488-001 Feb 13, 2003 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021379-001 Jul 24, 2002 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021731-001 Dec 14, 2004 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ELIGARD KIT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021343-001 Jan 23, 2002   Start Trial   Start Trial
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021488-001 Feb 13, 2003   Start Trial   Start Trial
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021488-001 Feb 13, 2003   Start Trial   Start Trial
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021488-001 Feb 13, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Medtronic

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