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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Fuji
Harvard Business School
Colorcon
Medtronic
US Department of Justice
Teva
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Cerilliant
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Generated: August 18, 2017

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 nine patents protecting this drug. Additional details are available on the ELIGARD profile page.

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

Summary for NDA: 021488

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:8
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

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 62935-302-30 1 KIT in 1 CARTON (62935-302-30) * .5 mL in 1 SYRINGE (62935-301-29) * .5 mL in 1 SYRINGE (62935-300-30)
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS 021488 NDA TOLMAR PHARMACEUTICALS INC. 62935-303 62935-303-30 1 KIT in 1 CARTON (62935-303-30) * .5 mL in 1 SYRINGE (62935-305-29) * .5 mL in 1 SYRINGE (62935-304-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength30MG/VIAL
Approval Date:Feb 13, 2003TE:RLD:Yes
Patent:► SubscribePatent Expiration:Mar 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Oct 28, 2018Product Flag?YSubstance Flag?YDelist Request?
Patent:► SubscribePatent Expiration:Nov 13, 2020Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021488

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021488-001Feb 13, 2003► Subscribe► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021488-001Feb 13, 2003► Subscribe► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021488-001Feb 13, 2003► Subscribe► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021488-001Feb 13, 2003► Subscribe► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021488-001Feb 13, 2003► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

US Army
Chinese Patent Office
QuintilesIMS
US Department of Justice
Argus Health
Cantor Fitzgerald
Deloitte
Harvard Business School
Queensland Health
Johnson and Johnson

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