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Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021731

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NDA 021731 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: 021731

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

Suppliers and Packaging for NDA: 021731

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS 021731 NDA TOLMAR PHARMACEUTICALS INC. 62935-452 62935-452-45 1 KIT in 1 CARTON (62935-452-45) * .375 mL in 1 SYRINGE (62935-451-44) * .375 mL in 1 SYRINGE (62935-450-45)
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS 021731 NDA TOLMAR PHARMACEUTICALS INC. 62935-453 62935-453-45 1 KIT in 1 CARTON (62935-453-45) * .375 mL in 1 SYRINGE (62935-454-44) * .375 mL in 1 SYRINGE (62935-455-45)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength45MG/VIAL
Approval Date:Dec 14, 2004TE:RLD:Yes
Patent:6,626,870Patent Expiration:Mar 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:8,486,455Patent Expiration:Oct 28, 2018Product Flag?YSubstance Flag?YDelist Request?
Patent:8,840,916Patent Expiration:Nov 13, 2020Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021731

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021731-001Dec 14, 20045,599,552► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021731-001Dec 14, 20046,395,293► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021731-001Dec 14, 2004RE37950► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021731-001Dec 14, 20044,938,763► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021731-001Dec 14, 20045,739,176► Subscribe
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Serving 500+ biopharmaceutical companies globally:

McKinsey
Queensland Health
Dow
Merck
Harvard Business School
Federal Trade Commission
Chinese Patent Office
Daiichi Sankyo
Chubb
Citi

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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