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Generated: September 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021379

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NDA 021379 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. Five suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

Summary for NDA: 021379

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

Suppliers and Packaging for NDA: 021379

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS 021379 NDA TOLMAR PHARMACEUTICALS INC. 62935-222 62935-222-05 1 KIT in 1 CARTON (62935-222-05) * .375 mL in 1 SYRINGE (62935-220-04) * .375 mL in 1 SYRINGE (62935-225-05)
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS 021379 NDA TOLMAR PHARMACEUTICALS INC. 62935-223 62935-223-05 1 KIT in 1 CARTON (62935-223-05) * .375 mL in 1 SYRINGE (62935-221-04) * .375 mL in 1 SYRINGE (62935-224-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength22.5MG/VIAL
Approval Date:Jul 24, 2002TE:RLD:Yes
Patent:► SubscribePatent Expiration:Oct 28, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING CANCER
Patent:► SubscribePatent Expiration:Mar 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Oct 28, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING CANCER

Expired Orange Book Patents for NDA: 021379

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379-001Jul 24, 2002► Subscribe► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379-001Jul 24, 2002► Subscribe► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379-001Jul 24, 2002► Subscribe► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379-001Jul 24, 2002► Subscribe► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379-001Jul 24, 2002► Subscribe► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379-001Jul 24, 2002► Subscribe► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379-001Jul 24, 2002► Subscribe► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379-001Jul 24, 2002► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Novartis
US Department of Justice
McKinsey
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Federal Trade Commission
Julphar
Dow
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Boehringer Ingelheim

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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