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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020517

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NDA 020517 describes LUPRON DEPOT, which is a drug marketed by Abbvie Endocrine Inc and is included in five NDAs. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the LUPRON DEPOT profile page.

The generic ingredient in LUPRON DEPOT 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 020517

Tradename:	LUPRON DEPOT
Applicant:	Abbvie Endocrine Inc
Ingredient:	leuprolide acetate
Patents:	3
Therapeutic Class:	Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 020517

Antineoplastic Agents, Hormonal
Fertility Agents, Female

Suppliers and Packaging for NDA: 020517

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517	NDA	AbbVie Inc.	0074-3346	N	0074-3346-03
LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517	NDA	AbbVie Inc.	0074-3473	N	0074-3473-03

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	22.5MG/VIAL
Approval Date:	Dec 22, 1995	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	30MG/VIAL
Approval Date:	May 30, 1997	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	45MG/VIAL
Approval Date:	Jun 17, 2011	TE:		RLD:	Yes
Patent:	➤ Try a Free Trial	Patent Expiration:	Jan 13, 2019	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 020517

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-001	Dec 22, 1995	➤ Try a Free Trial	➤ Try a Free Trial
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-001	Dec 22, 1995	➤ Try a Free Trial	➤ Try a Free Trial
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-002	May 30, 1997	➤ Try a Free Trial	➤ Try a Free Trial
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-001	Dec 22, 1995	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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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.