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Generated: November 12, 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
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020517
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 0074-3346-03 1 KIT in 1 CARTON (0074-3346-03) * 1 SWAB in 1 PACKET * 1.5 mL in 1 SYRINGE
LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020517 NDA AbbVie Inc. 0074-3473 0074-3473-03 1 KIT in 1 CARTON (0074-3473-03) * 1 SWAB in 1 PACKET * 1.5 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength22.5MG/VIAL
Approval Date:Dec 22, 1995TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength30MG/VIAL
Approval Date:May 30, 1997TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength45MG/VIAL
Approval Date:Jun 17, 2011TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jan 13, 2019Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 020517

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 ➤ Sign Up ➤ Sign Up
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020517-002 May 30, 1997 ➤ Sign Up ➤ Sign Up
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020517-002 May 30, 1997 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

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Accenture
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Fuji

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