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Last Updated: August 4, 2020

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LUPRON DEPOT Drug Profile

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When do Lupron Depot patents expire, and what generic alternatives are available?

Lupron Depot is a drug marketed by Abbvie Endocrine Inc and is included in five NDAs. There are two patents protecting this drug.

This drug has one hundred patent family members in forty-one countries.

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

US ANDA Litigation and Generic Entry Outlook for Lupron Depot

A generic version of LUPRON DEPOT was approved as leuprolide acetate by SANDOZ on August 4th, 1998.

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Drug patent expirations by year for LUPRON DEPOT
Drug Prices for LUPRON DEPOT

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Recent Clinical Trials for LUPRON DEPOT

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SponsorPhase
ECOG-ACRIN Cancer Research GroupPhase 3
Colorado Center for Reproductive MedicineEarly Phase 1
AbbVieEarly Phase 1

See all LUPRON DEPOT clinical trials

Paragraph IV (Patent) Challenges for LUPRON DEPOT
Tradename Dosage Ingredient NDA Submissiondate
LUPRON DEPOT INJECTABLE;INJECTION leuprolide acetate 019732

US Patents and Regulatory Information for LUPRON DEPOT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020011-001 Oct 22, 1990 DISCN Yes No   Start Trial   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020517-003 Jun 17, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020708-001 Mar 7, 1997 RX Yes Yes   Start Trial   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-005 Jan 21, 1994 RX Yes Yes   Start Trial   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020517-003 Jun 17, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-006 Jan 21, 1994 RX Yes Yes   Start Trial   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020011-002 Oct 26, 1995 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LUPRON DEPOT

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   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020011-001 Oct 22, 1990   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020517-002 May 30, 1997   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020011-001 Oct 22, 1990   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020708-001 Mar 7, 1997   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020011-001 Oct 22, 1990   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020517-002 May 30, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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