LUPRON DEPOT-PED KIT Drug Patent Profile

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Which patents cover Lupron Depot-ped Kit, and what generic alternatives are available?

Lupron Depot-ped Kit is a drug marketed by Abbvie Endocrine Inc and is included in one NDA. There are two patents protecting this drug.

This drug has thirty-five patent family members in twenty-eight countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lupron Depot-ped Kit

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

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Summary for LUPRON DEPOT-PED KIT

International Patents:	35
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	134
DailyMed Link:	LUPRON DEPOT-PED KIT at DailyMed

Drug patent expirations by year for LUPRON DEPOT-PED KIT

Recent Clinical Trials for LUPRON DEPOT-PED KIT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
NRG Oncology	Phase 2
Prostate Cancer Foundation	Phase 2
Panbela Therapeutics	Phase 2

See all LUPRON DEPOT-PED KIT clinical trials

US Patents and Regulatory Information for LUPRON DEPOT-PED KIT

LUPRON DEPOT-PED KIT is protected by two US patents and one FDA Regulatory Exclusivity.

Patents protecting LUPRON DEPOT-PED KIT

Sustained-release composition and method for producing the same
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Patent Expiration: ⤷ Sign Up

Sustained-release composition and method for producing the same
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PEDIATRIC PATIENTS WITH CENTRAL PRECOCIOUS PUBERTY

FDA Regulatory Exclusivity protecting LUPRON DEPOT-PED KIT

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Glossary

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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-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-003	Apr 16, 1993		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-008	Aug 15, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-005	Jan 21, 1994		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-009	Apr 14, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-002	Apr 16, 1993		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-004	Apr 16, 1993		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-006	Jan 21, 1994		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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-PED KIT

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-005	Jan 21, 1994	⤷ Sign Up	⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-004	Apr 16, 1993	⤷ Sign Up	⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-008	Aug 15, 2011	⤷ Sign Up	⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-005	Jan 21, 1994	⤷ Sign Up	⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-008	Aug 15, 2011	⤷ Sign Up	⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-003	Apr 16, 1993	⤷ Sign Up	⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-006	Jan 21, 1994	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for LUPRON DEPOT-PED KIT

See the table below for patents covering LUPRON DEPOT-PED KIT around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	3191004		⤷ Sign Up
Greece	860332	METHOD FOR PRODUCING MICROCAPSULE	⤷ Sign Up
Norway	347209		⤷ Sign Up
Norway	910555		⤷ Sign Up
Israel	198845	תכשיר פפטיד לשחרור ממושך, תהליך להכנתו ושימוש בו להכנת תרופות (Sustained-release peptide composition, process for producing the same and use thereof in the preparation of medicaments)	⤷ Sign Up
Greece	80818	METHOD FOR PRODUCING MICROCAPSULE	⤷ Sign Up
Canada	2671670	COMPOSITION A LIBERATION PROLONGEE ET PROCEDE DE PRODUCTION CORRESPONDANT (SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration