Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Fish and Richardson
Baxter
Johnson and Johnson
US Department of Justice
Healthtrust
Cantor Fitzgerald
UBS
Mallinckrodt
Medtronic
US Army

Generated: October 23, 2017

DrugPatentWatch Database Preview

LEUPROLIDE ACETATE - Generic Drug Details

« Back to Dashboard

What are the generic drug sources for leuprolide acetate and what is the scope of leuprolide acetate patent protection?

Leuprolide acetate
is the generic ingredient in seven branded drugs marketed by Abbvie Endocrine Inc, Genzyme, Sandoz, Tolmar Therap, Teva Pharms Usa, Sun Pharma Global, Ortho Mcneil Janssen, and Abbvie Endocrine, and is included in sixteen NDAs. There are twenty-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Leuprolide acetate has three hundred and seventy patent family members in forty-four countries.

There are twenty-one drug master file entries for leuprolide acetate. Five suppliers are listed for this compound.

Summary for Generic Name: LEUPROLIDE ACETATE

US Patents:23
Tradenames:7
Applicants:8
NDAs:16
Drug Master File Entries: see list21
Suppliers / Packagers: see list5
Bulk Api Vendors: see list38
Clinical Trials: see list1,008
Patent Applications: see list8,433
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:LEUPROLIDE ACETATE at DailyMed

Pharmacology for Ingredient: LEUPROLIDE ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379-001Jul 24, 2002RXYesYes► Subscribe► SubscribeYY ► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021343-001Jan 23, 2002RXYesYes► Subscribe► SubscribeY ► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021343-001Jan 23, 2002RXYesYes► Subscribe► SubscribeY ► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020517-003Jun 17, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020011-001Oct 22, 1990DISCNYesNo► Subscribe► Subscribe► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379-001Jul 24, 2002RXYesYes► Subscribe► SubscribeYY ► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021488-001Feb 13, 2003RXYesYes► Subscribe► SubscribeY ► Subscribe
Teva Pharms Usa
LEUPROLIDE ACETATE
leuprolide acetate
INJECTABLE;INJECTION075471-001Oct 25, 2000APRXNoNo► Subscribe► Subscribe► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379-001Jul 24, 2002RXYesYes► Subscribe► SubscribeY ► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION019732-001Jan 26, 1989RXYesYes► Subscribe► Subscribe ► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: leuprolide acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie Endocrine Inc
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION020263-005Jan 21, 1994► Subscribe► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION020263-006Jan 21, 1994► Subscribe► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020011-001Oct 22, 1990► Subscribe► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION020263-002Apr 16, 1993► Subscribe► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION019732-001Jan 26, 1989► Subscribe► Subscribe
Ortho Mcneil Janssen
VIADUR
leuprolide acetate
IMPLANT;IMPLANTATION021088-001Mar 3, 2000► Subscribe► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION020263-006Jan 21, 1994► Subscribe► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021343-001Jan 23, 2002► Subscribe► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021488-001Feb 13, 2003► Subscribe► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION020263-004Apr 16, 1993► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Non-Orange Book Patents for Generic Ingredient: leuprolide acetate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,851,451 Production of microspheres► Subscribe
7,655,257Sustained delivery of an active agent using an implantable system► Subscribe
6,635,268 Sustained delivery of an active agent using an implantable system► Subscribe
8,535,701Sustained delivery of an active agent using an implantable system► Subscribe
8,067,030Controlled release composition and method of producing the same► Subscribe
6,630,155 Controlled release liquid delivery compositions with low initial drug burst► Subscribe
8,298,562Sustained delivery of an active agent using an implantable system► Subscribe
9,713,595Sustained-release composition and method for producing the same► Subscribe
6,143,314 Controlled release liquid delivery compositions with low initial drug burst► Subscribe
8,080,259Sustained delivery of an active agent using an implantable system► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: leuprolide acetate

Country Document Number Estimated Expiration
New Zealand333294► Subscribe
Germany69731498► Subscribe
European Patent Office1491236► Subscribe
China1520895► Subscribe
Spain2181010► Subscribe
Slovakia287577► Subscribe
Japan2010513225► Subscribe
New Zealand503069► Subscribe
South Korea20090094272► Subscribe
Colombia4930286► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Dow
Daiichi Sankyo
Teva
US Department of Justice
McKesson
AstraZeneca
Queensland Health
Harvard Business School
UBS
Citi

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot