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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Teva
Moodys
Accenture
Johnson and Johnson
Daiichi Sankyo
Chinese Patent Office
Colorcon
Chubb
Cantor Fitzgerald

Generated: February 24, 2018

DrugPatentWatch Database Preview

Leuprolide acetate - Generic Drug Details

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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 Ortho Mcneil Janssen, Genzyme, Sandoz, Sun Pharma Global, Teva Pharms Usa, Abbvie Endocrine Inc, Tolmar Therap, and Abbvie Endocrine, and is included in sixteen NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Leuprolide acetate has two hundred and sixteen patent family members in forty-two countries.

There are twenty-two drug master file entries for leuprolide acetate. Five suppliers are listed for this compound.
Summary for leuprolide acetate
Pharmacology for leuprolide acetate
Medical Subject Heading (MeSH) Categories for leuprolide acetate

US Patents and Regulatory Information for leuprolide acetate

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 020517-003 Jun 17, 2011 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021731-001 Dec 14, 2004 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 019732-001 Jan 26, 1989 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms Usa LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 075471-001 Oct 25, 2000 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED leuprolide acetate INJECTABLE;INJECTION 020263-005 Jan 21, 1994 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020011-002 Oct 26, 1995 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Ortho Mcneil Janssen VIADUR leuprolide acetate IMPLANT;IMPLANTATION 021088-001 Mar 3, 2000 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020517-003 Jun 17, 2011 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020011-001 Oct 22, 1990 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021731-001 Dec 14, 2004 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for leuprolide acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021488-001 Feb 13, 2003 ➤ 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-PED leuprolide acetate INJECTABLE;INJECTION 020263-005 Jan 21, 1994 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED leuprolide acetate INJECTABLE;INJECTION 020263-004 Apr 16, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021343-001 Jan 23, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED leuprolide acetate INJECTABLE;INJECTION 020263-004 Apr 16, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED leuprolide acetate INJECTABLE;INJECTION 020263-003 Apr 16, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED leuprolide acetate INJECTABLE;INJECTION 020263-005 Jan 21, 1994 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED leuprolide acetate INJECTABLE;INJECTION 020263-004 Apr 16, 1993 ➤ 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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Non-Orange Book US Patents for 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
9,617,303 Sustained-release composition and method for producing the same ➤ Try a Free Trial
8,246,987 Controlled release composition and method of producing the same ➤ Try a Free Trial
6,143,314 Controlled release liquid delivery compositions with low initial drug burst ➤ Try a Free Trial
6,630,155 Controlled release liquid delivery compositions with low initial drug burst ➤ Try a Free Trial
9,713,595 Sustained-release composition and method for producing the same ➤ Try a Free Trial
8,067,030 Controlled release composition and method of producing the same ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for leuprolide acetate

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

Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Mallinckrodt
Colorcon
Queensland Health
Merck
McKesson
Deloitte
Farmers Insurance
Baxter

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.

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