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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Daiichi Sankyo
Fish and Richardson
Colorcon
US Army
McKesson
Merck
Federal Trade Commission
Queensland Health

Generated: April 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 fifteen 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
Synonyms for leuprolide acetate
(Des-Gly10,D-Leu6,Pro-NHEt9)-LHRH acetate
381L536
5-Oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tryosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide monoacetate
5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide--acetic acid (1/1)
53714-56-0
74381-53-6
743L536
A-43818
Abbott-43818
AC-28731
AC1LCW5G
AKOS015895632
AKOS030485977
Carcinil
CAS-74381-53-6
CHEBI:63597
CHEMBL1200775
CS-1434
des-Gly10-[D-Leu6]-LH-RH ethylamide
DSSTox_CID_28935
DSSTox_GSID_49009
DSSTox_RID_83201
DTXSID7049009
Enanton
Enantone
FT-0627807
HY-13665
L0249
Leuprolide acetate salt
Leuprorelin acetate
Leuprorelinacetate
Lupron
Lutrate
MFCD00072080
MFCD00167544
MLS000028695
NCGC00183364-01
Onectyl
Prostap
Pyr-His-Trp-Ser-Tyr-D-Leu-Leu-Arg-Pro-NHEt.HOAc
RGLRXNKKBLIBQS-XNHQSDQCSA-N
SCHEMBL3174
SMR000058945
TAP-144
Tox21_113507

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
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021379-001 Jul 24, 2002 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Abbvie Endocrine Inc LUPRON DEPOT-PED leuprolide acetate INJECTABLE;INJECTION 020263-005 Jan 21, 1994 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 019732-001 Jan 26, 1989 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021488-001 Feb 13, 2003 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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
Abbvie Endocrine Inc LUPRON DEPOT-PED leuprolide acetate INJECTABLE;INJECTION 020263-003 Apr 16, 1993 ➤ Sign Up ➤ Sign Up
Abbvie Endocrine Inc LUPRON DEPOT-PED leuprolide acetate INJECTABLE;INJECTION 020263-002 Apr 16, 1993 ➤ Sign Up ➤ Sign Up
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021488-001 Feb 13, 2003 ➤ Sign Up ➤ Sign Up
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020517-001 Dec 22, 1995 ➤ Sign Up ➤ Sign Up
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
6,143,314 Controlled release liquid delivery compositions with low initial drug burst ➤ Sign Up
8,067,030 Controlled release composition and method of producing the same ➤ Sign Up
8,246,987 Controlled release composition and method of producing the same ➤ Sign Up
9,617,303 Sustained-release composition and method for producing the same ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Chinese Patent Office
Baxter
Cipla
Moodys
McKinsey
Mallinckrodt
Colorcon
Accenture

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.