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Generated: June 19, 2019

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LEUPROLIDE ACETATE - Generic Drug Details

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What are the generic sources for leuprolide acetate and what is the scope of leuprolide acetate freedom to operate?

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

Leuprolide acetate has one hundred and ninety-four 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.

Pharmacology for LEUPROLIDE ACETATE
Medical Subject Heading (MeSH) Categories for LEUPROLIDE ACETATE
Synonyms for LEUPROLIDE 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
AK322237
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
Lupron
Lutrate
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
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020517-003 Jun 17, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021731-001 Dec 14, 2004 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021379-001 Jul 24, 2002 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021731-001 Dec 14, 2004 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020517-003 Jun 17, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021343-001 Jan 23, 2002 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 020263-006 Jan 21, 1994 ➤ Sign Up ➤ Sign Up
Ortho Mcneil Janssen VIADUR leuprolide acetate IMPLANT;IMPLANTATION 021088-001 Mar 3, 2000 ➤ Sign Up ➤ Sign Up
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021731-001 Dec 14, 2004 ➤ Sign Up ➤ Sign Up
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020708-001 Mar 7, 1997 ➤ Sign Up ➤ Sign Up
Abbvie Endocrine Inc LUPRON DEPOT-PED leuprolide acetate INJECTABLE;INJECTION 020263-004 Apr 16, 1993 ➤ Sign Up ➤ Sign Up
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020708-001 Mar 7, 1997 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

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Queensland Health
Cipla
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Daiichi Sankyo
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