Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Express Scripts
Medtronic
Moodys
Johnson and Johnson

Last Updated: November 15, 2019

DrugPatentWatch Database Preview

Leuprolide acetate - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

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

Leuprolide acetate is the generic ingredient in eight branded drugs marketed by Gp-pharm Sa, Ortho Mcneil Janssen, Genzyme, Sandoz, Sun Pharm, 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. Four suppliers are listed for this compound.

Drug Prices for leuprolide acetate

See drug prices for leuprolide acetate

Recent Clinical Trials for leuprolide acetate

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

SponsorPhase
Assiut UniversityPhase 4
Stanford UniversityPhase 2
University of North Carolina, Chapel HillPhase 2

See all leuprolide acetate clinical trials

Recent Litigation for leuprolide acetate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Horatio Washington Depot Technologies LLC v. Tolmar, Inc.2017-08-03
SUPERNUS PHARMACEUTICALS, INC. v. PAR PHARMACEUTICAL COMPANIES, INC.2015-01-16
Ferring B v. v. Watson Laboratories Inc.2014-04-17

See all leuprolide acetate litigation

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
Paragraph IV (Patent) Challenges for LEUPROLIDE ACETATE
Tradename Dosage Ingredient NDA Submissiondate
LUPRON DEPOT INJECTABLE;INJECTION leuprolide acetate 019732

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   Start Trial   Start Trial Y Y   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED leuprolide acetate INJECTABLE;INJECTION 020263-005 Jan 21, 1994 RX Yes Yes   Start Trial   Start Trial   Start Trial
Sandoz LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 074728-001 Aug 4, 1998 AP RX No Yes   Start Trial   Start Trial   Start Trial
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021488-001 Feb 13, 2003 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021488-001 Feb 13, 2003 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>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 leuprolide acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ortho Mcneil Janssen VIADUR leuprolide acetate IMPLANT;IMPLANTATION 021088-001 Mar 3, 2000   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED leuprolide acetate INJECTABLE;INJECTION 020263-005 Jan 21, 1994   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED leuprolide acetate INJECTABLE;INJECTION 020263-002 Apr 16, 1993   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED leuprolide acetate INJECTABLE;INJECTION 020263-005 Jan 21, 1994   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020517-001 Dec 22, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
AstraZeneca
McKesson
Johnson and Johnson
Mallinckrodt

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.