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

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Moodys
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Colorcon
Baxter

Last Updated: December 15, 2019

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LEUPROLIDE ACETATE Drug Profile

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When do Leuprolide Acetate patents expire, and when can generic versions of Leuprolide Acetate launch?

Leuprolide Acetate is a drug marketed by Genzyme, Sandoz, Sun Pharm, and Teva Pharms Usa. and is included in four NDAs.

The generic ingredient in LEUPROLIDE ACETATE is leuprolide acetate. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

US ANDA Litigation and Generic Entry Outlook for Leuprolide Acetate

A generic version of LEUPROLIDE ACETATE was launched as leuprolide acetate by SANDOZ on December 15th, 2019.

Drug patent expirations by year for LEUPROLIDE ACETATE
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
National Institute on Aging (NIA)Phase 2
Xiao X. WeiPhase 2
Assiut UniversityPhase 4

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
Genzyme LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 075721-001 Nov 29, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 075471-001 Oct 25, 2000 AP RX No No   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
>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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Serving leading biopharmaceutical companies globally:

McKinsey
Moodys
Mallinckrodt
Johnson and Johnson
McKesson
Boehringer Ingelheim

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.