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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 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 sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Leuprolide acetate has two hundred and thirty-two 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

International Patents:	232
US Patents:	16
Tradenames:	8
Applicants:	9
NDAs:	17
Drug Master File Entries:	22
Suppliers / Packagers:	5
Bulk Api Vendors:	38
Clinical Trials:	109
Patent Applications:	9,949
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for leuprolide acetate
DailyMed Link:	leuprolide acetate at DailyMed

Pharmacology for leuprolide acetate

Drug Class	Gonadotropin Releasing Hormone Receptor Agonist
Mechanism of Action	Gonadotropin Releasing Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for leuprolide acetate

Antineoplastic Agents, Hormonal

Fertility Agents, Female

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	021731-001	Dec 14, 2004		RX	Yes	Yes			Y
Tolmar Therap	ELIGARD	leuprolide acetate	INJECTABLE;SUBCUTANEOUS	021731-001	Dec 14, 2004		RX	Yes	Yes
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-003	Jun 17, 2011		RX	Yes	Yes			Y
Abbvie Endocrine Inc	LUPRON DEPOT-PED	leuprolide acetate	INJECTABLE;INJECTION	020263-006	Jan 21, 1994		RX	Yes	Yes

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
Tolmar Therap	ELIGARD	leuprolide acetate	INJECTABLE;SUBCUTANEOUS	021343-001	Jan 23, 2002
Abbvie Endocrine Inc	LUPRON DEPOT-PED	leuprolide acetate	INJECTABLE;INJECTION	020263-004	Apr 16, 1993
Abbvie Endocrine Inc	LUPRON DEPOT-PED	leuprolide acetate	INJECTABLE;INJECTION	020263-004	Apr 16, 1993

International Patents for leuprolide acetate

Country	Document Number	Estimated Expiration
Denmark	1322286
Austria	259217
China	1724066
Australia	2001292931