DrugPatentWatch Database Preview

Leuprolide acetate - Generic Drug Details

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

International Patents:	216
US Patents:	15
Tradenames:	7
Applicants:	8
NDAs:	16
Drug Master File Entries:	22
Suppliers / Packagers:	5
Bulk Api Vendors:	32
Clinical Trials:	1,026
Patent Applications:	7,617
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
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

+ Get email alerts for changes to this table

Glossary

This preview shows a limited data set. Subscribe for full access, or try a Free Trial
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

Expired US Patents for leuprolide acetate

This preview shows a limited data set. Subscribe for full access, or try a Free Trial
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

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.

This preview shows a limited data set. Subscribe for full access, or try a Free Trial
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

International Patents for leuprolide acetate

This preview shows a limited data set. Subscribe for full access, or try a Free Trial
Country	Document Number	Estimated Expiration
Austria	285261	➤ Sign Up
Malaysia	142066	➤ Sign Up
Japan	6087886	➤ Sign Up
Slovakia	5152003	➤ Sign Up
Country	Document Number	Estimated Expiration