You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: May 19, 2024

Leuprolide acetate - Generic Drug Details

✉ Email this page to a colleague

« 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 nine branded drugs marketed by Invagen Pharms, Ortho Mcneil Janssen, Amneal, Eugia Pharma, Genzyme, Meitheal, Rk Pharma, Sandoz, Sun Pharm, Abbvie Endocrine Inc, Tolmar, and Abbvie Endocrine, and is included in twenty-one NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Leuprolide acetate has forty-six patent family members in twenty-eight countries.

There are sixteen drug master file entries for leuprolide acetate. Ten suppliers are listed for this compound.

Summary for leuprolide acetate

International Patents:	46
US Patents:	3
Tradenames:	9
Applicants:	12
NDAs:	21
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	194
Patent Applications:	10,001
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for leuprolide acetate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for leuprolide acetate
What excipients (inactive ingredients) are in leuprolide acetate?	leuprolide acetate excipients list
DailyMed Link:	leuprolide acetate at DailyMed

See drug prices for leuprolide acetate

Recent Clinical Trials for leuprolide acetate

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

Sponsor	Phase
Johns Hopkins Bloomberg School of Public Health	Phase 2
Takeda	Phase 4
Emory University	Phase 4

See all leuprolide acetate clinical trials

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

US Patents and Regulatory Information for leuprolide acetate

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rk Pharma	LEUPROLIDE ACETATE	leuprolide acetate	INJECTABLE;INJECTION	213829-001	Aug 13, 2021	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie Endocrine	LUPANETA PACK	leuprolide acetate; norethindrone acetate	INJECTABLE, TABLET;INTRAMUSCULAR, ORAL	203696-001	Dec 14, 2012		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020708-001	Mar 7, 1997		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-005	Jan 21, 1994		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Meitheal	LEUPROLIDE ACETATE	leuprolide acetate	INJECTABLE;INJECTION	075471-001	Oct 25, 2000	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie Endocrine Inc	LUPRON	leuprolide acetate	INJECTABLE;INJECTION	019010-001	Apr 9, 1985		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-002	Apr 16, 1993		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-002	May 30, 1997	⤷ Try a Trial	⤷ Try a Trial
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-003	Apr 16, 1993	⤷ Try a Trial	⤷ Try a Trial
Ortho Mcneil Janssen	VIADUR	leuprolide acetate	IMPLANT;IMPLANTATION	021088-001	Mar 3, 2000	⤷ Try a Trial	⤷ Try a Trial
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-001	Dec 22, 1995	⤷ Try a Trial	⤷ Try a Trial
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-002	Apr 16, 1993	⤷ Try a Trial	⤷ Try a Trial
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021731-001	Dec 14, 2004	⤷ Try a Trial	⤷ Try a Trial
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021731-001	Dec 14, 2004	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for leuprolide acetate

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
Israel	303673	מערכות ושיטות לערבול מכלולי שסתומי מזרק (Systems and methods for mixing syringe valve assemblies)	⤷ Try a Trial
Japan	2010222371	SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME	⤷ Try a Trial
New Zealand	577281	SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME	⤷ Try a Trial
Japan	4564098		⤷ Try a Trial
European Patent Office	4135830	SYSTÈMES ET PROCÉDÉS DE COMBINAISON D'ENSEMBLES VALVE DE SERINGUE (SYSTEMS AND METHODS FOR MIXING SYRINGE VALVE ASSEMBLIES)	⤷ Try a Trial
Taiwan	202235113	Systems and methods for mixing syringe valve assemblies	⤷ Try a Trial
Chile	2007003658	COMPOSICION DE LIBERACION SOSTENIDA QUE COMPRENDE UN PEPTIDO; PROCEDIMIENTO PARA PREPARAR DICHA COMPOSICION; AGENTE PROFILACTICO O TERAPEUTICO PARA CANCER DE PROSTATA, HIPERPLASIA PROSTATICA, ENDOMETRIOSIS, FIBROIDE UTERINO, FIBROMA UTERINO, PUBERTAD	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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

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 verification 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.