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TERLIVAZ Drug Patent Profile

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

Terlivaz is a drug marketed by Mallinckrodt Ireland and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-seven patent family members in fourteen countries.

The generic ingredient in TERLIVAZ is terlipressin acetate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the terlipressin acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Terlivaz

Terlivaz will be eligible for patent challenges on September 14, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 14, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TERLIVAZ

International Patents:	27
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	63
Patent Applications:	3,511
Drug Prices:	Drug price information for TERLIVAZ
What excipients (inactive ingredients) are in TERLIVAZ?	TERLIVAZ excipients list
DailyMed Link:	TERLIVAZ at DailyMed

See drug prices for TERLIVAZ

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TERLIVAZ

Constraining patent/regulatory exclusivity:

TO IMPROVE KIDNEY FUNCTION IN ADULTS WITH HEPATORENAL SYNDROME WITH RAPID REDUCTION IN KIDNEY FUNCTION

NDA:

022231

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for TERLIVAZ

Drug Class	Vasopressin Receptor Agonist
Mechanism of Action	Vasopressin Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for TERLIVAZ

H01BA	Vasopressin and analogues
H01B	POSTERIOR PITUITARY LOBE HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for TERLIVAZ

TERLIVAZ is protected by one US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TO IMPROVE KIDNEY FUNCTION IN ADULTS WITH HEPATORENAL SYNDROME WITH RAPID REDUCTION IN KIDNEY FUNCTION.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TERLIVAZ

FDA Regulatory Exclusivity protecting TERLIVAZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mallinckrodt Ireland	TERLIVAZ	terlipressin acetate	POWDER;INTRAVENOUS	022231-001	Sep 14, 2022		RX	Yes	Yes
Mallinckrodt Ireland	TERLIVAZ	terlipressin acetate	POWDER;INTRAVENOUS	022231-001	Sep 14, 2022		RX	Yes	Yes
Mallinckrodt Ireland	TERLIVAZ	terlipressin acetate	POWDER;INTRAVENOUS	022231-001	Sep 14, 2022		RX	Yes	Yes

International Patents for TERLIVAZ

See the table below for patents covering TERLIVAZ around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2022171795	１型肝腎症候群患者の治療方法
Japan	2017534618	１型肝腎症候群患者の治療方法
Japan	6989571
China	117425488	治疗患有1型肝肾综合征的患者的方法 (Methods of treating patients with hepatorenal syndrome type 1)
Poland	3209317