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Last Updated: April 27, 2024

Terlipressin acetate - Generic Drug Details

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What are the generic sources for terlipressin acetate and what is the scope of freedom to operate?

Terlipressin acetate is the generic ingredient in one branded drug marketed by Mallinckrodt Ireland and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Terlipressin acetate has twenty-seven patent family members in fourteen countries.

There is one drug master file entry for terlipressin acetate. One supplier is listed for this compound.

Summary for terlipressin acetate

International Patents:	27
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	4
Patent Applications:	5,275
DailyMed Link:	terlipressin acetate at DailyMed

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

Generic Entry Date for terlipressin acetate^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: TO IMPROVE KIDNEY FUNCTION IN ADULTS WITH HEPATORENAL SYNDROME WITH RAPID REDUCTION IN KIDNEY FUNCTION 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.

Recent Clinical Trials for terlipressin acetate

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

Sponsor	Phase
Ain Shams University	Phase 2
Kasr El Aini Hospital	Phase 2
Mallinckrodt	Phase 3

See all terlipressin acetate clinical trials

Pharmacology for terlipressin acetate

Drug Class	Vasopressin Receptor Agonist
Mechanism of Action	Vasopressin Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for terlipressin acetate

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 terlipressin acetate

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mallinckrodt Ireland	TERLIVAZ	terlipressin acetate	POWDER;INTRAVENOUS	022231-001	Sep 14, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mallinckrodt Ireland	TERLIVAZ	terlipressin acetate	POWDER;INTRAVENOUS	022231-001	Sep 14, 2022		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

International Patents for terlipressin acetate

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Country	Patent Number	Title	Estimated Expiration
Japan	2022171795	１型肝腎症候群患者の治療方法	⤷ Try a Trial
Japan	2017534618	１型肝腎症候群患者の治療方法	⤷ Try a Trial
Japan	6989571		⤷ Try a Trial
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)	⤷ Try a Trial
Poland	3209317		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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