QBRELIS Drug Patent Profile

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

Qbrelis is a drug marketed by Azurity and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has ten patent family members in eight countries.

The generic ingredient in QBRELIS is lisinopril. There are twenty-one drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the lisinopril profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Qbrelis

A generic version of QBRELIS was approved as lisinopril by ASCENT PHARMS INC on July 1^st, 2002.

Summary for QBRELIS

International Patents:	10
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	2
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for QBRELIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QBRELIS
What excipients (inactive ingredients) are in QBRELIS?	QBRELIS excipients list
DailyMed Link:	QBRELIS at DailyMed

See drug prices for QBRELIS

Recent Clinical Trials for QBRELIS

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
St. Jude Children's Research Hospital	Phase 2
Mayo Clinic	Phase 2

See all QBRELIS clinical trials

Pharmacology for QBRELIS

Drug Class	Angiotensin Converting Enzyme Inhibitor
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for QBRELIS

C09AA	ACE inhibitors, plain
C09A	ACE INHIBITORS, PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for QBRELIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QBRELIS	Oral Solution	lisinopril	1 mg/mL	208401	1	2019-10-24

US Patents and Regulatory Information for QBRELIS

QBRELIS is protected by twenty-seven US patents.

Patents protecting QBRELIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes			Y
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes			Y
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes			Y
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes			Y

International Patents for QBRELIS

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3960156	FORMULATIONS DE LISINOPRIL (LISINOPRIL FORMULATIONS)
China	112972370	赖诺普利制剂 (LISINOPRIL FORMULATIONS)
Hong Kong	1258803	賴諾普利製劑 (LISINOPRIL FORMULATIONS)
European Patent Office	3368012	FORMULATIONS DE LISINOPRIL (LISINOPRIL FORMULATIONS)
China	108472252	赖诺普利制剂 (LISINOPRIL FORMULATIONS)
Spain	2886869
World Intellectual Property Organization (WIPO)	2017075368