LISINOPRIL - Generic Drug Details

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

Lisinopril is the generic ingredient in four branded drugs marketed by Azurity, Accord Hlthcare, Ascent Pharms Inc, Aurobindo, Chartwell Rx, Corepharma, Heritage Pharma, Hikma Intl Pharms, Invagen Pharms, Lupin, Prinston Inc, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Teva, Watson Labs, Wockhardt Bio Ag, Merck, and Twi Pharms, and is included in twenty-two NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lisinopril has ten patent family members in eight countries.

There are twenty-one drug master file entries for lisinopril. Forty-five suppliers are listed for this compound.

Summary for LISINOPRIL

International Patents:	10
US Patents:	9
Tradenames:	4
Applicants:	20
NDAs:	22
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	45
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	129
Patent Applications:	7,495
Drug Prices:	Drug price trends for LISINOPRIL
Drug Sales Revenues:	Drug sales revenues for LISINOPRIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LISINOPRIL
What excipients (inactive ingredients) are in LISINOPRIL?	LISINOPRIL excipients list
DailyMed Link:	LISINOPRIL at DailyMed

See drug prices for LISINOPRIL

Drug Sales Revenue Trends for LISINOPRIL

See drug sales revenues for LISINOPRIL

Recent Clinical Trials for LISINOPRIL

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

Sponsor	Phase
University of Rochester	Early Phase 1
Medical College of Wisconsin	Early Phase 1
Wake Forest University Health Sciences	Phase 4

See all LISINOPRIL clinical trials

Pharmacology for LISINOPRIL

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

Medical Subject Heading (MeSH) Categories for LISINOPRIL

Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiotonic Agents

Anatomical Therapeutic Chemical (ATC) Classes for LISINOPRIL

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

Paragraph IV (Patent) Challenges for LISINOPRIL

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 LISINOPRIL

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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
Prinston Inc	LISINOPRIL	lisinopril	TABLET;ORAL	075743-002	Jul 1, 2002	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Prinston Inc	LISINOPRIL	lisinopril	TABLET;ORAL	075743-004	Jul 1, 2002	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin	LISINOPRIL	lisinopril	TABLET;ORAL	077321-002	Sep 9, 2005	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sciegen Pharms Inc	LISINOPRIL	lisinopril	TABLET;ORAL	208920-003	Mar 4, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	LISINOPRIL	lisinopril	TABLET;ORAL	075783-003	Jul 1, 2002		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	LISINOPRIL	lisinopril	TABLET;ORAL	075994-001	Jul 1, 2002	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ascent Pharms Inc	LISINOPRIL	lisinopril	TABLET;ORAL	075903-005	Jul 1, 2002	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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 LISINOPRIL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	PRINIVIL	lisinopril	TABLET;ORAL	019558-006	Jan 28, 1994	⤷ Sign Up	⤷ Sign Up
Merck	PRINIVIL	lisinopril	TABLET;ORAL	019558-003	Dec 29, 1987	⤷ Sign Up	⤷ Sign Up
Merck	PRINIVIL	lisinopril	TABLET;ORAL	019558-004	Oct 25, 1988	⤷ Sign Up	⤷ Sign Up
Twi Pharms	ZESTRIL	lisinopril	TABLET;ORAL	019777-002	May 19, 1988	⤷ Sign Up	⤷ Sign Up
Twi Pharms	ZESTRIL	lisinopril	TABLET;ORAL	019777-001	May 19, 1988	⤷ Sign Up	⤷ Sign Up
Twi Pharms	ZESTRIL	lisinopril	TABLET;ORAL	019777-003	May 19, 1988	⤷ Sign Up	⤷ Sign Up
Twi Pharms	ZESTRIL	lisinopril	TABLET;ORAL	019777-004	May 19, 1988	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for LISINOPRIL

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Country	Patent Number	Title	Estimated Expiration
Japan	2018533583	リシノプリル製剤	⤷ Sign Up
China	112972370	赖诺普利制剂 (LISINOPRIL FORMULATIONS)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2017075368		⤷ Sign Up
Spain	2886869		⤷ Sign Up
China	108472252	赖诺普利制剂 (LISINOPRIL FORMULATIONS)	⤷ Sign Up
South Korea	20180069907	리시노프릴 제제	⤷ Sign Up
Hong Kong	1258803	賴諾普利製劑 (LISINOPRIL FORMULATIONS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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