LISINOPRIL Drug Patent Profile

When do Lisinopril patents expire, and what generic alternatives are available?

Lisinopril is a drug marketed by Accord Hlthcare, Annora Pharma, Aurobindo, Chartwell Rx, Corepharma, Heritage Pharma, Hikma Intl Pharms, Invagen Pharms, Lupin, Prinston Inc, Rising, Sciegen Pharms, Strides Pharma, Sun Pharm Inds Ltd, Teva, Watson Labs, Wockhardt Bio Ag, Aiping Pharm Inc, Epic Pharma Llc, and Pharmobedient. and is included in thirty-two NDAs.

The generic ingredient in LISINOPRIL is hydrochlorothiazide; lisinopril. There are thirty-two drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.

Summary for LISINOPRIL

US Patents:	0
Applicants:	20
NDAs:	32
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	132
Drug Prices:	Drug price information for LISINOPRIL
Drug Sales Revenues:	Drug sales revenues for LISINOPRIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LISINOPRIL
DailyMed Link:	LISINOPRIL at DailyMed

See drug prices for LISINOPRIL

See drug sales revenues for LISINOPRIL

Recent Clinical Trials for LISINOPRIL

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

Sponsor	Phase
Martin Rohacek	PHASE4
Ifakara Health Institute (IHI)	PHASE4
Merck Sharp & Dohme LLC	PHASE1

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	LISINOPRIL	lisinopril	TABLET;ORAL	075999-006	Jul 1, 2002		DISCN	No	No
Watson Labs	LISINOPRIL	lisinopril	TABLET;ORAL	076059-005	Jul 1, 2002	AB	RX	No	No
Hikma Intl Pharms	LISINOPRIL	lisinopril	TABLET;ORAL	076063-006	Jun 27, 2003		DISCN	No	No
Heritage Pharma	LISINOPRIL	lisinopril	TABLET;ORAL	075752-002	Jul 1, 2002		DISCN	No	No
Sun Pharm Inds Ltd	LISINOPRIL	lisinopril	TABLET;ORAL	075944-002	Jul 1, 2002	AB	RX	No	No
Aurobindo	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	077606-003	Mar 14, 2006	AB	RX	No	No

Market Dynamics and Financial Trajectory for Lisinopril

Last updated: February 19, 2026

Lisinopril is an angiotensin-converting enzyme (ACE) inhibitor prescribed primarily for hypertension and heart failure. Its patent expiration, competitive landscape, and regulatory environment shape its market trajectory, influencing revenue streams and investment considerations.

Industry Landscape

Patent Status and Generic Competition

Lisinopril's original patent expired in most markets by 2006. Generic manufacturers account for over 90% of prescriptions globally. Popular formulations include 10 mg, 20 mg, and 40 mg tablets. The widespread availability of generics has driven prices down but expanded access and volume.

Market Size and Growth

The global ACE inhibitor market was valued at approximately USD 7 billion in 2021. Lisinopril dominated with an estimated 60% market share among ACE inhibitors, translating to roughly USD 4.2 billion.[1] Growth is driven by:

• Increasing prevalence of hypertension (estimated at 1.3 billion adults worldwide)
• Aging populations
• Rising awareness of cardiovascular disease management

Despite competition from other ACE inhibitors like enalapril, perindopril, and ramipril, lisinopril maintains a leading position due to generic dominance.

Pricing Trends

Average retail prices per tablet have declined by 70% since patent expiry. For example, a 30-day supply of 10 mg lisinopril has dropped from approximately USD 30 in 2006 to USD 4–5 currently.[2] This compresses revenue per unit but increases overall volume.

Key Market Drivers

• Widespread Adoption: Existing approval and proven efficacy foster high prescribing rates.
• Expanding Medical Guidelines: Recommendations favor ACE inhibitors for hypertension and heart failure, broadening market scope.
• Generic Penetration: Facilitates access, but limits pricing power for manufacturers.

Revenue and Financial Trajectory

Historical Revenue Patterns

Brand sales declined rapidly post-patent expiry, with Eli Lilly’s proprietary lisinopril (Zestoretic) dropping from over USD 200 million annually pre-patent expiry to negligible levels in most markets by 2010. Generic sales now constitute the core revenue stream.

Current Market Valuation

Leading generic suppliers, including Teva, Mylan (now Viatris), and Lupin, report annual lisinopril revenues ranging from USD 200 million to USD 400 million.[3]

Future Outlook

Market growth is projected to be modest (~2–3% annually) through 2027, constrained by:

• Market saturation
• Price compression
• Competition from newer therapeutic classes, such as angiotensin receptor blockers (ARBs) and SGLT2 inhibitors

Impact of Biosimilars and New Formulations

There is limited innovation around lisinopril formulations. Biologics and biosimilars are less relevant, maintaining the focus on generics.

Regulatory and Policy Influences

Price Control Measures

In several countries, including the UK and Canada, government policies limit reimbursement prices for generic ACE inhibitors, affecting profit margins.

Patent Litigation and Exclusivity

Few patent litigations exist for lisinopril post-expiry, but orphan drug status or formulation patents could influence small regional markets.

Strategic Considerations

• Market saturation diminishes revenue opportunities.
• Companies focus on cost reduction and supply chain efficiencies.
• Developing fixed-dose combinations with other antihypertensives offers niche growth.

Conclusion

Lisinopril's market is mature, primarily driven by volume rather than price. Revenue streams are stable but limited by generic competition and regulatory price caps. The overall financial trajectory points to moderate growth, emphasizing cost efficiency and strategic formulation advancements.

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Key Takeaways

• Lisinopril's patent expired in most markets by 2006, leading to dominance by generics.
• The global ACE inhibitor market was valued at USD 7 billion in 2021, with lisinopril holding approximately 60% of the segment.
• Prices have dropped 70% since patent expiry; revenue now depends on high sales volumes.
• Growth prospects are modest (~2–3% annually), constrained by saturation and competition.
• Regulatory policies and price controls impact profitability in various regions.

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FAQs

1. What is the main factor limiting lisinopril’s revenue growth?

The primary factor is generic competition, which lowers prices and reduces profit margins despite high prescription volumes.

2. How does market saturation affect lisinopril's future?

High adoption rates mean the market is near saturation, leading to limited incremental growth opportunities.

3. Are there new formulations or combinations that could revive lisinopril sales?

Fixed-dose combinations with other antihypertensives are niche options but have limited impact on overall revenue growth.

4. How do regulatory policies influence lisinopril’s market?

Price control regulations in regions such as Europe and North America limit profit margins for generic suppliers.

5. Is there any innovation that could impact lisinopril’s market?

No significant innovation is underway; most focus is on generic supply and cost efficiencies.

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References

[1] MarketsandMarkets. (2022). ACE inhibitors Market by Drug Class and Region.

[2] Healthcare Bluebook. (2022). Average prices for lisinopril.

[3] IQVIA. (2022). Pharmaceutical Market Analysis Reports.