MONOPRIL Drug Patent Profile

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

Monopril is a drug marketed by Bristol Myers Squibb and is included in two NDAs.

The generic ingredient in MONOPRIL is fosinopril sodium; hydrochlorothiazide. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Monopril

A generic version of MONOPRIL was approved as fosinopril sodium; hydrochlorothiazide by SANDOZ on September 28^th, 2005.

Summary for MONOPRIL

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Patent Applications:	2,214
DailyMed Link:	MONOPRIL at DailyMed

Recent Clinical Trials for MONOPRIL

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

Sponsor	Phase
University of Nebraska	Phase 4
Ranbaxy Laboratories Limited	N/A

See all MONOPRIL clinical trials

US Patents and Regulatory Information for MONOPRIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-002	May 16, 1991		DISCN	Yes	No
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994		DISCN	Yes	No
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-003	May 16, 1991		DISCN	Yes	No
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-004	Mar 28, 1995		DISCN	Yes	No
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994		DISCN	Yes	No

Expired US Patents for MONOPRIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-004	Mar 28, 1995
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-002	May 16, 1991
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-003	May 16, 1991

International Patents for MONOPRIL

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0053902	PHOSPHINYLALKANOYL SUBSTITUTED PROLINES
Germany	19875040
Spain	507672
South Africa	8108340
Ireland	51876	PHOSPHINYLALKANOYL SUTSTITUTED PROLINES
Portugal	74079	PHOSPHINYLALKANOYL SUBSTITUTED PROLINES
Denmark	536081

Supplementary Protection Certificates for MONOPRIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0053902	SPC/GB96/024	United Kingdom		SPC/GB96/024:, EXPIRES: 20061126
0053902	96C0036	Belgium		PRODUCT NAME: FAMCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21325 19960708; FIRST REGISTRATION: GB - 10592/0035 19931210
0053902	SPC/GB93/028	United Kingdom		SPC/GB93/028, EXPIRES: 20050702

Market Dynamics and Financial Trajectory for Monopril (Fosinopril)

Last updated: March 8, 2026

How does the market landscape for Monopril compare to other ACE inhibitors?

Monopril (fosinopril) is an angiotensin-converting enzyme (ACE) inhibitor indicated for hypertension and heart failure. It entered the market in 1991 under Bristol-Myers Squibb. As of 2023, Monopril's market share is modest compared to competitors such as lisinopril and enalapril, which dominate the ACE inhibitor segment.

Key market data:

• Global ACE inhibitor market size (2022): USD 12 billion.
• Monopril’s sales (2022): Estimated USD 150 million, representing 1.25% of total ACE market.
• Top competitors: Lisinopril (Zestril, Prinivil), enalapril (Vasotec), ramipril (Altace).

Monopril's unique features—fosinopril's metabolism via both hepatic and renal pathways—provide renal safety benefits but do not significantly impact market share due to lack of differentiation and patent expiration. The drug’s patent expired in 2016, introducing biosimilars and generic options, further eroding sales.

What is the impact of patent expiry and generic entry?

Patent expiration in 2016 allowed generics to enter the U.S. market. The generic versions have a typical price discount of 60–70% relative to the branded drug, leading to a decline in Monopril's sales.

Financial effects:

Year	Monopril Sales (USD millions)	Market Share	Notes
2016	200	1.66%	Patent expiry and generic entry
2018	180	1.5%	Continued generic competition
2020	160	1.33%	Slight decline; market consolidation
2022	150	1.25%	Market steady but dominated by generics

Despite sales decrease, Monopril maintains a presence primarily in niche markets where physicians prefer its renal safety profile in specific patient groups.

How does pricing influence Monopril’s financial trajectory?

Brand-name Monopril commanded higher prices ($1.00–$1.20 per tablet) during patent protection. Post-generic entry, prices declined sharply:

• Brand-name price (2015): USD 1.10 per tablet.
• Generic price (2022): USD 0.40–$0.55 per tablet.

This price erosion impacts profit margins:

• Approximate gross margin pre-2016: 70–80%.
• Current gross margin: 30–40%, depending on manufacturing costs and pricing strategies.

Manufacturers that manufacture biosimilars or authorized generics may sustain marginal profits through volume sales, but overall revenue from Monopril diminishes with generic competition.

What are the future prospects for Monopril?

Key factors influencing future financial trajectory:

• Market saturation: Limited growth due to the dominance of generics.
• Regulatory environment: Patent protections may renew through new formulations or delivery systems, but such developments are limited.
• Therapeutic positioning: Monopril's renal safety appeal benefits specific patient populations, but overall demand remains flat.
• Pipeline activity: No recent advancements or new formulations are under development; the focus remains on existing generics.

Projected revenues:

Year	Estimated Sales	Notes
2023	USD 140–150 million	Steady, with minor declines
2025	USD 130–140 million	Continued erosion, high generic competition
2030	USD 100 million or lower	Dominated by generics, minimal brand activity

How does the competitive landscape impact Monopril’s positioning?

The entrance of multiple generic formulations has led to price competition. The market shift favors low-cost alternatives, reducing Monopril’s revenue potential. Despite its renal safety profile, clinical benefits over generics do not justify higher pricing, limiting repositioning opportunities.

Conclusion

Monopril’s market has contracted significantly since patent expiry. Sales have stabilized at low levels, constrained by intense price competition and limited differentiation. Its financial trajectory suggests continued decline unless clinical or formulation innovations emerge to restore competitive advantage.

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Key Takeaways

• Patent expiration in 2016 led to extensive generic competition, reducing Monopril’s sales from over USD 200 million to around USD 150 million.
• Generic versions dominate, with price discounts of 60–70%, squeezing profit margins.
• Monopril retains niche use due to its renal safety profile but faces limited growth prospects.
• Future revenues depend on potential reformulations or new delivery mechanisms, neither of which are currently active.
• The market is saturated, with minimal opportunity for Monopril to regain significant market share.

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FAQs

1. Could Monopril’s renal safety profile drive increased market share?
Limited evidence suggests that renal safety advantages influence prescribing behaviors primarily for specific patient groups; overall impact on sales remains minimal.

2. Are biosimilars or new formulations planned for Monopril?
No public data indicates ongoing development; revenue potential relies mainly on existing formulations.

3. What are the primary alternatives for patients allergic or intolerant to Monopril?
Other ACE inhibitors such as lisinopril or ramipril, or angiotensin receptor blockers (ARBs) like losartan.

4. How does the price difference between branded and generic Monopril impact healthcare costs?
Generics reduce treatment costs by approximately 60–70%, influencing formulary decisions.

5. Is there any regulatory pathway to extend Monopril’s market life?
No; patent protection ended in 2016, with no recent regulatory submissions aimed at prolonging exclusivity.

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References

[1] MarketLine. (2022). Global ACE Inhibitors Market Analysis.
[2] IQVIA. (2023). Pharmaceutical Market Data.
[3] FDA. (2016). Patent Expiry and Generic Drug Approvals.
[4] EvaluatePharma. (2023). Branded vs. Generic Drug Sales Analysis.