RAMIPRIL - Generic Drug Details

What are the generic sources for ramipril and what is the scope of patent protection?

Ramipril is the generic ingredient in three branded drugs marketed by King Pharms Llc, Accord Hlthcare, Actavis Elizabeth, Anda Repository, Aurobindo Pharma Ltd, Chartwell Molecular, Chartwell Rx, Cipla, Corepharma, Hikma, Lupin, Ranbaxy Labs Ltd, Teva Pharms, Watson Labs, Zydus Pharms Usa, Rosemont Pharms, King Pfizer, Apotex, Natco Pharma, and Zydus Pharms Usa Inc, and is included in twenty NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Ramipril has three patent family members in two countries.

There are nineteen drug master file entries for ramipril. Eighteen suppliers are listed for this compound.

Summary for RAMIPRIL

International Patents:	3
US Patents:	1
Tradenames:	3
Applicants:	20
NDAs:	20
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	176
Patent Applications:	5,731
Drug Prices:	Drug price trends for RAMIPRIL
Drug Sales Revenues:	Drug sales revenues for RAMIPRIL
What excipients (inactive ingredients) are in RAMIPRIL?	RAMIPRIL excipients list
DailyMed Link:	RAMIPRIL at DailyMed

See drug prices for RAMIPRIL

See drug sales revenues for RAMIPRIL

Recent Clinical Trials for RAMIPRIL

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

Sponsor	Phase
Abant Izzet Baysal University	NA
The University of Hong Kong	PHASE4
Arab Contractors Medical Centre	PHASE1

See all RAMIPRIL clinical trials

Pharmacology for RAMIPRIL

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

Medical Subject Heading (MeSH) Categories for RAMIPRIL

Angiotensin-Converting Enzyme Inhibitors

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for RAMIPRIL

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

US Patents and Regulatory Information for RAMIPRIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	RAMIPRIL	ramipril	CAPSULE;ORAL	076549-001	Oct 24, 2005	AB	RX	No	No
Accord Hlthcare	RAMIPRIL	ramipril	CAPSULE;ORAL	202392-002	Apr 15, 2014		DISCN	No	No
Chartwell Molecular	RAMIPRIL	ramipril	CAPSULE;ORAL	078745-003	Jun 18, 2008	AB	RX	No	No
Ranbaxy Labs Ltd	RAMIPRIL	ramipril	CAPSULE;ORAL	078849-002	Mar 6, 2009		DISCN	No	No
Zydus Pharms Usa	RAMIPRIL	ramipril	CAPSULE;ORAL	078832-001	Sep 2, 2008	AB	RX	No	No
Corepharma	RAMIPRIL	ramipril	CAPSULE;ORAL	079116-002	Jun 20, 2008	AB	RX	No	No
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-002	Jan 28, 1991		DISCN	Yes	No

Expired US Patents for RAMIPRIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-001	Feb 27, 2007
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-001	Feb 27, 2007
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-002	Jan 28, 1991
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-002	Feb 27, 2007
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-004	Jan 28, 1991
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-003	Jan 28, 1991
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-001	Jan 28, 1991

International Patents for RAMIPRIL

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2591389
World Intellectual Property Organization (WIPO)	2020039262
United Kingdom	202103724

Supplementary Protection Certificates for RAMIPRIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0265685	99C0001	Belgium		PRODUCT NAME: FELODIPINUM + RAMIPRILUM; NATL. REGISTRATION NO/DATE: 354 IS 373 F 3 19981103; FIRST REGISTRATION: SE 13597 19970919
0265685	C980030	Netherlands		PRODUCT NAME: FELODIPINE, DESGEWENST IN DE VORM VAN FYSIOLOGISCH AANVAARDBAAR ZOUT, EN (2S, 3AS, 6AS)-1-[(S)-N-[(S)-1-CARBOXY-3-FENYLPROPYL]A LANYL]OCTAHYDROCYCLOPENTA[B]-PYRROOL-2-CARBONZUUR (RAMIPRILAAT) , DESGEWENST IN DE VORM VAN EEN .....ZIE VERDER IN HET DOSSIER; NAT. REGISTRATION NO/ DATE: RVG 22449, RVG 22450 19980618; FIRST REGISTRATION: SE 13596, 13597 19970919
0265685	SPC/GB98/047	United Kingdom		PRODUCT NAME: COMBINATIONS OF RAMIPRIL, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, AND FELODIPINE, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: SE 13596 19970919; SE 13597 19970919; UK 00017/0402 19980825; UK 00017/0403 19980825

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Ramipril

Last updated: July 27, 2025

Introduction

Ramipril, a potent angiotensin-converting enzyme (ACE) inhibitor, is widely prescribed to manage hypertension, reduce cardiovascular event risk, and treat congestive heart failure. Since its approval in the 1990s, ramipril has established itself as a staple in cardiovascular therapy, with its market trajectory influenced by evolving clinical guidelines, patent landscapes, emerging competitors, and healthcare policy reforms. This analysis details the current market dynamics and forecasts ramipril's financial trajectory while considering challenges and growth opportunities.

Market Overview and Historical Context

Ramipril was first approved by the U.S. Food and Drug Administration (FDA) in 1991 under the brand name Altace (by Boehringer Ingelheim). Its initial success was fueled by clinical evidence demonstrating significant benefits in reducing mortality among high-risk cardiovascular patients (HOPE trial). Despite its established presence, the drug's market share has evolved due to patents expiring globally, the advent of newer therapeutic agents, and regulations impacting generic drug penetration.

Market Dynamics

1. Patent Expiry and Generic Competition

The expiration of patent protection critically influences ramipril's market trajectory. Generic versions launched shortly after patent expiry (around 2012 in the U.S.) led to substantial price erosion. As of 2023, generic ramipril captures the majority of prescriptions, significantly reducing the revenue potential for originator formulations. The increased availability of generics offers widespread affordability, fostering broad patient access but compressing profit margins for manufacturers.

2. Clinical Guidelines and Prescribing Trends

Guideline updates from organizations such as the American College of Cardiology (ACC) and the American Heart Association (AHA) endorse ACE inhibitors, including ramipril, as first-line therapy for hypertension and heart failure management. The HOPE trial's landmark findings reinforced ramipril's cardiovascular protective role, leading to sustained prescribing rates. However, recent shifts favor newer agents like angiotensin receptor blockers (ARBs) and direct renin inhibitors for specific patient subsets, influencing market share dynamics.

3. Competition from Alternative Therapeutics

The cardiovascular drug market is highly competitive, with ARBs (e.g., losartan, candesartan) providing similar efficacy with potentially fewer side effects like cough. The introduction of combination therapies further diversifies treatment options. Additionally, novel agents such as neprilysin inhibitors (e.g., sacubitril/valsartan) are challenging traditional ACE inhibitor roles in heart failure management.

4. Regulatory and Reimbursement Environment

Stringent pricing controls and reimbursement policies in various markets limit revenue growth. Countries implementing value-based care models prioritize cost-effectiveness, favoring generics. In developing regions, expanding healthcare access and increasing cardiovascular disease prevalence present growth opportunities.

Financial Trajectory

1. Revenue Trends

In mature markets, ramipril's revenues have plateaued, primarily driven by generic sales and declining brand-specific formulations. According to IQVIA data, the global cardiovascular drug market generated approximately $XX billion in 2022, with ramipril's contribution waning post-patent expiry but maintaining steady prescription volumes in certain regions due to its cost-effectiveness.

2. Regional Market Variations

• United States: The patented phase has transitioned to generics, with annual sales declining accordingly.
• Europe: Similar patent expiries have impacted revenues; ongoing prescribing continues due to established clinical protocols.
• Emerging Markets: Rapid urbanization and increasing CVD burden propel demand, with price-sensitive markets favoring lower-cost generics, providing growth avenues.

3. Future Growth Drivers

• Expanded Indications: Research exploring ramipril's efficacy in renal protection and diabetic nephropathy sustains interest.
• Formulation Innovations: Developing fixed-dose combinations and injectable forms may enhance adherence, opening new markets.
• Strategic Partnerships: Licensing or co-marketing with local pharma firms can facilitate penetration into untapped markets.

4. Risks and Challenges

• Intensified Competition: The prevalence of generic ACE inhibitors and emerging therapeutic classes threaten market dominance.
• Regulatory Constraints: Pricing caps and reimbursement limitations curb revenue potential.
• Clinical Paradigm Shifts: The ascendancy of ARBs and novel drug classes could diminish prescribing of ACE inhibitors.

Potential for Growth and Investment

While immediate prospects for ramipril-centric revenues are subdued due to patent expiries, strategic positioning in emerging markets and indications could sustain moderate growth. Companies might invest in differentiating formulations and combination therapies, leveraging ramipril’s well-established efficacy and safety profile.

Conclusion

Ramipril's market has matured, transitioning from a branded blockbuster to a predominantly generic-driven segment. Its financial trajectory hinges on market expansion in developing regions, ongoing clinical utility, and the ability to innovate within its therapeutic framework. The competitive landscape and regulatory environment pose challenges but also create opportunities for strategic differentiation and sustained profitability.

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Key Takeaways

• Patent expiries have led to significant generic competition, diminishing revenue streams but expanding global access.
• Clinical guidelines continue to support ramipril for hypertension and heart failure, maintaining a baseline prescribing rate.
• Emerging therapies such as ARBs and novel agents are shifting the therapeutic landscape, impacting market share.
• Growth opportunities remain in emerging markets and new indications, provided companies adapt formulations and branding strategies.
• Pricing pressures and regulatory policies require manufacturers to innovate cost-effectively and differentiate their offerings.

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FAQs

1. How has patent expiry impacted ramipril's market dominance?
Patent expiry has significantly increased generic availability, reducing brand-specific revenues but expanding access and prescribing across diverse markets.

2. What clinical trials support ramipril's use in cardiovascular disease?
The HOPE trial established ramipril’s efficacy in reducing mortality and cardiovascular events in high-risk patients, reinforcing its role in standard care.

3. Are there new formulations or indications for ramipril in development?
Current research focuses on renal protective effects and combination therapies, with some formulations incorporating fixed-dose combinations to improve adherence.

4. How do emerging competitors like ARBs affect ramipril's market share?
ARBs offer similar efficacy with fewer side effects, leading to substitution in certain patient populations and constraining ramipril's growth.

5. What regulatory and reimbursement changes influence ramipril’s market trajectory?
Price controls and cost-effectiveness assessments, especially in publicly funded healthcare systems, limit revenue growth but favor affordable generic options.

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References

[1] Yusuf S, et al. "The Heart Outcomes Prevention Evaluation (HOPE) study," Lancet, 2000.
[2] IQVIA. "Global Pharmaceutical Market Insights," 2022.
[3] American College of Cardiology/American Heart Association. "Hypertension Guidelines," 2017.
[4] Boehringer Ingelheim. "Altace (Ramipril) Product Overview," 2022.
[5] World Health Organization. "Cardiovascular Disease Fact Sheet," 2021.