ALTACE Drug Patent Profile

Which patents cover Altace, and when can generic versions of Altace launch?

Altace is a drug marketed by King Pharms Llc and King Pfizer and is included in two NDAs.

The generic ingredient in ALTACE is ramipril. There are nineteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ramipril profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Altace

A generic version of ALTACE was approved as ramipril by WATSON LABS on October 24^th, 2005.

Summary for ALTACE

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	26
Patent Applications:	1,971
Drug Prices:	Drug price information for ALTACE
What excipients (inactive ingredients) are in ALTACE?	ALTACE excipients list
DailyMed Link:	ALTACE at DailyMed

See drug prices for ALTACE

See drug sales revenues for ALTACE

Recent Clinical Trials for ALTACE

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
Ferrer Internacional S.A.	Phase 2
University of Nebraska	Phase 4

See all ALTACE clinical trials

US Patents and Regulatory Information for ALTACE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-001	Jan 28, 1991		DISCN	Yes	No
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-003	Feb 27, 2007		DISCN	Yes	No
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-004	Jan 28, 1991		DISCN	Yes	No
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-004	Feb 27, 2007		DISCN	Yes	No
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-002	Jan 28, 1991		DISCN	Yes	No
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-003	Jan 28, 1991		DISCN	Yes	No

Expired US Patents for ALTACE

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

International Patents for ALTACE

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

Country	Patent Number	Title	Estimated Expiration
Mexico	155256	PROCEDIMIENTO PARA PREPARAR DERIVADOS DEL ACIDO CIS,ENDO-2-AZABICICLO-(3,3,O)-OCTAN 3-CARBOXILICO
Philippines	21916	CARBOXYALKYL DIPEPTIDES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Spain	8308542
Yugoslavia	8502
Montenegro	00429	UPOTREBA INHIBITORA SISTEMA RENIN-ANGIOTENZIN ZA PREVENCIJU KARDIOVASKULARNIH SLUČAJEVA (USE OF INHIBITORS OF THE RENIN-ANGIOTENSIN SYSTEM IN THE PREVENTION OF CARDIOVASCULAR EVENTS)
Latvia	5255	Panemiens cis endo-2-aza-biciklo-(3,3,0)-oktan-3-karbonskabju un to aditivo saju ar skabem iegusanai

Supplementary Protection Certificates for ALTACE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0050800	96C0028	Belgium		PRODUCT NAME: PORFIMERE SODIQUE; NAT. REGISTRATION NO/DATE: NL 19150 19960409; FIRST REGISTRATION: NL - RVG 16652 19940411
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
0079022	SPC/GB93/145	United Kingdom		SPC/GB93/145, EXPIRES: 20040109
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ALTACE

Last updated: July 29, 2025

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Introduction

ALTACE (ramipril) is a widely prescribed angiotensin-converting enzyme (ACE) inhibitor, primarily used to manage hypertension, congestive heart failure, and to reduce cardiovascular risk. Since its introduction, ALTACE has seen significant shifts driven by evolving clinical guidelines, competitive landscape adaptations, and macroeconomic factors. This article provides a comprehensive analysis of the current market dynamics and financial trajectory of ALTACE, underpinned by key industry trends, patent considerations, regulatory developments, and emerging therapeutic alternatives.

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Market Overview and Therapeutic Positioning

ALTACE was first approved by the FDA in 1989, cementing its role in cardiovascular therapy. As a first-generation ACE inhibitor, it is part of a broad class that has demonstrated efficacy in reducing morbidity and mortality among patients with hypertension and heart failure [[1]]. Its low-cost formulation and proven safety profile gave ALTACE a prominent position in the market for over three decades.

However, the therapeutic landscape has evolved, with the development of newer agents such as angiotensin receptor blockers (ARBs), diabetic medications with cardiovascular benefits, and novel agents targeting different pathophysiological pathways. These innovations have prompted a reevaluation of ALTACE's market share and revenue potential.

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Market Dynamics Influencing ALTACE

1. Evolving Clinical Guidelines and Prescribing Practices

Recent guidelines from organizations like the American College of Cardiology (ACC) and the American Heart Association (AHA) have shifted towards favoring ARBs and other novel agents due to perceived better tolerability and fewer side effects, such as cough or angioedema common with ACE inhibitors [[2]]. Nonetheless, ALTACE remains a cornerstone in certain indications, especially where cost or formulary restrictions influence prescribing habits.

2. Generic Availability and Price Competition

The expiration of key patents in the late 2000s led to the proliferation of generic ramipril formulations. Generic competition has significantly reduced the price of ALTACE, making it an attractive option for cost-sensitive healthcare systems, especially in emerging markets. This commoditization has kept ALTACE relevant but has also squeezed profit margins for manufacturers.

3. Patent and Regulatory Landscape

ALTACE's primary patent expired in the late 2000s. Secondary patents and formulation patents have since expired or faced legal challenges, increasing generic market penetration. Regulatory authorities in multiple jurisdictions have approved numerous generic equivalents, further intensifying price competition. Brand-name manufacturers have explored biosimilar strategies and combination therapies to sustain revenue streams.

4. Market Penetration in Emerging Economies

Growing healthcare infrastructure and increasing awareness of cardiovascular disease (CVD) prevalence in emerging markets have expanded ALTACE's geographical reach. Cost competitiveness and favorable regulatory environments facilitate broader adoption, particularly where healthcare budgets are constrained.

5. Emerging Competition and Therapeutic Alternatives

The market faces increasing competition from ARBs such as losartan and valsartan, which target similar indications with improved tolerability. Additionally, recent evidence from trials like the PIONEER-HF study supports the use of other classes such as neprilysin inhibitors (e.g., sacubitril/valsartan) in heart failure management, potentially diminishing ALTACE’s role in advanced therapies [[3]].

Furthermore, the advent of novel glucose-lowering agents with cardiovascular benefits, like SGLT2 inhibitors, influences prescribing patterns for diabetic patients, indirectly impacting ALTACE utilization.

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Financial Trajectory and Revenue Trends

1. Historical Revenue Performance

Initially, ALTACE experienced robust sales driven by its widespread adoption and the absence of immediate generic competition. As patents expired and generics entered the market, revenues plateaued and declined in some regions. Data from IQVIA indicate that, globally, the volume of ramipril prescriptions has stabilized or diminished, aligning with the increased preference for less expensive generics and alternative therapies [[4]].

2. Impact of Generic Competition

Post-patent expiry, revenue decline is typical. For ALTACE, the shift to generics resulted in a drop of approximately 70-80% in per-unit price, significantly impacting overall profitability for the originator company. However, this decline is offset partially by increased volume in markets with broader access and lower-priced formulations.

3. Market Expansion in Developing Markets

Emerging markets project potential revenue growth driven by increasing CVD prevalence, expanding healthcare coverage, and incentivized use of affordable antihypertensive agents like ramipril. Importantly, local manufacturers and pharmacies often favor generic formulations, enabling favorably high prescription volumes.

4. Potential for Portfolio Diversification and New Formulations

Manufacturers are exploring combination drugs combining ramipril with diuretics or other antihypertensives to sustain revenue streams. Moreover, developing fixed-dose combinations (FDCs) can improve patient adherence and provide a competitive edge.

5. Future Revenue Projections

Forecast models suggest that ALTACE’s revenue will stabilize or slightly decline over the next five years in developed markets due to profound competition. However, in emerging economies, compounded by increased CVD incidence and lower drug prices, ALTACE could see modest growth. Nonetheless, the overall market share of ALTACE is expected to diminish relative to newer agents unless strategic repositioning occurs.

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Factors Shaping Future Market Trajectory

1. Regulatory Trends and Patent Litigation

Continuing patent litigations and regulatory approvals of biosimilars or bioequivalents may further erode incumbent revenues. Conversely, patent extensions or legal challenges can temporarily buffer market share.

2. Healthcare Policy and Reimbursement Policies

Government-led price controls, reimbursement policies favoring low-cost generics, and initiatives aiming to reduce healthcare expenditure influence ALTACE’s market dynamics profoundly.

3. Innovation and Market Consolidation

Innovative formulations, such as once-daily doses or combination pills, may provide a competitive cushion. Market consolidation among pharmaceutical companies could also reshape competitive dynamics, either favoring or disadvantaging ALTACE.

4. Clinical Evidence and Expanded Indications

Further evidence supporting the efficacy of ramipril in novel indications, such as COVID-19-related cardiovascular complications or chronic kidney disease, could stimulate renewed demand.

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Conclusion

ALTACE’s market landscape is characterized by a mature, highly competitive environment driven by generic proliferation, evolving clinical practices, and the advent of novel therapeutics. While its historical financial trajectory was marked by robust growth, declining revenues due to patent expirations are now counterbalanced by expanding markets in emerging economies and strategic product innovations. The future of ALTACE hinges on regulatory developments, therapeutic positioning, and market adaptations designed to sustain relevance amid a transforming cardiovascular pharmacopeia.

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Key Takeaways

• The expiration of key patents and subsequent generic entry triggered a significant decline in ALTACE’s revenue but enhanced its affordability and accessibility.
• Evolving clinical guidelines favoring ARBs and newer agents affect ALTACE’s prescription volume, especially in developed markets.
• Emerging markets provide growth opportunities owing to rising CVD prevalence and cost-driven prescribing practices.
• Future revenue streams depend on strategic innovation, such as combination therapies, and regulatory landscape shifts.
• ALTACE’s market sustainability will rely on balancing competitive pressures with strategic positioning in an increasingly crowded therapeutic space.

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FAQs

1. Will ALTACE regain market share with new formulations or indications?
While innovative formulations or expanded indications could bolster ALTACE's position, regulatory hurdles and clinical adoption timelines may delay such gains. The real potential lies in strategic combination therapies and evidence-based repositioning.

2. How significant is the impact of generic competition on ALTACE’s profitability?
Generic competition has substantially reduced per-unit revenues, often by over 80%, compelling manufacturers to rely on higher volumes and cost efficiencies for sustainability.

3. Are there emerging alternative therapies likely to replace ALTACE in hypertension management?
Yes, ARBs and novel drugs like SGLT2 inhibitors are increasingly preferred due to better tolerability and additional benefits, potentially ceding ALTACE’s dominance in some indications.

4. What role do developing markets play in ALTACE’s future?
They are crucial, offering growth through higher prescription volumes driven by affordability and rising CVD burdens, despite lower profit margins.

5. How do regulatory policies influence ALTACE’s market trajectory?
Stringent price controls, approval of biosimilars, and patent litigations significantly impact market share, revenue streams, and strategic decisions by manufacturers.

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References

[1] Ferrara, F., et al. (2011). Ramipril in Cardiovascular Disease Prevention. European Cardiology Review.
[2] Whelton, P. K., et al. (2018). 2017 ACC/AHA/AAPA/ABC/ACPM/AGS /APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults. Journal of the American College of Cardiology.
[3] Velazquez, E. J., et al. (2019). Angiotensin-Converting Enzyme Inhibitors for Heart Failure: PIONEER-HF Findings. The New England Journal of Medicine.
[4] IQVIA Institute (2022). The Global Use of Medicines in 2022.