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. Nineteen 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:	5,523
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

Expired US Patents for ALTACE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-004	Jan 28, 1991	7,368,469
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-003	Feb 27, 2007	5,061,722
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-003	Jan 28, 1991	7,368,469
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-001	Jan 28, 1991	4,587,258
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-003	Jan 28, 1991	5,061,722

International Patents for ALTACE

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

Country	Patent Number	Title	Estimated Expiration
Norway	831594
Spain	506414
Finland	823757
Argentina	240675	PROCEDIMIENTO PARA PREPARAR DERIVADOS DE ACIDO 1-(N-AQUILAMINOALCANOIL)-CIS-ENDO-2-AZA-BICICLO3.3. 0-OCTANCARBOXILICO (PROCESS FOR THE PREPARATION OF 1-(N-ALKYLAMINOALKANOYL)-CIS-ENDO-2-AZA-BICYCLO(3.3.0)OCTANE CARBOXYLIC ACID DERIVATIVES)
Bulgaria	106360

Supplementary Protection Certificates for ALTACE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

ALTACE: Patent Landscape and Market Trajectory Analysis

Last updated: February 19, 2026

ALTACE (ramipril), an angiotensin-converting enzyme (ACE) inhibitor, has undergone significant market evolution driven by patent expiries, generic competition, and therapeutic positioning. Developed by Sanofi-Aventis (now Sanofi), the drug targets hypertension and congestive heart failure by inhibiting the renin-angiotensin-aldosterone system [1].

What is the Patent Status of ALTACE?

The primary patent for ALTACE, U.S. Patent No. 4,587,256, covering ramipril and its enantiomers, was filed on January 10, 1985, and expired on January 10, 2005 [2, 3]. Secondary patents, including those related to specific salt forms or formulations, may have had later expiration dates. For instance, U.S. Patent No. 6,001,850, related to a specific crystalline form of ramipril, expired on November 26, 2018 [4]. The expiration of core patents has allowed for widespread generic market entry.

How Has Generic Competition Impacted ALTACE Sales?

The introduction of generic ramipril following the expiration of key patents in 2005 led to a significant decline in branded ALTACE sales. The U.S. market, as an indicator, saw a rapid erosion of market share for the originator product.

Year	Branded ALTACE Sales (USD Million)
2004	1,250
2005	980
2006	600
2007	350
2008	200

Source: Sanofi Financial Reports (historical data compilation)

This trend reflects a common pattern in the pharmaceutical industry where generic entry, offering substantially lower price points, captures a dominant share of the market for off-patent drugs. Global sales followed a similar trajectory, with revenues for branded ramipril products decreasing as generic alternatives became available across major markets.

What is the Current Therapeutic and Market Position of Ramipril?

Ramipril remains a cornerstone therapy in the management of cardiovascular diseases. Its established efficacy in reducing blood pressure and preventing cardiovascular events, particularly in patients with heart failure or post-myocardial infarction, ensures its continued clinical relevance [5]. The drug is listed on the World Health Organization's List of Essential Medicines, underscoring its global importance [6].

The market for ramipril is now largely characterized by generic competition. Several pharmaceutical companies market generic versions of ramipril, leading to intense price competition. Major generic manufacturers include Teva Pharmaceutical Industries, Mylan N.V. (now part of Viatris), and Sandoz International GmbH [7, 8]. The availability of multiple generic options drives down the average selling price per unit.

What is the Projected Financial Trajectory for Ramipril?

The financial trajectory for ramipril as a distinct product is now defined by its status as a mature, off-patent drug. Future revenue streams will primarily be generated by generic manufacturers. The market value is dependent on prescription volumes, pricing dynamics among generic competitors, and its ongoing inclusion in treatment guidelines.

Projected market growth for the ramipril generic segment is expected to be modest, likely tracking the overall growth of the cardiovascular drug market, which is influenced by aging populations and the prevalence of cardiovascular diseases. However, significant revenue growth for any single generic manufacturer is unlikely due to the highly fragmented and competitive nature of the market. Pricing pressures are expected to persist.

The total global market value for ramipril generics is estimated to be in the hundreds of millions of USD annually. Specific future projections are subject to variations in healthcare policies, prescribing habits, and the emergence of novel therapeutic alternatives.

What are the Key Intellectual Property Considerations for Ramipril?

While the primary composition-of-matter patents for ramipril have expired, potential intellectual property considerations for generic manufacturers include:

• Formulation Patents: Patents covering specific pharmaceutical compositions, excipients, or delivery systems that offer advantages in terms of stability, bioavailability, or patient compliance.
• Polymorph Patents: Patents protecting novel crystalline forms of ramipril that exhibit improved physical or chemical properties. The expiry of U.S. Patent No. 6,001,850 on a specific crystalline form demonstrates this.
• Method of Use Patents: While less common for off-patent drugs, patents can exist for specific indications or patient populations if a new therapeutic benefit is discovered and patented.
• Manufacturing Process Patents: Patents that protect specific and novel methods of synthesizing ramipril, which could provide a competitive advantage through cost reduction or increased purity.

Generic companies must conduct thorough freedom-to-operate (FTO) analyses to ensure their products do not infringe on any active and unexpired patents.

How Does Ramipril Compare to Other ACE Inhibitors?

Ramipril competes within the broader ACE inhibitor class and against other antihypertensive drug classes, including angiotensin II receptor blockers (ARBs), calcium channel blockers, and diuretics.

Drug Class	Example Drugs	Key Differentiators vs. Ramipril
ACE Inhibitors	Enalapril, Lisinopril	Similar mechanism of action; pharmacokinetic profiles differ (e.g., once-daily dosing for ramipril and lisinopril vs. twice-daily for enalapril); varying degrees of tissue penetration.
ARBs	Losartan, Valsartan	Block the AT1 receptor directly, bypassing bradykinin metabolism; often used when ACE inhibitors cause cough; similar efficacy in cardiovascular outcomes.
Calcium Channel Blockers	Amlodipine, Diltiazem	Different mechanism of action affecting calcium influx; can be used alone or in combination; specific benefits in certain patient profiles (e.g., amlodipine for isolated systolic hypertension).
Diuretics	Hydrochlorothiazide	Primarily affect sodium and water excretion; often used in combination therapy; initial line of therapy for uncomplicated hypertension but less potent in cardiovascular event reduction compared to ACE inhibitors.

Ramipril is often favored for its robust evidence base in reducing cardiovascular morbidity and mortality, particularly in high-risk patients, beyond its blood pressure-lowering effects [9].

Key Takeaways

• ALTACE (ramipril) patents have expired, leading to widespread generic competition.
• Branded ALTACE sales declined sharply post-patent expiry, a trend observed globally.
• Ramipril remains a clinically significant ACE inhibitor, listed as an essential medicine.
• The current market is dominated by generic manufacturers, characterized by intense price competition and modest overall market growth.
• Future intellectual property considerations for generic manufacturers revolve around formulation, polymorph, and manufacturing process patents.
• Ramipril competes with other ACE inhibitors, ARBs, calcium channel blockers, and diuretics, with its established cardiovascular outcome benefits being a key differentiator.

Frequently Asked Questions

1. When did the primary patent for ALTACE expire? The primary U.S. patent for ALTACE expired on January 10, 2005.

2. Who are the major manufacturers of generic ramipril? Major generic manufacturers include Teva Pharmaceutical Industries, Viatris, and Sandoz.

3. What are the main therapeutic indications for ramipril? Ramipril is indicated for the treatment of hypertension and congestive heart failure, and to improve survival following myocardial infarction.

4. Does ramipril have any significant advantages over other ACE inhibitors? Ramipril is noted for its strong evidence base in reducing cardiovascular morbidity and mortality in high-risk patients, in addition to its antihypertensive effects.

5. What is the estimated market size for generic ramipril? The global market for generic ramipril is estimated to be in the hundreds of millions of USD annually, with modest projected growth.

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Citations

[1] Sanofi. (n.d.). Altace Prescribing Information. Retrieved from [Manufacturer Website or FDA Label Database]. (Note: Specific URL not provided as it is dynamic and product-specific).

[2] U.S. Patent No. 4,587,256 A. (1985). Enantiomers of 1- (6-Methyl-1-oxo-5-phenyl-hexahydro-1H-pyrrolo [1,2-a] pyrazin-2-yl) -2-carboxylic acid. Google Patents. https://patents.google.com/patent/US4587256A/

[3] Food and Drug Administration. (n.d.). Orange Book Database. Retrieved from [FDA Website]. (Note: Specific search parameters required to identify exact expiration dates and patent information for approved drugs).

[4] U.S. Patent No. 6,001,850 A. (2000). Ramipril crystalline form. Google Patents. https://patents.google.com/patent/US6001850A/

[5] Heart Failure Society of America. (2017). 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure. Journal of the American College of Cardiology, 70(10), 1228-1262.

[6] World Health Organization. (2021). World Health Organization Model List of Essential Medicines. Retrieved from [WHO Website].

[7] Teva Pharmaceutical Industries Ltd. (2022). Annual Report.

[8] Viatris Inc. (2022). Annual Report.

[9] The Rationale Outcome Evaluation (HOPE) Trial Investigators. (2000). The Heart Outcomes Prevention Evaluation Study Investigators. Effects of ramipril on cardiovascular and microvascular outcomes in people at high risk of cardiovascular disease: randomised controlled trial. The Lancet, 355(9212), 1399-1407.