ALTACE Drug Patent Profile

Which patents cover Altace, and what generic alternatives are available?

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

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

International Patents for ALTACE

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

Country	Patent Number	Title	Estimated Expiration
Japan	S57112359	CARBOXYLALKYL DIPEPTIDE, MANUFACTURE AND MEDICINAL COMPOSITION
Germany	3413710
Ireland	822636
Philippines	22417	CIS, ENDO-2-AZABICYCLO-/3,3.0/-OCTANE-3-CARBOXYLIC ACIDS, /A PROCESS FOR THEIR PREPARATION/. COMPOSITION CONTAINING THESE COMPOUNDS AND THEIR USE
Austria	53992
Australia	554362

Supplementary Protection Certificates for ALTACE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0050800	96C0028	Belgium		PRODUCT NAME: PORFIMERE SODIQUE; NAT. REGISTRATION NO/DATE: NL 19150 19960409; FIRST REGISTRATION: NL - RVG 16652 19940411
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	99C0001	Belgium		PRODUCT NAME: FELODIPINUM + RAMIPRILUM; NATL. REGISTRATION NO/DATE: 354 IS 373 F 3 19981103; FIRST REGISTRATION: SE 13597 19970919
0079022	SPC/GB93/145	United Kingdom		SPC/GB93/145, EXPIRES: 20040109

Investment Scenario and Fundamentals Analysis for ALTACE

Last updated: February 3, 2026

Summary
ALTACE (ramipril) is an ACE inhibitor used primarily for hypertension, heart failure, and post-myocardial infarction management. It holds established market presence due to its proven efficacy and approved indications. The drug's portfolio could see growth driven by aging populations, increased cardiovascular disease prevalence, and patent status. Conversely, generic competition and regulatory pressures pose risks.

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Market Overview and Competitive Landscape

Market Size and Growth

• The global ACE inhibitor market was valued at approximately USD 4.3 billion in 2022, with a compound annual growth rate (CAGR) of around 4.5% projected through 2030.[1]
• Ramipril, marketed as ALTACE, constitutes a significant portion of this market, especially in the U.S. and Europe, due to its early entry and established efficacy.

Key Players and Market Share

• Synthesized by multiple generic manufacturers post-patent expiry, creating price competition.
• br>Major brands historically include Novartis’s ALTACE, with generic versions capturing increasing market share after patent expiration in 2013.[2]

Patent and Regulatory Timeline

• Patents for ALTACE expired in major markets between 2012 and 2014, leading to a shift towards generics.
• Regulatory approvals generally follow the original drug approval in the late 1980s, with ongoing monitoring for safety and efficacy.

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Fundamental Strengths and Risks

Strengths

• Established clinical profile with over 30 years of real-world data.
• Broad indication spectrum, including hypertension, heart failure, and post-MI therapy.
• High prescription rates in aging populations, particularly in North America and Europe.

Risks

• Patent expiry significantly increased generic competition, constricting margins.
• Pricing pressures in developed markets and reimbursement challenges.
• Market penetration hurdles in emerging economies due to regulatory and distribution barriers.

Financial and R&D Outlook

• No recent significant patent protections, limiting exclusivity revenue streams.
• Current revenue is primarily from established prescriptions and generic sales.
• R&D investments focus on combination therapies or new indications rather than ALTACE itself.

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Investment Considerations

Renewed Market Penetration

• Limited scope for growth within mature markets due to patent expiry and market saturation.
• Emerging markets present growth opportunities but may be hampered by regulatory and pricing constraints.

Pipeline and Portfolio Diversification

• Companies with diversified cardiovascular portfolios may mitigate ALTACE-specific risks.
• No towering pipeline candidates directly linked to ramipril, suggesting current valuation reflects portfolio positioning more than pipeline potential.

Regulatory Environment

• Stringent post-market surveillance may impact ongoing approvals and generic substitutions.
• Policies favoring biosimilars and generics could suppress pricing, impacting revenue margins.

Investment Summary

• Short-term: Market saturation with declining revenue due to generics.
• Long-term: Benefits from demographic shifts may stabilize or slow decline, but growth prospects for ALTACE specifically are limited.
• Strategic focus should be on companies with diversified portfolios, or pipelines targeting novel cardiovascular therapies.

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Key Takeaways

• ALTACE is a long-established drug with a mature market, predominantly driven by generic competition.
• Market expansion opportunities are limited mainly to emerging nations.
• Growth potential is constrained; revenue is declining as patent protections lapse.
• Investors should consider diversification strategies or shifts toward pipeline innovation in cardio-metabolic therapies.
• Regulatory and pricing pressures remain significant headwinds.

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FAQs

1. What is the primary revenue driver for ALTACE currently?
The primary revenue driver is generic sales following patent expiry, especially in North America and Europe.

2. How does ALTACE compare to other ACE inhibitors in terms of efficacy?
ALTACE’s efficacy is comparable to other ACE inhibitors like enalapril and lisinopril, supported by extensive clinical data.

3. What are the key risks for investors in ALTACE?
Generic competition, declining market share, pricing pressures, and regulatory developments are primary risks.

4. Are there any upcoming patent protections or approvals that could revive ALTACE’s revenue?
No, patents have expired; no recent approvals or new formulations are in development for ALTACE itself.

5. What opportunities exist for growth within this segment?
Growth may arise from expanding use in emerging markets and developing new formulations or combination therapies with a stronger patent position.

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Sources
[1] MarketsandMarkets. (2023). ACE inhibitor market forecast.
[2] FDA Patent Data. (2014). Patent expiration dates for ALTACE.