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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	26
Patent Applications:	5,481
Drug Prices:	Drug price information for ALTACE
Drug Sales Revenues:	Drug sales revenues 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

Pharmacology for ALTACE

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

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	AB	RX	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	AB	RX	Yes	Yes
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	AB	RX	Yes	No
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-003	Jan 28, 1991	AB	RX	Yes	No
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-002	Feb 27, 2007		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	022021-003	Feb 27, 2007
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-003	Jan 28, 1991
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-001	Feb 27, 2007
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-002	Feb 27, 2007
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-003	Feb 27, 2007
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-004	Jan 28, 1991
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-002	Jan 28, 1991

International Patents for ALTACE

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

Country	Patent Number	Title	Estimated Expiration
Japan	H0531544
Mexico	9217	PROCEDIMIENTO PARA LA PREPARACION DE DERIVADOS DE AMINOACIDO Y PRODUCTO RESULTANTE
Finland	83633
Spain	517066
Czechoslovakia	247159	METHOD OF CIS,ENDO-2-AZABICYCLO(3,3,1) OCTAL-3-CARBOXYL ACID'S DERIVATIVES PRODUCTION
Australia	6851087
Norway	157138

Supplementary Protection Certificates for ALTACE

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
0079022	SPC/GB93/145	United Kingdom		SPC/GB93/145, EXPIRES: 20040109
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

ALTACE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ACE Inhibitors: A Focus on Ramipril (ALTACE)

Introduction to ACE Inhibitors and Ramipril

ACE inhibitors, or angiotensin-converting enzyme inhibitors, are a class of drugs widely used to treat hypertension, heart failure, and other cardiovascular conditions. Ramipril, marketed under the brand name Altace, is a prominent member of this class. Here, we delve into the market dynamics and financial trajectory of ramipril, highlighting key drivers, challenges, and future prospects.

Market Size and Growth

The global ramipril market was valued at USD 550 million in 2021 and is projected to reach USD 729.86 million by 2029, growing at a CAGR of 3.6% during the forecast period from 2022 to 2029[4].

Key Market Drivers

Rising Prevalence of Cardiovascular Diseases

The increasing incidence of cardiovascular diseases such as hypertension and heart failure is a primary driver for the growth of the ramipril market. As the global population ages and lifestyle factors contribute to higher rates of these diseases, the demand for effective treatments like ACE inhibitors continues to rise[1][3][4].

Advancements in Treatment

Improvements in the formulation of ramipril and the growing adoption of ACE inhibitors for chronic disorders are significant drivers. These advancements enhance the efficacy and safety profiles of the drug, making it a preferred choice for managing hypertension and heart failure[4].

Growing Demand for Affordable Drugs

The increasing healthcare expenditure and the rising need for cost-effective treatments also boost the market. Ramipril, being a well-established drug, offers a balance between efficacy and affordability, which is crucial in the current healthcare landscape[4].

Market Challenges

Competition from Other Antihypertensive Drugs

The ACE inhibitors market faces competition from other classes of antihypertensive medications such as angiotensin II receptor blockers (ARBs), calcium channel blockers, and diuretics. These alternatives offer different mechanisms of action and side effect profiles, which healthcare providers must consider when tailoring treatment regimens[1].

Navigating Market Dynamics

To remain competitive, pharmaceutical companies must innovate and differentiate their products. This involves developing novel formulations, enhancing drug delivery mechanisms, or exploring combination therapies to offer unique value propositions to patients and healthcare providers[1].

Regional Market Overview

North America

North America, particularly the United States, is a dominant market for ACE inhibitors, including ramipril. The region's advanced healthcare infrastructure, high awareness of hypertension risks, and proactive stance towards preventive measures fuel the growth of the ACE inhibitors market[1].

Global Perspective

Globally, the hypertension drug market, which includes ACE inhibitors, is expected to grow from USD 24,983.70 million in 2024 to USD 34,646.10 million by 2032, with a CAGR of 4.2% during the forecast period. North America leads this global market, driven by improved access to healthcare services and rising awareness of hypertension as a critical health issue[3].

Financial Trajectory

Revenue and CAGR

The financial trajectory of the ramipril market is characterized by steady growth. With a projected CAGR of 3.6% from 2022 to 2029, the market is expected to increase from USD 550 million in 2021 to USD 729.86 million by 2029[4].

Key Players and Market Strategies

Major pharmaceutical companies like Pfizer, Novartis, and AstraZeneca are key players in the ACE inhibitors market. These companies engage in strategic collaborations, pricing strategies, and continuous innovation to maintain their market share and drive growth. For instance, Novartis's FDA clearance for Entresto, a novel ACE inhibitor, marks a significant advancement in cardiovascular therapy[1].

Recent Developments and Innovations

FDA Approvals and New Therapies

Recent FDA approvals, such as the clearance for FILSPARI (sparsentan) by Travere Therapeutics, highlight the ongoing innovation in the treatment landscape. These developments offer new hope for patients and underscore the potential for ACE inhibitors and related therapies to address unmet medical needs[1].

Opportunities and Future Prospects

Research and Development

The rise in research and development on ACE inhibitors, including ramipril, presents significant opportunities for market growth. Financial donations from governing bodies and advancements in market regulations further support these efforts[4].

Personalized Medicine and Innovative Treatments

The emphasis on personalized medicine and innovative treatment approaches positions the ACE inhibitors market for sustained growth. The U.S., in particular, is at the forefront of advancing ACE inhibitor therapies, fostering continuous market expansion[1].

Illustrative Statistics

• The North America ACE Inhibitors Market was valued at USD 2.18 billion in 2023 and is anticipated to reach USD 2.93 billion by 2029, growing at a CAGR of 5.25%[1].
• The global hypertension drug market is expected to grow from USD 24,983.70 million in 2024 to USD 34,646.10 million by 2032, with a CAGR of 4.2%[3].
• The ramipril market is projected to grow from USD 550 million in 2021 to USD 729.86 million by 2029, with a CAGR of 3.6%[4].

Quotes from Industry Experts

"The ACE inhibitors market is poised for sustained growth, driven by the rising burden of cardiovascular diseases and ongoing research and development efforts to enhance existing drugs and develop novel therapies." - Industry Analyst[1].

Highlight: Innovation in Treatment

"In May 2021, Novartis disclosed FDA clearance for Entresto, its novel ACE inhibitor medication, targeting heart failure treatment. Demonstrating efficacy in decreasing hospitalization and mortality rates among heart failure patients, this approval marks a significant advancement in cardiovascular therapy." - Source: TechSci Research[1]

Key Takeaways

• The ramipril market is driven by the rising prevalence of cardiovascular diseases and advancements in treatment.
• The market faces competition from other antihypertensive drugs but retains a significant share due to its established efficacy and safety profiles.
• North America, particularly the U.S., is a dominant market for ACE inhibitors.
• Continuous innovation and strategic market initiatives are crucial for sustaining market growth.
• The global hypertension drug market, including ACE inhibitors, is expected to grow significantly over the forecast period.

FAQs

Q: What is the primary use of ramipril in medical treatment? A: Ramipril is primarily used to treat high blood pressure, heart failure, and diabetic kidney disease.

Q: What is the projected CAGR for the ramipril market from 2022 to 2029? A: The ramipril market is expected to grow at a CAGR of 3.6% from 2022 to 2029.

Q: Which region is the largest market for ACE inhibitors, including ramipril? A: North America, particularly the United States, is the largest market for ACE inhibitors.

Q: What are the major challenges faced by the ACE inhibitors market? A: The market faces competition from other antihypertensive drugs and requires continuous innovation to remain competitive.

Q: What recent developments have impacted the ACE inhibitors market? A: Recent FDA approvals for novel ACE inhibitor medications, such as Entresto and FILSPARI, have marked significant advancements in cardiovascular therapy.

Cited Sources

1. TechSci Research: North America ACE Inhibitors Market By Size, Share and Forecast.
2. ALTG Q4 2023 Earnings Presentation: This presentation includes non-GAAP financial measures.
3. Polaris Market Research: Hypertension Drug Market Share, Size, Trends Report, 2024-2032.
4. Data Bridge Market Research: Global Ramipril Market Size, Scope & Growth Opportunities By 2029.