ACARBOSE - Generic Drug Details

What are the generic drug sources for acarbose and what is the scope of freedom to operate?

Acarbose is the generic ingredient in two branded drugs marketed by Avet Lifesciences, Dash Pharms, Hangzhou Zhongmei, Hikma, Impax Labs, Somerset Theraps Llc, Strides Pharma, Watson Labs, and Bayer Hlthcare, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for acarbose. Ten suppliers are listed for this compound.

Summary for ACARBOSE

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	93
Patent Applications:	7,120
Drug Prices:	Drug price trends for ACARBOSE
What excipients (inactive ingredients) are in ACARBOSE?	ACARBOSE excipients list
DailyMed Link:	ACARBOSE at DailyMed

See drug prices for ACARBOSE

Recent Clinical Trials for ACARBOSE

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

Sponsor	Phase
Empros Pharma AB	Phase 1
CTC Clinical Trial Consultants AB	Phase 1
University of Zambia	Phase 3

See all ACARBOSE clinical trials

Pharmacology for ACARBOSE

Drug Class	alpha-Glucosidase Inhibitor
Mechanism of Action	alpha Glucosidase Inhibitors

Medical Subject Heading (MeSH) Categories for ACARBOSE

Glycoside Hydrolase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ACARBOSE

A10BF	Alpha glucosidase inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for ACARBOSE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRECOSE	Tablets	acarbose	25 mg, 50 mg and 100 mg	020482	1	2005-03-22

US Patents and Regulatory Information for ACARBOSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs	ACARBOSE	acarbose	TABLET;ORAL	078441-003	May 14, 2009	AB	RX	No	No
Impax Labs	ACARBOSE	acarbose	TABLET;ORAL	078441-002	May 14, 2009	AB	RX	No	No
Dash Pharms	ACARBOSE	acarbose	TABLET;ORAL	091053-001	Jan 6, 2011		DISCN	No	No
Strides Pharma	ACARBOSE	acarbose	TABLET;ORAL	090912-003	Jul 27, 2011	AB	RX	No	No
Impax Labs	ACARBOSE	acarbose	TABLET;ORAL	078441-001	May 14, 2009	AB	RX	No	No

Expired US Patents for ACARBOSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-004	May 29, 1997
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-002	Sep 6, 1995
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-001	Sep 6, 1995

ACARBOSE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acarbose

Introduction to Acarbose

Acarbose, a drug commonly used to control type 2 diabetes, has been on the market since 1996 under the brand name Precose, developed by Bayer. It is an alpha-glucosidase inhibitor that helps normalize blood glucose levels by slowing down the intestinal absorption of sugars[3].

Market Size and Growth

The Acarbose market is experiencing significant growth driven by several key factors:

• Rising Prevalence of Diabetes: The increasing number of diabetic patients worldwide is a major driver. With nearly 500 million adults affected by type 2 diabetes globally, the demand for antidiabetic therapies like acarbose is on the rise[3][4].
• Geographical Expansion: The market is segmented into North America, Europe, Asia Pacific, and the rest of the world. The Asia-Pacific region, particularly countries like China and India, contributes significantly to the market due to a large patient pool and high prevalence of diabetes[1].
• Forecasted Growth: The Acarbose market is estimated to grow at a moderate to significant pace from 2021 to 2028 and beyond, with projections indicating robust growth rates through 2031[1][4].

Key Drivers

Several factors are driving the growth of the Acarbose market:

• Increasing Demand for Antidiabetic Therapies: The rising demand for treating type 2 diabetes, coupled with the introduction of new drugs and therapies, is fueling market growth[1].
• Anti-Aging Potential: Recent studies have shown that acarbose may have anti-aging effects, which could expand its market beyond diabetes treatment. In mice, acarbose has been shown to increase healthy lifespan by up to 22% in males and 5-10% in females[2].
• Improvements in Manufacturing: Research by Oregon State University has elucidated the biosynthetic pathway of acarbose, opening avenues for biotechnological improvements in its production. This could lead to more efficient and cost-effective manufacturing processes[3].

Market Segmentation

The Acarbose market is segmented based on several criteria:

• Geographical Segmentation: The market is divided into North America, Europe, Asia Pacific, and the rest of the world. The Asia-Pacific region is a significant contributor due to its large patient population and high prevalence of diabetes[1].
• Product Segmentation: Acarbose is available in various forms, including tablets. The Acarbose Tablets Market is expected to see significant expansion from 2023 to 2031[4].

Competitive Landscape

The competitive landscape of the Acarbose market includes several major players:

• Bayer: The original developer of acarbose under the brand name Precose.
• CKDBio Corporation
• Hangzhou East China Pharmaceutical
• Livzon Pharmaceutical Group
• Hebei Huarong Pharmaceutical
• Zhejiang Hisun Pharmaceutical
• Zhebei Pharmaceutical
• Mitsubishi
• Amneal Pharmaceuticals
• Mayne Pharma

These companies are involved in various strategies such as market share expansion, product development, and strategic partnerships to maintain their market position[1].

Financial Trajectory

The financial trajectory of the Acarbose market is promising:

• Revenue Growth: The market is expected to grow significantly, with projections indicating a remarkable CAGR during the forecast period from 2023 to 2031[4].
• Market Value: The Acarbose Drug Market was valued at a substantial amount in 2023 and is expected to reach even higher values by the end of 2031[5].
• Investment and Funding: Research and development in the field of acarbose are supported by various funding sources, including the Glenn Foundation for Medical Research and the National Institute on Aging. These investments are crucial for further advancements in the production and application of acarbose[2].

Challenges and Opportunities

While the market for acarbose is growing, there are several challenges and opportunities to consider:

• Regulatory Approvals: The approval process for new uses of acarbose, such as anti-aging, will be a critical factor in its market expansion.
• Competition from Other Antidiabetic Drugs: The market for antidiabetic drugs is highly competitive, with other drugs like metformin and rapamycin also being studied for their potential benefits.
• Biotechnological Advancements: Understanding the biosynthetic pathway of acarbose opens opportunities for improving its production through biotechnology, which could make the drug more accessible and affordable[3].

Future Outlook

The future outlook for the Acarbose market is positive, driven by increasing demand and advancements in production and application:

• Expanded Use Cases: Beyond its current use in diabetes treatment, acarbose may see expanded use in anti-aging therapies, further boosting its market potential.
• Global Health Impact: As research continues to show the benefits of acarbose in slowing down aging and managing diabetes, it is likely to have a significant impact on global health outcomes[2].

Key Takeaways

• The Acarbose market is growing significantly due to the rising prevalence of type 2 diabetes.
• The Asia-Pacific region is a major contributor to the market.
• Biotechnological advancements are expected to improve the production efficiency of acarbose.
• The drug has shown promising anti-aging effects, which could expand its market.
• Major players are actively involved in market expansion strategies.

FAQs

Q: What is acarbose used for? A: Acarbose is primarily used to treat type 2 diabetes by inhibiting the breakdown of starchy foods and slowing down the intestinal absorption of sugars.

Q: Who are the major players in the Acarbose market? A: Major players include Bayer, CKDBio Corporation, Hangzhou East China Pharmaceutical, Livzon Pharmaceutical Group, and others.

Q: What are the potential anti-aging effects of acarbose? A: Studies have shown that acarbose can increase the healthy lifespan of mice by up to 22% in males and 5-10% in females.

Q: How is acarbose produced? A: Acarbose is derived from soil bacteria, specifically Actinoplanes bacteria, and its biosynthetic pathway has recently been elucidated by Oregon State University research.

Q: What is the forecasted growth of the Acarbose market? A: The market is expected to grow significantly from 2023 to 2031, with a remarkable CAGR during the forecast period.

Sources

1. Verified Market Research - Acarbose Market Size And Forecast
2. Michigan Medicine - A New Drug Slows Aging in Mice. What About Us?
3. Oregon State University - Oregon State research reveals how key diabetes drug is made in nature
4. Market Research Intellect - Global Acarbose Tablets Market Size, Trends and Projections
5. Market Research Intellect - Acarbose Drug Marktomvang, reikwijdte en prognoserapport