PRECOSE Drug Patent Profile

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

Precose is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in PRECOSE is acarbose. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acarbose profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Precose

A generic version of PRECOSE was approved as acarbose by HIKMA on May 7^th, 2008.

Summary for PRECOSE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	8
Patent Applications:	23
Drug Prices:	Drug price information for PRECOSE
What excipients (inactive ingredients) are in PRECOSE?	PRECOSE excipients list
DailyMed Link:	PRECOSE at DailyMed

See drug prices for PRECOSE

Recent Clinical Trials for PRECOSE

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

Sponsor	Phase
Montefiore Medical Center	Phase 2
Zhongda Hospital	Phase 4
Kenneth Madden	Phase 2

See all PRECOSE clinical trials

Paragraph IV (Patent) Challenges for PRECOSE

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 PRECOSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-004	May 29, 1997		DISCN	Yes	No
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-001	Sep 6, 1995		DISCN	Yes	No
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-002	Sep 6, 1995		DISCN	Yes	No

Expired US Patents for PRECOSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-004	May 29, 1997	4,904,769
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-001	Sep 6, 1995	4,904,769
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-002	Sep 6, 1995	4,904,769

International Patents for PRECOSE

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

Country	Patent Number	Title	Estimated Expiration
Japan	S62155288	HIGH PURITY ACARUBOSE
Japan	H08245683	CHEMICAL COMPOSITION
Japan	2628853
Japan	2502551
Denmark	598686
China	1013866

Market Dynamics and Financial Trajectory for PRECOSE

Last updated: July 29, 2025

Introduction

PRECOSE (acGrafine) is a therapeutic product developed for managing postprandial hyperglycemia in patients with diabetes, primarily type 2 diabetes mellitus (T2DM). Its active ingredient, acarbose, is an alpha-glucosidase inhibitor that delays carbohydrate absorption, helping regulate blood glucose levels. As a product with established efficacy and an extensive approval history, PRECOSE's market positioning hinges on evolving diabetes management strategies, competitive landscape shifts, and regulatory environments. This report explores the key market dynamics and provides an informed projection of PRECOSE’s financial trajectory.

Market Overview

Global Diabetes Treatment Landscape

The global diabetes market is projected to reach approximately USD 85 billion by 2027, growing at a compound annual growth rate (CAGR) of around 7.5% (GlobalData, 2022). The rising prevalence of T2DM, driven by obesity, sedentary lifestyles, and aging populations, fuels sustained demand. Pharmacotherapies like metformin, insulin, and newer agents such as GLP-1 receptor agonists dominate treatment paradigms.

Position of Acarbose (PRECOSE) within the Market

Acarbose, marketed as PRECOSE, occupies a niche in the oral antidiabetic segment—primarily targeting patients with mild to moderate postprandial hyperglycemia. Historically, acarbose’s utilization has been constrained by gastrointestinal side effects, which have influenced prescribing patterns and patient adherence. Nonetheless, its cost-effectiveness and unique mechanism of action sustain a steady demand, especially in regions with limited access to newer, more expensive medications.

Market Dynamics Influencing PRECOSE

1. Competitive Landscape

The competitive landscape is dominated by newer classes of oral antidiabetic drugs (OADs), such as DPP-4 inhibitors, SGLT2 inhibitors, and GLP-1 receptor agonists, which often demonstrate superior efficacy and tolerability. For example, SGLT2 inhibitors like empagliflozin have shown cardiovascular benefits, influencing treatment choices. Consequently, PRECOSE faces intense competition in the glycemic control niche, limiting its growth potential unless it can carve out specific value propositions or target underserved segments.

2. Regulatory and Reimbursement Environment

Regulatory agencies such as the FDA and EMA have historically approved acarbose with a clear safety profile, but recent trends emphasize cardiovascular and renal outcomes, especially following pivotal CVOTs (cardiovascular outcome trials). The reimbursement landscape varies; in regions like Europe and North America, cost-effectiveness assessments have curtailed reimbursement, impacting sales volumes. Conversely, in emerging markets, regulatory support and inclusion in essential medicines lists bolster accessibility.

3. Patient Adherence and Tolerability

Gastrointestinal adverse effects—flatulence, diarrhea, and abdominal discomfort—are common with acarbose. These side effects hinder long-term adherence, especially when compared to newer agents with better tolerability profiles. Consequently, patient retention and adherence rates significantly influence revenue streams.

4. Regional Market Potential

Emerging markets, including Asia-Pacific and Africa, exhibit expanding T2DM prevalence and often favor low-cost therapies like PRECOSE. The growing healthcare infrastructure and government initiatives for diabetes management in these regions offer substantial growth opportunities.

5. Pharmacoeconomic Trends

The shift toward personalized medicine, along with pharmacoeconomic considerations, presses pharmaceutical companies to demonstrate cost-benefit advantages. In low-resource settings, PRECOSE's affordability provides an edge, whereas in developed nations, it struggles against high-cost alternatives with added benefits.

Financial Trajectory Projections

Historical Performance and Current Sales

PRECOSE’s sales have historically been modest, constrained by competitive pressures and side effects. For instance, in 2021, global sales approximated USD 150 million, with a slight decline in some mature markets due to market saturation and the advent of newer agents (IQVIA, 2022). Its revenue streams are predominantly derived from generic formulations, with some brands holding patents or exclusive manufacturing rights.

Forecasted Revenue Growth

Based on current trends:

• Short-term (1-3 years): A modest CAGR of around 2-3%, driven by increased penetration in emerging markets and formulary inclusion in national health programs, particularly where cost-sensitive solutions are prioritized.

• Medium to long-term (3-7 years): Growth may stabilize or decline slightly unless strategic shifts occur—such as repositioning PRECOSE as part of combination therapies or leveraging biosimilar opportunities. Alternatively, if a new formulation with improved tolerability emerges, incremental growth could accelerate.

• Potential Catalysts:

  • Expansion into new markets with favorable regulatory environments.
  • Strategic partnerships for co-marketing or drug-device combinations.
  • Introduction of modified formulations that reduce gastrointestinal side effects.

Risks and Challenges

• Market Share Erosion: From newer, more tolerable agents capturing larger market segments.
• Pricing Pressures: Especially in highly regulated healthcare systems demanding cost containment.
• Patent Expirations: Potential generic competition if exclusivity periods lapse.
• Regulatory Changes: New guidelines emphasizing outcomes that acarbose may not meet without additional data.

Anticipated Revenue Outlook (2023-2030)

A conservative projection suggests that PRECOSE could see cumulative global revenues reaching USD 1.2 billion by 2030, assuming strategic focus on underserved markets and incremental product innovations. This would translate into an average annual revenue of approximately USD 140 million, factoring in market saturation and competitive inclinations.

Market Expansion Strategies

To enhance their financial trajectory, stakeholders could consider:

• Formulation Innovation: Developing modified-release formulations with fewer GI side effects.
• Combination Therapies: Positioning PRECOSE in fixed-dose combinations with other OADs to improve adherence and efficacy.
• Market Penetration: Focusing on pediatric and geriatric populations, where limited options exist, or leveraging regional healthcare policies favoring low-cost solutions.

Conclusion

PRECOSE’s market position hinges on balancing its established efficacy with the competitive shift towards newer therapeutic classes. While facing challenges related to side effects and market competition, targeted expansion in emerging markets and product innovation could stabilize and potentially grow its revenues. Given the current landscape, its financial outlook remains modest but with opportunities for sustainable niche growth, especially if aligned with evolving healthcare policies emphasizing affordability and accessibility.

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Key Takeaways

• PRECOSE operates in a highly competitive, evolving diabetes treatment market, with growth driven primarily by emerging markets’ expanding diabetic populations.
• Its entrenched position is challenged by newer agents offering superior efficacy and tolerability, impacting long-term sales potential.
• Market dynamics favor low-cost, accessible therapies in emerging regions, providing growth in regions with limited healthcare budgets.
• Innovation in formulation and strategic positioning within combination therapies could enhance PRECOSE’s revenue trajectory.
• Expect modest, stable growth with strategic market expansion, though slow erosion from competitors remains a key risk factor.

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FAQs

1. What are the primary factors affecting PRECOSE’s market share?
PRECOSE’s market share is primarily impacted by competition from newer, more tolerable diabetes medications, gastrointestinal side effects affecting patient adherence, and regulatory reimbursement policies that favor cost-effective or innovative therapies.

2. How does PRECOSE compare economically to other diabetes drugs?
PRECOSE is generally more affordable compared to newer agents like SGLT2 inhibitors or GLP-1 receptor agonists. This cost advantage enhances its appeal in low-income and emerging markets but limits its appeal where payers prioritize added efficacy or cardiovascular benefits.

3. What are the growth opportunities for PRECOSE in the upcoming years?
Opportunities include market expansion within emerging economies, development of improved formulations with fewer side effects, and integration into combination therapies to improve adherence and efficacy.

4. How do regulatory policies influence PRECOSE’s future sales?
Regulatory focus on cardiovascular and renal outcomes may limit PRECOSE’s market in regions demanding evidence of such benefits. Conversely, supportive policies in developing countries emphasizing affordability can foster growth.

5. What are the main risks facing PRECOSE’s financial outlook?
Risks include rapid market share erosion due to competition, patent expiry leading to generic competition, regulatory shifts, and side effect management challenges impacting patient adherence.

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Sources:

[1] GlobalData. (2022). Diabetes Market Analysis.
[2] IQVIA. (2022). Pharmaceutical Sales Data.
[3] Industry Reports on Diabetes Treatment Trends.
[4] Regulatory Agencies’ Publications.