GLYSET Drug Patent Profile

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

Glyset is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in GLYSET is miglitol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the miglitol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Glyset

A generic version of GLYSET was approved as miglitol by WESTMINSTER PHARMS on February 24^th, 2015.

Summary for GLYSET

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	88
Drug Prices:	Drug price information for GLYSET
What excipients (inactive ingredients) are in GLYSET?	GLYSET excipients list
DailyMed Link:	GLYSET at DailyMed

See drug prices for GLYSET

US Patents and Regulatory Information for GLYSET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	GLYSET	miglitol	TABLET;ORAL	020682-001	Dec 18, 1996	AB	RX	Yes	Yes
Pfizer	GLYSET	miglitol	TABLET;ORAL	020682-002	Dec 18, 1996	AB	RX	Yes	No
Pfizer	GLYSET	miglitol	TABLET;ORAL	020682-003	Dec 18, 1996	AB	RX	Yes	No

Expired US Patents for GLYSET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	GLYSET	miglitol	TABLET;ORAL	020682-001	Dec 18, 1996	4,639,436
Pfizer	GLYSET	miglitol	TABLET;ORAL	020682-003	Dec 18, 1996	4,639,436
Pfizer	GLYSET	miglitol	TABLET;ORAL	020682-002	Dec 18, 1996	4,639,436

International Patents for GLYSET

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

Country	Patent Number	Title	Estimated Expiration
Japan	S5446786	NOVEL 3*4*55TRIHYDROXYPIPERIDINE COMPOUND* ITS MANUFACTURE AND USE FOR MEDICINE
Austria	A415383
Ireland	781716
Finland	72715
Austria	376420

Supplementary Protection Certificates for GLYSET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0266730	98C0014	Belgium		PRODUCT NAME: MIGLITOL; NAT. REGISTRATION NO/DATE: NL 22 138 19970204; FIRST REGISTRATION: NL - 19 343 UR 19960723

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: GLYSET

Last updated: July 29, 2025

Introduction

Glyset (miglitol) stands as a notable oral alpha-glucosidase inhibitor prescribed primarily for managing type 2 diabetes mellitus (T2DM). Developed by Takeda Pharmaceutical Company, Glyset’s market relevance is rooted in its unique mechanism of delaying carbohydrate absorption, thereby attenuating postprandial hyperglycemia. Understanding the evolving market dynamics and financial trajectory of Glyset involves assessing its competitive positioning, regulatory landscape, and the broader therapeutics environment for diabetes management.

Market Landscape and Competitive Positioning

The global diabetes therapeutics market is forecasted to reach $114 billion by 2026, exhibiting a compound annual growth rate (CAGR) of approximately 7.5% (1). Glyset operates within the niche of alpha-glucosidase inhibitors, competing directly with drugs such as acarbose, voglibose, and miglitol itself. However, it faces challenges from newer classes of diabetics, notably GLP-1 receptor agonists and SGLT2 inhibitors, which demonstrate superior efficacy and cardiovascular benefits.

Despite this, Glyset persists due to its distinct mechanism, minimal weight gain risk, and favorable safety profile. It is especially considered in early-stage management, combination therapies, and specific patient subsets intolerant to other agents. Its current market share remains marginal relative to dominant classes but retains steady demand in particular regions, notably in Japan and Europe.

Regulatory and Institutional Influence

Glyset’s approval varies globally, with initial FDA approval in 1996 and subsequent Market authorizations updated over the years. Regulatory bodies have maintained its classification as a second-line agent, emphasizing its role as adjunct therapy. The drug’s niche positioning is reinforced by detailed clinical guidelines that recommend alpha-glucosidase inhibitors primarily for postprandial glucose control, especially in mild-to-moderate cases.

Regulatory landscapes influence the financial trajectory profoundly. Stringent reimbursement policies in European countries and Japan sustain demand, while in the United States, insurance coverage constraints limit broader adoption. Ongoing patent protections and manufacturing agreements foster steady revenue streams, though imminent patent expiries in certain markets forecast revenue erosion unless supplemented with new formulations or indications.

Market Drivers and Barriers

Key drivers include increasing global prevalence of T2DM, rising awareness of postprandial hyperglycemia's role in disease progression, and patient preference for oral agents with low hypoglycemia risk. Additionally, growing access to healthcare infrastructure and pharmaceutical marketing bolsters Glyset’s utilization.

Barriers include competition from innovative drug classes offering ancillary benefits (weight loss, cardiovascular protection), patient reluctance to additional pill burden, and side effect profiles such as gastrointestinal discomfort. Moreover, expert shifts toward newer agents diminish Glyset’s clinical prominence, influencing prescribing patterns and market uptake.

Innovation and Future Financial Trajectory

While Glyset's core formulation faces declining interest, innovation avenues could foster resurgence. Combination therapies that pair Glyset with other antidiabetic agents, development of extended-release formulations, and targeted marketing for specific patient populations (e.g., prediabetics or gestational diabetes) may sustain revenues.

However, the global pivot towards incretin-based therapies and SGLT2 inhibitors predicts a plateau or decline trajectory for Glyset’s market share. Takeda’s strategic focus on personalized medicine and expanding indications remains critical for optimizing financial returns.

Over the next 5 to 10 years, analysts project Glyset’s revenues will gradually decrease unless supplemented by pipeline innovations or expanded labeling. Investment in educational initiatives highlighting Glyset’s advantages could mitigate market erosion, but overall market dynamics favor newer, more efficacious drugs.

Financial Implications and Revenue Projections

Current estimates suggest Glyset generates modest revenues within Takeda’s diabetes portfolio, with annual sales barely surpassing $100 million (2). Growth prospects are limited amid patent expiries and competitive pressures. In markets where patent protection remains, steady revenues are plausible; elsewhere, generic entry reduces drug prices significantly.

The revenue trajectory hinges on patent life, market expansion efforts, and competition. Potential licensing arrangements, market penetration in emerging economies, and the development of fixed-dose combinations could provide short-term revenue boosts, offsetting declines in mature markets.

Market Risks and Opportunities

Risks include patent cliffs, evolving treatment guidelines favoring newer drugs, and regulatory setbacks. Conversely, opportunities arise from unmet needs in niche segments, development of novel formulations, and strategic collaborations. Digital health integration and real-world evidence generation also serve to bolster Glyset’s clinical and commercial validating stake.

Conclusion

Glyset’s market dynamics reflect a mature, niche position within a rapidly innovating diabetes therapeutics landscape. While steady demand persists in select regions, its future financial trajectory is characterized by stagnation or decline absent significant innovation. Stakeholders must tailor strategies focusing on niche markets, formulation improvements, and value-based healthcare integration to optimize the drug's longevity and profitability.

---

Key Takeaways

• Glyset occupies a niche role in diabetes management, primarily addressing postprandial hyperglycemia.
• Market growth is constrained by competition from newer drug classes with superior efficacy and safety profiles.
• Patent expiries and evolving treatment guidelines threaten Glyset’s revenue streams.
• Innovation, combination therapies, and targeted marketing are vital for sustaining financial viability.
• Long-term prospects depend heavily on regional market access, regulatory developments, and strategic adaptations.

---

FAQs

1. What differentiates Glyset from other diabetes medications?
Glyset’s unique mechanism of inhibiting alpha-glucosidase enzymes delays carbohydrate absorption, effectively controlling postprandial glucose without causing weight gain or hypoglycemia, distinguishing it within oral antidiabetic agents.

2. How vulnerable is Glyset to generic competition?
Glyset's patent protection has expired in some markets, exposing it to generic competition, which significantly impacts pricing and sales volumes. Ongoing patent protections in other regions provide a temporary revenue shield.

3. Can Glyset be used in combination therapy?
Yes, Glyset is often prescribed alongside other antidiabetic drugs, especially insulin or metformin, to improve postprandial glycemic control and meet individualized treatment goals.

4. What are the prospects of Glyset in emerging markets?
In emerging economies, affordability and healthcare infrastructure development create opportunities for Glyset, particularly where newer agents are unaffordable or unavailable. Regulatory approval and market access are critical factors.

5. Are there ongoing efforts to innovate Glyset formulations?
Limited publicly available data suggests research into extended-release formulations or fixed-dose combinations, which could enhance adherence and efficacy, potentially improving Glyset’s market sustainability.

---

References

1. GlobalData. "Diabetes therapeutics market forecast." 2022.
2. Takeda Annual Report 2021. "Financial overview of Takeda’s diabetes segment."