MIGLITOL - Generic Drug Details

What are the generic drug sources for miglitol and what is the scope of patent protection?

Miglitol is the generic ingredient in two branded drugs marketed by Pfizer and Westminster Pharms, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for miglitol. Two suppliers are listed for this compound.

Summary for MIGLITOL

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	13
Patent Applications:	7,229
Drug Prices:	Drug price trends for MIGLITOL
What excipients (inactive ingredients) are in MIGLITOL?	MIGLITOL excipients list
DailyMed Link:	MIGLITOL at DailyMed

See drug prices for MIGLITOL

Recent Clinical Trials for MIGLITOL

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

Sponsor	Phase
University of Zambia	Phase 3
University Teaching Hospital, Lusaka, Zambia	Phase 3
Drug Safety and Effectiveness Network, Canada

See all MIGLITOL clinical trials

Pharmacology for MIGLITOL

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

Anatomical Therapeutic Chemical (ATC) Classes for MIGLITOL

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

US Patents and Regulatory Information for MIGLITOL

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		DISCN	Yes	No
Westminster Pharms	MIGLITOL	miglitol	TABLET;ORAL	203965-001	Feb 24, 2015		RX	No	Yes
Westminster Pharms	MIGLITOL	miglitol	TABLET;ORAL	203965-003	Feb 24, 2015		RX	No	No

Expired US Patents for MIGLITOL

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	020682-002	Dec 18, 1996	4,639,436
Pfizer	GLYSET	miglitol	TABLET;ORAL	020682-003	Dec 18, 1996	4,639,436

Market Dynamics and Financial Trajectory for Miglitol

Last updated: February 20, 2026

What is Miglitol and How Is It Positioned in the Market?

Miglitol is an alpha-glucosidase inhibitor approved primarily for type 2 diabetes management. It reduces postprandial blood glucose levels by delaying carbohydrate absorption. Developed by Bayer, it received FDA approval in 1996 and is marketed under the brand name Glyset among others.

Market Size and Growth Drivers

As of 2023, the global oral antidiabetic drug market was valued at approximately $60 billion. Miglitol's segment accounts for a minor proportion but is positioned to grow with the broader diabetes therapeutics market.

Key factors influencing growth:

• increasing prevalence of type 2 diabetes, projected to reach 700 million cases globally by 2045 (IDF, 2021).
• shift towards oral medications driven by patient preference for non-injectables.
• regulatory approval in emerging markets expanding geographic reach.
• rising awareness of glycemic control strategies.

Limitations impacting market expansion:

• competition from newer drug classes such as SGLT2 inhibitors and GLP-1 receptor agonists.
• comparatively lower efficacy and tolerability issues (e.g., gastrointestinal side effects).
• patent expiration of some formulations reducing exclusivity.

Competitive Market Landscape

Miglitol's primary competitors include acarbose, voglibose, and newer agents like empagliflozin and semaglutide.

Drug Class	Market Share (2023)	Notable Features
Alpha-glucosidase inhibitors	10%	Oral, well-established, but limited by side effects
SGLT2 inhibitors	25%	Cardio-renal benefits, broader metabolic effects
GLP-1 receptor agonists	15%	Superior glycemic control, weight loss benefits

Miglitol's market share remains under 2%, constrained by competition and side effect profile.

Regulatory and Policy Environment

Patent expirations for key formulations are imminent or occurred in recent years, opening opportunities for generics. Regulatory agencies in the US and EU reinforce the need for post-market surveillance to monitor adverse events.

Emerging markets like China, India, and Latin America have approved Miglitol, expanding its access but with variable reimbursement policies and market penetration.

Financial Trajectory and Revenue Prospects

Current revenues: Bayer reports Glyset sales in the low single-digit millions annually, reflecting limited market penetration.

Forecasts:

• Market analysts project the global alpha-glucosidase inhibitor segment to grow at approximately 2-3% annually through 2030.
• Miglitol sales are expected to remain flat or decline unless new formulations are introduced or expanded into orphan or niche indications.
• Generic competition post-patent expiry is expected to decrease prices, impacting profit margins.

Investment considerations:

• Limited R&D investments are observed for Miglitol, with Bayer focusing on newer therapeutic classes.
• Opportunities for licensing or partnership could emerge if patent opportunities reopen with formulations for new indications or delivery methods.

Key Takeaways

• Miglitol holds a small share within a competitive, mature market.
• Growth is constrained by newer drugs with better efficacy and side effect profiles.
• Geographic expansion into emerging markets offers incremental volume.
• Patent expirations may introduce generics, reducing prices but impacting revenues.
• R&D focus shifts away from Miglitol toward innovative therapies.

FAQs

1. What factors could increase Miglitol’s market share?
Introducing formulations with improved tolerability, expanding into niche indications, or gaining regulatory approval in new jurisdictions.

2. How does patent expiry affect Miglitol?
It opens the market for generics, lowering price points and pressuring brand sales.

3. Are there developments in Miglitol's formulation or delivery?
No major recent updates; most focus is on newer drug classes.

4. What are the primary competitors for Miglitol?
Acarose, voglibose, SGLT2 inhibitors (e.g., empagliflozin), GLP-1 receptor agonists.

5. How is the global market for alpha-glucosidase inhibitors expected to evolve?
Growth is modest, around 2-3% annually, influenced largely by new therapies and patent landscape changes.

References

1. International Diabetes Federation. (2021). IDF Diabetes Atlas, 10th Edition.
2. Bayer. (2022). Glyset Product Data Sheet.
3. MarketWatch. (2023). Global Oral Antidiabetic Drugs Market Report.
4. U.S. Food and Drug Administration. (1996). Approval of Miglitol.
5. Statista. (2023). Diabetes Therapeutics Market Revenue Projections.