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:	88
Clinical Trials:	13
Patent Applications:	7,441
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
Canadian Institutes of Health Research (CIHR)

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
Westminster Pharms	MIGLITOL	miglitol	TABLET;ORAL	203965-001	Feb 24, 2015	AB	RX	No	No
Westminster Pharms	MIGLITOL	miglitol	TABLET;ORAL	203965-002	Feb 24, 2015	AB	RX	No	No
Pfizer	GLYSET	miglitol	TABLET;ORAL	020682-001	Dec 18, 1996	AB	RX	Yes	Yes
Pfizer	GLYSET	miglitol	TABLET;ORAL	020682-003	Dec 18, 1996	AB	RX	Yes	No
Westminster Pharms	MIGLITOL	miglitol	TABLET;ORAL	203965-003	Feb 24, 2015	AB	RX	No	No
Pfizer	GLYSET	miglitol	TABLET;ORAL	020682-002	Dec 18, 1996	AB	RX	Yes	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	020682-003	Dec 18, 1996	4,639,436
Pfizer	GLYSET	miglitol	TABLET;ORAL	020682-002	Dec 18, 1996	4,639,436

MIGLITOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Miglitol

Introduction to Miglitol

Miglitol, marketed under the brand name Glyset, is an oral alpha-glucosidase inhibitor used in the management of type 2 diabetes mellitus. It works by delaying the absorption of complex carbohydrates in the small intestine, thereby reducing postprandial glucose concentrations[3].

Market Size and Growth

The global miglitol market is experiencing steady growth, driven by several key factors. As of 2023, the market size for miglitol API stands at approximately USD 7 million. Looking ahead, the market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.80% from 2024 to 2032[4].

Drivers of Market Growth

Increasing Prevalence of Type 2 Diabetes

The rising prevalence of type 2 diabetes, particularly among the elderly and in regions with high obesity rates, is a significant driver of the miglitol market. Type 2 diabetes is becoming increasingly common, especially in youth, due to factors such as obesity and pubertal insulin resistance[2].

Growing Elderly Population

The global elderly population is increasing, and this demographic is more prone to developing type 2 diabetes. Miglitol, being a safe and effective treatment option for elderly patients, is likely to see increased demand[3].

Awareness and Management of Diabetes

There is a growing awareness about the importance of managing diabetes effectively, which includes the use of medications like miglitol. This increased awareness, coupled with better diagnostic tools and treatment guidelines, is driving the market forward[2].

Competitive Landscape

The competitive landscape for miglitol includes other alpha-glucosidase inhibitors such as acarbose. However, there are no major clinical or financial advantages to using one agent over the other, making miglitol a viable choice in the market[3].

Pharmacological and Therapeutic Benefits

Miglitol's mechanism of action involves the inhibition of alpha-glucosidase enzymes, which delays carbohydrate absorption and reduces postprandial glucose levels. This makes it an effective treatment for patients who are inadequately controlled with diet or oral sulfonylurea therapy. It is particularly beneficial for patients at risk of hypoglycemia, weight gain, or lactic acidosis[3].

Clinical Efficacy

Clinical trials have shown that miglitol can decrease postprandial glucose concentrations and modestly reduce glycosylated hemoglobin (HbA1c) levels by approximately 0.5-1.0%. These trials also highlight the safety profile of miglitol, with mild and transitory adverse effects such as flatulence, diarrhea, and abdominal pain[3].

Regional Market Dynamics

The demand for miglitol varies across different regions, influenced by factors such as the prevalence of type 2 diabetes, healthcare infrastructure, and regulatory environments. Customized market reports can provide detailed insights into specific regions or segments, helping businesses tailor their strategies accordingly[1].

Financial Projections

The projected CAGR of 4.80% from 2024 to 2032 indicates a stable and growing market. This growth is expected to be driven by the increasing demand for effective and safe diabetes management options. The financial trajectory suggests that investments in the miglitol market could yield significant returns over the next decade[4].

Market Challenges and Opportunities

Challenges

• Competition from Other Diabetes Medications: The diabetes market is highly competitive, with various classes of medications such as SGLT2 inhibitors, DPP-4 inhibitors, and GLP-1 agonists. Miglitol must compete with these alternatives to maintain market share[5].
• Adverse Effects: While the adverse effects of miglitol are generally mild, they can still impact patient compliance and satisfaction.

Opportunities

• Growing Demand in Emerging Markets: There is a significant opportunity for growth in emerging markets where the prevalence of type 2 diabetes is increasing rapidly.
• Combination Therapies: Miglitol can be used in combination with other diabetes medications, offering a potential area for growth and innovation.

Key Takeaways

• The global miglitol market is expected to grow at a CAGR of 4.80% from 2024 to 2032.
• The market is driven by the increasing prevalence of type 2 diabetes, the growing elderly population, and increasing awareness about diabetes management.
• Miglitol offers a safe and effective treatment option with a favorable safety profile.
• The competitive landscape includes other alpha-glucosidase inhibitors, but miglitol remains a viable choice.
• Financial projections indicate a stable and growing market with significant investment potential.

FAQs

Q: What is the primary mechanism of action of miglitol?

A: Miglitol works by inhibiting alpha-glucosidase enzymes, which delays the absorption of complex carbohydrates in the small intestine, reducing postprandial glucose concentrations[3].

Q: What are the common adverse effects of miglitol?

A: The common adverse effects of miglitol include flatulence, diarrhea, and abdominal pain, which are generally mild and transitory[3].

Q: How does the market size of miglitol API project to grow?

A: The market size for miglitol API is projected to grow at a CAGR of 4.80% from 2024 to 2032, reaching a significant market size by 2032[4].

Q: Who are the primary beneficiaries of miglitol treatment?

A: Miglitol is particularly beneficial for patients who are inadequately controlled with diet or oral sulfonylurea therapy, including Hispanic, African-American, and elderly patients, or those at risk of hypoglycemia, weight gain, or lactic acidosis[3].

Q: How does miglitol compare to other diabetes medications?

A: Miglitol is comparable to other alpha-glucosidase inhibitors like acarbose and offers a safe and effective treatment option without major clinical or financial advantages over other agents[3].

Sources

1. Dataintelo: Miglitol Market Research Report 2032.
2. Diabetes Journals: Evaluation and Management of Youth-Onset Type 2 Diabetes.
3. PubMed: Miglitol: assessment of its role in the treatment of patients with type 2 diabetes mellitus.
4. Absolute Reports: Global Miglitol API Market.
5. DrugBank Online: Type 2 Diabetes Mellitus (DBCOND0029752).