NATEGLINIDE - Generic Drug Details

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

Nateglinide is the generic ingredient in two branded drugs marketed by Alvogen, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Rising, Strides Pharma Intl, Teva Pharms, Watson Labs, Zydus Pharms, and Novartis, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for nateglinide. Eleven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for NATEGLINIDE

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	24
Patent Applications:	7,372
Drug Prices:	Drug price trends for NATEGLINIDE
What excipients (inactive ingredients) are in NATEGLINIDE?	NATEGLINIDE excipients list
DailyMed Link:	NATEGLINIDE at DailyMed

See drug prices for NATEGLINIDE

Recent Clinical Trials for NATEGLINIDE

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

Sponsor	Phase
Texas Diabetes Institute	Phase 4
Ministry of Health, Kuwait	Phase 4
Dasman Diabetes Institute	Phase 4

See all NATEGLINIDE clinical trials

Generic filers with tentative approvals for NATEGLINIDE

Applicant	Application No.	Strength	Dosage Form
		120MG	TABLET;ORAL
		60MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for NATEGLINIDE

Drug Class	Glinide
Mechanism of Action	Potassium Channel Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for NATEGLINIDE

A10BX	Other blood glucose lowering drugs, excl. insulins
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for NATEGLINIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STARLIX	Tablets	nateglinide	60 mg and 120 mg	021204		2004-12-22

US Patents and Regulatory Information for NATEGLINIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Ltd	NATEGLINIDE	nateglinide	TABLET;ORAL	077461-002	Sep 9, 2009	AB	RX	No	No
Alvogen	NATEGLINIDE	nateglinide	TABLET;ORAL	205055-002	Dec 11, 2015		DISCN	No	No
Strides Pharma Intl	NATEGLINIDE	nateglinide	TABLET;ORAL	077463-001	Sep 9, 2009	AB	RX	No	No
Cadila Pharms Ltd	NATEGLINIDE	nateglinide	TABLET;ORAL	206432-001	Apr 19, 2019	AB	RX	No	No
Watson Labs	NATEGLINIDE	nateglinide	TABLET;ORAL	077462-001	Mar 30, 2011	AB	RX	No	No

Expired US Patents for NATEGLINIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-001	Dec 22, 2000
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-002	Dec 22, 2000
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-001	Dec 22, 2000
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-002	Dec 22, 2000
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-002	Dec 22, 2000

EU/EMA Drug Approvals for NATEGLINIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Starlix	nateglinide	EMEA/H/C/000335Nateglinide is indicated for combination therapy with metformin in type-2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.	Withdrawn	no	no	no	2001-04-03
Novartis Europharm Ltd.	Trazec	nateglinide	EMEA/H/C/000383Nateglinide is indicated for combination therapy with metformin in type 2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.	Withdrawn	no	no	no	2001-04-03

Last updated: July 28, 2025

rket Dynamics and Financial Trajectory for Nateglinide

Introduction

Nateglinide, marketed primarily under the brand name Starlix, is an oral antihyperglycemic agent classified as a meglitinide analogue. Approved by the FDA in 2000, Nateglinide is designed to improve glycemic control in type 2 diabetes mellitus (T2DM) by stimulating rapid insulin secretion. Its development was driven by the need for flexible, short-acting insulin secretagogues to better manage postprandial blood glucose levels. Over the past two decades, the drug's market position has been shaped by evolving treatment paradigms, regulatory landscapes, and competitive innovations.

Market Fundamentals and Key Drivers

Prevalence of Type 2 Diabetes and Market Potential

The global burden of T2DM fuels demand for effective oral hypoglycemics. According to the International Diabetes Federation (IDF), the number of adults with diabetes exceeded 537 million in 2021, projected to rise to 643 million by 2030 [1]. This demographic shift presents a substantial market opportunity for drugs like Nateglinide, especially in regions with expanding healthcare infrastructure in Asia, Latin America, and Africa.

Therapeutic Role and Positioning

Nateglinide operates as a short-acting insulin secretagogue, primarily addressing postprandial hyperglycemia. Its rapid onset and short duration make it suitable for meal-time glucose control, complementing other oral agents like metformin or sulfonylureas. However, its market penetration depends on clinician preferences, treatment guidelines, and comparative efficacy data.

Competitive Landscape and Therapeutic Alternatives

Nateglinide faces substantial competition from other insulin secretagogues such as repaglinide, and from drugs with different mechanisms like DPP-4 inhibitors (e.g., sitagliptin) and SGLT2 inhibitors (e.g., empagliflozin). The focus on cardiovascular safety and tolerability has shifted prescribing habits, with newer drugs gaining favor over traditional secretagogues, including Nateglinide.

Regulatory and Reimbursement Environment

Regulatory bodies have stricter safety and efficacy standards, especially concerning hypoglycemia risk—a notable concern with secretagogues. Reimbursement policies favor drugs with demonstrated clinical benefits and favorable safety profiles, affecting Nateglinide's market accessibility and adoption rates.

Market Dynamics

Clinical and Safety Profile Influences

Nateglinide’s relatively low risk of hypoglycemia compared to sulfonylureas initially gave it an edge. Nonetheless, concerns emerged over its modest efficacy and limited cardiovascular outcome data, which constrained its widespread acceptance compared to more contemporary agents.

Intellectual Property and Generic Competition

Nateglinide’s patent life concluded in the late 2010s, leading to the entry of generic formulations. Price erosion from generics significantly impacts pharmaceutical revenues and influences prescribing trends, potentially diminishing the financial trajectory of branded Nateglinide products.

Innovative Therapies and Pipeline Challenges

The pipeline of novel antidiabetic agents, particularly SGLT2 inhibitors and GLP-1 receptor agonists, has shifted the focus toward drugs that provide cardiometabolic benefits beyond glycemic control. This paradigm shift reduces the market share for older secretagogues like Nateglinide, which lack such benefits.

Financial Trajectory and Commercial Performance

Historical Revenue Trends

Initially, Nateglinide achieved moderate sales growth driven by its approval in multiple markets and early clinical adoption. However, over the last decade, revenues have plateaued and declined owing to market saturation, less favorable efficacy and safety profiles, and increasing competition from superior agents [2].

Current Market Share and Outlook

Presently, Nateglinide’s market share is limited to niche segments or regions where other therapies are inaccessible or unaffordable. Market analyses suggest a continued decline in sales, with some formulations phased out or holding minimal market presence in highly competitive regions like North America and Western Europe.

Future Market Projections

Forecasts indicate a steep decline in Nateglinide's revenues over the next 5–10 years, driven by patent expirations, generic proliferation, and the shift toward drugs with proven cardiovascular benefits. Nonetheless, in emerging markets where affordability is prioritized, limited but steady demand may persist.

Regulatory and Industry Trends

• Safety Concerns: Increased scrutiny on hypoglycemia risk has dampened Nateglinide’s growth prospects, encouraging prescribers to favor agents with safer profiles.
• Regulatory Limitations: Some regulatory authorities suggest revisiting the risk-benefit profile of secretagogues, further constraining their market viability.
• Market Consolidation: Big pharma consolidation and acquisitions have led to a focus on high-margin, innovative therapies, relegating older agents like Nateglinide to secondary or off-label use.

Implications for Stakeholders

• Pharmaceutical Companies: Companies holding rights to Nateglinide must weigh ongoing revenues against declining market share and treatment landscape shifts. Diversification into newer therapeutic areas or combination formulations may compensate for declining standalone sales.
• Investors: Expect phased revenue declines, emphasizing the importance of strategic licensing, pipeline diversification, or repositioning.
• Healthcare Payers: Cost considerations favor generic, inexpensive options, though safety profiles remain paramount.

Key Takeaways

• Nateglinide’s market has experienced a significant decline post-patent expiry, owing to safety concerns, limited efficacy, and stiff competition from newer agents.
• The global T2DM burden sustains potential demand, particularly in regions with limited access to advanced therapies.
• The future of Nateglinide remains constrained by evolving treatment patterns emphasizing cardiometabolic safety and durability.
• Industry players must innovate or reposition older drugs to sustain commercial viability amidst a shifting healthcare landscape.
• Regulatory and reimbursement policies increasingly favor agents with proven cardiovascular and safety benefits, marginalizing traditional secretagogues like Nateglinide.

---

FAQs

Q1: Why has the market share of Nateglinide declined significantly since its launch?
A1: The decline stems from safety concerns related to hypoglycemia, limited efficacy data compared to newer agents, and the emergence of drugs with additional benefits like cardiovascular protection, leading clinicians to favor alternatives.

Q2: Are there ongoing efforts to reposition or reformulate Nateglinide for better market acceptance?
A2: Currently, efforts are limited. However, some pharmaceutical companies explore combination therapies and novel delivery mechanisms to enhance drug profile and patient compliance.

Q3: How do patent expirations impact the financial trajectory of Nateglinide?
A3: Patent expiry results in generic entry, significantly reducing prices and revenues for branded formulations, accelerating market share erosion.

Q4: What regions present the greatest growth opportunities for Nateglinide?
A4: Emerging markets with less access to advanced therapies and affordability constraints may sustain modest demand for Nateglinide.

Q5: What is the outlook for secretagogues like Nateglinide in the context of current diabetes treatment guidelines?
A5: Current guidelines favor drugs with proven cardiovascular benefits and safety profiles, positioning secretagogues as secondary options or adjuncts rather than first-line therapies, thereby limiting their broader adoption.

---

References

1. International Diabetes Federation. “IDF Diabetes Atlas, 9th Edition,” 2021.
2. Market research reports on antidiabetic drugs, 2022.