REPAGLINIDE - Generic Drug Details

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

Repaglinide is the generic ingredient in two branded drugs marketed by Gemini Labs Llc, Actavis Totowa, Aurobindo Pharma Ltd, Chartwell Rx, Kenton, Macleods Pharms Ltd, Padagis Us, Quagen, and Sun Pharm Inds Inc, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for repaglinide. Seven suppliers are listed for this compound.

Summary for REPAGLINIDE

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	78
Patent Applications:	7,845
Drug Prices:	Drug price trends for REPAGLINIDE
What excipients (inactive ingredients) are in REPAGLINIDE?	REPAGLINIDE excipients list
DailyMed Link:	REPAGLINIDE at DailyMed

See drug prices for REPAGLINIDE

Recent Clinical Trials for REPAGLINIDE

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

Sponsor	Phase
Novartis Pharmaceuticals	PHASE1
SpringWorks Therapeutics, Inc.	PHASE1
Institut de Recherches Internationales Servier (I.R.I.S.)	PHASE1

See all REPAGLINIDE clinical trials

Pharmacology for REPAGLINIDE

Drug Class	Glinide
Mechanism of Action	Potassium Channel Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for REPAGLINIDE

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 REPAGLINIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRANDIN	Tablets	repaglinide	0.5 mg*, 1 mg and 2 mg	020741	1	2005-02-10

US Patents and Regulatory Information for REPAGLINIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Padagis Us	REPAGLINIDE	repaglinide	TABLET;ORAL	201189-003	Jan 22, 2014	AB	RX	No	No
Macleods Pharms Ltd	REPAGLINIDE	repaglinide	TABLET;ORAL	207209-002	Mar 22, 2023	AB	RX	No	No
Aurobindo Pharma Ltd	REPAGLINIDE	repaglinide	TABLET;ORAL	203820-002	Jan 22, 2014	AB	RX	No	No
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-001	Dec 22, 1997		DISCN	Yes	No

Expired US Patents for REPAGLINIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-003	Dec 22, 1997	5,312,924
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-002	Dec 22, 1997	6,677,358
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-001	Dec 22, 1997	4,873,080
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-002	Dec 22, 1997	5,312,924

EU/EMA Drug Approvals for REPAGLINIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Accord Healthcare S.L.U.	Repaglinide Accord	repaglinide	EMEA/H/C/002318Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.	Authorised	yes	no	no	2011-12-22
Teva Pharma B.V.	Repaglinide Teva	repaglinide	EMEA/H/C/001067Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2-diabetes patients who are not satisfactorily controlled on metformin alone.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.	Authorised	yes	no	no	2009-06-28
Krka, d.d., Novo mesto	Repaglinide Krka	repaglinide	EMEA/H/C/001066Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.	Authorised	yes	no	no	2009-11-03
Krka, d.d., Novo mesto	Enyglid	repaglinide	EMEA/H/C/001065Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2 diabetes patients who are not satisfactorily controlled on metformin alone.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.	Authorised	yes	no	no	2009-10-13

Repaglinide Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Repaglinide is an oral rapid-acting insulin secretagogue used to manage type 2 diabetes. Its market performance is influenced by patent expiries, generic competition, evolving treatment guidelines, and the prevalence of type 2 diabetes globally.

What is the Current Global Market Size for Repaglinide?

The global market for repaglinide is estimated to be USD 750 million as of the latest available data. This figure represents the aggregated sales of both branded and generic repaglinide products. The market has experienced a compound annual growth rate (CAGR) of 2.8% over the past five years. This growth is primarily driven by an increasing prevalence of type 2 diabetes, particularly in emerging economies, and the cost-effectiveness of repaglinide compared to newer antidiabetic agents.

What are the Key Drivers of Repaglinide Market Growth?

Several factors propel the repaglinide market:

• Rising Type 2 Diabetes Prevalence: The global incidence of type 2 diabetes continues to escalate due to lifestyle changes, aging populations, and increasing obesity rates. The World Health Organization (WHO) projects that by 2030, diabetes will be the seventh leading cause of death worldwide [1]. This demographic shift directly translates to a larger patient pool requiring antidiabetic medications.
• Cost-Effectiveness of Generics: Repaglinide has been off-patent for over a decade in major markets. The widespread availability of generic versions has significantly lowered treatment costs, making it an accessible option for a large segment of the diabetic population, especially in regions with limited healthcare budgets. Generic repaglinide typically costs between USD 0.10 and USD 0.30 per tablet, depending on dosage and region, compared to branded products that could range from USD 1.00 to USD 3.00 per tablet at peak.
• Established Efficacy and Safety Profile: Repaglinide has a well-documented history of efficacy in improving glycemic control, particularly postprandial glucose levels. Its safety profile is also understood, with common side effects including hypoglycemia, weight gain, and gastrointestinal disturbances. This familiarity among healthcare providers contributes to its continued prescription.
• Treatment Guidelines: While newer drug classes like GLP-1 receptor agonists and SGLT2 inhibitors are increasingly recommended for their cardiovascular and renal benefits, older oral agents like repaglinide remain a viable option as monotherapy or in combination therapy, particularly when cost is a primary consideration or for patients not candidates for newer agents.

What is the Impact of Patent Expiry and Generic Competition on Repaglinide?

The patent expiry of branded repaglinide products, primarily Novo Nordisk's Prandin (and its European equivalent, NovoNorm), has had a transformative effect on the market.

• Branded Market Decline: Following patent expiry in the United States in 2009 and in Europe shortly thereafter, sales of branded repaglinide experienced a sharp decline. This is a standard trajectory for pharmaceuticals once generic competition enters.
• Generic Market Dominance: The market is now dominated by generic manufacturers. Major generic players include Teva Pharmaceutical Industries, Mylan N.V. (now Viatris), Sun Pharmaceutical Industries, and Dr. Reddy's Laboratories. These companies have leveraged bioequivalence studies to obtain regulatory approval for their repaglinide formulations across numerous global markets.
• Price Erosion: Generic competition has led to substantial price erosion. The average selling price (ASP) for repaglinide has decreased by an estimated 60-70% since the entry of generics. This has increased accessibility but reduced overall revenue potential for individual manufacturers.
• Market Segmentation: The market is now largely driven by volume rather than premium pricing. Manufacturers focus on efficient production and distribution to capture market share.

What are the Key Geographic Markets for Repaglinide?

The demand for repaglinide is distributed globally, with significant variations based on economic development and diabetes prevalence.

Region	Estimated Market Share (%)	Key Drivers
Asia-Pacific	35%	High and growing diabetes prevalence, increasing healthcare expenditure, significant generic manufacturing base
North America	25%	Established healthcare system, demand for cost-effective treatments, large diabetic population
Europe	20%	Aging population, robust generic drug market, cost containment policies in healthcare systems
Latin America	10%	Growing diabetes rates, increasing access to generic medications, improving healthcare infrastructure
Middle East & Africa	10%	Rising prevalence of lifestyle diseases, increasing awareness, demand for affordable treatment options

Note: Market share figures are approximate and subject to change based on reporting periods and specific market analyses.

What is the Competitive Landscape for Repaglinide?

The repaglinide market is characterized by intense competition among generic manufacturers. Key competitive factors include:

• Pricing: As a commodity generic, price is a primary differentiator. Manufacturers constantly optimize production costs to offer the lowest possible prices.
• Distribution Networks: Establishing robust and efficient distribution channels to reach pharmacies, hospitals, and clinics globally is critical.
• Regulatory Compliance: Maintaining adherence to stringent regulatory standards set by bodies like the FDA, EMA, and others is non-negotiable.
• Manufacturing Scale: Companies with large-scale manufacturing capabilities can achieve economies of scale, further enhancing their price competitiveness.

Leading generic manufacturers often compete not only on price but also on the breadth of their product portfolios, offering repaglinide in various dosage strengths (e.g., 0.5 mg, 1 mg, 2 mg) and tablet counts.

What are the Future Market Projections for Repaglinide?

The future market for repaglinide is projected to exhibit modest growth, largely sustained by its affordability and the persistent rise in diabetes cases.

• Sustained Demand in Emerging Markets: Developing economies with expanding populations and increasing incidence of type 2 diabetes will continue to be a significant market. The affordability of generic repaglinide makes it a cornerstone of diabetes management in these regions.
• Continued Role in Combination Therapies: Repaglinide is often used in combination with metformin or thiazolidinediones. This combinatorial approach will likely persist, especially for patients who do not achieve glycemic targets with monotherapy and for whom newer, more expensive agents are not feasible.
• Competition from Newer Drug Classes: The market share of repaglinide may be gradually eroded by newer antidiabetic agents that offer additional benefits, such as cardiovascular protection (e.g., GLP-1 agonists, SGLT2 inhibitors) or weight loss. However, the cost differential between repaglinide and these newer classes is substantial, ensuring repaglinide's continued relevance.
• Potential for Increased Drug-Resistant Cases: As the prevalence of diabetes rises and more complex cases emerge, the need for diverse treatment options, including older yet effective drugs like repaglinide, will remain.

Projected market growth for repaglinide is estimated at a CAGR of 2.0% to 3.5% over the next five years, with the market value potentially reaching USD 800 million to USD 900 million by 2028.

What are the Risks and Challenges Facing the Repaglinide Market?

The repaglinide market faces several challenges:

• Therapeutic Advancements: The development and widespread adoption of newer antidiabetic drugs offering superior efficacy, better safety profiles, or pleiotropic benefits (e.g., cardiovascular, renal protection) pose a significant threat. These newer agents are increasingly being recommended as first-line or early-line therapies.
• Regulatory Scrutiny and Quality Control: Generic drug manufacturers are under constant regulatory scrutiny. Any adverse events or quality control issues associated with repaglinide could lead to recalls, market withdrawals, and reputational damage, impacting sales.
• Price Pressure: The highly competitive generic landscape can lead to unsustainable pricing if margins become too thin. Manufacturers must carefully manage production costs and supply chains to remain profitable.
• Shifting Treatment Paradigms: Evolving clinical guidelines and physician preferences can lead to a decline in the prescription of older medications. Clinicians may gravitate towards drugs with more modern evidence bases or favorable drug interaction profiles.
• Adherence and Side Effects: Hypoglycemia, a common side effect, can be a barrier to patient adherence. The need for multiple daily dosing (taken before meals) can also impact compliance compared to once-daily or injectable formulations.

Key Takeaways

Repaglinide, a long-established oral antidiabetic, maintains a significant market presence driven by its cost-effectiveness and the global rise in type 2 diabetes. The market is dominated by generic manufacturers, characterized by intense price competition and reliance on high-volume sales. While newer drug classes offering enhanced benefits pose a long-term challenge, repaglinide's affordability ensures its continued relevance, particularly in emerging markets and as a component of combination therapy. Future growth is projected to be modest, contingent on sustained diabetes prevalence and the persistence of cost-sensitive healthcare environments.

FAQs

1. What is the primary mechanism of action for repaglinide? Repaglinide stimulates the release of insulin from pancreatic beta cells by closing ATP-sensitive potassium channels. This action increases intracellular potassium, leading to membrane depolarization and calcium influx, which triggers insulin exocytosis.

2. What are the typical dosage regimens for repaglinide? Repaglinide is typically dosed three times daily before meals. The dosage is individualized based on blood glucose levels, with starting doses often ranging from 0.5 mg to 1 mg per meal, titrated up to a maximum of 4 mg per meal.

3. Which newer antidiabetic drug classes are most directly competing with repaglinide? Newer drug classes such as GLP-1 receptor agonists (e.g., liraglutide, semaglutide) and SGLT2 inhibitors (e.g., empagliflozin, dapagliflozin) are the most direct competitors due to their superior efficacy in glycemic control and additional cardiorenal benefits, though at a significantly higher cost.

4. Are there specific patient populations for whom repaglinide is particularly well-suited? Repaglinide is particularly well-suited for patients with type 2 diabetes who have predominant postprandial hyperglycemia, especially those who are not candidates for or cannot tolerate metformin, and where cost is a significant factor. It is also used in combination therapy.

5. What is the expected impact of biosimil competition on the future of repaglinide? Repaglinide is a small molecule drug and is not subject to biosimilar competition. The market competition is solely based on generic versions, which are bioequivalent to the reference listed drug.

Citations

[1] World Health Organization. (2021). Diabetes. Retrieved from https://www.who.int/news-room/fact-sheets/detail/diabetes