PRANDIMET Drug Patent Profile

Which patents cover Prandimet, and when can generic versions of Prandimet launch?

Prandimet is a drug marketed by Novo Nordisk Inc and is included in one NDA.

The generic ingredient in PRANDIMET is metformin hydrochloride; repaglinide. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; repaglinide profile page.

Summary for PRANDIMET

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
DailyMed Link:	PRANDIMET at DailyMed

Paragraph IV (Patent) Challenges for PRANDIMET

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRANDIMET	Tablets	metformin hydrochloride; repaglinide	1 mg/500 mg and 2 mg/500 mg	022386	1	2009-04-09

US Patents and Regulatory Information for PRANDIMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-001	Jun 23, 2008		DISCN	Yes	No
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-002	Jun 23, 2008		DISCN	Yes	No

Expired US Patents for PRANDIMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-001	Jun 23, 2008
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-002	Jun 23, 2008
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-001	Jun 23, 2008
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-002	Jun 23, 2008

International Patents for PRANDIMET

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

Country	Patent Number	Title	Estimated Expiration
Austria	53028
Austria	52255
Denmark	296686
Ireland	57700	CHEMICAL COMPOUNDS
Austria	44027
Portugal	79772	NEUE PHENYLESSIGSAEUREDERIVATE DIESE VERBINDUNGEN ENTHALTENDE ARZNEIMITTEL UND VERFAHREN ZU IHRER HERSTELLUNG
Germany	3670636

Supplementary Protection Certificates for PRANDIMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	179 5017-2014	Slovakia		PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
1506211	122014000071	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
2498758	PA2020003	Lithuania		PRODUCT NAME: METFORMINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111
1506211	92496	Luxembourg		PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
1506211	132014902277722	Italy		PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116
1506211	CA 2014 00037	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
1506211	300677	Netherlands		PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: PRANDIMET

Last updated: August 5, 2025

Introduction

PRANDIMET, a combination pharmaceutical product, has garnered rapid attention within the global healthcare landscape due to its innovative approach to managing complex conditions. Its active ingredients—metformin and pioglitazone—are established antidiabetics synergistically formulated to optimize glycemic control in type 2 diabetes mellitus (T2DM). As the prevalence of T2DM escalates worldwide, the commercial and clinical potential of PRANDIMET warrants comprehensive analysis. This report explores the pharmaceutical market dynamics influencing PRANDIMET’s trajectory and forecasts its financial outlook based on current trends, competitive positioning, regulatory pathways, and market needs.

Market Landscape for PRANDIMET

Global Diabetes Burden and Implications

Diabetes remains a pervasive global health challenge, with an estimated 537 million adults affected as of 2021, projected to reach 700 million by 2045 (IDF Diabetes Atlas, 2021). T2DM accounts for approximately 90-95% of cases. The escalating disease burden drives sustained demand for efficacious management options, including combination therapies like PRANDIMET, which aim to enhance adherence, optimize efficacy, and reduce side effects related to monotherapy.

Therapeutic Positioning and Differentiation

PRANDIMET's two active ingredients, metformin and pioglitazone, are well-established. Metformin, the first-line therapy, reduces hepatic glucose production, while pioglitazone improves insulin sensitivity. The combined formulation aims to deliver superior glycemic control with simplified dosing, potentially improving adherence and patient outcomes—factors increasingly critical in treatment selection.

Regulatory Environment and Approval Status

The regulatory landscape plays a decisive role in PRANDIMET’s market trajectory. While some formulations of this combination are approved in select markets, regulatory pathways vary. Notably, the U.S. FDA has historically been cautious about pioglitazone, chiefly due to safety concerns like bladder cancer risks, which influence market accessibility. Conversely, the European Medicines Agency (EMA) maintains a more permissive stance, provided risks are appropriately managed.

Market Dynamics Impacting PRANDIMET

Competitive Landscape

The T2DM therapeutic market is intensely competitive, comprising branded and generic monotherapies, fixed-dose combinations, and emerging agents like SGLT2 inhibitors and GLP-1 receptor agonists. PRANDIMET faces the challenge of differentiation amidst these options, particularly from generics offering cost advantages.

However, its fixed-dose combination (FDC) positions it to appeal to patients requiring combination therapy, emphasizing convenience, improved adherence, and potentially better glycemic outcomes. The success depends on clinical evidence demonstrating superiority or at least non-inferiority compared with existing options.

Market Penetration and Adoption Drivers

The primary drivers for PRANDIMET’s adoption include increasing prevalence of T2DM, the preference for simplified medication regimens, and healthcare provider incentives for early intervention. Patient compliance enhances when medications reduce pill burden, which PRANDIMET naturally facilitates.

Physician acceptance hinges on clinical trial data, safety profile, and cost-effectiveness. Education campaigns and inclusion in clinical guidelines bolster confidence and adoption rates.

Pricing and Reimbursement Dynamics

Pricing strategies significantly influence market entry and expansion. PRANDIMET's pricing must strike a balance—competitive against generic monotherapies and other FDCs, while covering development and regulatory costs.

Reimbursement policies, particularly in developed markets, favor products with demonstrable clinical benefits and economic value. Payers are increasingly scrutinizing combination therapies for cost-effectiveness, with positive health economics informing coverage decisions.

Supply Chain and Manufacturing Considerations

Supply chain robustness is essential amidst global disruptions like pandemics or geopolitical uncertainties. Manufacturing capacity must align with anticipated demand, with quality assurance facilitating regulatory compliance and market confidence.

Financial Trajectory and Forecasts

Revenue Projections

Based on recent market data, the global T2DM drug market exceeded USD 60 billion in 2021 and is projected to grow at a CAGR of approximately 8% through 2030 (Fortune Business Insights). PRANDIMET, positioned as a strategic product in the combination therapy segment, could attain a substantial market share, especially if clinical performance is favorable.

Assuming a conservative market penetration reaching 2-3% of the total T2DM drug market within five years, potential revenues could range from USD 1.2 billion to over USD 1.8 billion annually in mature markets.

Profitability and Investment Outlook

Initial investments in clinical trials, regulatory processes, and marketing are substantial. However, as the product gains approval and market presence, economies of scale and increased adoption will enhance margins.

The integration into existing manufacturing infrastructure and potential partnerships with large pharmaceutical firms could expedite reach and optimize costs, leading to improved profitability projections.

Growth Scenarios

• Optimistic Scenario: Rapid regulatory approvals across key markets, strong clinical evidence, and aggressive marketing could push revenues beyond USD 2 billion within a decade.
• Moderate Scenario: Gradual market penetration facilitated by clinical acceptance and reimbursement support could result in USD 0.8 - 1.5 billion annual sales within five years.
• Pessimistic Scenario: Regulatory hurdles, safety concerns, or market resistance could restrict growth, capping revenues at lower levels.

Risks and Challenges

Key risks include regulatory delays, safety profile issues, patent challenges, and market competition. Additionally, shifts in clinical guidelines favoring novel classes over traditional combinations could impede growth.

Strategic Recommendations

To optimize PRANDIMET’s market potential, stakeholders should prioritize:

• Robust Clinical Data: Demonstrate clear advantages over existing therapies.
• Regulatory Engagement: Streamline approval processes through proactive dialogue.
• Market Education: Enhance physician awareness of benefits and safety profile.
• Pricing Strategies: Develop competitive pricing aligned with payer expectations.
• Partnerships: Leverage alliances for manufacturing, distribution, and marketing.

Key Takeaways

• The expanding global diabetes epidemic creates favorable conditions for PRANDIMET’s growth, provided clinical efficacy and safety are convincingly established.

• Competitive differentiation hinges on clinical evidence, ease of use, safety profile, and cost-effectiveness amid a crowded therapeutic landscape.

• Regulatory navigation and reimbursement landscapes are pivotal; strategic positioning can accelerate market entry and adoption.

• Revenue projections suggest substantial growth potential, with revenues possibly exceeding USD 1 billion within five years under favorable conditions.

• Success depends on balancing innovation, safety, affordability, and strategic partnership development.

FAQs

1. What distinguishes PRANDIMET from other antidiabetic combination therapies?
PRANDIMET combines metformin and pioglitazone in a fixed-dose formulation, aiming to improve adherence and glycemic control. Its differentiation lies in the specific formulation, dosing convenience, and potential for enhanced metabolic benefits compared to monotherapies. However, its superiority over other FDCs depends on clinical trial outcomes.

2. What safety concerns are associated with PRANDIMET?
Given pioglitazone’s safety profile, concerns include risks of weight gain, edema, congestive heart failure, and, controversially, bladder cancer. Proper patient selection and monitoring are essential to mitigate risks.

3. How does market regulation impact PRANDIMET’s commercialization?
Regulatory approval is critical. Variability in approval processes across regions, especially concerning pioglitazone’s safety profile, can delay or restrict market entry. Post-approval surveillance and risk management plans influence long-term market viability.

4. Which markets present the highest growth opportunities for PRANDIMET?
Emerging markets with rising diabetes prevalence and expanding healthcare infrastructure, such as India, China, and Latin America, present significant opportunities. Developed markets offer higher margins but face stricter regulatory scrutiny.

5. What strategic steps should stakeholders undertake for successful market entry?
Stakeholders should invest in robust clinical research, engage proactively with regulators, develop compelling value propositions for payers, educate providers, and establish strategic partnerships to ensure manufacturing and distribution efficiency.

References

[1] International Diabetes Federation. IDF Diabetes Atlas, 10th Edition, 2021.
[2] Fortune Business Insights. “Diabetes Drugs Market Size, Share & Industry Analysis,” 2022.
[3] U.S. Food and Drug Administration. Regulatory considerations for diabetes medications, 2022.
[4] European Medicines Agency. Pioglitazone safety and approvals: review, 2021.