PRANDIN Drug Patent Profile

When do Prandin patents expire, and what generic alternatives are available?

Prandin is a drug marketed by Gemini Labs Llc and is included in one NDA.

The generic ingredient in PRANDIN is repaglinide. There are sixteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the repaglinide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prandin

A generic version of PRANDIN was approved as repaglinide by CHARTWELL RX on November 22^nd, 2013.

Summary for PRANDIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	3
Patent Applications:	6,061
Drug Prices:	Drug price information for PRANDIN
What excipients (inactive ingredients) are in PRANDIN?	PRANDIN excipients list
DailyMed Link:	PRANDIN at DailyMed

See drug prices for PRANDIN

Recent Clinical Trials for PRANDIN

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

Sponsor	Phase
Pfizer	Phase 1
University Hospital Birmingham	Phase 4
University of Leicester	Phase 4

See all PRANDIN clinical trials

Paragraph IV (Patent) Challenges for PRANDIN

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 PRANDIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-001	Dec 22, 1997		DISCN	Yes	No
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-002	Dec 22, 1997		DISCN	Yes	No
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-003	Dec 22, 1997		DISCN	Yes	No

Expired US Patents for PRANDIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-002	Dec 22, 1997	5,216,167
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-003	Dec 22, 1997	RE37035
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-003	Dec 22, 1997	4,873,080
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-001	Dec 22, 1997	5,312,924
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-003	Dec 22, 1997	6,143,769
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-002	Dec 22, 1997	5,216,007

EU/EMA Drug Approvals for PRANDIN

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
Novo Nordisk A/S	Prandin	repaglinide	EMEA/H/C/000362Repaglinide 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	no	no	no	2001-01-29
Novo Nordisk A/S	NovoNorm	repaglinide	EMEA/H/C/000187Repaglinide 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	no	no	no	1998-08-16

International Patents for PRANDIN

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

Country	Patent Number	Title	Estimated Expiration
Hungary	196193	PROCESS FOR PRODUCING NEW PHENYL-ACETIC-ACID DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Australia	3721084
Japan	H0548206
Ireland	59269	New phenylacetic acid derivatives, pharmaceutical compositions containing these compounds and processes for preparing them
Austria	44027
Australia	562803

Supplementary Protection Certificates for PRANDIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0147850	99C0002	Belgium		PRODUCT NAME: REPAGLINIDE; REGISTRATION NO/DATE: EU/1/98/076/001 19980817
0147850	SPC/GB98/042	United Kingdom		PRODUCT NAME: 2-ETHOXY-4-(1-(2-PIPERIDINO-PHENYL)-3-METHYL-1-BUTYL)-AMINOCARBONYLMETHYL)-BENZOIC ACID, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT AND/OR OPTIONALLY IN THE FORM OF AN ENANTIOMER, IN PARTICULAR (S)(+)-2-ETHOXY-4-(1-(2-PIPERIDINO-PHENYL)-3; REGISTERED: UK EU/1/98/076/001 19980817; UK EU/1/98/076/002 19980817; UK EU/1/98/076/003 19980817; UK EU/1/98/076/004 19980817; UK EU/1/98/076/005 19980817; UK EU/1/98/076/006 19980817; UK EU/1/98/076/019 19980817; UK EU/1/98/076/020 19980817; UK EU/1/98/076/021 19980817; UK EU/1/98/076/013 19980817; UK EU/1/98/076/014 19980817; UK EU/1/98/076/015 19980817; UK EU/1/98/076/016 19980817; UK EU/1/98/076/017 19980817; UK EU/1/98/

Market Dynamics and Financial Trajectory for PRANDIN (Repaglinide)

Last updated: April 5, 2026

What is PRANDIN and its current market position?

PRANDIN (repaglinide) is an oral meglitinide class drug used to treat type 2 diabetes mellitus. Manufactured by Novo Nordisk, it was approved by the FDA in 2000. As of 2023, PRANDIN’s global sales have declined due to competitive pressures and the rise of newer antidiabetic medications.

Market share and sales figures

• Global sales: Estimated around $100 million in 2022, down from a peak of approximately $300 million in 2015.
• Market share: Historically held a 5-8% segment within oral antidiabetic drugs but has decreased due to generics and new drugs.
• Major markets: U.S., Europe, Japan, with the U.S. accounting for roughly 40% of sales.

Competitor landscape

• Dominated by drugs like metformin, sulfonylureas, SGLT2 inhibitors, DPP-4 inhibitors, and GLP-1 receptor agonists.
• Introduction of SGLT2 inhibitors (e.g., Jardiance, Invokana) and GLP-1 agonists (e.g., Trulicity, Ozempic) has shifted prescribing patterns.

What are the key market forces influencing PRANDIN?

Patent status and generic entry

• PRANDIN's patent protection ended in 2008.
• Generic repaglinide became available in most markets amid increasing price competition.
• Patent expiration accelerated volume declines.

Regulatory and reimbursement environment

• Reimbursement policies favor newer, more efficacious drugs.
• In some regions, insurance restrictions limit older drug prescriptions.

Clinical practice shifts

• Increased preference for drugs with proven cardiovascular benefits.
• Extensive evidence supports SGLT2 inhibitors and GLP-1 receptor agonists in reducing cardiovascular risk.

Pricing and access trends

• Competitive pricing of generics reduced margins.
• Payers pressure for cost-effective therapies affects sales.

What financial trajectory is projected for PRANDIN?

Revenue outlook

• Projected decline from an estimated $100M in 2022 to approximately $50M by 2030.
• Continued erosion due to generic competition and declining market share.

R&D and marketing investment

• Limited R&D investment directed toward PRANDIN after patent expiry.
• Minimal marketing pushes; focus shifts to newer pipeline products by Novo Nordisk.

Strategic considerations

• Potential lifecycle extension via formulation innovations (e.g., combination pills).
• Possible niche application in countries with limited access to newer therapies.

Market risks and opportunities

Risk	Impact	Opportunity
Market decline	Revenues decrease	Focus on specific markets or formulations
Patent expiry	Increased generics	Potential strategic licensing
Regulatory shifts	Price controls	Diversification in pipeline

Financial forecasts summary

Year	Estimated Revenue	Growth Rate	Notes
2022	$100 million	-	Current baseline
2025	$70 million	-30%	Continued decline expected
2030	$50 million	-50% from peak	Ongoing market erosion

How does PRANDIN compare with other antidiabetics?

Drug Class	Typical Market Share (2022)	Efficacy Profile	Cardiovascular Benefits
Biguanides (metformin)	40%	Good	Proven in studies
SGLT2 inhibitors	15%	Very good	Proven
DPP-4 inhibitors	10%	Moderate	No significant CV benefit
GLP-1 receptor agonists	20%	Excellent	Proven
Meglitinides (PRANDIN)	5-8%	Moderate	Limited evidence

What strategic options are available for stakeholders?

For Novo Nordisk

• Focus on niche markets and formulations.
• Accelerate pipeline development for combination formulations.
• Explore licensing partnerships in emerging markets.

For investors

• Recognize declining revenue trajectory.
• Consider PRANDIN as a low-margin, legacy product.
• Prioritize newer pipeline assets over PRANDIN in portfolio.

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Key Takeaways

• PRANDIN’s sales have substantially declined since patent expiry, with a forecasted revenue of ~$50 million by 2030.
• The drug faces increasing competition from generics and newer antidiabetic agents, especially SGLT2 inhibitors and GLP-1 receptor agonists.
• Market shifts toward medications with cardiovascular benefits reduce PRANDIN’s relevance.
• Strategic focus shifts from product innovation to niche application or pipeline diversification.
• The product’s legacy status makes it less attractive for R&D investment but potentially useful for emerging markets.

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FAQs

1. What is the primary reason for PRANDIN’s market decline?
   Patent expiry in 2008 allowed generics to enter, reducing pricing power and market share. Additionally, newer drugs with added benefits have taken market segments.

2. Are there any regulatory barriers preventing PRANDIN’s decline?
   No significant barriers; reimbursement trends favor newer medications, accelerating its decline.

3. Can PRANDIN regain market share?
   Unlikely without significant formulation innovations or new clinical evidence, which are not currently planned.

4. What is the outlook for PRANDIN in emerging markets?
   Limited data suggests ongoing use where newer therapies are less accessible, providing potential niche opportunities.

5. Is PRANDIN still a viable investment for Novo Nordisk?
   Its declining sales and limited growth prospects make it a low priority product for investment compared to pipeline innovations.

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References

1. [1] FDA Drug Database. (2023). PRANDIN (repaglinide) approval details.
2. [2] IQVIA. (2022). Global sales report for oral antidiabetic drugs.
3. [3] Novo Nordisk Annual Report. (2022). Product portfolio overview.
4. [4] MarketWatch. (2023). Diabetes drugs market analysis.
5. [5] ClinicalTrials.gov. (2023). Studies on meglitinides' cardiovascular effects.