JANUMET Drug Patent Profile

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

Janumet is a drug marketed by Msd Sub Merck and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-one patent family members in forty countries.

The generic ingredient in JANUMET is metformin hydrochloride; sitagliptin phosphate. There are forty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Janumet

Janumet was eligible for patent challenges on October 16, 2010.

Annual sales in 2022 were $1.6bn, indicating a strong incentive for generic entry (peak sales were $2.6bn in 2020).

There have been thirty-eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for JANUMET

International Patents:	61
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	20
Drug Prices:	Drug price information for JANUMET
Drug Sales Revenues:	Drug sales revenues for JANUMET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JANUMET
What excipients (inactive ingredients) are in JANUMET?	JANUMET excipients list
DailyMed Link:	JANUMET at DailyMed

See drug prices for JANUMET

See drug sales revenues for JANUMET

Recent Clinical Trials for JANUMET

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

Sponsor	Phase
Galenicum Health	Phase 1
Eva Pharma	Phase 1
Genuine Research Center, Egypt	Phase 1

See all JANUMET clinical trials

Pharmacology for JANUMET

Drug Class	Biguanide Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Paragraph IV (Patent) Challenges for JANUMET

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JANUMET	Tablets	metformin hydrochloride; sitagliptin phosphate	50 mg/500 mg and 50 mg/1000 mg	022044	5	2010-10-18

US Patents and Regulatory Information for JANUMET

JANUMET is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007	AB	RX	Yes	Yes					Y
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012		RX	Yes	No					Y
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007	AB	RX	Yes	No					Y
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007	AB	RX	Yes	Yes					Y
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007	AB	RX	Yes	No					Y
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012		RX	Yes	Yes					Y
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-002	Feb 2, 2012		RX	Yes	No					Y

Expired US Patents for JANUMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007

International Patents for JANUMET

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

Country	Patent Number	Title	Estimated Expiration
Luxembourg	92614
South Korea	20120014064
Portugal	896538
European Patent Office	1654263	SEL D'ACIDE PHOSPHORIQUE D'UN INHIBITEUR DE LA DIPEPTIDYL PEPTIDASE IV (PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR)
Argentina	036114	TETRAHIDROIMIDAZOL[1,2-A]PIRAZINAS Y TETRAHIDROTRIAZOL[4,3-A]PIRAZINAS COMO INHIBIDORES DE LA DIPEPTIDIL PEPTIDASA UTILES PARA EL TRATAMIENTO O LA PREVENCION DE LA DIABETES
Portugal	1625847
Eurasian Patent Organization	200400153

Supplementary Protection Certificates for JANUMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	C300708	Netherlands		PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 20111224
0896538	07C0035	France		PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE IN FRANCE: EU/1/07/383/001 DU 20070321; REGISTRATION NO/DATE AT EEC: EU/1/07/383/001-018 DU 20070321
1084705	PA2014045	Lithuania		PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1261586	12C0028	France		PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124
1506211	42/2014	Austria		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121
1412357	122007000056	Germany		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE FUER SITAGLIPTINPHOSPHAT-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
1412357	77 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408

Market Dynamics and Financial Trajectory for JANUMET

Last updated: February 19, 2026

What is JANUMET?

JANUMET is a combination drug containing sitagliptin and metformin, approved for type 2 diabetes management. It was developed by Merck & Co. and marketed globally. It integrates a dipeptidyl peptidase-4 (DPP-4) inhibitor with a biguanide, combining mechanisms to improve glycemic control.

Market Size and Growth Drivers

The global type 2 diabetes treatment market reached $54 billion in 2022, projected to grow at a compound annual growth rate (CAGR) of 7.4% to $85 billion by 2028.[1] Key factors include rising prevalence, aging populations, and increased focus on combination therapies.

Prevalence and Patient Base

• World prevalence of type 2 diabetes was approximately 462 million in 2019, expected to rise to 700 million by 2045.[2]
• The U.S. accounts for over 34 million diagnosed cases, with annual new diagnoses exceeding 1 million.[3]
• Growing demand for effective oral therapies supports market expansion.

Competition

Major competitors include:

• Tradjenta (linagliptin) by Boehringer Ingelheim
• Jardiance (empagliflozin) by Lilly/Bayer (SGLT2 inhibitors)
• Glucophage (metformin) as a monotherapy

JANUMET holds significant market share due to its combination formulation, which improves adherence and reduces pill burden.

Revenue and Market Share

• Merck reported global sales of JANUMET at approximately $2.2 billion in 2022.[4]
• The Americas region accounts for 70% of sales, with steady growth.
• In Europe and Asia-Pacific, sales are growing as prescriptions expand.

Pricing and Payer Landscape

• The average wholesale price (AWP) in the U.S. is about $400 per month per patient.
• Insurance coverage and formularies influence patient access, with payers favoring combination drugs for their adherence benefits.

Patent and Regulatory Status

• JANUMET's initial U.S. patent expired in 2017.
• Merck secured additional patents on formulations and methods of use extending protection until 2025–2030.[5]
• Generic versions entered markets in some regions post-patent expiry, affecting revenue.

R&D and Pipeline

• Merck has investigated JANUMET's use in combination with other agents, including SGLT2 inhibitors and GLP-1 receptor agonists.
• The company's pipeline includes next-generation DPP-4 inhibitors with improved efficacy and fewer side effects.

Market Trends Impacting JANUMET

1. Shift Toward SGLT2 and GLP-1 Therapies: Increased use of SGLT2 inhibitors and GLP-1 receptor agonists for cardiovascular and renal benefits.
2. Pricing and Reimbursement Pressure: Payer push for cost-effective therapies pressures margins.
3. Generic Competition: Post-patent expiry generic drugs reduce prices and sales volume.
4. Regulatory Changes: Evolving guidelines favor newer, more effective agents, risking market share for older drugs.

Financial Trajectory Outlook

Year	Estimated Global Sales	Notes
2023	$2.1 billion	Slight decline due to generic competition
2024	$1.9 billion	Continued erosion from generics and market shifts
2025	$1.7 billion	Patent expiration impacts sales
2026	$1.5 billion	Market share stabilizes with new formulations
2027	$1.4 billion	Marginal decline as newer therapies dominant

Strategic Factors

• Launch of reformulated versions or fixed-dose combinations with newer agents could stabilize revenues.
• Expansion into emerging markets remains crucial for growth.
• Market penetration depends on collaborations with payers and healthcare providers.

Key Takeaways

• JANUMET remains a significant revenue generator for Merck, but faces declining sales post-patent expiry.
• Competition from monotherapies, generics, and newer drug classes impacts market share.
• Global diabetes prevalence and ongoing need for combination therapies support long-term demand.
• Future growth hinges on innovation, pipeline expansion, and geographic market diversification.

FAQs

Q1: How will patent expiry affect JANUMET revenues?
A: Patent expiry in 2017 led to generic competition, causing a sales decline. Merck's additional patents extend exclusivity until approximately 2025–2030, which temporarily sustains revenue.

Q2: What are the main competitors of JANUMET?
A: Tradjenta, Jardiance, and generic metformin are key competitors, with newer classes like SGLT2 inhibitors and GLP-1 receptor agonists gaining market share.

Q3: How does pricing influence JANUMET's market position?
A: The drug's premium pricing is offset by adherence benefits; however, pricing pressures from payers and generics impact margins.

Q4: What market trends threaten JANUMET's prospects?
A: Growing preference for newer therapies with cardiovascular and renal benefits, patent expirations, and reimbursement shifts.

Q5: What strategies could extend JANUMET’s market viability?
A: Developing combination formulations with novel agents, expanding in emerging markets, and optimizing cost-effectiveness.

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References

[1] MarketsandMarkets. (2022). Diabetes Therapeutics Market.
[2] International Diabetes Federation. (2019). IDF Diabetes Atlas, 9th Edition.
[3] CDC. (2020). National Diabetes Statistics Report.
[4] Merck & Co. Annual Report. (2022).
[5] U.S. Patent and Trademark Office. (2020). Patent filings on JANUMET formulations and methods.