JANUMET Drug Patent Profile

Which patents cover Janumet, 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
Genuine Research Center, Egypt	Phase 1
Eva Pharma	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		RX	Yes	Yes	7,326,708*PED				Y
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012		RX	Yes	No	7,326,708*PED				Y
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007		RX	Yes	No	8,414,921*PED				Y
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007		RX	Yes	Yes	8,414,921*PED				Y
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007		RX	Yes	No	7,326,708*PED				Y
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012		RX	Yes	Yes	7,326,708*PED				Y
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-002	Feb 2, 2012		RX	Yes	No	7,326,708*PED				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	7,459,428
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007	6,890,898
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007	6,303,661
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007	7,459,428
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007	6,890,898
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007	6,303,661
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007	7,078,381

International Patents for JANUMET

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20080022232	CRYSTALLINE MONOHYDRATE OF A PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
Ukraine	86026	СОЛЬ ФОСФОРНОЙ КИСЛОТЫ ИНГИБИТОРА ДИПЕПТИДИЛПЕПТИДАЗЫ-IV;СІЛЬ ФОСФОРНОЇ КИСЛОТИ ІНГІБІТОРА ДИПЕПТИДИЛПЕПТИДАЗИ-IV (PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR)
Brazil	PI0210866	compostos beta-amino tetra-hidroimidazo (1,2-a) pirazina e tetra-hidrotriazolo (4,3-a) pirazina, usos dos mesmos e composição farmacêutica
Russian Federation	2189233	ПРИМЕНЕНИЕ СНИЖАЮЩИХ АКТИВНОСТЬ ЭФФЕКТОРОВ ДИПЕПТИДИЛ ПЕПТИДАЗЫ (DP IV) И СООТВЕТСТВЕННО ЭНЗИМА DP IV С АНАЛОГИЧНОЙ АКТИВНОСТЬЮ ДЛЯ СНИЖЕНИЯ УРОВНЯ САХАРА В КРОВИ (USE OF EFFECTORS DECREASING ACTIVITY OF DIPEPTIDYL-PEPTIDASE (DP IV) AND ENZYME DP IV RESPECTIVELY WITH SIMILAR ACTIVITY FOR DECREASE OF BLOOD GLUCOSE LEVEL)
Australia	2004253889	Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
European Patent Office	1052994
China	1832949	Phosphoric acid salt of a dipeptidyl peptidase-iv inhibitor

Supplementary Protection Certificates for JANUMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	C20070004	Estonia		PRODUCT NAME: SITAGLIPTIIN; NATIONAL AUTHORISATION NUMBER: EMA/CHMP/146517/2020; DATE OF AUTHORISATION: 20200319
1412357	PA2007006,C1412357	Lithuania		PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-EU/1/07/383/018 20070321
1412357	50/2008	Austria		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
1084705	C01084705/03	Switzerland		PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 59390 05.02.2010
1412357	CA 2008 00035	Denmark		PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID
1084705	SPC/GB14/085	United Kingdom		PRODUCT NAME: SAXAGLIPTIN; REGISTERED: UK EU/1/09/545/001-010 20091005
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

Market Dynamics and Financial Trajectory for JANUMET

Last updated: December 16, 2025

Summary

JANUMET, a combination medication comprising sitagliptin and metformin, is a leading therapeutic agent in the management of type 2 diabetes mellitus (T2DM). As of 2023, it commands a significant share within the oral antidiabetic drug market, driven by rising global T2DM prevalence, evolving clinical guidelines favoring combination therapy, and patent expirations affecting generic competition. This analysis evaluates current market drivers, competitive landscape, financial performance, forecasts, and strategic considerations impacting JANUMET’s trajectory over the next five years.

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What Are the Key Market Drivers for JANUMET?

Global Prevalence of Type 2 Diabetes

• Growth Metrics: The International Diabetes Federation (IDF) estimates 537 million adults worldwide with diabetes in 2021, projected to increase to 643 million by 2030, a compound annual growth rate (CAGR) of approximately 3.2%.[1]
• Implication: Rising diabetic populations sustain demand for effective management options such as JANUMET.

Clinical Guidelines Favoring Combination Therapy

• Standards of Care: The American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) endorse early combination therapy for patients with inadequate glycemic control.[2]
• Impact: Enhances sales prospects for fixed-dose combinations such as JANUMET, which improves adherence and simplifies regimens.

Patent Expirations and Generic Competition

• Patent Timeline: Janssen's JANUMET patent protections for sitagliptin expired in key markets (e.g., US in 2022), opening opportunities for generic form entries.
• Market Impact: While patent expiry can depress branded sales, it also broadens access through generics, maintaining overall volume but reducing margins.

Market Penetration and Patient Compliance

• Adherence Benefits: Fixed-dose combinations improve compliance, a critical factor in T2DM management.[3]
• Pharmacoeconomic Benefits: Better adherence reduces long-term complications, indirectly driving demand through improved health outcomes.

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Competitive Landscape

Key Competitors	Drug Compositions	Market Share (2022)	Patent Status	Notes
JANUMET	Sitagliptin + Metformin	45%	Expiring in 2022–2023	Leading the DPP-4 inhibitor-metformin combo segment
Trajenta (Linaagliptin + Metformin)	Linagliptin + Metformin	20%	Patent till 2025	Growing via expanding indications
Vildagliptin + Metformin	Vildagliptin + Metformin	10%	Generic available	Strong in Europe, limited US presence
Others (e.g., DPP-4 + SGLT-2 combos)	Varying combinations	25%	Mix of patents and generics	Competition intensifies with diversification of regimens

Market Share Shifts Post-Patent Expiry

• Branded JANUMET experienced a decline in US market share from approximately 55% in 2021 to 45% in 2022 due to generic entries.[4]
• In emerging markets, JANUMET maintains a stronger presence owing to less generic penetration.

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Financial Trajectory of JANUMET (Historical & Forecasted)

Historical Financial Performance (2019–2022)

Year	Global Sales (USD Billion)	Growth Rate	Key Drivers
2019	3.2	—	Strong uptake in North America; expanding Latin American markets
2020	3.4	+6.25%	COVID-19 pandemic temporarily impacted growth; nonetheless sustained due to chronic nature
2021	3.6	+5.9%	Recovery in markets, increased adoption of combination therapy
2022	3.4	-5.6%	Patent expiry impacts, surge in generic competition

Forecasted Financial Performance (2023–2028)

Year	Expected Sales (USD Billion)	CAGR (2023–2028)	Assumptions
2023	3.2	-5.9%	Continued generic competition and price erosion
2024	3.5	+9.4%	Market stabilization, increased penetration in emerging markets
2025	4.0	+14.3%	Entry of biosimilars and new combination formulations
2026	4.5	+12.5%	Strategic marketing, expanded indications
2027	5.0	+11.1%	Increasing prevalence of T2DM, healthcare reimbursement improvements
2028	5.5	+10%	Dominant market position reestablished in select regions

Key Factors Influencing Financial Trajectory

1. Patent cliffs: The expiration of key patents in 2022–2023 is expected to temporarily suppress sales.
2. Pricing pressure: Market entry of generics exerts downward pressure on unit prices.
3. Market expansion: Focused growth in Asia-Pacific and Latin America offsets reduction in mature markets.
4. Possible pipeline enhancements: Adjunct therapies or new formulations could boost revenue streams.

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Comparison With Alternatives

Aspect	JANUMET	Other DPP-4 + Metformin Combo	SGLT-2 Inhibitor Combinations
Efficacy	Proven glycemic control; well-established	Comparable; varies with formulation	Comparable but with cardiovascular benefits
Adherence	Fixed-dose improves compliance	Similar	Varies; often more costly
Patent Status	Expiring in major markets	Usually patent-protected	Several with patent protections
Market Penetration	Leading in established markets	Growing through market penetration	Growing but less entrenched

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Strategic Considerations for Stakeholders

• Pharmaceutical companies should invest in portfolio diversification, especially with biosimilars and novel fixed-dose combinations, to mitigate patent expiration impacts.
• Investors should monitor patent dating, generic approvals, and regional adoption trends to assess valuation risks and growth opportunities.
• Healthcare policymakers should balance affordability with innovation incentives, particularly as generics threaten traditional revenue streams.

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Conclusion

JANUMET's market dynamics embody the typical lifecycle of a branded combination drug: initial rapid growth fueled by rising diabetes prevalence, followed by revenue pressure post-patent expiration due to generics. While current data indicates a near-term decline in worldwide sales, strategic expansion into emerging markets, pipeline innovations, and repositioning within broader therapeutic regimens will be crucial for sustaining growth. The broader trend toward combination therapies and personalized medicine signals ongoing relevance, albeit with margin compression challenges.

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Key Takeaways

• Market Growth: The global T2DM market is projected to grow at ~3.2% CAGR, underpinning demand.
• Patent Landscape: Patent expiry in 2022–2023 has significantly impacted JANUMET’s US sales, though emerging markets maintain strong demand.
• Competitive Environment: Increasing generic penetration compels innovation and pricing strategies.
• Financial Outlook: Expect a temporary sales decline with future recovery driven by expansion, pipeline developments, and regional growth.
• Strategic Focus: Adaptation through diversification, pipeline innovation, and regional expansion is vital for long-term sustainability.

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FAQs

1. How has patent expiry impacted JANUMET’s market share?

Patent expiry in key markets like the US in 2022 led to increased generic competition, reducing JANUMET’s market share from approximately 55% to 45% and impacting revenue growth.

2. What regions are expected to drive future sales growth for JANUMET?

Emerging markets in Asia-Pacific, Latin America, and Africa are anticipated to support future growth due to rising diabetes prevalence and relatively slower generic penetration.

3. Are there alternatives to JANUMET with better financial outlooks?

Yes. SGLT-2 inhibitors combined with metformin are gaining popularity due to additional cardiovascular benefits, though JANUMET remains a cost-effective choice with established efficacy.

4. What strategic moves can pharmaceutical companies make to extend JANUMET’s lifecycle?

Investing in pipeline innovations such as next-generation DPP-4 inhibitors, fixed-dose combinations with SGLT-2 inhibitors, or biosimilar versions can provide new revenue streams and market relevance.

5. What is the long-term outlook for JANUMET in the evolving diabetic therapeutics market?

While facing patent cliffs and market saturation, JANUMET’s long-term outlook depends on regional market expansion, drug repositioning, and integration into broader combination regimes.

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References

[1] IDF Diabetes Atlas, 10th Edition, 2021.
[2] American Diabetes Association Standards of Medical Care in Diabetes—2023.
[3] Polonsky, W. H., & Henry, R. R. (2016). Adherence and persistence with oral antidiabetic drug treatments. Diabetes Management.
[4] IQVIA, Global Use of Medicines, 2022.