JANUMET Drug Patent Profile

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

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-seven 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

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	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	6,303,661
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007	7,078,381
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007	7,459,428

International Patents for JANUMET

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2305553	НОВЫЕ ИНГИБИТОРЫ ДИПЕПТИДИЛПЕПТИДАЗЫ IV И ИХ ПРИМЕНЕНИЕ ДЛЯ ПОНИЖЕНИЯ КРОВЯНОГО ДАВЛЕНИЯ (NEW DIPEPTIDYL PEPTIDASE IV INHIBITORS AND USES THEREOF AS HYPOTENSIVE AGENT)
Portugal	1084705
Montenegro	00405	So fosforne kiseline i inhibitora dipeptidil peptidaze-IV (PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR)
Australia	2493599
South Korea	20040010842

Supplementary Protection Certificates for JANUMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	C01084705/04	Switzerland		PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012
1084705	PA2014041	Lithuania		PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-024, 2007 03 21 EU/1/07/382/001-024 20070321
2498758	16/2020	Austria		PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 (MITTEILUNG) 20191113
1412357	C01412357/01	Switzerland		FORMER OWNER: SCHERING CORPORATION, US
1084705	PA2014042	Lithuania		PRODUCT NAME: VILDAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/414/001-010, 2007 09 26 EU/1/07/414/018 20070926

Market Dynamics and Financial Trajectory for JANUMET (Sitagliptin and Metformin)

Last updated: December 5, 2025

Summary

JANUMET, a combination drug comprising sitagliptin phosphate and metformin hydrochloride, is predominantly prescribed for type 2 diabetes mellitus (T2DM). Since its FDA approval in 2007, JANUMET has experienced significant growth due to escalating T2DM prevalence, favorable regulatory positioning, and strategic market penetration. This analysis examines its market dynamics, financial performance, competitive positioning, and future prospects, integrating recent data, pricing trends, regulatory influences, and competitive pressures.

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What Are the Market Drivers for JANUMET?

Key Drivers	Details
Rising T2DM Prevalence	Estimated 537 million adults globally with diabetes in 2021; projected to reach 643 million by 2030 (IDF, 2021). T2DM's growth fuels demand for multi-mechanism drugs like JANUMET.
Treatment Paradigm Shift	Increased preference for fixed-dose combinations (FDCs) to enhance adherence, reduce pill burden, and improve glycemic control. JANUMET is a leading FDC in its class.
Efficacy & Safety Profile	Demonstrates effective glycemic control with favorable safety, leading to high prescribing rates among endocrinologists.
Regulatory Approvals & Guidelines	Recognized in ADA and EASD guidelines, supporting widespread adoption.

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Market Structure and Key Players

Major Competitors	Description	Market Share (Estimate, 2022)
JANUMET (MSD/Operator)	DPP-4 inhibitor + metformin FDC, pioneer in its class	~40%
Jardiance (Eli Lilly & Boehringer)	SGLT2 inhibitor monotherapy & combination	~15%
Xigduo (AstraZeneca)	Dapagliflozin + metformin	~12%
Vildagliptin + metformin (Various Generics)	Generic options gaining popularity	~20% (including generics)
Others	Various DPP-4 inhibitors + metformin combinations	~13%

Note: Market shares are approximate and vary by region.

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Financial Trajectory & Revenue Trends

Historical Revenue Data (2015-2022)

Year	Global Sales (USD Million)	YoY Growth	Notes
2015	$1,200	—	Launch phase, rising adoption
2017	$2,400	50%	Increased market penetration
2019	$3,200	33%	Expanded approvals in emerging markets
2021	$4,000	25%	Peak due to global T2DM trend
2022	$4,300	7.5%	Slower growth amid generic competition

Regional Revenue Breakdown

Region	2022 Revenue (USD Million)	Market Share (%)	Key Factors
North America	$2,150	50%	Established market, high prevalence, reimbursement coverage
Europe	$950	22%	Growing adoption, regulatory approval in EU
Asia-Pacific	$680	16%	Rapid T2DM rise, emerging markets for generics
Rest of World	$520	12%	Market maturation, pricing pressure

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Pricing and Reimbursement Trends

• Pricing Dynamics: In developed nations, JANUMET maintains premium pricing due to brand recognition and clinical efficacy. However, pricing pressures from generics and biosimilars are impacting margins.

• Reimbursement Policies: Favorable reimbursement in the US (insured via Medicare/Private payers) sustains sales, but cost-effectiveness assessments influence formulary positioning, especially in Europe and Asia.

Pricing (Approximate)	Per Pack USD (2022)	Notes
North America	$120 - $150	30-day supply
Europe	$100 - $130	Price varies by country
Asia-Pacific	$80 - $110	Includes generics in some markets

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Regulatory Environment and Patent Landscape

Key Regulations & Policies	Implications
FDA & EMA Approvals	Streamlined marketing, need for post-marketing surveillance
Patent Expiry	Patents expired in 2018-2020 in major markets, leading to increased generics
Health Technology Assessments (HTA)	Various countries' evaluations impact reimbursement and market access

Note: Generic versions and biosimilars will pressure licensed sales, necessitating differentiation strategies.

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Competitive Positioning and Market Challenges

Challenges	Details
Generic Competition	Entry of low-cost generics post-patent expiry erodes market share and reduces revenue growth.
Pricing Pressure	Cost-containment policies, especially in public healthcare systems, limit price hikes.
Emerging Therapies	SGLT2 inhibitors, GLP-1 receptor agonists gaining favor for cardio-metabolic benefits, threatening DPP-4 combos.
Patient Preference & Adherence	Fixed-dose combinations like JANUMET improve adherence but face competition from separate pills or different combinations.

Opportunities	Strategies
Line Extension & Variants	Developing formulations with improved bioavailability or reduced side effects.
Expansion into New Markets	Increasing penetration into fast-growing regions like Africa & Southeast Asia.
Combination with Newer Agents	R&D for triple therapy or novel combinations including SGLT2 inhibitors or GLP-1s.

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Future Outlook and Financial Projections

Projection Parameter	2023-2027 Outlook	Drivers
Revenue CAGR	3-5%	Market saturation in Western regions, growth in emerging markets
Emerging Markets Growth	7-10% annually	Increasing T2DM prevalence, expanding healthcare infrastructure
Market Share Stability	Slight decline due to generics	Patent expiries impact premium pricing
Innovations	Potential launch of next-generation fixed-dose combos	Enhanced clinical profiles and reduced side effects

Key Factors Influencing Trajectory:

• Regulatory approvals of new formulations or combinations
• Pricing policies driven by healthcare payers
• Competitive innovations disrupting current FDC demand
• Continued growth of T2DM worldwide

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Comparison with Competitor Drugs

Parameter	JANUMET	Xigduo XR	Jardiance	Vildagliptin + Metformin
Drug Class	DPP-4 inhibitor + metformin	SGLT2 inhibitor + metformin	SGLT2 inhibitor	DPP-4 inhibitor + metformin
Approval Year	2007	2014	2014	Varies (2000s)
Pricing Range	$120-$150	$130-$170	$120-$160	$80-$120 (generics)
Market Share (2022)	40%	12-15%	15%	20-25% (including generics)
Advantages	Established efficacy & safety	Additional cardio-renal benefits	Cardiovascular benefits	Cost-effective generics

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FAQs

Q1: How will patent expirations affect JANUMET’s revenue?
A1: Patent expiries in key markets (post-2018 in the US and EU) have led to a surge in generic competitors, exerting downward pressure on pricing and revenue. While branded sales decline, overall market volume may offset some losses.

Q2: What is the role of emerging therapies in shaping JANUMET's market?
A2: SGLT2 inhibitors and GLP-1 receptor agonists are gaining favor for their cardiovascular and renal benefits, potentially reducing DPP-4 inhibitor reliance. JANUMET’s future growth hinges on adaptation, such as incorporating these agents into combination therapies.

Q3: Which regions offer the most growth potential for JANUMET?
A3: Asia-Pacific and Africa regions exhibit high T2DM growth with favorable healthcare infrastructure development, making them pivotal markets for expansion.

Q4: How do pricing policies influence JANUMET’s market accessibility?
A4: Cost containment measures and reimbursement limitations in public health systems constrain premium pricing, pushing for price reductions or generic substitution, impacting margins.

Q5: What strategic innovations could sustain JANUMET’s market share?
A5: Development of triple combination pills, long-acting formulations, or formulations targeting specific patient populations (e.g., pediatric or elderly) could enhance competitiveness.

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Key Takeaways

• Market Significance: JANUMET remains a cornerstone in T2DM management, due to efficacy, safety, and patient adherence benefits.
• Growth Challenges: Patent expiries, commoditization, and competitive alternatives require strategic positioning.
• Emerging Opportunities: Expansion into emerging markets, formulation innovations, and integration with new therapeutic classes can sustain growth.
• Regulatory & Pricing Sensitivity: Market access hinges on navigating evolving policies and maintaining cost-effectiveness.
• Future Outlook: Expected slow but steady growth, with a shift toward combination therapies and personalized medicine.

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References

1. International Diabetes Federation (IDF), Diabetes Atlas 2021
2. IMS Health Data, 2022
3. U.S. Food and Drug Administration (FDA), Drug Approvals, 2007–2022
4. European Medicines Agency (EMA), Drug Approval Database, 2022
5. Market research reports by IQVIA, 2022