JANUMET XR Drug Patent Profile

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

Janumet Xr is a drug marketed by Msd Sub Merck and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has fifty-two patent family members in forty countries.

The generic ingredient in JANUMET XR 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 Xr

Annual sales in 2022 were $352mm indicating the motivation for generic entry (peak sales were $1.1bn in 2018).

There have been thirty-three 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 XR

International Patents:	52
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	20
Drug Prices:	Drug price information for JANUMET XR
Drug Sales Revenues:	Drug sales revenues for JANUMET XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JANUMET XR
What excipients (inactive ingredients) are in JANUMET XR?	JANUMET XR excipients list
DailyMed Link:	JANUMET XR at DailyMed

See drug prices for JANUMET XR

See drug sales revenues for JANUMET XR

Recent Clinical Trials for JANUMET XR

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 XR clinical trials

Pharmacology for JANUMET XR

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

Paragraph IV (Patent) Challenges for JANUMET XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JANUMET XR	Extended-release Tablets	metformin hydrochloride; sitagliptin phosphate	100 mg/1000 mg	202270	1	2012-10-22
JANUMET XR	Extended-release Tablets	metformin hydrochloride; sitagliptin phosphate	50 mg/500 mg and 50 mg/1000 mg	202270	1	2012-03-16

US Patents and Regulatory Information for JANUMET XR

JANUMET XR is protected by one 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 XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-002	Feb 2, 2012		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	202270-001	Feb 2, 2012		RX	Yes	No					Y

Expired US Patents for JANUMET XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-002	Feb 2, 2012

International Patents for JANUMET XR

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

Country	Patent Number	Title	Estimated Expiration
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)
European Patent Office	1416932
Portugal	1412357
Jordan	2230	مثبطات انزيم داي ببتيديل المحتوي على حلقه غير متجانسه من حلقات البيتا امينو للعلاج او للوقايه من مرض السكري (BETA AMINO HETEROCYCLIC DIPEPTIDYL PEPTIDASE INHIBITORS FOR THE TREATMETN OR PREVENTION OF DIABETES)
Montenegro	00405	So fosforne kiseline i inhibitora dipeptidil peptidaze-IV (PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR)
Norway	2007010

Supplementary Protection Certificates for JANUMET XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	CR 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
1532149	C300569	Netherlands		PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
1261586	132012902044560	Italy		PRODUCT NAME: SAXAGLIPTIN E METFORMINA(KOMBOGLYZE); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/11/731/001 A EU/1/11/731/014, 20111124
2498758	2090013-0	Sweden		PRODUCT NAME: A COMBINATION OF METFORMIN HYDROCHLORIDE, SAXAGLIPTIN OR A PHARMACEUTICALLY ACCEPABLE SALT THEREOF, AND DAPAGLIFLOZIN OR PH ARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF; REG. NO/DATE: EU/1/19/1401 20191113
1084705	CA 2014 00063	Denmark		PRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070321
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

Market Dynamics and Financial Trajectory for JANUMET XR

Last updated: October 30, 2025

Introduction

JANUMET XR (sitagliptin and metformin extended-release) represents a pivotal therapy in managing type 2 diabetes mellitus (T2DM). Its unique pharmacological profile, combining two well-established antihyperglycemics, positions it in a competitive landscape driven by evolving demand for effective, convenient, and safe diabetes treatments. Analyzing its market dynamics and financial trajectory involves examining factors like competitive positioning, regulatory landscape, market demand trends, patent considerations, and R&D pipeline influence.

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Market Landscape and Competitive Positioning

Growing Global Diabetes Epidemic

The global prevalence of T2DM has surged, with estimates reaching over 537 million adults as of 2021 and projections exceeding 700 million by 2045 [1]. This expanding patient base fuels sustained demand for combination therapies like JANUMET XR, which simplifies regimens and enhances adherence.

Product Profile and Market Differentiation

JANUMET XR combines sitagliptin (a DPP-4 inhibitor) with metformin extended-release, offering advantages over immediate-release formulations through improved gastrointestinal tolerability and compliance. Its once-daily dosing appeals to both physicians and patients seeking simplicity.

Competitive Arena

The primary competitors include other combination agents such as:

• Jardiance (empagliflozin/metformin): Sodium-glucose cotransporter-2 (SGLT2) inhibitors paired with metformin.
• Xigduo XR (dapagliflozin/metformin): Another SGLT2 inhibitor combo.
• Tradjenta (linagliptin) and other DPP-4 inhibitors.

The market’s competitive intensity hinges on emerging therapies, pricing strategies, and positioning within treatment algorithms.

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Regulatory Environment and Patent Dynamics

Regulatory Approvals

JANUMET XR received FDA approval in 2014, and subsequent approvals in Europe and other jurisdictions expand its market access. Regulatory agencies continuously evaluate safety profiles, influencing market confidence.

Patent Life and Exclusivity

Johnson & Johnson’s (J&J) patent protections safeguarded JANUMET’s core formulations until patent expirations in various markets, compelling J&J to innovate and extend the portfolio with extended-release versions. Patent cliffs threaten revenue streams, prompting the company to invest in new formulations, biomarkers, or complementary therapeutics.

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Market Demand Drivers and Growth Factors

Preference for Fixed-Dose Combinations

Fixed-dose combinations (FDCs) reduce pill burden, enhance adherence, and optimize glycemic control, stimulating demand. JANUMET XR’s once-daily profile aligns with this trend, bolstering sales.

Shift Toward Cardiovascular and Renal Benefits

Recent evidence highlights the cardiovascular and renal benefits of SGLT2 inhibitors and DPP-4 inhibitors. While JANUMET XR doesn’t directly incorporate SGLT2 inhibitors, integration with such therapies in treatment regimens affects pharmacotherapy choice and market share.

Patient Demographics and Lifestyle Factors

The rising prevalence of obesity and sedentary lifestyles amplifies T2DM incidence, underpinning consistent demand growth for effective oral convene—like JANUMET XR.

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Financial Trajectory and Revenue Outlook

Historical Revenue Trends

J&J reported that JANUMET, including XR formulations, generated approximately $1.4 billion globally in 2022, representing a significant portion of the company's diabetes franchise revenue previously exceeding $2 billion annually. However, recent years show stabilization or slight declines in developed markets attributable to patent expirations and emerging competitors [2].

Impact of Patent Expirations and Generics

Patent expirations, notably in 2021 and 2022, introduced generic sitagliptin and metformin, exerting price pressures and volume shifts. The result is a potential revenue compression unless J&J accelerates innovation, shifts focus to high-growth regions, or leverages unique formulations.

Market Expansion and Regional Growth Opportunities

Emerging markets, including Asia-Pacific and Latin America, demonstrate rising diabetes prevalence. Expansion strategies targeting these regions could sustain top-line growth. Additionally, digital health integration and personalized medicine could augment revenue streams.

Pipeline and Innovation

J&J's R&D initiatives aim to develop next-generation DPP-4 inhibitors, novel extended-release formulas, or combination therapies with cardiovascular benefits, potentially extending patent exclusivity and enhancing the product’s life cycle.

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Challenges and Market Risks

• Erosion of Market Share: Patent expirations and generic penetration threaten revenue.
• Pricing Pressures: Payers’ push for cost-effective therapies could lead to tighter formulary access.
• Clinical Competition: The rising prominence of SGLT2 inhibitors and GLP-1 receptor agonists offers alternatives perceived as superior in cardiovascular and weight-loss benefits.
• Regulatory Risks: Changes in drug approval frameworks or post-market safety concerns may impact sales.

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Strategic Implications

To optimize JANUMET XR’s financial trajectory amid evolving market dynamics, stakeholders should consider:

• Accelerating innovation in formulation or delivery mechanisms.
• Expanding into underserved geographic markets with high diabetes prevalence.
• Strengthening physician and patient engagement to highlight unique benefits.
• Developing combination strategies that integrate emerging therapeutic classes.

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Key Takeaways

• Sustained Demand Driven by Diabetes Prevalence: The expanding global T2DM epidemic underpins ongoing demand for fixed-dose combination therapies like JANUMET XR.
• Patent Life and Competition: Patent expirations pose revenue risks; innovation and market diversification are essential.
• Regional Growth Opportunities: Emerging markets offer substantial growth prospects owing to rising diabetes prevalence.
• Pipeline and Innovation Are Critical: Enhancing formulations and exploring combination regimens with cardiovascular and renal benefits can extend product life cycles.
• Pricing and Payer Dynamics: Cost considerations and formulary placements significantly influence revenue trajectory.

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FAQs

Q1: What factors influence the market share of JANUMET XR in the diabetes therapeutic landscape?
A1: Market share is driven by patent protections, competitive positioning, clinical efficacy, safety profiles, patient adherence benefits, and reimbursement policies.

Q2: How does patent expiration impact JANUMET XR’s revenue?
A2: Patent expiration introduces generic конкурентов, leading to price erosion and volume substitution, which can significantly reduce revenue unless mitigated by innovation.

Q3: Are there emerging therapies that could threaten JANUMET XR’s market dominance?
A3: Yes. SGLT2 inhibitors and GLP-1 receptor agonists with proven cardiovascular and weight-loss benefits are increasingly favored, potentially reducing demand for DPP-4 inhibitor combinations.

Q4: What strategies can prolong JANUMET XR’s market viability?
A4: Strategies include developing next-generation formulations, expanding into new markets, integrating with novel therapeutic classes, and emphasizing patient-centric benefits.

Q5: How important is regional market expansion for JANUMET XR’s future?
A5: Critical. Regions like Asia-Pacific and Latin America present high-growth potential due to rising disease prevalence and limited existing treatment infrastructure.

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References

[1] IDF Diabetes Atlas, 9th Edition, 2019.
[2] Johnson & Johnson Annual Report, 2022.