JANUVIA Drug Patent Profile

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

Januvia is a drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent protecting this drug and four Paragraph IV challenges.

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

The generic ingredient in JANUVIA is sitagliptin phosphate. There are thirty-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sitagliptin phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Januvia

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 24, 2027. This may change due to patent challenges or generic licensing.

Annual sales in 2022 were $9.7bn, indicating a strong incentive for generic entry.

There have been thirty-two 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.

There are seventeen tentative approvals for the generic drug (sitagliptin phosphate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for JANUVIA

International Patents:	52
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	161
Patent Applications:	3,839
Drug Prices:	Drug price information for JANUVIA
Drug Sales Revenues:	Drug sales revenues for JANUVIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JANUVIA
What excipients (inactive ingredients) are in JANUVIA?	JANUVIA excipients list
DailyMed Link:	JANUVIA at DailyMed

See drug prices for JANUVIA

See drug sales revenues for JANUVIA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for JANUVIA

Constraining patent/regulatory exclusivity:

7,326,708*PED

NDA:

021995

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for JANUVIA

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

Sponsor	Phase
National Polytechnic Institute, Mexico	Phase 4
Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social	Phase 4
Peking University People's Hospital	Phase 2

See all JANUVIA clinical trials

Pharmacology for JANUVIA

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

Paragraph IV (Patent) Challenges for JANUVIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JANUVIA	Tablets	sitagliptin phosphate	50 mg/10 mg 50 mg/20 mg 50 mg/40 mg	021995	1	2012-11-06
JANUVIA	Tablets	sitagliptin phosphate	100 mg/20 mg	021995	1	2012-06-25
JANUVIA	Tablets	sitagliptin phosphate	100 mg/10 mg and 100 mg/40 mg	021995	1	2012-06-19
JANUVIA	Tablets	sitagliptin phosphate	25 mg, 50 mg and 100 mg	021995	6	2010-10-18

US Patents and Regulatory Information for JANUVIA

JANUVIA is protected by one US patents.

This potential generic entry date is based on patent 7,326,708.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	Oct 16, 2006		RX	Yes	No	7,326,708*PED				Y
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006		RX	Yes	No	7,326,708*PED				Y
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006		RX	Yes	Yes	7,326,708*PED				Y

Expired US Patents for JANUVIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006	7,078,381
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	Oct 16, 2006	6,303,661
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006	7,078,381
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006	6,890,898
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006	7,459,428
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006	6,890,898

International Patents for JANUVIA

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1033420
Norway	20031574
Colombia	5660266	SAL DE ACIDO FOSFORICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA-IV
European Patent Office	2226324
Montenegro	00439	BETA-AMINO TETRAHIDROMIDAZO (1,2-A) PIRAZINI I TETRAHIDROTRIAZOLO (4,3-A) PIRAZINI KAO INHIBITORI DIPEPTIDIL PEPTIDAZE U LIJEČENJU ILI PREVENCIJI DIJABETESA (BETA-AMINO TETRAHYDROIMIDAZO (1, 2-A) PYRAZINES AND TETRAHYDROTRIOAZOLO (4, 3-A) PYRAZINES AS DIPEPTIDYL PEPTIDASE INHIBITORS FOR THE TREATMENT OR PREVENTION OF DIABETES)
South Korea	20100036363

Supplementary Protection Certificates for JANUVIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	PA2008013	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
1084705	C300707	Netherlands		PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
1084705	SPC/GB14/085	United Kingdom		PRODUCT NAME: SAXAGLIPTIN; REGISTERED: UK EU/1/09/545/001-010 20091005
1084705	CA 2014 00065	Denmark		PRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110824
1412357	122008000046	Germany		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
1412357	0790041-8	Sweden		PRODUCT NAME: SITAGLIPTINFOSFATMONOHYDRAT

Market Dynamics and Financial Trajectory for JANUVIA (Sitagliptin): A Comprehensive Analysis

Last updated: December 10, 2025

Executive Summary

JANUVIA (sitagliptin), marketed by Merck & Co., is a leading oral antidiabetic agent launched in 2006 for managing Type 2 Diabetes Mellitus (T2DM). Over the past decade, the drug has experienced dynamic market changes driven by regulatory developments, competitive pressures, and evolving treatment paradigms. This report delves into the current market landscape, analyzing sales trajectories, competitive positioning, regulatory influences, and future growth prospects.

Key Highlights:

• JANUVIA's global sales reached approximately $5.2 billion in 2022, reflecting stabilized yet mature market performance.
• The drug benefits from a wide label suitable for monotherapy and combination therapies, enhancing its market appeal.
• Market growth is increasingly influenced by emerging markets, biosimilar threats, and shifting guidelines.
• The global antidiabetic market is projected to grow at a CAGR of 7%-9% through 2027, with JANUVIA poised to maintain significant share.
• Key challenges include pricing pressures, patent challenges, and competition from incretin mimetics and SGLT2 inhibitors.

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Market Dynamics

What Is the Current Market Landscape for JANUVIA?

Market Positioning & Market Share:

Parameter	Details
Approved Indications	T2DM as monotherapy or add-on therapy
Market Share (2022)	~7% of global oral antidiabetic market
Leading Competitors	Tradjenta (lina Gliptin), Onglyza (saxagliptin), DPP-4 inhibitors in combination
Geographic Revenue Distribution	U.S. (55%), Europe (20%), Asia-Pacific (20%), Others (5%)

Sales and Revenue Trends:

Year	Global Sales (USD Billion)	Annual Growth	Comments
2018	4.1	4%	Steady growth driven by chronic disease prevalence
2019	4.3	4.9%	Regulatory approvals in additional markets
2020	4.4	2.3%	Pandemic impact, shift to oral therapies
2021	4.8	9%	Recovery and market expansion
2022	5.2	8%	Mature stage, stabilization

Source: Merck Annual Reports, EvaluatePharma

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What Are the Market Drivers and Barriers?

Key Drivers:

• Growing T2DM Prevalence: Global prevalence hit approximately 537 million in 2021; projected to reach 700 million by 2045 [1], fueling demand.
• Chronic Disease Management Needs: Shift in treatment from insulin to oral agents, including DPP-4 inhibitors.
• Regulatory Approvals in Emerging Markets: Expanding access in Asia, Latin America, and Africa.
• Hi-tech Combinations: Co-formulations with metformin and other classes bolster market appeal.

Key Barriers:

• Pricing and Reimbursement Pressures: Governments seek cost-effective therapies, reducing ARV (average relative value).
• Patent Expiry & Biosimilars: Patent landscape shifts threaten exclusivity.
• Competitive Pipeline: Incretin mimetics (e.g., Trulicity, Ozempic) gaining preference due to efficacy.

What Is the Competitive Landscape?

Competitor	Mechanism	Market Share (2022)	Strengths	Challenges
JANUVIA	DPP-4 inhibitor	7%	Well established, favorable safety profile	Marginally lower efficacy vs. GLP-1 RAs
Onglyza (saxagliptin)	DPP-4 inhibitor	2%	Strong global presence	Safety concerns (e.g., heart failure)
Tradjenta (linagliptin)	DPP-4 inhibitor	5%	Longer half-life, single daily dose	Limited efficacy advantage
Trulicity (dulaglutide)	GLP-1 RA	Leading class	Superior efficacy in weight loss & glucose control	Injectables, higher cost

Note: The overall oral antidiabetic market is forecast to grow, while each class's growth rate varies.

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Financial Trajectory and Forecasting

Historical Revenue Analysis

• Consistent Revenue Streams: Since 2010, Januvia's steady revenue growth has been driven by increased adoption, especially in combination therapies.
• Impact of Patent Expiries: The primary patent expired in 2022, with potential biosimilar entries expected in 2024-2025, possibly impacting revenue.

Projected Financial Trajectory (2023-2027)

Year	Estimated Sales (USD Billion)	Growth Rate	Key Assumptions
2023	5.3	+2%	Patent cliffs begin; regulatory pressures
2024	5.1	-3%	Biosimilar entry, price erosion
2025	4.9	-2.9%	Market consolidation, new formulations
2026	4.8	+0.8%	Introduction of fixed-dose combinations
2027	4.9	+2.1%	Market saturation, incremental innovation

Forecast based on internal analyses, market trends, and patent timelines.

Factors Influencing Financial Outcomes

• Patent and Intellectual Property: Expiration in major markets in 2022, with potential biosimilar competition affecting pricing.
• Pipeline Innovation: Merck's R&D pipeline includes next-generation DPP-4 inhibitors and combination approaches to sustain revenue.
• Regulatory Dynamics: Approval of new delivery methods or expanded indications could alter trajectory.
• Pricing Strategies: Market access negotiations and value-based agreements to mitigate revenue decline.

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Comparison with Major Competitors

Attribute	JANUVIA (Sitagliptin)	Trulicity (Dulaglutide)	Glucophage (Metformin)	Jardiance (Empagliflozin)
Mechanism	DPP-4 inhibitor	GLP-1 receptor agonist	Biguanide	SGLT2 inhibitor
Approval Year	2006	2014	1957	2014
Peak Sales (2022)	~$5.2 billion	~$6.5 billion	N/A	~$2 billion
Administration	Oral	Injectable	Oral	Oral
Side Effects	Nasopharyngitis, UTI	Nausea, pancreatitis	GI upset	Genital infections

Implication: While JANUVIA maintains a stable, mature market role, emerging therapies with superior efficacy could impact future sales.

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Regulatory and Policy Environment

Key Regulatory Milestones

• FDA Approval (2006): Initial approval for T2DM management.
• EMA & Other Authorities: Approvals across Europe, Asia, and Latin America, with localized guidelines influencing usage.
• Patent Expiry & Biosimilar Entry: Patent for Janvua expired in 2022 in the US; biosimilar development ongoing.

Reimbursement & Pricing Policies

• US: Medicare and private payers favor cost-effective oral agents.
• Europe: National health systems utilize cost-effectiveness evaluations; reimbursement varies.
• Emerging Markets: Price sensitivity dominates; generics and biosimilars are critical.

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Deepening Market Prospects: Future Opportunities and Challenges

Opportunities

• Expanding Indications: Potential approval for non-alcoholic fatty liver disease (NAFLD) or other metabolic syndromes.
• Combination Therapies: Fixed-dose combinations with metformin or SGLT2 inhibitors to improve adherence.
• Biologics and Biosimilars: Potential entry as biosimilars reduce prices.

Challenges

• Market Saturation: Declined growth post-patent expiration.
• Intense Competition: GLP-1 RAs and SGLT2 inhibitors gaining preference.
• Pricing Pressures & Healthcare Cost Containment: Impacting profit margins.

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Key Takeaways

• Stability in Revenue: Despite patent loss, JANUVIA's mature market position sustains revenues (~$5.2 billion in 2022).
• Shift Toward Innovative Pipelines: Future growth hinges on novel formulations, combination therapies, and potential indications.
• Market Challenges: Patent cliffs, biosimilar competition, and evolving treatment guidelines will impact sales.
• Strategic Focus: Emphasize pipeline innovation, market expansion in emerging territories, and portfolio diversification.
• Long-term Outlook: Growth is expected to slow but remain positive; careful navigation of competitive and regulatory landscapes is vital.

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FAQs

1. How has JANUVIA's market share evolved over the past decade?
JANUVIA's market share has remained relatively stable at around 7%, benefiting from its established position and favorable safety profile. However, post-patent expiry, its share faces pressure from generics and newer classes like SGLT2 inhibitors.

2. What are the main competitive threats facing JANUVIA?
The primary threats include biosimilar entries post-patent expiry, increasing preference for injectable GLP-1 RAs, and the rise of SGLT2 inhibitors with superior cardiovascular and weight loss benefits.

3. How does regulatory policy influence JANUVIA's future sales?
Stringent cost-containment policies, especially in developed markets, can lower reimbursement levels. Conversely, approvals in emerging markets and expanded indications can offer growth avenues.

4. What role do combination therapies play in JANUVIA's market strategy?
Fixed-dose combinations (FDCs) with metformin and other antidiabetic agents enhance adherence and broaden market appeal, representing a key innovation for sustained sales.

5. What are the prospects for JANUVIA in non-diabetes indications?
Current research is investigating sitagliptin's role in NAFLD, obesity, and cardiovascular disease, which could unlock new markets if regulators approve these indications.

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References

[1] International Diabetes Federation. (2021). IDF Diabetes Atlas, 10th Edition.
[2] EvaluatePharma. (2022). World Market Forecasts.
[3] Merck & Co. Annual Reports (2010–2022).
[4] U.S. Food & Drug Administration. (2006). JANUVIA Approval Announcement.