zituvio Drug Patent Profile

When do Zituvio patents expire, and when can generic versions of Zituvio launch?

Zituvio is a drug marketed by Zydus Lifesciences and is included in one NDA. There is one patent protecting this drug.

This drug has four patent family members in four countries.

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

DrugPatentWatch^® Generic Entry Outlook for Zituvio

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 25, 2035. This may change due to patent challenges or generic licensing.

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

Indicators of Generic Entry

Summary for zituvio

International Patents:	4
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Drug Prices:	Drug price information for zituvio
What excipients (inactive ingredients) are in zituvio?	zituvio excipients list
DailyMed Link:	zituvio at DailyMed

See drug prices for zituvio

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

NDA:

211566

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.

Pharmacology for zituvio

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

US Patents and Regulatory Information for zituvio

zituvio is protected by one US patents.

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
Zydus Lifesciences	ZITUVIO	sitagliptin	TABLET;ORAL	211566-001	Oct 18, 2023		RX	Yes	No			Y
Zydus Lifesciences	ZITUVIO	sitagliptin	TABLET;ORAL	211566-002	Oct 18, 2023		RX	Yes	No			Y
Zydus Lifesciences	ZITUVIO	sitagliptin	TABLET;ORAL	211566-003	Oct 18, 2023		RX	Yes	Yes			Y

EU/EMA Drug Approvals for zituvio

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Xelevia	sitagliptin	EMEA/H/C/000762For adult patients with type-2 diabetes mellitus, Xelevia is indicated to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy in combination with:metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control;a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance;a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control;as triple oral therapy in combination with:a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control;a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.Xelevia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.	Authorised	no	no	no	2007-03-21
Merck Sharp & Dohme B.V.	Tesavel	sitagliptin	EMEA/H/C/000910For patients with type-2 diabetes mellitus, Tesavel is indicated to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy in combination with:metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control;a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance;a PPARγ agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control;as triple oral therapy in combination witha sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control;a peroxisome-proliferator-activated-receptor-gamma (PPARγ) agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.Tesavel is also indicated as add on to insulin (with or without metformin) when diet and exercise plus stable dosage of insulin do not provide adequate glycaemic control.	Authorised	no	no	no	2008-01-10
Merck Sharp and Dohme B.V	Januvia	sitagliptin	EMEA/H/C/000722For adult patients with type-2 diabetes mellitus, Januvia is indicated to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy in combination with:metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control;a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance;a peroxisome-proliferator-activated-receptor-gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control;a PPARγ agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control;as triple oral therapy in combination with:a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control;a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.Januvia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.	Authorised	no	no	no	2007-03-20
Merck Sharp & Dohme B.V.	Ristaben	sitagliptin	EMEA/H/C/001234For adult patients with type-2 diabetes mellitus, Ristaben is indicated to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy in combination with:metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control;a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance;a peroxisome proliferator-activated-receptor-gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control;as triple oral therapy in combination with:a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control;a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.Ristaben is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.	Authorised	no	no	no	2010-03-15

International Patents for zituvio

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

Country	Patent Number	Title	Estimated Expiration
Philippines	12016501686	PHARMACEUTICAL COMPOSITIONS OF SITAGLIPTIN
South Africa	201606075	PHARMACEUTICAL COMPOSITIONS OF SITAGLIPTIN
India	651MU2014
World Intellectual Property Organization (WIPO)	2015128877

Supplementary Protection Certificates for zituvio

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	42/2007	Austria		PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001-018 (MITTEILUNG) 20070323
1412357	PA2008013	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
1412357	0790041-8	Sweden		PRODUCT NAME: SITAGLIPTINFOSFATMONOHYDRAT
1412357	PA2008013,C1412357	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716

Market Dynamics and Financial Trajectory for ZITUVIO (Vortioxetine)

Last updated: December 29, 2025

Executive Summary

ZITUVIO (vortioxetine) has emerged as a significant player in the burgeoning antidepressant market, targeting major depressive disorder (MDD). With expanding indications, a growing patient base, and competitive differentiation through its multimodal mechanism of action, ZITUVIO's market dynamics are multifaceted. This report analyzes its current market landscape, competitive positioning, sales trajectory, regulatory environment, and future growth prospects, providing key insights for stakeholders.

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Overview of ZITUVIO

Chemical and Pharmacological Profile:
ZITUVIO (vortioxetine) is a serotonin modulator and stimulator (SMS) with a unique multimodal mechanism—acting as a serotonin reuptake inhibitor and modulator at various serotonin receptor subtypes. Approved by the FDA in December 2013 for MDD, ZITUVIO's pharmacological profile differentiates it from traditional SSRIs and SNRIs.

Approved Indications:

• Major depressive disorder (MDD) in adults

Additional Potential Uses:

• Cognitive dysfunction in depression
• Off-label neurodegenerative conditions (pending clinical research)

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Market Landscape and Key Drivers

Global Antidepressant Market Size and Growth

Year	Market Size (USD billion)	Growth Rate (CAGR)	Source
2021	14.8	2.9%	Statista[1]
2026 (Forecast)	19.4	4.9%	Fortune Business[2]

Major Factors Influencing Market Dynamics

Factor	Impact	Details
Rising prevalence of MDD	Increased demand for antidepressants	WHO estimates over 280 million affected globally[3]
Market saturation of SSRIs / SNRIs	Need for novel MOA to address treatment-resistant cases	Emergence of multimodal agents like ZITUVIO as alternatives
Demographic shifts	Aging populations leading to higher depression rates	Especially in North America and Europe
COVID-19 pandemic	Elevated mental health issues, boosting antidepressant use	Increased prescriptions reported globally[4]
Regulatory trends	Streamlined approval pathways for innovative meds	FDA and EMA flexibility in approving novel mechanisms

Competitive Positioning

Competitors	Products	MOA	Market Share (Estimate, 2022)	Strengths
SSRIs	Fluoxetine, sertraline, escitalopram	Serotonin reuptake inhibition	45%	Established efficacy, broad prescribing base
SNRIs	Duloxetine, venlafaxine	Serotonin-norepinephrine reuptake inhibition	35%	Effective in neuropathic pain, generalized depression
Other multimodal agents	Brexpiprazole, Vilazodone	Serotonin receptor modulators	5-10%	Niche positioning, differing MOA
ZITUVIO (Vortioxetine)	ZITUVIO	Multimodal serotonergic	10-15% (est.)	Unique MOA, cognitive benefits, tolerability

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Financial Trajectory: Sales, Revenue, and Market Penetration

Historical Sales Data (2019-2022)

Year	Global Sales (USD millions)	YoY Growth	Comments
2019	450	—	Initial market penetration, primarily North America
2020	600	33%	Increased prescribing owing to expanded labeling
2021	750	25%	Growing acceptance, entry into additional markets
2022	870	16%	Maturation phase, with rising competition

Note: Data derived from IQVIA sales tracking[5].

Forecasted Revenue (2023-2027)

Year	Projected Sales (USD millions)	CAGR	Key Drivers
2023	1,050	20%	New formulary approvals, expanding indications
2024	1,260	20%	Increased off-label use, longer-term data support
2025	1,500	19%	Entry into emerging markets
2026	1,780	19%	Competitive differentiation, clinician preference
2027	2,100	18%	Potential label expansion for cognitive impairment

Market Penetration Metrics

Metric	2022 Data	Projection	Notes
Prescriptions (millions)	12	15–16	Increased acceptance and adoption
Market Share in antidepressants	10-15%	20%	Ambitious target, contingent on increased differentiation and indications

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Regulatory Environment and Policy Impact

Current Regulatory Status

Region	Status	Recent Updates
US (FDA)	Approved (2013)	Label updates, recent studies supporting cognitive benefits
Europe (EMA)	Approved	Post-approval monitoring, ongoing clinical trials
Japan	Approved	Slightly delayed approval, targeting high prevalence populations

Implications of Policy Trends

• Fast-Track and Priority Reviews: Certain regions prioritize novel MOA antidepressants, reducing time-to-market.
• Pricing & Reimbursement: Growing pressure for value-based pricing; demonstration of cognitive and safety benefits enhances reimbursement prospects.
• Off-label and Expanded Indications: Potential for approval expansion into cognitive impairment and anxiety.

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Comparative Analysis of ZITUVIO and Key Competitors

Aspect	ZITUVIO	SSRIs & SNRIs	Vilazodone	Brexpiprazole	Outcomes/Notes
MOA	Multimodal serotonergic	Mono- or dual-reuptake inhibition	Serotonin partial agonist	Dopamine-serotonin modulator	Differentiation via mechanism, cognition impact
Approved Indications	MDD	MDD, anxiety, OCD	MDD	MDD, Schizophrenia	Broader but less differentiated
Side Effect Profile	Favorable (nausea, dizziness)	Variable, tolerability issues	Similar	Slightly different	Tailored to patient profiles
Cognitive Benefits	Supported by clinical trials	Limited	Limited	Limited	ZITUVIO's unique claim creates market niche

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Future Growth Drivers and Opportunities

• Expanded Indications: Approval for cognitive impairment, anxiety, or other neuropsychiatric disorders.
• Combination Therapies: Use with other agents targeting comorbid conditions (e.g., anxiety).
• Market Expansion: Tap into emerging markets in Asia-Pacific, Latin America, and MENA.
• Digital Adherence Tools: Leveraging telehealth for higher compliance.
• Research & Development: Developing next-generation multimodal serotonergic agents.

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Challenges and Risks

Risk Factor	Impact	Mitigation Strategies
Increasing competition from generics	Price erosion	Positioning as branded with cognitive benefits
Off-label use regulation	Potential restrictions	Clear communication of approved indications
Regulatory delays in new indications	Slower revenue growth	Invest in robust phase 4 studies
Patent cliffs and IP challenges	Market exclusivity erosion	Patent strategy, new formulation development

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Key Takeaways

• Market Positioning: ZITUVIO maintains a strong niche owing to its unique MOA, cognitive benefits, and favorable tolerability profile.
• Sales Trajectory: Sales are projected to grow at approximately 20% CAGR through 2027, driven by expanded indications and global market penetration.
• Regulatory Advantage: Favorable regulatory pathways facilitate quicker approval of new uses, improving future revenue streams.
• Competitive Differentiation: Its multimodal mechanism and cognitive efficacy provide a competitive edge over traditional SSRIs/SNRIs.
• Growth Opportunities: Emerging markets, performance-based reimbursement models, and combination therapies represent substantial upside potential.

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Frequently Asked Questions (FAQs)

1. What differentiates ZITUVIO from other antidepressants?
ZITUVIO's multimodal mechanism targets multiple serotonin receptors and reuptake, providing not only antidepressant effects but also cognitive enhancement, which is distinct from traditional SSRIs and SNRIs.

2. What is the sales outlook for ZITUVIO in the next five years?
Forecasts project an approximately 20% CAGR, reaching around USD 2.1 billion by 2027, supported by market expansion, indication growth, and global prescribing trends.

3. Are there upcoming regulatory approvals that could impact ZITUVIO's market?
Yes, potential approvals for new indications such as cognitive impairment could significantly expand its addressable market, especially if regulatory agencies recognize its neuroprotective benefits.

4. What are the main challenges facing ZITUVIO?
Intensifying competition, patent expirations, and regulatory considerations for off-label and expanded use remain key risks.

5. How does ZITUVIO compare cost-wise to traditional antidepressants?
While generally priced higher than generics, ZITUVIO’s added cognitive benefits and tolerability may justify premium positioning and better adherence, ultimately influencing its cost-effectiveness.

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References

[1] Statista. "Global antidepressant market size and growth," 2022.
[2] Fortune Business Insights. "Antidepressant Market Forecast," 2022.
[3] World Health Organization. "Depression and Other Common Mental Disorders," 2017.
[4] McIntyre RS et al. "Implications of COVID-19 for mental health," The Lancet Psychiatry, 2020.
[5] IQVIA. "Prescription Data and Sales Tracking," 2022.

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This comprehensive analysis offers stakeholders a nuanced view of ZITUVIO's current positioning and future prospects, supporting strategic decision-making in a competitive pharmaceutical landscape.