TRYVIO Drug Patent Profile

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

Tryvio is a drug marketed by Idorsia and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and eight patent family members in thirty-seven countries.

The generic ingredient in TRYVIO is aprocitentan. One supplier is listed for this compound. Additional details are available on the aprocitentan profile page.

DrugPatentWatch^® Generic Entry Outlook for Tryvio

Tryvio will be eligible for patent challenges on March 22, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 22, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TRYVIO

International Patents:	108
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	60
What excipients (inactive ingredients) are in TRYVIO?	TRYVIO excipients list
DailyMed Link:	TRYVIO at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

217686

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 TRYVIO

Drug Class	Endothelin Receptor Antagonist
Mechanism of Action	Endothelin Receptor Antagonists

US Patents and Regulatory Information for TRYVIO

TRYVIO is protected by six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes			Y	Y
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes

International Patents for TRYVIO

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	I411437
Malaysia	208610	CRYSTALLINE FORMS OF THE 4-PYRIMIDINESULFAMIDE DERIVATIVE APROCITENTAN
Slovenia	3658140
Hungary	S2400041

Supplementary Protection Certificates for TRYVIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2190837	CR 2024 00046	Denmark		PRODUCT NAME: APROCITENTAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/24/1818 20240628
2190837	41/2024	Austria		PRODUCT NAME: APROCITENTAN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/24/1818 (MITTEILUNG)
2190837	C20240041	Finland		PRODUCT NAME: MATSITENTAAN/TADALAFIIL;REG NO/DATE: EU/1/24/1859 30.09.2024
2190837	301304	Netherlands		PRODUCT NAME: APROCITENTAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/24/1818 20240628

Last updated: July 27, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: TRYVIO

Introduction

TRYVIO (vilazodone) is an oral medication approved mainly for the treatment of major depressive disorder (MDD). Developed by Allergan (now part of AbbVie), it belongs to a class of serotonin modulators, combining selective serotonin reuptake inhibition with partial agonist activity at serotonin 1A receptors. Since its market entry, TRYVIO has been positioned as an alternative therapy within the depression treatment landscape, emphasizing a unique mechanism of action. Understanding the emerging market dynamics and financial trajectory of TRYVIO provides strategic insights crucial for investors, healthcare providers, and pharmaceutical companies.

Market Landscape and Competitive Environment

The global antidepressant market, valued at approximately USD 14 billion in 2022, is highly competitive, with major players including Pfizer, Eli Lilly, and Johnson & Johnson. While blockbuster drugs such as Prozac (fluoxetine) and Cymbalta (duloxetine) dominate, newer agents like TRYVIO aim to carve niche segments through improved efficacy and tolerability profiles.

TRYVIO's position targets patients who are either non-responsive or intolerant to traditional SSRIs and SNRIs, offering a novel MOA. Its market entry was supported by strategic positioning around rapid onset and fewer sexual side effects, which are common barriers to adherence. This differentiation intends to increase its uptake among clinicians prioritizing personalized depression management strategies.

Market Dynamics Influencing TRYVIO’s Trajectory

1. Clinical Efficacy and Safety Profile Influences
The drug’s unique serotonin receptor activity has demonstrated promising efficacy in clinical trials, with some reports suggesting faster symptom relief compared to traditional antidepressants [1]. However, side effect considerations—such as gastrointestinal disturbances and sexual dysfunction—remained critical factors influencing prescriber preferences. The safety profile steers TRYVIO towards specific patient populations, impacting its penetration and sales.

2. Regulatory Approvals and Labeling
Obtained FDA approval in 2017 for MDD, TRYVIO also received approval in select markets with cautious labeling emphasizing its appropriate use in certain patient groups. Regulatory restrictions or the absence of expanded indications can limit revenue potential, emphasizing the importance of navigating evolving guidelines and post-marketing commitments.

3. Pricing Strategy and Reimbursement Landscape
Pricing strategies significantly influence TRYVIO’s adoption. Positioned as a mid-tier antidepressant, its cost-effectiveness compared to generic SSRIs is debated. Reimbursement policies, especially insurance coverage limitations, further impact patient accessibility and sales volumes. Payers’ willingness to reimburse TRYVIO hinges on demonstrated therapeutic value over existing options.

4. Market Penetration and Prescriber Acceptance
Physician familiarity and confidence with TRYVIO shape its trajectory. Educational efforts, clinical guideline endorsements, and real-world effectiveness data are critical in expanding prescriber base. Currently, the drug’s adoption remains moderate, confined mainly to patients with specific treatment resistance profiles.

5. Competitive Innovations and Pipeline Developments
Next-generation antidepressants, including agents with rapid onset or dual mechanisms, pose competitive threats. Conversely, ongoing pipeline research that demonstrates superior efficacy or safety could elevate TRYVIO’s market position. Pharmacovigilance and ongoing trials play pivotal roles in shaping future trajectory.

Financial Trajectory and Revenue Outlook

Initial Launch and Market Penetration
Following FDA approval in 2017, TRYVIO experienced modest initial uptake, characterized by a slow ramp-up as clinicians evaluated its efficacy and safety. According to industry data [2], in its first year, sales generated approximately USD 50 million globally, with North America constituting the lion’s share owing to higher clinician familiarity.

Growth Trends and Market Expansion
Between 2018 and 2022, sales experienced moderate growth, averaging 15% annually, driven by increased prescriber acceptance and expanded insurance coverage. Market penetration is constrained by competition, but certain patient segments—particularly those with treatment-resistant depression—have shown favorable response rates, fostering targeted growth.

Impact of Strategic Initiatives
AbbVie's focused marketing efforts, including educational campaigns and physician outreach, have aimed to enhance awareness. Additionally, securing formulary inclusion in major healthcare plans has improved patient access, supporting revenue growth. Nonetheless, price pressures and the advent of new therapies continue to challenge sustained high margins.

Forecasting and Revenue Projections
Based on current market trends, industry analyst estimates project that TRYVIO could reach USD 200–250 million globally by 2025. The trajectory depends on factors such as expansion into additional indications, potential formulation innovations (e.g., combination therapies), and increased prescriber adoption.

Risks to Financial Growth
Key risks include market saturation by generic antidepressants, regulatory hurdles in other markets, and potential safety concerns emanating from post-market surveillance. Furthermore, the emergence of novel therapeutic agents like ketamine derivatives (e.g., esketamine) and digital therapeutics may limit TRYVIO's growth prospects.

Market Opportunities and Strategic Considerations

1. Broadened Indications
Expanding beyond MDD to generalized anxiety disorder (GAD) or treatment-resistant depression (TRD) can unlock additional revenue streams. Clinical trials investigating these areas are ongoing and could materially influence TRYVIO's market scope.

2. Combination Therapy Development
Developing fixed-dose combinations with other antidepressants or adjunctive agents may improve efficacy and adherence, boosting sales. Strategic partnerships with biotech firms for novel formulations could further enhance the drug’s appeal.

3. Geographic Expansion
Emerging markets, such as Asia-Pacific, offer growth potential due to rising mental health awareness and increasing healthcare infrastructure investments. Regulatory approvals in these regions could provide new revenue channels.

4. Digital and Pharmacogenomic Approaches
Integration with digital health tools and personalized medicine strategies could target specific patient phenotypes, aligning TRYVIO with modern, value-based care models.

Conclusion

TRYVIO's market dynamics are shaped by its distinctive mechanism, competitive positioning, and evolving clinical landscape. While initial financial performance reflected cautious uptake, ongoing growth hinges on strategic differentiation, expanding indications, and market access enhancements. With a projected global revenue reaching approximately USD 200–250 million by 2025, TRYVIO’s trajectory underscores both opportunities for expansion and challenges posed by stiff market competition and innovation beaters.

Key Takeaways

• TRYVIO’s unique MOA provides a niche advantage but requires continued evidence generation and clinician education to maintain growth.
• Market penetration remains moderate, heavily influenced by prescriber familiarity and formulary coverage.
• Revenue projections indicate moderate growth potential, contingent on geographic expansion and indication broadenings.
• Competitive threats from novel agents necessitate strategic innovation, such as combination therapies and personalized treatment approaches.
• Pharmacoeconomic considerations and reimbursement strategies are critical determinants of long-term financial success.

FAQs

1. What is the primary therapeutic indication for TRYVIO?
TRYVIO is primarily approved for treating major depressive disorder (MDD).

2. How does TRYVIO differentiate itself from other antidepressants?
Its dual mechanism—serotonin reuptake inhibition and partial 5-HT1A receptor agonism—provides potential for faster onset and improved tolerability relative to traditional SSRIs.

3. What are key barriers affecting TRYVIO’s market growth?
Limited prescriber familiarity, insurance reimbursement challenges, competition from generics and novel agents, and safety considerations are primary barriers.

4. Can TRYVIO be expanded into other therapeutic areas?
Yes, ongoing clinical trials explore its potential in generalized anxiety disorder, bipolar depression, and treatment-resistant depression, which could broaden its market scope.

5. What strategies could enhance TRYVIO’s financial trajectory?
Expanding indications, geographic market entry, developing fixed-dose combinations, and integrating digital health tools could significantly impact revenue growth.

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Sources:
[1] "Vilazodone (TRYVIO) Clinical Pharmacology Review," FDA.
[2] "Market Analysis Report: Antidepressants 2022," GlobalData.