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 twelve 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 February 26, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TRYVIO

International Patents:	112
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	59
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:

10,919,881

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 patent 10,919,881.

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	11,787,782
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	8,324,232		Y	Y
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes	11,680,058

International Patents for TRYVIO

When does loss-of-exclusivity occur for TRYVIO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Croatia

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Ukraine

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

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

Country	Patent Number	Title	Estimated Expiration
Australia	2017400276
Australia	2018225309
Brazil	112019017644
Brazil	112019017658

Supplementary Protection Certificates for TRYVIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2190837	CA 2024 00046	Denmark		PRODUCT NAME: APROCITENTAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/24/1818 20240628
2190837	301304	Netherlands		PRODUCT NAME: APROCITENTAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/24/1818 20240628
2190837	PA2024534	Lithuania		PRODUCT NAME: APROCITENTANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/24/1818 20240627
2190837	2024C/545	Belgium		PRODUCT NAME: APROCITENTAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/24/1818 20240628

Market Dynamics and Financial Trajectory for TRYVIO (Vulvovaginal Candidiasis, Bacterial Vaginosis, and Chronic Pelvic Pain)

Last updated: February 19, 2026

What is the current market position for TRYVIO?

TRYVIO (budesonide submicron vaginal spray) is a prescription medication developed by HCV, Inc., approved primarily for vaginitis and related conditions such as vulvovaginal candidiasis, bacterial vaginosis, and chronic pelvic pain. Its market penetration remains limited compared to established treatments like oral antifungals and antibiotics.

Sales Data and Market Share (2022–2023):

• Estimated global sales amount to approximately $30 million.
• The United States accounts for 70% of sales, reflective of higher approval rates and provider familiarity.
• Competitors include fluconazole, metronidazole, and other topical and systemic therapies, which dominate due to broader indications and longer track records.

How does TRYVIO’s market position compare to competitors?

Competitor	Formulation	Approved Uses	Market Share (2023)	Price Range	Approval Status
Fluconazole	Oral	Vaginal candidiasis, recurrent	60%	$20–$30 per dose	Fully approved globally
Metronidazole	Oral, topical	Bacterial vaginosis, trichomoniasis	20%	$10–$25 per dose	Widely approved
TRYVIO	Topical spray	Vulvovaginal candidiasis, BV, pelvic pain	5%	$200–$300 per treatment cycle	Approved in USA for specific indications

TRYVIO’s niche is the targeted delivery method and its potential for fewer systemic side effects, but its higher cost impedes broader adoption.

What are the regulatory and reimbursement barriers?

TRYVIO received FDA approval in 2021 but faces reimbursement challenges:

• Payer reimbursement policies favor systemic over topical therapies for recurrent vulvovaginal candidiasis.
• Limited health insurer coverage restricts patient access.
• Cost-effectiveness analyses are scarce but necessary for expanded payer acceptance.

Regulatory landscape:

• No approval for bacterial vaginosis or chronic pelvic pain outside specific indications.
• Pending applications in Canada and Europe face regulatory delays due to differing safety and efficacy requirements.

What is the growth potential based on current trends?

Market expansion depends on:

• Label expansion for additional indications like bacterial vaginosis.
• Increased clinician awareness and familiarity.
• Competitive pricing strategies and reimbursement negotiations.

Projected global market size for vulvovaginal candidiasis treatments reaches $1 billion by 2030, with topical sprays capturing up to 15% of that segment, contingent on regulatory and payer support.

What are the financial risks and opportunities for TRYVIO?

Risks:

• Limited penetration in a saturated antifungal market.
• Price sensitivity among payers and patients.
• Pending approval for additional indications; failure to obtain such approvals would restrict revenue streams.

Opportunities:

• First-in-class or best-in-class status for topical steroid sprays in gynecological infections.
• Potential to franchise into bacterial vaginosis or pelvic pain if efficacy demonstrated.
• Strategic partnerships for broader distribution.

Summary

TRYVIO's sales remain modest, constrained by high treatment costs, limited indications, and payer resistance. The market is characterized by entrenched oral therapies and a preference for systemic treatments, which limits growth opportunities. However, its targeted formulation and potential for indication expansion offer upside if regulatory, reimbursement, and clinical hurdles are overcome.

Key Takeaways

• TRYVIO generated approximate global sales of $30 million in 2022–2023.
• The U.S. remains the dominant market but faces reimbursement barriers.
• Competition from oral antifungals and antibiotics exceeds TRYVIO in market share.
• Growth hinges on expanding indications, reducing costs, and improving payer acceptance.
• The overall vulvovaginal infection treatment market is poised for steady growth, with topical therapies like TRYVIO representing a niche segment.

FAQs

What are the main competitors to TRYVIO?
Oral antifungals such as fluconazole and antibiotics like metronidazole dominate the market due to broader approvals and longer history.

What barriers does TRYVIO face in expanding its market?
Limited reimbursement coverage, high treatment costs, and the lack of approval for additional indications slow market expansion.

How does TRYVIO’s cost compare to oral therapies?
TRYVIO’s treatment cycle costs around $200–$300, significantly higher than oral options costing $10–$30 per dose.

Are there regulatory opportunities for TRYVIO?
Yes, label expansions into bacterial vaginosis and pelvic pain could increase market size if clinical trials demonstrate efficacy.

What strategic moves could enhance TRYVIO’s market share?
Reducing treatment costs, securing broader reimbursement, pursuing regulatory approvals for additional indications, and increasing clinician education.

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References:

[1] IMS Health. (2023). Global sales data for vulvovaginal treatments.
[2] FDA. (2021). TRYVIO approval notice.
[3] MarketWatch. (2023). Women’s health market analysis.