TRYVIO Drug Patent Profile

Which patents cover Tryvio, and what generic alternatives are available?

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

US Patents and Regulatory Information for TRYVIO

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

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
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			Y

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
Canada	3053991
Canada	3053994
Chile	2019002464

Supplementary Protection Certificates for TRYVIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2190837	2024C/545	Belgium		PRODUCT NAME: APROCITENTAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/24/1818 20240628
2190837	C202430048	Spain		PRODUCT NAME: APROCITENTAN O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/24/1818; DATE OF AUTHORISATION: 20240627; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/24/1818; DATE OF FIRST AUTHORISATION IN EEA: 20240627
2190837	C20240041	Finland		PRODUCT NAME: MATSITENTAAN/TADALAFIIL;REG NO/DATE: EU/1/24/1859 30.09.2024
2190837	CA 2024 00046	Denmark		PRODUCT NAME: APROCITENTAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. 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	PA2024534,C2190837	Lithuania		PRODUCT NAME: APROCITENTANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/24/1818 20240627
2190837	24C1047	France		PRODUCT NAME: APROCITENTAN OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/24/1818 20240628

Tryvio (Lugol’s?) Investment Scenario and Patent/Exclusivity Fundamentals Analysis

Last updated: July 14, 2026

Executive summary: TRYVIO is a branded drug with a defined FDA status and a finite patent and exclusivity timeline that will shape generic entry risk. This analysis maps the exclusivity and patent estate to practical investment timing: (1) near-term revenue stability vs. (2) mid-term litigation and Paragraph IV risk windows vs. (3) late-cycle generic pressure tied to Orange Book listings, patent expirations, and any data exclusivity constraints.

What is TRYVIO and what is its FDA commercial setup?

TRYVIO’s investment profile starts with its FDA approval type and regulatory exclusivity framework. Investment-grade diligence requires tying the commercial thesis to FDA pathway context because it determines the earliest permissible “legal” generic or biosimilar timeline.

What does TRYVIO treat and who markets it?

The investment case depends on indication, prescriber base, and reimbursement access, but the fundamental driver in IP risk is the specific approved formulation and label scope tied to Orange Book patents.

Is TRYVIO an NDA, ANDA reference product, or both?

For generic entry risk, the relevant questions are:

• Is TRYVIO listed in FDA’s Orange Book as an NDA reference listed drug (RLD)?
• Which dosage form(s) and strength(s) are listed?
• Are method-of-use patents present that can support additional “blocking” under 35 USC 271(e)?

Featured snippet answer: what controls generic timing for TRYVIO?

Generic timing for an Orange Book-listed RLD is controlled by:

1. patent expiration of listed patents (including method-of-use, formulation, and process where applicable), and
2. statutory exclusivity (NCE, 3-year, 5-year, pediatric, and relevant data exclusivities tied to the NDA).

Investment implication: the earliest “freedom-to-operate” date is the maximum of (a) relevant patent expiration(s) and (b) the end of exclusivity for the specific claimed conditions of use, unless a court decision clears a blocking patent earlier.

What patents protect TRYVIO?

A defensible investment scenario requires a complete patent “estate map” tied to the Orange Book. That estate determines:

• whether generic challengers must litigate (Paragraph IV) multiple patents
• whether any patents are weak (high invalidity risk) or easy to design around
• how much remaining exclusivity exists in each claim family

Which Orange Book-listed patent types usually matter for TRYVIO?

For most small-molecule branded drugs, the Orange Book patent categories that most often control generic entry are:

• composition/formulation patents (protect the specific drug substance form, salt, polymorph, excipients, or manufacturing composition)
• method-of-use patents (protect dosing regimens or therapeutic uses)
• process patents (protect manufacturing steps; sometimes designed around)
• device or packaging patents (less common to block ANDA directly, but can affect commercial rollout)

Featured snippet answer: how many TRYVIO patents block generics?

A true investment-grade answer requires exact Orange Book listings and their expiration dates. Without the Orange Book listing set and patent numbers, any “count” would be speculative and not investable.

When does TRYVIO lose exclusivity and patent protection?

The investment horizon is anchored on two clocks:

• patent expiration dates (with patent-term adjustment impacts and extensions)
• exclusivity end dates (with pediatric exclusivity adding time and NDA supplements shifting exclusivity depending on regulatory history)

How to translate the legal timeline into investment milestones

A typical investment schedule uses three windows:

• 0 to 18 months: revenue defensibility, litigation posture development, and commercial expansion impact
• 18 to 48 months: highest sensitivity to Paragraph IV filings and early court schedule
• 48 months and beyond: primary sensitivity to actual patent expirations and any settlement triggers

Investment implication: underwriting should stress-test gross margin and market share compression in the 6-24 months following the last blocking patent expiration (assuming no successful “design-around” or damages outcome delay).

What patent litigation affects TRYVIO and what Paragraph IV challenges exist?

Paragraph IV challenges are the practical trigger for generic entry risk. They also influence the settlement dynamics that can extend exclusivity through pay-for-delay settlements (where enforceable and disclosed) or through authorized generic timing.

What are the expected litigation mechanics for an Orange Book RLD like TRYVIO?

For each filed ANDA Paragraph IV:

• the brand receives notice and must list patents asserted in the notice
• the challenger must litigate within the statutory framework
• the court’s scheduling and any stipulations can shift effective launch timing
• settlements can define “carve-out” dates or launch entry windows

Featured snippet answer: what is the key litigation KPI for TRYVIO?

The KPI is the effective “launch permission date,” defined as the earliest date the generic can market without infringing blocking claims after:

• patent expirations and/or
• a court ruling invalidating or non-infringing the challenged patents, or
• a settlement-driven workaround/trigger date.

Investment implication: modeling should use the later of (1) statutory 30-month stay endpoints or court outcomes and (2) any settlement “trigger” date tied to patent expiration.

What is the Orange Book status of TRYVIO by dosage form and strength?

Orange Book status is not a single number. It is a matrix:

• dosage form
• strength
• listed patents
• patent expiration dates
• exclusivity listings (if shown)

What generic entry risks exist for each listed TRYVIO strength?

Generic challengers typically file against the RLD that matches dosage form and strength. If TRYVIO has multiple strengths:

• a challenger may target the “closest” economic strength first
• method-of-use patents may block all strengths only if they cover the same condition of use
• formulation patents may block only specific strengths that use different excipients or dosage technology

Investment implication: revenue downside is rarely uniform across strengths; underwriting must map which strength drives bulk sales and its last blocking patent.

What formulations are protected by TRYVIO patents?

Formulation IP often drives design-around difficulty and impacts:

• bioequivalence risk (if formulation patents force a different release profile)
• manufacturability and cost of goods (if manufacturing steps are constrained)
• switching and payor contracts (if “generic-like” alternatives differ in patient adherence)

What formulation levers can a generic challenger use?

Typical design-around levers include:

• alternate salts/polymorphs (if the drug substance is flexible)
• different excipient systems
• different film coating and release profiles
• alternative manufacturing processes that avoid specific process steps

Investment implication: if TRYVIO has robust formulation patents that are hard to design around, the effective entry window narrows to a later “legal launch” date even if exclusivity ends earlier.

What method-of-use patents protect TRYVIO?

Method-of-use (MoU) patents can materially extend control even after composition patents expire if the labeled indications match MoU claims.

How do MoU patents interact with generic labeling?

Generic ANDAs can sometimes use label carve-outs. If an MoU patent covers:

• a specific dosing regimen
• a specific patient subgroup
• a specific combination with another product then generic launch may depend on either:
• a label carve-out acceptable to FDA, or
• winning litigation on claim scope.

Investment implication: if TRYVIO’s sales depend on a specific dosing regimen or patient subset covered by MoU patents, label carve-out risk becomes the largest driver of market-share erosion timing.

How strong is the patent estate for TRYVIO?

Patent strength is not just the number of patents. Investment-grade strength analysis depends on:

• claim scope breadth relative to generic design-around space
• prosecution history signals (narrowing, disclaimers)
• prior art density
• litigation outcomes for similar claim families in the same technological area

What to benchmark for strength scoring

A robust scoring model typically uses:

• filing-to-issuance timeline (proxy for art complexity)
• number of independent claims (breadth)
• whether there is a pattern of terminal disclaimers or continuation strategy
• any known validity challenges in similar patents by the same assignee group

Investment implication: absent a mapped Orange Book list and family claim analysis, strength scoring cannot be performed as a factual exercise.

Which companies are positioned to challenge TRYVIO?

Generic and biosimilar challengers are identified via:

• Paragraph IV notices
• ANDA filing databases
• ANDA approvals and label transition patterns
• litigation parties in public dockets

What competitor behavior typically indicates TRYVIO’s threat level?

High challenge frequency usually correlates with:

• high sales concentration
• easier MoU label carve-out possibilities
• brand patent portfolio that has predictable weak points or predictable design-around.

Investment implication: the earliest credible generic threat is not the first filer. It is the filer with the highest probability of succeeding on blocking patents and completing manufacturing readiness.

How does TRYVIO compare with competing drugs on exclusivity and risk?

A comparative framework is required for portfolio allocation. The standard approach is:

• map each competitor to last blocking patent expiration
• compare time-to-generic modeled launch
• adjust for whether competitors have shared class-level reimbursement headwinds or differentiated clinical benefit

Investment-grade comparison dimensions

• label overlap vs. carve-outs
• MoU patent presence
• formulation design-around complexity
• settlement history in comparable NDA/Orange Book estates

Investment implication: TRYVIO’s relative risk is the difference between its last blocking date and peers’ last blocking dates, adjusted for probability of successful challengers.

What are the revenue exposure assumptions for TRYVIO through patent expiry?

Revenue modeling for IP-linked products typically uses:

• expected erosion curve starting at the first legal launch date
• authorized generic risk (often accelerates revenue decline)
• payor contract behavior and formulary switching lag
• channel inventory dynamics

How to underwrite TRYVIO market share decline

Underwriting inputs:

• share of sales tied to the protected indications and strengths
• expected generic penetration by year after launch
• price discount trajectory by managed care segment
• whether the label can be competitively matched at launch with adequate bioequivalence

Investment implication: the largest error risk is timing. Precision requires the last blocking patent expiration and exclusivity end date per strength.

What manufacturing and IP barriers could delay generic launch for TRYVIO?

Even when patents expire, there are practical barriers:

• process IP (non-infringement by process change still requires proving)
• regulatory readiness: stability, scale-up validation, and ANDA technical packages
• supply chain qualification for new generic manufacturers

Investment implication

If TRYVIO has complex manufacturing constraints covered by patents or if there are hard-to-replicate formulation steps, actual launch can lag legal permission, creating a window for sustained margins.

Key Takeaways

• TRYVIO’s investment risk and return are driven by the Orange Book-linked patent estate and statutory exclusivity timeline, not by approval date alone.
• The most decision-relevant milestones are the last blocking patent expiration per dosage form and the effective launch date created by Paragraph IV outcomes or settlements.
• Method-of-use and formulation patents determine whether generic entrants can launch with label carve-outs or design-around.
• Revenue exposure should be modeled from the last blocking date with a staged erosion curve, adjusted for authorized generic and payor switching lag.
• Competitor challenge behavior (number and strength of Paragraph IV filings) is the leading indicator of how soon market pressure will translate into realized price erosion.

FAQs

1. How do method-of-use patents on an Orange Book RLD like TRYVIO affect ANDA label carve-out strategies?
2. What is the difference between statutory exclusivity and patent expiration for TRYVIO’s generic launch risk?
3. How should investors model revenue erosion if TRYVIO faces multiple Orange Book blocking patents with different expiration dates?
4. What litigation outcomes most directly change the effective launch date for generics challenging TRYVIO?
5. How can formulation design-around change bioequivalence risk and launch timelines for TRYVIO competitors?

References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. U.S. Food and Drug Administration. (n.d.). Drugs@FDA. U.S. Food and Drug Administration.