UPTRAVI Drug Patent Profile

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

Uptravi is a drug marketed by Actelion and is included in two NDAs. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and seventy-seven patent family members in forty-two countries.

The generic ingredient in UPTRAVI is selexipag. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the selexipag profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Uptravi

A generic version of UPTRAVI was approved as selexipag by ALEMBIC on October 11^th, 2023.

Summary for UPTRAVI

International Patents:	177
US Patents:	6
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	5
Patent Applications:	510
Drug Prices:	Drug price information for UPTRAVI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for UPTRAVI
What excipients (inactive ingredients) are in UPTRAVI?	UPTRAVI excipients list
DailyMed Link:	UPTRAVI at DailyMed

See drug prices for UPTRAVI

Recent Clinical Trials for UPTRAVI

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

Sponsor	Phase
Humanis Saglk Anonim Sirketi	PHASE1
Sheffield Teaching Hospitals NHS Foundation Trust	Phase 4
University of Glasgow	Phase 4

See all UPTRAVI clinical trials

Pharmacology for UPTRAVI

Drug Class	Prostacyclin Receptor Agonist
Mechanism of Action	Prostacyclin Receptor Agonists

Paragraph IV (Patent) Challenges for UPTRAVI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
UPTRAVI	For Injection	selexipag	1.8 mg/vial	214275	1	2022-07-29
UPTRAVI	Tablets	selexipag	0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg and 1.6 mg	207947	4	2019-12-23

US Patents and Regulatory Information for UPTRAVI

UPTRAVI is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-007	Dec 21, 2015	AB	RX	Yes	No	7,205,302*PED				Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-005	Dec 21, 2015	AB	RX	Yes	No	9,284,280*PED				Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-008	Dec 21, 2015	AB	RX	Yes	No	9,173,881*PED				Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-007	Dec 21, 2015	AB	RX	Yes	No	10,821,108*PED				Y

EU/EMA Drug Approvals for UPTRAVI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen Cilag International NV	Uptravi	selexipag	EMEA/H/C/003774Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II–III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies., , Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.,	Authorised	no	no	no	2016-05-12

International Patents for UPTRAVI

When does loss-of-exclusivity occur for UPTRAVI?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

European Patent Office

Finland

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Russian Federation

San Marino

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

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 UPTRAVI around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2016366073
Brazil	112018009534
Canada	3005169
Chile	2018001464

Supplementary Protection Certificates for UPTRAVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1400518	300836	Netherlands		PRODUCT NAME: SELEXIPAG OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1083 20160519
1400518	93266	Luxembourg		PRODUCT NAME: SELEXIPAG OU UN SEL DE CELUI-CI; FIRST REGISTRATION DATE: 20160519
1400518	CA 2016 00048	Denmark		PRODUCT NAME: SELEXIPAG ELLER ET SALT DERAF; REG. NO/DATE: EU/1/15/1083 20160519
1400518	16C0042	France		PRODUCT NAME: SELEXIPAG OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/15/1083 20160519

UPTRAVI (selexipag) market dynamics and financial trajectory: exclusivity timeline, competitive pressure, and earnings exposure

Last updated: June 23, 2026

Executive summary

• UPTRAVI (selexipag, oral IP pathway for pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension) is the only commercially launched selexipag product in the US and has no direct generic substitution during core exclusivity. Pricing and volume are the main swing factors, with patient persistence, dose titration, and payer coverage driving demand.
• Financial trajectory is dominated by net price and channel mix rather than new clinical launches in the near term, with growth constrained by a maturing PAH population and competitive class exposure from other prostacyclin pathway agents (oral, inhaled, and parenteral).
• Key watchpoints for investor and licensing decisions are US patent/Exclusivity cliffs, biosimilar-style competitive dynamics do not apply (small molecule), and the earliest generic entry risk is a function of Orange Book patent expiration and potential Paragraph IV filings, plus any authorized generic behavior after first-to-file outcomes.

What patents protect UPTRAVI (selexipag) and when do they expire?

UPTRAVI’s US exclusivity and patent estate control generic launch timing. The critical question for market dynamics is whether competitors can file to trigger Hatch-Waxman stays and then launch shortly after expiration.

What is UPTRAVI’s US regulatory classification and Orange Book status?

Featured-snippet answer: UPTRAVI is an FDA-approved small-molecule oral therapy; its US generic risk is governed by Orange Book-listed patents rather than biologics-related exclusivity.

What patent types typically cover selexipag products?

For small-molecule PAH therapies like selexipag, patent coverage commonly spans:

• Active ingredient (selexipag) composition-of-matter
• Formulation patents (tablet strengths, controlled release or excipient systems if applicable to the branded product)
• Methods of treatment for specific indications such as:
  • PAH
  • chronic thromboembolic pulmonary hypertension (CTEPH) in patients with persistent/recurrent disease after surgical treatment

How strong is the patent estate for UPTRAVI versus generic entry?

Featured-snippet answer: The estate is evaluated by (1) number of listed patents, (2) time-to-expiration, (3) breadth of claims, and (4) whether any patents are likely to be successfully challenged in a first-to-file scenario.

Market impact channel: a late-stage portfolio that still has unexpired claims delays generic entry and supports branded pricing power. If a cluster of key composition or method patents expires early, the risk shifts to earlier Paragraph IV-driven erosion.

When does UPTRAVI lose exclusivity in the US and what drives the timing?

Featured-snippet answer: Generic entry timing depends on the latest-expiring Orange Book patent tied to the approved drug product, plus any regulatory exclusivity attached to the original NDA approval.

What is the typical exclusivity stack for small-molecule PAH drugs?

• Patents: govern most generic timing.
• Regulatory exclusivities (if applicable): can extend the ability to market an unapproved-labeled generic.
• Hatch-Waxman procedural stays: can create a legal buffer even after an expiration event if a Paragraph IV challenge triggers statutory stays.

How does patent expiration translate into revenue cliffs?

Revenue erosion often follows one of three patterns:

1. Delay then step-down around the first launch.
2. Stepped erosion if multiple patents fall in sequence and generics enter in phases.
3. Sustained brand resilience if payer contracting or limited interchangeable formulations slow volume transfer.

For investors: the “cliff” is less about FDA labels and more about contracting rules, formulary status, and manufacturer substitution incentives.

How many patents cover UPTRAVI and which jurisdictions matter most for market access?

Featured-snippet answer: US patents and US FDA listing drive the major commercial risk for the US revenue base.

Which territories typically matter for PAH revenue?

• United States: Orange Book listing drives generics and market share loss.
• EU and UK: local patent status influences secondary entry and parallel trade constraints.
• Japan and Canada: market entry depends on local patent enforcement and national regulatory processes.

Commercial point: multi-territory enforcement affects total profit resilience even when US is protected, because branded manufacturers often face spillover pricing pressure from parallel imports and cross-border sourcing.

What patent litigation affects UPTRAVI and how does it change generic entry risks?

Featured-snippet answer: For market dynamics, the key is whether Paragraph IV challenges have been filed and whether the brand secured automatic 30-month stays or settlement agreements controlling launch design.

What to track in UPTRAVI litigation outcomes

• Case filings: identifies challengers and the specific patents at issue.
• Claim construction / validity rulings: indicates strength of the estate.
• Settlement terms: can define:
  • launch date
  • carve-outs (specific strengths or dosage forms)
  • authorized generic timing and restrictions

Why litigation posture impacts financial trajectory before expiration

Even before expiration, the market often reprices risk based on:

• probability of successful challenge outcomes
• likelihood of negotiated settlements
• expected launch calendars and planned workarounds

What formulations are protected by UPTRAVI patents and what does that mean for “skinny labels”?

Featured-snippet answer: Brand product formulation and strength-specific claims can block “easy” generic workarounds that rely on label limitation.

UPTRAVI dosage and dose titration complexity

UPTRAVI is used with dose titration across strengths. This creates commercial stickiness:

• patients often remain on branded therapy to avoid titration disruptions
• payers may tighten prior authorization for switchers post-entry
• prescribers may prefer known titration protocols

IP relevance: even if a generic can satisfy labeling equivalence, formulation or method claims can slow true interchangeability if litigation limits launch scope.

How does UPTRAVI compare with competing PAH drugs on market dynamics and pricing pressure?

Featured-snippet answer: UPTRAVI faces competitive pressure from other prostacyclin pathway therapies and combination regimens that expand across payer formularies.

Competitive set by mechanism and administration route

UPTRAVI is a prostacyclin pathway agent. Competitors include:

• Oral prostacyclin pathway and IP alternatives (class crossover via formulary tiers)
• Inhaled prostacyclin therapies (patients seek reduced systemic exposure)
• Parenteral prostacyclins (high-severity cohorts; may displace oral step-ups)

Why competitive substitution matters more than generic timing

Even with patent protection intact, brand sales can soften when:

• payers incentivize preferred alternatives through step therapy
• patients switch due to tolerability (GI effects, headache, flushing) or titration burdens
• clinicians shift to combination protocols where different agents become anchor therapies

What is the Orange Book status of UPTRAVI and what generics entry risks exist?

Featured-snippet answer: Orange Book listings determine which generic filings are permitted and which patents trigger stays.

What entry scenarios typically play out

1. No Paragraph IV filings: brand maintains pricing through exclusivity.
2. Paragraph IV filings with settlements: generics enter at a negotiated date, often with limited launch scope.
3. Paragraph IV litigation losses: challengers delay, brand retains exclusivity.
4. Paragraph IV litigation wins: generic entry accelerates and triggers faster volume transfer.

How to map entry risk to revenue exposure

Use a risk model:

• US revenue share tied to UPTRAVI
• time to last expiring patent
• expected market share at generic entry (often shaped by payer contracting and patient support programs)
• degree of brand price concessions pre-entry (can mask underlying demand softness)

What FDA status milestones and label expansion affect UPTRAVI revenue growth?

Featured-snippet answer: Revenue trajectory is tied to approved indications and treatment line positioning.

Indication coverage that matters for commercial uptake

UPTRAVI is used in:

• PAH patients
• CTEPH patients with persistent/recurrent disease after surgical treatment

Commercial mechanism: indication scope affects prescriber pool and payer coverage, driving patient volumes and adherence.

Which companies are challenging UPTRAVI and what settlement patterns matter?

Featured-snippet answer: Generic challengers are typically identified by Paragraph IV filings. Settlement patterns, when they occur, often determine launch calendars and authorized generic exposure.

What a settlement changes in financial terms

• earlier or later launch dates shift revenue impact windows
• authorized generic terms can reduce brand price and delay payback of R&D spend
• launch design (strength selection) can limit immediate erosion

UPTRAVI revenue trajectory: what drives growth versus decline under patent protection?

Featured-snippet answer: Under exclusivity, UPTRAVI’s financial path depends on net revenue per patient, persistence, dose adherence, and payer mix.

Key financial drivers

• Net product sales trend: unit demand times net price after rebates
• Patient counts: new starts plus continuation rates
• Dose adherence and titration completion: tolerability and persistence affect effective dosing
• Payer mix: commercial vs government mix changes net price and speed of formulary uptake

What tends to cause plateaus in PAH oral therapies

• maturing prevalence pool
• slower new diagnosis or referral patterns
• competitive shifts toward preferred prostacyclin options
• formulary restrictions for non-preferred brands
• intolerance-driven discontinuations

What generic entry risks exist for UPTRAVI and how would a launch scenario play out?

Featured-snippet answer: The main risk is a post-expiration, first-to-market generic entry accelerated by a successful Paragraph IV route, with revenue erosion governed by interchangeability and contracting.

Launch scenario framework for market sizing

• Soft launch (limited coverage, step edits, tighter prior auth): slower share loss
• Broad launch (automatic coverage, favorable contracting): faster erosion
• Authorized generic: increases competitive intensity and compresses price earlier

What could protect brand profitability despite generic entry

• patient support and titration programs
• prescriber habits and clinical familiarity
• payer restrictions on non-preferred substitutions
• dosage titration schedules that can create “switching friction”

Key Takeaways

• UPTRAVI’s near-term market dynamics are shaped primarily by patent expiry windows, Orange Book-listed protections, and payer-driven competitive positioning, not biologics-style competition.
• The financial trajectory is driven by persistence, dosing adherence, net price, and formulary access, with competitive class agents affecting growth even without generic entry.
• The highest-impact events for revenue are Orange Book expiration milestones and any Paragraph IV litigation or settlement terms that determine generic launch timing and scope.
• Generic entry risk translates into a step-down pattern if multiple protections fall together; otherwise erosion occurs in phases as patents expire and challengers launch.

FAQs

1. How do Paragraph IV filings on UPTRAVI affect the timing of generic launches in the US?
2. Do UPTRAVI’s method-of-use claims create barriers to “skinny label” generics for PAH and CTEPH?
3. What payer behaviors most influence UPTRAVI net price and persistence after competitor formulary switches?
4. How does UPTRAVI’s dose titration design impact switching rates versus other oral PAH therapies?
5. Which regulatory milestones for PAH drug labels typically drive uptake and sustain revenue under exclusivity?

References

1. US Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (UPTRAVI). FDA.
2. FDA. Hatch-Waxman Act framework and Paragraph IV certification provisions. FDA guidance materials.

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