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 fifty-one patent family members in thirty-eight countries.

The generic ingredient in UPTRAVI is selexipag. There are two drug master file entries for this compound. One supplier is 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:	151
US Patents:	6
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	4
Patent Applications:	216
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
University of Sheffield	Phase 4
University of Cambridge	Phase 4
University of Newcastle Upon-Tyne	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	9,173,881
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-005	Dec 21, 2015		RX	Yes	No	10,821,108		Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-008	Dec 21, 2015	AB	RX	Yes	No	9,284,280
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-007	Dec 21, 2015	AB	RX	Yes	No	10,828,298		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/003774 Uptravi 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

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Russian Federation

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
China	1516690
Argentina	073031	COMPOSICIONES TERAPEUTICAS QUE CONTIENEN MACITENTAN
Croatia	P20200539
Peru	20181072	COMPOSICION FARMACEUTICA QUE CONTIENE 2-{4-[N-(5,6-DIFENILPIRAZIN-2-IL)-N-ISOPROPILAMINO]BUTILOXI}-N-(METILSULFONIL)ACETAMIDA

Supplementary Protection Certificates for UPTRAVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1400518	1690044-1	Sweden		PRODUCT NAME: SELEXIPAG OR SALT THEROF; REG. NO/DATE: EU/1/15/1083 20160519
2447254	325 10-2018	Slovakia		PRODUCT NAME: SELEXIPAG; 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	132016000106856	Italy		PRODUCT NAME: SELEXIPAG O UN SUO SALE(UPTRAVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1083, 20160519

UPTRAVI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Uptravi

Introduction

Uptravi, also known as selexipag, is a groundbreaking drug in the treatment of pulmonary arterial hypertension (PAH), developed by Johnson & Johnson in collaboration with Nippon Shinyaku. This article delves into the market dynamics and financial trajectory of Uptravi, highlighting its clinical significance, market performance, and future prospects.

Clinical Significance of Uptravi

Uptravi is a first-in-class oral selective non-prostanoid prostaglandin I2 (PGI2) receptor agonist. It and its active metabolite, ACT-333679, have a mode of action similar to prostacyclin analogs but with greater selectivity for the PGI2 receptor. This drug has been pivotal in slowing disease progression and reducing the risk of hospitalization in PAH patients, making it a significant advancement in the treatment of this condition[3].

Market Positioning

Uptravi is positioned to become the second highest-selling drug in the PAH market, following Opsumit (macitentan), another Johnson & Johnson product. The strong clinical profile of Uptravi, including its oral dosing which eliminates the need for injections or inhalations, has contributed to its growing market share. It is expected to achieve peak sales of $1.5 billion across forecast markets[3].

Financial Performance

In 2023, Uptravi generated sales of $1.6 billion, representing a 20% increase from the previous year. This significant growth underscores the drug's acceptance and efficacy in treating PAH. Johnson & Johnson's dominance in the PAH market is further solidified by the combined performance of Uptravi and Opsumit, with Opsumit generating $2 billion in revenue in 2023, up 14% from 2022[1].

Market Trends and Competition

The PAH market is witnessing a shift towards prostacyclins, with Uptravi and Opsumit leading this trend. Historically, endothelin receptor antagonists (ERAs) were the most commercially lucrative class, but prostacyclins have surpassed them. In 2019, prostacyclins generated $2.675 billion in sales, compared to $2.286 billion for ERAs. This gap is expected to widen as ERAs face generic competition and the increasing use of prostacyclins in triple combination therapies[4].

Clinical Trials and Label Expansions

Uptravi is being investigated in clinical trials for potential label expansions, including its use in combination with a phosphodiesterase 5 (PDE5) inhibitor and an endothelin receptor antagonist (ERA). These trials aim to support the use of Uptravi in treating newly diagnosed patients aggressively and potentially expanding its use to WHO Functional Class II and III patients. Although some trials, like the TRITON trial, have shown numerical reductions in disease progression events and overall mortality, additional studies are needed to achieve statistical significance[4].

Future Prospects

The approval of pipeline candidates, such as sotatercept which targets the transforming growth factor beta (TGF) pathway, is expected to diversify the PAH market and address unmet needs. Uptravi's role in early implementation of polytherapy, as established by the AMBITION trial, is likely to continue growing. The drug's strong positioning in treatment guidelines and robust efficacy data will further solidify its market presence[4].

Physician and Patient Adoption

Physician familiarity and strong positioning in treatment guidelines have contributed to the strong uptake of Uptravi. The drug's oral dosing and clinical efficacy have made it a preferred choice for both physicians and patients. This adoption is expected to continue as more clinical data supports its use in various patient populations[3].

Global Market Outlook

The global PAH market is projected to reach $6.7 billion by 2031, growing at a CAGR of 2.3% over the forecast period. Johnson & Johnson's dominance, driven by Uptravi and Opsumit, is expected to continue, with these drugs being key drivers of market growth[1].

Key Takeaways

• Clinical Significance: Uptravi is a first-in-class oral PGI2 receptor agonist with a strong clinical profile in slowing disease progression and reducing hospitalization in PAH patients.
• Market Performance: Uptravi generated $1.6 billion in sales in 2023, with a 20% increase from the previous year.
• Market Trends: The PAH market is shifting towards prostacyclins, with Uptravi and Opsumit leading this trend.
• Future Prospects: Uptravi is expected to continue its strong market presence through clinical trials and potential label expansions.
• Global Market Outlook: The global PAH market is projected to reach $6.7 billion by 2031, with Johnson & Johnson's products driving growth.

FAQs

Q: What is the mechanism of action of Uptravi? A: Uptravi is a selective non-prostanoid prostaglandin I2 (PGI2) receptor agonist, acting similarly to prostacyclin analogs but with greater selectivity for the PGI2 receptor[3].

Q: How has Uptravi performed financially? A: In 2023, Uptravi generated $1.6 billion in sales, representing a 20% increase from the previous year[1].

Q: What are the key market trends affecting Uptravi? A: The PAH market is shifting towards prostacyclins, with Uptravi and Opsumit leading this trend. ERAs are facing generic competition, and the use of prostacyclins in triple combination therapies is increasing[4].

Q: What are the potential future uses of Uptravi? A: Uptravi is being investigated for potential label expansions, including its use in combination therapies and for treating newly diagnosed patients aggressively[4].

Q: How does Uptravi fit into the global PAH market outlook? A: The global PAH market is projected to reach $6.7 billion by 2031, with Johnson & Johnson's products, including Uptravi, driving this growth[1].

Sources

1. Global Pulmonary Arterial Hypertension Market $6.7 Billion by 2031 - iHealthcareAnalyst
2. Johnson & Johnson Reports Q4 and Full-Year 2023 Results - Johnson & Johnson Investor Relations
3. Uptravi (selexipag; Johnson & Johnson/Nippon Shinyaku) Drug Overview - Business Wire
4. Global Pulmonary Arterial Hypertension Market Report 2021 - GlobeNewswire