Selexipag - Generic Drug Details

What are the generic sources for selexipag and what is the scope of freedom to operate?

Selexipag is the generic ingredient in two branded drugs marketed by Actelion, Alembic, and Zydus Lifesciences, and is included in four NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Selexipag has one hundred and fifty-three patent family members in thirty-nine countries.

There are two drug master file entries for selexipag. Two suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for selexipag

International Patents:	153
US Patents:	6
Tradenames:	2
Applicants:	3
NDAs:	4
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	23
Patent Applications:	424
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for selexipag
What excipients (inactive ingredients) are in selexipag?	selexipag excipients list
DailyMed Link:	selexipag at DailyMed

Recent Clinical Trials for selexipag

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

Sponsor	Phase
University of Newcastle Upon-Tyne	Phase 4
Sheffield Teaching Hospitals NHS Foundation Trust	Phase 4
University of Glasgow	Phase 4

See all selexipag clinical trials

Generic filers with tentative approvals for SELEXIPAG

Applicant	Application No.	Strength	Dosage Form
		1400MCG	TABLET;ORAL
		1200MCG	TABLET;ORAL
		1000MCG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for selexipag

Drug Class	Prostacyclin Receptor Agonist
Mechanism of Action	Prostacyclin Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for selexipag

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for SELEXIPAG

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 selexipag

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	207947-008	Dec 21, 2015	AB	RX	Yes	No			Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-001	Dec 21, 2015	AB	RX	Yes	No			Y	Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-006	Dec 21, 2015		RX	Yes	No			Y	Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-006	Dec 21, 2015		RX	Yes	No			Y	Y

EU/EMA Drug Approvals for selexipag

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 selexipag

Country	Patent Number	Title	Estimated Expiration
Croatia	P20180171
Hungary	E048467
Hong Kong	1244788	晶體 (CRYSTALS)
Lithuania	PA2018008

Supplementary Protection Certificates for selexipag

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1400518	122016000077	Germany		PRODUCT NAME: SELEXIPAG ODER SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1083/001-010 20160512
1400518	300836	Netherlands		PRODUCT NAME: SELEXIPAG OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1083 20160519
2447254	2018015	Norway		PRODUCT NAME: 2-4-(N-(5,6-DIFENYLPYRAZIN-2- YL)-N- ISOPROPYLAMINO)BUTYLOKSY-N-; REG. NO/DATE: EU/1/15/1083 20160530
1400518	44/2016	Austria		PRODUCT NAME: SELEXIPAG ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1083 (MITTEILUNG) 20160519

Market Dynamics and Financial Trajectory for Selexipag

Introduction to Selexipag

Selexipag, marketed under the brand name Uptravi, is an oral prostacyclin receptor agonist used in the treatment of pulmonary arterial hypertension (PAH). It is a significant advancement in PAH therapy, offering improved convenience and patient compliance compared to traditional prostacyclin analogs.

Market Size and Growth

The PAH market, within which selexipag operates, is experiencing substantial growth. As of 2023, the global PAH market size was valued at approximately USD 7.1 billion to USD 7.7 billion, depending on the source[1][4].

• The market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.6% to 5.2% from 2023 to 2030 or 2032, reaching nearly USD 10.12 billion to USD 11.6 billion by the end of the forecast period[1][4].

Key Drivers of Market Growth

Several factors are driving the growth of the PAH market and, by extension, the demand for selexipag:

Increasing Prevalence of PAH

The prevalence of PAH is on the rise, with around 500 to 1000 new cases diagnosed annually in the U.S. Women aged 30 to 60 are more susceptible, and idiopathic or genetic factors contribute to about 15 to 20% of cases[4].

Advancements in Drug Development

Innovative therapies like selexipag are a major driver. Selexipag targets the prostacyclin pathway to dilate blood vessels and reduce elevated pressure in the pulmonary arteries, offering a more convenient oral administration compared to traditional intravenous prostacyclin analogs[4].

Expanding Geriatric Population

The growing geriatric population is another significant factor, as older adults are more likely to develop PAH and other pulmonary disorders[1].

Strategic Collaborations and Innovations

Pharmaceutical companies are actively involved in strategic collaborations and innovations, including the development of new delivery systems and therapies. For example, the FDA approval of combination therapies like OPSYNVI® (macitentan and tadalafil) and the advancement of ralinepag into Phase 3 clinical trials are indicative of this trend[1][3].

Financial Performance of Selexipag

Revenue and Market Share

Selexipag has been a significant contributor to the revenues of its manufacturers. For instance, in 2021, selexipag (Uptravi) generated U.S. revenues of approximately $1.1 billion, making it a competitive product in the PAH market[3].

Competitive Landscape

Selexipag competes with other PAH treatments, including endothelin receptor antagonists, phosphodiesterase-5 (PDE-5) inhibitors, and soluble guanylate cyclase (sGC) stimulators. However, its oral administration and once-daily dosing make it highly competitive, especially against other prostacyclin analogs like intravenous prostacyclins[1][4].

Regional Market Dynamics

North America

North America, particularly the United States, has the largest market share for PAH drugs, including selexipag. This is due to the introduction of novel therapies, robust healthcare infrastructure, significant investments in R&D, and strategic collaborations between pharmaceutical companies and research institutions[1].

Other Regions

The Asia Pacific, Europe, Latin America, the Middle East, and Africa also represent significant markets. However, the growth and adoption rates vary based on factors such as healthcare infrastructure, regulatory environments, and patient awareness[1].

Future Outlook

Innovations and Label Expansions

The future outlook for selexipag is promising, with ongoing research and development aimed at enhancing its efficacy and convenience. Label expansions and new formulations are expected to drive further growth. For example, United Therapeutics is working on new delivery systems and additional indications for similar therapies, which could further bolster the market[3].

Competitive Advancements

The PAH market is highly competitive, with companies like Arena Pharmaceuticals advancing ralinepag, a next-generation oral prostacyclin receptor agonist, into Phase 3 clinical trials. This competition is expected to drive innovation and improve treatment options for PAH patients[1][3].

Key Takeaways

• Market Growth: The PAH market, driven by factors like increasing prevalence and innovative therapies, is expected to grow significantly.
• Selexipag's Role: Selexipag is a key player in this market, offering a convenient oral administration and targeting the prostacyclin pathway.
• Financial Performance: Selexipag has generated substantial revenues and is expected to continue contributing to the growth of the PAH market.
• Regional Dynamics: North America leads in market share, but other regions are also significant and growing.
• Future Outlook: Innovations, label expansions, and competitive advancements are expected to drive further growth.

FAQs

Q: What is selexipag used for? Selexipag is used for the treatment of pulmonary arterial hypertension (PAH), targeting the prostacyclin pathway to dilate blood vessels and reduce elevated pressure in the pulmonary arteries.

Q: How does selexipag differ from other PAH treatments? Selexipag differs from other PAH treatments by its oral administration, which is more convenient compared to traditional intravenous prostacyclin analogs.

Q: What is the projected market size for PAH drugs by 2030? The global PAH market is projected to reach nearly USD 10.12 billion to USD 11.6 billion by 2030.

Q: Which region has the largest market share for PAH drugs? North America, particularly the United States, has the largest market share for PAH drugs due to the introduction of novel therapies and robust healthcare infrastructure.

Q: What are some of the key drivers of the PAH market growth? Key drivers include the increasing prevalence of PAH, advancements in drug development, an expanding geriatric population, and strategic collaborations and innovations in the pharmaceutical industry.

Sources

1. Biospace: Pulmonary Arterial Hypertension Drugs Market Size to Reach USD 11.6 Billion by 2032[1].
2. United Therapeutics: 2022 Annual Meeting Proxy Statement[3].
3. Maximize Market Research: Pulmonary Arterial Hypertension Market: Global Industry[4].