VOYDEYA Drug Patent Profile

When do Voydeya patents expire, and what generic alternatives are available?

Voydeya is a drug marketed by Alexion Pharms Inc and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and seven patent family members in twenty-four countries.

The generic ingredient in VOYDEYA is danicopan. One supplier is listed for this compound. Additional details are available on the danicopan profile page.

DrugPatentWatch^® Generic Entry Outlook for Voydeya

Voydeya will be eligible for patent challenges on March 29, 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 March 29, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VOYDEYA

International Patents:	107
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	36
What excipients (inactive ingredients) are in VOYDEYA?	VOYDEYA excipients list
DailyMed Link:	VOYDEYA at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VOYDEYA

Constraining patent/regulatory exclusivity:

TREATMENT OF EXTRAVASCULAR HEMOLYSIS (EVH) IN ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)

NDA:

218037

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.

US Patents and Regulatory Information for VOYDEYA

VOYDEYA is protected by two US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF EXTRAVASCULAR HEMOLYSIS (EVH) IN ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH).

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
Alexion Pharms Inc	VOYDEYA	danicopan	TABLET;ORAL	218037-001	Mar 29, 2024		RX	Yes	No				Y
Alexion Pharms Inc	VOYDEYA	danicopan	TABLET;ORAL	218037-002	Mar 29, 2024		RX	Yes	Yes
Alexion Pharms Inc	VOYDEYA	danicopan	TABLET;ORAL	218037-001	Mar 29, 2024		RX	Yes	No
Alexion Pharms Inc	VOYDEYA	danicopan	TABLET;ORAL	218037-002	Mar 29, 2024		RX	Yes	Yes
Alexion Pharms Inc	VOYDEYA	danicopan	TABLET;ORAL	218037-001	Mar 29, 2024		RX	Yes	No
Alexion Pharms Inc	VOYDEYA	danicopan	TABLET;ORAL	218037-001	Mar 29, 2024		RX	Yes	No

International Patents for VOYDEYA

See the table below for patents covering VOYDEYA around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2015130830
Brazil	112016019526
Mexico	2016011034	COMPUESTOS DE AMIDA PARA EL TRATAMIENTO DE TRASTORNOS MEDIADOS POR COMPLEMENTO. (AMIDE COMPOUNDS FOR TREATMENT OF COMPLEMENT MEDIATED DISORDERS.)
Japan	7374967
Israel	247452	תרכובות לטיפול בהפרעות מתווכות משלימות (Compounds for treatment of complement mediated disorders)
European Patent Office	4129407	COMPOSÉS ARYLE, HÉTÉROARYLE ET HÉTÉROCYCLIQUES POUR LE TRAITEMENT DE TROUBLES INDUITS PAR UN COMPLÉMENT (ARYL, HETEROARYL, AND HETEROCYCLIC COMPOUNDS FOR TREATMENT OF COMPLEMENT MEDIATED DISORDERS)

VOYDEYA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Voydeya

Introduction to Voydeya

Voydeya, developed by AstraZeneca and originally known as danicopan, is a groundbreaking drug approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare and serious blood disorder. This first-in-class, oral Factor D inhibitor has marked a significant advancement in the treatment of PNH, particularly for patients who experience residual hemolytic anemia despite standard treatments.

Approval and Regulatory Status

Voydeya has received approvals in several key markets, including the United States, the European Union, and Japan. In the U.S., it was approved by the FDA as an add-on therapy to the standard PNH treatments, Ultomiris and Soliris[1][2][4].

In the EU, the European Commission approved Voydeya based on the positive opinion of the Committee for Medicinal Products for Human Use, following the results of the pivotal ALPHA Phase III trial[2].

Mechanism of Action and Clinical Benefits

Voydeya works by selectively inhibiting Factor D, a protein in the complement system that plays a crucial role in the amplification of the complement system response. By blocking this factor, Voydeya reduces the premature destruction of red blood cells, a hallmark of PNH. Clinical trials have shown that adding Voydeya to standard treatments like Ultomiris or Soliris increases hemoglobin levels and reduces the need for blood transfusions[1][2].

Market Position and Competition

AstraZeneca's acquisition of Alexion Pharmaceuticals in 2020 positioned the company strongly in the rare disease market, particularly in PNH treatment. Voydeya is part of this portfolio, which includes top-selling drugs Ultomiris and Soliris. These drugs generate significant revenue, with combined sales exceeding $6 billion in 2023[1].

However, Voydeya may face competition from other pharmaceutical companies like Novartis, Roche, and Amgen, which are also active in the PNH treatment domain[4].

Financial Projections and Revenue Potential

Jefferies analyst Peter Welford has estimated peak annual worldwide sales for Voydeya in PNH to be around $750 million. This projection underscores the drug's potential to contribute significantly to AstraZeneca's revenue stream[1].

Clinical Trials and Ongoing Research

The ALPHA Phase III trial demonstrated the efficacy and safety of Voydeya as an add-on therapy. The trial met its primary endpoint and all key secondary endpoints, including improvements in hemoglobin levels and fatigue scores. The drug was generally well-tolerated, with common side effects such as headache, nausea, arthralgia, and diarrhea[2].

In addition to its use in PNH, AstraZeneca is also testing Voydeya in a Phase 2 trial for the treatment of geographic atrophy, an eye disease[1].

Regulatory Designations and Global Access

Voydeya has been granted several prestigious designations, including Breakthrough Therapy designation by the FDA, PRIority MEdicines (PRIME) status by the EMA, and Orphan Drug Designation in the U.S., EU, and Japan. These designations highlight the drug's innovative nature and its potential to address significant unmet medical needs[2][4].

Impact on AstraZeneca's Portfolio and Strategy

The approval of Voydeya strengthens AstraZeneca's position in rare disease research and treatment. Through its acquisition of Alexion, AstraZeneca has expanded its portfolio to include multiple forms of amyloidosis and has made forays into genetic medicine and cell therapy. This strategic expansion aims to address a broader range of rare diseases and solidify the company's leadership in complement science[1].

Global Pharmaceutical Market Context

The global pharmaceutical market is projected to grow significantly, reaching $1.15 trillion in 2024 and exceeding $1.4 trillion by 2028. This growth is driven by the increasing global burden of chronic diseases, which prompts pharmaceutical companies to invest heavily in R&D to address these unmet medical needs[3].

Challenges and Future Outlook

Despite the promising financial trajectory, the pharmaceutical industry faces challenges such as declining ROI for R&D, increasing regulatory hurdles, and short exclusivity periods. However, the approval and market performance of drugs like Voydeya indicate that targeted, innovative therapies can still yield substantial returns and improve patient outcomes[3].

Quote from Industry Expert

"The approval of first-in-class, Factor D inhibitor Voydeya marks an important advancement in the treatment of PNH and builds on our leadership and commitment to bring forward innovation in complement science," said Alexion CEO Marc Dunoyer[1].

Statistics and Data

• Combined sales of Ultomiris and Soliris exceeded $6 billion in 2023[1].
• Estimated peak annual worldwide sales for Voydeya in PNH: $750 million[1].
• Global pharmaceutical market revenue projected to exceed $1.4 trillion by 2028[3].

Key Takeaways

• Innovative Therapy: Voydeya is a first-in-class, oral Factor D inhibitor approved for PNH treatment.
• Market Approval: Approved in the U.S., EU, and Japan as an add-on therapy to standard PNH treatments.
• Financial Potential: Estimated peak annual sales of $750 million.
• Clinical Benefits: Increases hemoglobin levels and reduces blood transfusions.
• Regulatory Designations: Breakthrough Therapy, PRIME status, and Orphan Drug Designation.
• Global Market Context: Part of a growing pharmaceutical market driven by chronic disease burden.

FAQs

What is Voydeya used for?

Voydeya is used as an add-on therapy for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare and serious blood disorder.

How does Voydeya work?

Voydeya works by selectively inhibiting Factor D, a protein in the complement system, thereby reducing the premature destruction of red blood cells.

What are the common side effects of Voydeya?

Common side effects include headache, nausea, arthralgia, and diarrhea.

What is the estimated peak annual sales for Voydeya?

The estimated peak annual worldwide sales for Voydeya in PNH is around $750 million.

Has Voydeya received any special regulatory designations?

Yes, Voydeya has received Breakthrough Therapy designation by the FDA, PRIority MEdicines (PRIME) status by the EMA, and Orphan Drug Designation in the U.S., EU, and Japan.

Sources

1. Yahoo Finance: AstraZeneca gets FDA OK for rare disease drug acquired in Alexion ...
2. AstraZeneca: Voydeya approved in the EU as add-on treatment to ravulizumab or eculizumab for adults with rare disease PNH ...
3. DrugBank Blog: Investment Trends in Pharmaceutical Research
4. DelveInsight: Voydeya Gains Approval for PNH Treatment in Japan