DANICOPAN - Generic Drug Details

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

Danicopan is the generic ingredient in one branded drug marketed by Alexion Pharms Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for DANICOPAN

International Patents:	107
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	24
Patent Applications:	40
What excipients (inactive ingredients) are in DANICOPAN?	DANICOPAN excipients list
DailyMed Link:	DANICOPAN at DailyMed

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

Constraining patent/regulatory exclusivity:

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

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.

Recent Clinical Trials for DANICOPAN

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

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2
Alexion Pharmaceuticals	Phase 3
Celerion	Phase 1

See all DANICOPAN clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DANICOPAN

L04AJ	Complement inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for DANICOPAN

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	218037-002	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
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				Y
Alexion Pharms Inc	VOYDEYA	danicopan	TABLET;ORAL	218037-002	Mar 29, 2024		RX	Yes	Yes

International Patents for DANICOPAN

Country	Patent Number	Title	Estimated Expiration
Japan	2021193128	補体媒介障害の治療のためのアリール化合物、ヘテロアリール化合物及び複素環式化合物 (ARYL, HETEROARYL AND HETEROCYCLIC COMPOUNDS FOR TREATMENT OF COMPLEMENT MEDIATED DISORDERS)
South Korea	20160116016	보체 매개 질환의 치료를 위한 아미노 화합물 (AMINO COMPOUNDS FOR TREATMENT OF COMPLEMENT MEDIATED DISORDERS)
Mexico	2016011038	COMPUESTOS PARA EL TRATAMIENTO DE TRASTORNOS MEDIADOS POR COMPLEMENTO. (COMPOUNDS FOR TREATMENT OF COMPLEMENT MEDIATED DISORDERS.)
Australia	2020260434	Aryl, Heteroaryl, and Heterocyclic Compounds for Treatment of Complement Mediated Disorders
South Korea	20160116018	보체 매개 질환의 치료를 위한 아미드 화합물 (AMIDE COMPOUNDS FOR TREATMENT OF COMPLEMENT MEDIATED DISORDERS)
Canada	2940772	COMPOSES ARYLE, HETEROARYLE ET HETEROCYCLIQUES POUR LE TRAITEMENT DE TROUBLES INDUITS PAR UN COMPLEMENT (ARYL, HETEROARYL, AND HETEROCYCLIC COMPOUNDS FOR TREATMENT OF COMPLEMENT MEDIATED DISORDERS)

DANICOPAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Danicopan

Introduction to Danicopan

Danicopan, also known as ALXN2040, is a promising drug candidate developed by Alexion Pharmaceuticals, now a subsidiary of AstraZeneca. It is designed as a proximal factor D inhibitor, targeting the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disorder.

Regulatory Milestones

Danicopan has achieved several significant regulatory milestones, including Breakthrough Therapy Designation and Orphan Drug Designation by the FDA, as well as PRIME designation by the EMA. These designations highlight the drug's potential to address an unmet medical need and expedite its development and review process[4].

Clinical Trials and Development

The drug is currently in advanced clinical trials, with a comprehensive assessment of its efficacy and safety. The clinical trials landscape includes detailed information on trial conditions, statuses, and timelines. These trials are crucial for understanding Danicopan's potential impact on PNH treatment and for securing final regulatory approvals[4].

Mechanism of Action

Danicopan works by inhibiting factor D, a key component of the alternative pathway of the complement system. This mechanism is novel and offers a more targeted approach to managing PNH, potentially reducing the severity of the disease and improving patient outcomes[4].

Market Forecast and Projections

The market forecast for Danicopan is highly optimistic, with predictions indicating significant market engagement and competitive positioning through 2032. Here are some key insights:

• Projected Sales and Market Share: The report forecasts substantial sales and market share for Danicopan in seven major global markets, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan[4].
• Emerging Therapies Competition: Danicopan is expected to compete favorably with other emerging therapies in the PNH treatment landscape. The report provides a detailed analysis of the competitive landscape, helping stakeholders understand Danicopan's market positioning[4].
• Barriers and Challenges: Despite its promising outlook, the report also evaluates potential barriers and challenges to Danicopan's market acceptance, including regulatory hurdles, clinical trial outcomes, and market adoption rates[4].

Financial Impact and Revenue Projections

The financial trajectory for Danicopan is anticipated to be robust, driven by several factors:

• Revenue Growth: With the potential approval and market entry of Danicopan, the drug is expected to contribute significantly to the revenue growth of AstraZeneca and the broader pharmaceutical industry. The market forecast report provides detailed revenue projections up to 2032[4].
• Market Size: The factor D complement inhibitor market, which includes Danicopan, is projected to experience rapid growth due to the expansion of indications for already approved therapies and the anticipated approval of emerging therapies. This market is expected to grow at a significant CAGR by 2034[1].

Strategic Environment and SWOT Analysis

A comprehensive SWOT analysis (Strengths, Weaknesses, Opportunities, and Threats) is provided in the market forecast report. This analysis helps stakeholders understand the strategic environment surrounding Danicopan, facilitating informed decision-making and investment strategies[4].

Impact on Patient Care and Medical Economics

Danicopan's emergence is poised to redefine the standards of care in PNH. The drug offers improved outcomes for patients suffering from this rare blood disorder, which could lead to better quality of life and reduced healthcare costs associated with managing the disease. The report provides a framework for understanding the evolving PNH treatment paradigm underscored by Danicopan's significance[4].

Industry Expert Insights

Industry experts highlight the importance of innovative treatments like Danicopan in addressing rare diseases. For example, Ludwig Hantson, Ph.D., former CEO of Alexion, emphasized the company's commitment to delivering life-changing therapies and the strong foundation laid for future growth through such developments[3].

Conclusion

Danicopan represents a significant advancement in the treatment of paroxysmal nocturnal hemoglobinuria, with a strong potential for market dominance and financial growth. Its regulatory milestones, clinical trial progress, and projected market performance position it as a beacon of hope for patients and a substantial opportunity for the pharmaceutical industry.

Key Takeaways

• Regulatory Approvals: Danicopan has received Breakthrough Therapy and Orphan Drug Designations, indicating its potential to address an unmet medical need.
• Clinical Trials: The drug is in advanced clinical trials, with a focus on efficacy and safety.
• Market Projections: Significant revenue growth and market share are forecasted through 2032.
• Competitive Landscape: Danicopan is expected to compete favorably with other emerging therapies.
• Financial Impact: The drug is anticipated to contribute to the revenue growth of AstraZeneca and the broader pharmaceutical industry.

FAQs

Q: What is Danicopan and how does it work? A: Danicopan (ALXN2040) is a proximal factor D inhibitor designed to treat paroxysmal nocturnal hemoglobinuria (PNH). It works by inhibiting factor D, a key component of the alternative pathway of the complement system.

Q: What regulatory milestones has Danicopan achieved? A: Danicopan has received Breakthrough Therapy Designation and Orphan Drug Designation by the FDA, as well as PRIME designation by the EMA.

Q: What is the current status of Danicopan's clinical trials? A: Danicopan is currently in advanced clinical trials, with a comprehensive assessment of its efficacy and safety.

Q: How is Danicopan expected to impact the PNH treatment market? A: Danicopan is expected to redefine the standards of care in PNH, offering improved outcomes for patients and potentially reducing healthcare costs associated with managing the disease.

Q: What are the projected revenue and market share for Danicopan? A: The report forecasts substantial sales and market share for Danicopan in seven major global markets through 2032.

Sources

1. GlobeNewswire: Factor D Complement Inhibitor Market Will Witness Robust Growth with Emerging Therapies by 2034 | DelveInsight
2. AstraZeneca: Fixed-income investor update | AstraZeneca
3. Alexion Pharmaceuticals: Alexion Reports Third Quarter 2019 Results
4. GlobeNewswire: Paroxysmal Nocturnal Hemoglobinuria Treatment Advances with Comprehensive Danicopan Market Forecast to 2032
5. Alexion Pharmaceuticals: Alexion Reports Third Quarter 2019 Results