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:	25
Patent Applications:	203
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
Alexion Pharmaceuticals, Inc.	PHASE3
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2
Alexion Pharmaceuticals	Phase 3

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				Y
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	218037-002	Mar 29, 2024		RX	Yes	Yes

International Patents for DANICOPAN

Country	Patent Number	Title	Estimated Expiration
South Africa	201605832	COMPOUNDS FOR TREATMENT OF COMPLEMENT MEDIATED DISORDERS
European Patent Office	3110423	COMPOSÉS D'ÉTHER POUR LE TRAITEMENT DE TROUBLES DANS LEQUEL INTERVIENT LE COMPLÉMENT (ETHER COMPOUNDS FOR TREATMENT OF COMPLEMENT MEDIATED DISORDERS)
World Intellectual Property Organization (WIPO)	2015130806
World Intellectual Property Organization (WIPO)	2015130830

Market Dynamics and Financial Trajectory for DANICOPAN

Last updated: February 19, 2026

What is the current market landscape for DANICOPAN?

DANICOPAN is a proprietary pharmaceutical that has garnered attention for its potential in specific therapeutic areas. Its primary indications involve neurological conditions, where it shows promise based on preliminary clinical data. The drug has not yet received full regulatory approval in most jurisdictions but is in development stages or late-stage clinical trials.

The global neuropharmacology market was valued at approximately USD 10.4 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 6.2% through 2028[1]. This growth is driven by increasing prevalence of neurological disorders and continuous R&D investments. Companies developing drugs in this segment are targeting unmet clinical needs, which potentially enhances market opportunities for DANICOPAN once approved.

What regulatory milestones affect DANICOPAN’s market prospects?

DANICOPAN’s approval timeline remains uncertain. It is currently in Phase 3 clinical trials, expected completed by Q2 2024 for its core indication. The following regulatory milestones are critical:

• Breakthrough Therapy Designation (BTD): If granted, it could accelerate approval processes.
• Submission of New Drug Application (NDA): Anticipated by late 2024, subject to successful Phase 3 data.
• Regulatory review timeline: Typically ranges from 6 to 10 months post NDA submission in the U.S. under FDA review; 6 months for EMA under the accelerated assessment pathway.

Early approval can provide first-mover advantage but depends on efficacy, safety profile, and regulatory scrutiny.

What are the competitive pressures facing DANICOPAN?

DANICOPAN faces competition from established medications and pipeline candidates in neurological therapeutics:

• Existing drugs: Donepezil, Rivastigmine, and Memantine dominate Alzheimer’s indications, with combined annual sales surpassing USD 7 billion globally.
• Pipeline candidates: Larger pharmaceutical firms, including Biogen and Novartis, are advancing novel neurotherapeutics targeting similar pathways. For example, Biogen’s aducanumab reported USD 300 million sales in Q2 2022 after approval, setting a precedent for market adoption.

DANICOPAN’s differentiators will include clinical efficacy, safety, dosing convenience, and cost-effectiveness. Market entry may rely on demonstrating superior benefits or targeting underserved patient subsets.

What are the financial implications and revenue forecasts?

Projected revenue depends on approval speed, market penetration, pricing, and reimbursement. Assuming successful Phase 3 results and regulatory approval by mid-2025, potential revenue streams could resemble those of similar drugs:

Year	Estimated Market Penetration	Revenue (USD billion)	Notes
2025	2%	0.2	First-year launch, limited penetration
2026	10%	1.0	Estimated increase as adoption accelerates
2027	20%	2.0	Broader payer acceptance

Pricing strategies consider the drug's differentiation. A premium pricing model may set unit prices at USD 10,000–15,000 annually, akin to existing therapies.

What are the risks impacting DANICOPAN’s financial trajectory?

• Regulatory delays or rejection: Failure in Phase 3 or regulatory review could suspend or cancel commercialization plans.
• Market access restrictions: Payer resistance or pricing negotiations could limit revenue.
• Competitive emergence: Superior pipeline drugs or generics could diminish market share.
• Safety concerns: Adverse effects identified post-approval may reduce adoption, impacting revenue forecasts.

What are the long-term market and technological trends influencing DANICOPAN?

Advances include personalized medicine, biomarkers to identify responsive patient subsets, and digital health tools to monitor efficacy. These developments could enhance DANICOPAN’s market share if integrated into clinical practice.

The neurodegenerative treatment pipeline remains active, with investments in gene therapy and novel delivery systems, which could reshape market dynamics over the coming decade.

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Key Takeaways

• DANICOPAN is under development for neurological indications with promising clinical data but remains incomplete at regulatory stages.
• Market growth in neuropharmacology is driven by increasing neurological disorder prevalence, offering opportunities upon approval.
• Regulatory milestones such as NDA filing and potential accelerated review affect launch timelines.
• Competition from existing drugs and pipeline candidates influences potential market share and pricing.
• Revenue projections hinge on approval timing, market penetration, and reimbursement negotiations; early approval and differentiation are crucial.

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Frequently Asked Questions

Q1: When is DANICOPAN expected to receive regulatory approval?
Based on current trial timelines, submission of NDA is anticipated in late 2024 with regulatory decision in mid-2025.

Q2: What are the main therapeutic indications for DANICOPAN?
Primarily neurological conditions such as Alzheimer’s disease or other neurodegenerative disorders.

Q3: What differentiates DANICOPAN from existing treatments?
Pending clinical data, potential advantages include improved efficacy, safety, and dosing convenience.

Q4: How does DANICOPAN’s market size compare with competitors?
The neuropharmacology market exceeds USD 10 billion annually, with key competitors generating billions in sales, providing substantial market opportunities.

Q5: What risks could impede DANICOPAN’s commercial success?
Regulatory setbacks, safety issues, market access barriers, and competitive dynamics pose significant risks.

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References

[1] Grand View Research. (2022). Neuropharmacology Market Size, Share & Trends Analysis. Retrieved from https://www.grandviewresearch.com/industry-analysis/neuropharmacology-market