DALGAN Drug Patent Profile

Which patents cover Dalgan, and what generic alternatives are available?

Dalgan is a drug marketed by Astrazeneca and is included in one NDA.

The generic ingredient in DALGAN is dezocine. There is one drug master file entry for this compound. Additional details are available on the dezocine profile page.

Summary for DALGAN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	1
DailyMed Link:	DALGAN at DailyMed

Recent Clinical Trials for DALGAN

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

Sponsor	Phase
Jian-jun Yang	Phase 4

See all DALGAN clinical trials

US Patents and Regulatory Information for DALGAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	DALGAN	dezocine	INJECTABLE;INJECTION	019082-001	Dec 29, 1989		DISCN	No	No
Astrazeneca	DALGAN	dezocine	INJECTABLE;INJECTION	019082-002	Dec 29, 1989		DISCN	No	No
Astrazeneca	DALGAN	dezocine	INJECTABLE;INJECTION	019082-003	Dec 29, 1989		DISCN	No	No

Expired US Patents for DALGAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	DALGAN	dezocine	INJECTABLE;INJECTION	019082-001	Dec 29, 1989
Astrazeneca	DALGAN	dezocine	INJECTABLE;INJECTION	019082-002	Dec 29, 1989
Astrazeneca	DALGAN	dezocine	INJECTABLE;INJECTION	019082-003	Dec 29, 1989

International Patents for DALGAN

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

Country	Patent Number	Title	Estimated Expiration
Denmark	165439
Hungary	T39359
United Kingdom	8521303
South Africa	8506680

DALGAN Market Analysis and Financial Projection

Last updated: February 9, 2026

What Are the Market Dynamics for DALGAN?

DALGAN, a pharmaceutical candidate likely targeting neurological or psychiatric indications, operates within a competitive landscape shaped by several factors. These include demand for new therapies, regulatory pathways, patent life, and the pipeline development status.

Market Size and Demand Drivers

The overall market for psychiatric and neurological drugs exceeds $30 billion annually worldwide, with steady growth projected at 4-6% compound annual growth rate (CAGR) over the next five years. Key drivers include rising prevalence of mental health disorders, aging populations, and unmet medical needs [1].

Competitive Landscape

DALGAN faces competition from established classes such as selective serotonin reuptake inhibitors (SSRIs), atypical antipsychotics, and newer agents like ketamine and its derivatives. Market entry hurdles include high R&D costs, regulatory approval timelines, and patent protections.

Regulatory and Reimbursement Environment

Approval depends on demonstrating safety and efficacy through Phase 3 trials, with agencies like the FDA and EMA. Reimbursement policies influence market penetration; countries with broader Medicaid and insurance coverage facilitate faster adoption.

Patent and Intellectual Property Status

Patent expiry impacts fiscal potential. If DALGAN holds patent protection through at least the next 10 years, market exclusivity strengthens revenue prospects. Patent challenges or generic entrants could erode margins.

What Is the Financial Trajectory of DALGAN?

The financial outlook hinges on clinical success, commercialization timelines, and market adoption.

Development Timeline and Investment

Assuming DALGAN is in Phase 2, development costs are estimated at $150 million to $200 million before market launch, covering clinical trials, manufacturing, and regulatory submissions [2].

Revenue Projections

Post-approval, revenues depend on the size of the target population, pricing strategies, and payer negotiations. For a niche psychiatric drug, peak annual sales could range from $500 million to $1 billion; for broader indications, potential sales could reach several billion dollars.

Cost Structure

Pre-commercial costs include clinical trial expenses, regulatory filing fees, and manufacturing setup. Post-launch, marketing, distribution, and ongoing R&D comprise primary costs.

Key Financial Milestones

• Regulatory Approval: Targeted 18-24 months post-Phase 3 completion.
• Market Launch: Expected within 2 years after approval, contingent on market access and reimbursement.
• Sales Ramp-Up: Rapid growth anticipated within the first 3-5 years, reaching peak sales in 7-10 years.

Investment and Partnering Opportunities

Cost-sharing through licensing deals or co-development agreements accelerates time-to-market and reduces capital requirements. Investors seek indicators like Phase 2 efficacy signals and strategic partnerships.

How Do These Factors Affect DALGAN’s Market and Financial Outlook?

Market adoption hinges on clinical efficacy, safety profile, regulatory clarity, and payer acceptance. Financial trajectory depends on clinical success, patent longevity, and competitive positioning.

Risks

• Clinical setbacks could delay or prevent approval.
• Competitive pressure may limit market share.
• Pricing pressures and reimbursement restrictions could suppress revenue.

Opportunities

• Filing for expedited review pathways (e.g., Breakthrough Therapy designation) could shorten approval times.
• Demonstrating superior efficacy or safety could justify premium pricing.
• Strategic partnerships could provide resource support and market access.

Key Takeaways

• DALGAN operates in a rapidly growing, competitive market constrained by high development costs and regulatory hurdles.
• The market potential exceeds $1 billion annually for successful drugs targeting common neurological or psychiatric conditions.
• Financial success depends on timely approval, effective commercialization, and protecting patent rights.
• Delays or clinical failures represent significant risks to both market share and revenue projections.
• Strategic partnerships and accelerated approval routes are crucial for optimizing DALGAN’s market and financial trajectory.

FAQs

Q1: What stage is DALGAN currently in?
A: Based on available data, DALGAN appears to be in clinical development, likely in Phase 2 or early Phase 3 [3].

Q2: What are the primary competitors for DALGAN?
A: Competing therapies include SSRIs, atypical antipsychotics, and emerging drugs like ketamine derivatives, which target similar indications.

Q3: How does patent protection influence DALGAN’s commercialization?
A: Patent protection provides market exclusivity, allowing for premium pricing and higher returns. Loss of patent rights could lead to generic competition and reduced revenues.

Q4: What regulatory pathways could DALGAN utilize?
A: If demonstrating significant clinical benefit, DALGAN may qualify for expedited review programs such as Breakthrough Therapy or Priority Review.

Q5: What are the main risk factors for DALGAN’s market success?
A: Clinical trial failures, regulatory delays, pricing pressures, and competition from existing and pipeline therapies pose risks to DALGAN’s success.

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Sources

[1] GlobalData, "Psychiatric and Neurological Drug Market," 2022.
[2] IQVIA, "Cost of Clinical Development," 2021.
[3] Company disclosures and clinical trial registries, 2023.