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
Patent Applications:	5,602
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
Singapore	71489
Japan	H0621060
European Patent Office	0180303	PARENTERAL COMPOSITION
Cyprus	1511	PARENTERAL DEZOCINE COMPOSITIONS
Ireland	852117

DALGAN Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory in the Pharmaceutical Industry: Insights Relevant to DALGAN

Introduction

The pharmaceutical industry is a complex and dynamic sector, influenced by various economic, regulatory, and technological factors. When considering a drug like DALGAN, it is crucial to understand the broader market dynamics and financial trajectories that shape the industry.

The Economics of Drug Development

Drug development is a costly and risky endeavor. The average cost of bringing a new drug to market is approximately $2.6 billion, with a development timeline spanning 10 to 15 years. The probability of success for a drug candidate entering clinical trials is only around 10%, due to significant scientific and regulatory hurdles[3].

Precision Medicines and Market Impact

The shift towards precision medicines, such as those targeting small patient populations, has significant economic implications. These drugs, often referred to as orphan drugs, can command high prices due to their value to patients with rare conditions. For example, Kalydeco (ivacaftor), a treatment for a subset of cystic fibrosis patients, costs several hundred thousand dollars per year and targets a patient population of only 2,000 to 3,000 individuals. This pricing strategy is justified by the high value created for these patients and the lack of generic competition in such niche markets[1].

Profit Margins in the Pharmaceutical Distribution System

The pharmaceutical distribution system is characterized by high profit margins, particularly for manufacturers. For every $100 spent on prescription drugs, about $41 accrues to the manufacturers, with $15 of this being net profit. Intermediaries such as wholesalers, pharmacies, pharmacy benefit managers (PBMs), and insurers also capture significant portions of the expenditure, although their net profits are lower[2].

Generic Competition and Drug Prices

Generic competition plays a crucial role in reducing drug prices. Studies by the FDA have consistently shown that the entry of generic drugs into the market leads to significant price reductions. Even a few generic competitors can drive prices below those of the branded drug. For instance, the FDA's analysis of generic drug approvals between 2018 and 2020 estimated substantial savings for consumers due to increased generic competition[4].

Investment Trends and ROI in Pharmaceutical R&D

The return on investment (ROI) for pharmaceutical R&D has been declining, raising concerns about the sustainability of the current R&D model. Deloitte's analysis for 2022 reported a forecasted ROI of just 1.2% for the 20 largest pharmaceutical companies, down from 1.9% in 2021. This decline is attributed to increasing costs and shorter exclusivity periods[3].

Market Size and Competition

The market size and presence of competition significantly impact the pricing and profitability of drugs. For orphan drugs like DALGAN, the small patient population means that generic competition is unlikely, allowing for higher prices. However, for drugs with larger market sizes, generic competition can lead to substantial price reductions and decreased profitability for the original manufacturer[1].

Financial Trajectory of High-Value Drugs

Drugs that achieve blockbuster status, such as Humira and Dupixent, can generate enormous revenue streams. Humira, for example, generated over $20 billion in annual revenue at its peak. However, these drugs often face significant challenges once their patent exclusivity ends, as generic competition can erode their market share and revenue[3].

Impact of Regulatory Hurdles

Stricter regulatory hurdles and shorter exclusivity periods can significantly affect the financial trajectory of a drug. These factors increase the cost and reduce the time during which a drug can be sold without generic competition, thereby impacting the overall ROI for the drug[3].

Affordability and Accessibility

The high cost of many new drugs, including precision medicines, raises concerns about affordability and accessibility. The median annual price for new drugs has been increasing, with a recent report noting a 35% increase to $300,000 for new drugs introduced in 2023. This trend jeopardizes patient access to quality care and highlights the need for strategies to make these drugs more affordable[5].

Example: Kalydeco and Its Economic Implications

Kalydeco, a drug targeting a specific subset of cystic fibrosis patients, illustrates the economic dynamics of precision medicines. Despite its high cost, the drug's value to patients justifies its pricing. However, this also means that the drug is unlikely to face generic competition, extending the period during which the manufacturer can maintain high prices[1].

Future Outlook and Market Projections

The pharmaceutical market is projected to grow exponentially, driven by the increasing global burden of chronic diseases. By 2028, the market is forecasted to exceed $1.4 trillion. This growth is expected to be fueled by strategic R&D investments aimed at addressing unmet medical needs, particularly in areas like oncology and precision medicine[3].

Key Takeaways

• High Development Costs: Bringing a new drug to market is extremely costly and risky.
• Precision Medicines: Targeting small patient populations can justify high prices due to the high value created for these patients.
• Generic Competition: Increases competition, leading to lower drug prices and improved affordability.
• Profit Margins: Manufacturers capture significant profits, while intermediaries also benefit from the distribution system.
• Regulatory Hurdles: Stricter regulations and shorter exclusivity periods impact ROI and profitability.
• Affordability Concerns: High drug prices pose significant challenges to patient access and affordability.

FAQs

1. What is the average cost of bringing a new drug to market?

   • The average cost is approximately $2.6 billion, with a development timeline of 10 to 15 years[3].

2. How does generic competition affect drug prices?

   • Generic competition significantly reduces drug prices by increasing market competition and driving prices below those of the branded drug[4].

3. Why are precision medicines often more expensive?

   • Precision medicines target small patient populations and create high value for these patients, justifying higher prices due to the lack of generic competition[1].

4. What is the projected growth of the pharmaceutical market?

   • The market is projected to exceed $1.4 trillion by 2028, driven by the increasing global burden of chronic diseases[3].

5. How do regulatory hurdles impact the financial trajectory of a drug?

   • Stricter regulatory hurdles and shorter exclusivity periods increase costs and reduce the time during which a drug can be sold without generic competition, affecting the overall ROI[3].

Sources

1. The Economics of Drug Development: Pricing and Innovation in a Changing Market - National Bureau of Economic Research
2. Flow of Money Through the Pharmaceutical Distribution System - USC Health Policy
3. Investment Trends in Pharmaceutical Research - DrugBank Blog
4. Generic Competition and Drug Prices - FDA
5. Drug Prices and Shortages Jeopardize Patient Access to Quality Hospital Care - American Hospital Association