LUSEDRA Drug Patent Profile

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

Lusedra is a drug marketed by Eisai Inc and is included in one NDA.

The generic ingredient in LUSEDRA is fospropofol disodium. Additional details are available on the fospropofol disodium profile page.

Summary for LUSEDRA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	8
Patent Applications:	54
DailyMed Link:	LUSEDRA at DailyMed

Recent Clinical Trials for LUSEDRA

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

Sponsor	Phase
Grace Shih, MD	N/A
Mayo Clinic	Phase 4
Eisai Inc.	Phase 1

See all LUSEDRA clinical trials

US Patents and Regulatory Information for LUSEDRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eisai Inc	LUSEDRA	fospropofol disodium	SOLUTION;INTRAVENOUS	022244-001	Dec 12, 2008		DISCN	No	No

Expired US Patents for LUSEDRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eisai Inc	LUSEDRA	fospropofol disodium	SOLUTION;INTRAVENOUS	022244-001	Dec 12, 2008	6,204,257
Eisai Inc	LUSEDRA	fospropofol disodium	SOLUTION;INTRAVENOUS	022244-001	Dec 12, 2008	6,872,838

International Patents for LUSEDRA

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1102776	PROMÉDICAMENTS SOLUBLES DANS L'EAU À FONCTION PHENOL MASQUÉ (WATER SOLUBLE PRODRUGS OF HINDERED PHENOLS)
Denmark	1102776
Brazil	9912853
Japan	4554081
Spain	2268876
New Zealand	509795	Water soluble prodrugs of hindered alcohols or phenols
Canada	2339834	PROMEDICAMENTS SOLUBLES DANS L'EAU A FONCTION ALCOOL OU PHENOL MASQUE (WATER SOLUBLE PRODRUGS OF HINDERED ALCOHOLS OR PHENOLS)

LUSEDRA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lusedra (Fospropofol Disodium)

Introduction to Lusedra

Lusedra, also known as fospropofol disodium, is a sedative-hypnotic agent approved by the FDA in 2008 for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures. It is a phosphonooxymethyl derivative of propofol, which is converted to propofol by alkaline phosphatases after administration[5].

Market Position and Revenue

Current Market Size

As part of the broader US general anesthesia drugs market, Lusedra contributes to the overall revenue. The US general anesthesia drugs market was valued at $2.0 billion in 2020 and is projected to reach $2.4 billion by 2025, growing at a CAGR of 3.4% during this period[1].

Segment Contribution

Lusedra falls under the intravenous segment of the general anesthesia drugs market, which is the largest segment. Intravenous drugs, including Lusedra, are preferred due to their lower cost and the absence of need for expensive machines for administration. They also result in less cardiovascular depression and provide better postoperative analgesia[1].

Patent Expiry and Market Impact

Patent Expiry

The patent for Lusedra was set to expire by 2022. This expiration is significant because it allows generic versions of the drug to enter the market, potentially increasing competition and reducing prices[1].

Market Opportunities

The patent expiry of Lusedra is seen as a major opportunity for growth in the US general anesthesia drugs market. Generic drugs are generally more affordable, which can increase market penetration and drive growth. This is particularly beneficial for key players operating in the market, as it opens up new avenues for revenue generation through generic versions of Lusedra[1].

Financial Trajectory

Pre-Patent Expiry

Before the patent expiry, Lusedra was a proprietary product, and its sales contributed significantly to the revenue of its manufacturer. The drug's unique status as a sedative-hypnotic agent for MAC sedation ensured a steady market demand.

Post-Patent Expiry

Following the patent expiry, the market is expected to see an influx of generic versions of fospropofol disodium. This will likely lead to increased competition, potentially reducing the market share of the original manufacturer. However, the overall market size for intravenous anesthesia drugs is expected to grow, driven by factors such as the rising prevalence of cancer, the rapid growth in the geriatric population, and an increase in emergency surgeries[1].

Market Drivers and Trends

Rising Prevalence of Cancer

The increasing incidence of cancer is a significant driver for the general anesthesia drugs market, including Lusedra. Cancer treatments often require surgical procedures, which in turn demand the use of anesthesia drugs[1].

Geriatric Population Growth

The growing geriatric population is another key driver. Older patients often require more surgical interventions, which increases the demand for anesthesia drugs like Lusedra[1].

Emergency Surgeries

The rise in emergency surgeries also contributes to the growing demand for general anesthesia drugs. Emergency procedures often require immediate anesthesia, and intravenous drugs like Lusedra are preferred due to their rapid onset of action[1].

Distribution and Access

Distribution Structure

The distribution structure for Lusedra, like other general anesthesia drugs, involves a network of hospitals, ambulatory surgery centers, and pharmaceutical distributors. The hospitals segment dominates the market, accounting for a substantial revenue share, while ambulatory surgery centers are expected to grow at a faster CAGR during the forecast period[1][3].

Competitive Landscape

Generic Competition

The entry of generic versions of Lusedra post-patent expiry will increase competition in the market. This competition can lead to price reductions and increased market accessibility, but it also poses a challenge for the original manufacturer to maintain market share[1].

Market Share

Before the patent expiry, Lusedra held a significant market share within the intravenous segment. However, with the introduction of generics, the market share of the original product is likely to decrease, although the overall segment is expected to grow[1].

Conclusion

The financial trajectory of Lusedra is marked by its transition from a proprietary product to a market with generic competition. While this shift presents challenges for the original manufacturer, it also opens up opportunities for growth in the broader US general anesthesia drugs market. The increasing demand driven by rising cancer prevalence, a growing geriatric population, and more emergency surgeries ensures a positive outlook for the market as a whole.

Key Takeaways

• Patent Expiry: Lusedra's patent expiry by 2022 allows for generic versions to enter the market.
• Market Growth: The US general anesthesia drugs market is expected to grow at a CAGR of 3.4% from 2020 to 2025.
• Intravenous Segment: The intravenous segment, which includes Lusedra, holds the largest share of the market.
• Market Drivers: Rising cancer prevalence, growing geriatric population, and increased emergency surgeries drive market growth.
• Distribution: Hospitals dominate the market, while ambulatory surgery centers are expected to grow faster.

FAQs

1. What is Lusedra used for? Lusedra (fospropofol disodium) is used for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

2. When did Lusedra's patent expire? Lusedra's patent was set to expire by 2022.

3. How does the patent expiry of Lusedra affect the market? The patent expiry allows generic versions of Lusedra to enter the market, increasing competition and potentially reducing prices.

4. What segment of the general anesthesia drugs market does Lusedra belong to? Lusedra belongs to the intravenous segment of the general anesthesia drugs market.

5. What are the key drivers for the growth of the US general anesthesia drugs market? The key drivers include the rising prevalence of cancer, the rapid growth in the geriatric population, and an increase in emergency surgeries.

Sources

1. MarketsandMarkets, "US General Anesthesia Drugs Market by Route of Administration (Intravenous and Inhalational), End User (Hospitals, Ambulatory Surgery Centers) - Global Forecast to 2025"
2. Annual Reports, "2018 Annual Report - Sun BioPharma, Inc."
3. Biospace, "U.S. General Anesthesia Drugs Market Size to Hit USD 2.56 Billion by 2033"
4. DEA Diversion Control Division, "IQVIA Report on Stimulant Trends from 2012 - 2022"
5. Regulations.gov, "Docket No. FDA-2009-E-0204-0001"