LOTRONEX Drug Patent Profile

Which patents cover Lotronex, and when can generic versions of Lotronex launch?

Lotronex is a drug marketed by Sebela Ireland Ltd and is included in one NDA.

The generic ingredient in LOTRONEX is alosetron hydrochloride. There are three drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the alosetron hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lotronex

A generic version of LOTRONEX was approved as alosetron hydrochloride by AMNEAL PHARMS on December 22^nd, 2016.

Summary for LOTRONEX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	158
Patent Applications:	1,655
Drug Prices:	Drug price information for LOTRONEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LOTRONEX
What excipients (inactive ingredients) are in LOTRONEX?	LOTRONEX excipients list
DailyMed Link:	LOTRONEX at DailyMed

See drug prices for LOTRONEX

Pharmacology for LOTRONEX

Drug Class	Serotonin-3 Receptor Antagonist
Mechanism of Action	Serotonin 3 Receptor Antagonists

Paragraph IV (Patent) Challenges for LOTRONEX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LOTRONEX	Tablets	alosetron hydrochloride	0.5 mg and 1 mg	021107	1	2010-12-02

US Patents and Regulatory Information for LOTRONEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sebela Ireland Ltd	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-002	Dec 23, 2003	AB	RX	Yes	No
Sebela Ireland Ltd	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-001	Feb 9, 2000	AB	RX	Yes	Yes

Expired US Patents for LOTRONEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-002	Dec 23, 2003
Sebela Ireland Ltd	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-001	Feb 9, 2000
Sebela Ireland Ltd	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-001	Feb 9, 2000

International Patents for LOTRONEX

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0306323	Dérivés de lactames. (Lactam derivatives.)
World Intellectual Property Organization (WIPO)	9917755
Croatia	P20000198

LOTRONEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LOTRONEX (Alosetron Hydrochloride)

Market Overview

LOTRONEX, also known as alosetron hydrochloride, is a drug approved for the treatment of irritable bowel syndrome (IBS) in women whose predominant bowel symptom is diarrhea. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Growth and Projections

The global alosetron market, which includes LOTRONEX, is expected to grow at a CAGR of 3.50% from 2021 to 2028. This growth is driven by several factors, including the rising prevalence of IBS, an increase in the geriatric female population, and higher health expenditure[1].

Segmentation

The alosetron market is segmented based on dosage type, application, mode of purchase, and distribution channel. The drug is available in 0.5mg and 1mg dosages, primarily used for chronic irritable bowel syndrome, visceral pain, and gastrointestinal diseases. It can be purchased via prescription or over-the-counter (OTC) modes and is distributed through hospital pharmacies, retail pharmacies, and online pharmacies[1].

Geographical Analysis

North America is expected to hold the largest market share due to the increased availability of alosetron drugs, rising prevalence of IBS, and supportive health policies. The Asia-Pacific region is anticipated to be the fastest-growing market, driven by the establishment of new clinics and hospitals, increased awareness about IBS symptoms, and a reliable supply of the drug[1].

Drivers of Market Growth

Several factors are driving the growth of the alosetron market:

• Increasing Prevalence of IBS: The rising number of patients suffering from IBS, particularly in North America, is a significant driver.
• Health Expenditure: Higher health expenditure in various regions contributes to the market growth.
• Existing Drug Presence: The presence of existing alosetron drugs and the demand for oral tablets are additional factors[1].

Restraints and Challenges

Despite the growth drivers, there are several restraints and challenges:

• Regulatory Protocols: Strict regulatory protocols can hinder market growth.
• Lack of Awareness: Limited awareness about IBS symptoms and prevention can reduce demand.
• Side Effects: Serious side effects such as constipation, ischemic colitis, and other gastrointestinal complications can deter patients.
• Supply Chain Issues: Problems in the supply chain and logistics can affect the distribution of the drug[1].

Opportunities and Future Outlook

The market presents several opportunities for growth:

• Emerging Markets: Untapped opportunities in emerging markets can propel the market forward.
• Government and R&D Activities: Increased government and research activities focused on producing alosetron drugs can enhance market growth.
• Healthcare Infrastructure: Improvements in healthcare architecture and the rise of new clinics and hospitals can support the market[1].

Historical Context and Regulatory Changes

LOTRONEX was initially approved in February 2000 but was voluntarily withdrawn from the market in November 2000 due to serious adverse events, including ischemic colitis and complications of constipation. It was reintroduced in June 2002 with a risk management program that included restricted distribution and prescriber training[4].

Risk Evaluation and Mitigation Strategies (REMS)

The FDA implemented a REMS program to manage the risks associated with LOTRONEX. However, since 2016, the REMS program has been modified to make prescriber training voluntary and remove the prescription sticker requirement. Despite these changes, the reporting of adverse events has remained stable, and there has been no observed increase in severe outcomes[4].

Financial Impact and Utilization Trends

The approval of generic versions of alosetron hydrochloride has not led to an increase in drug utilization trends. Instead, there has been an ongoing downward trend in the estimated total number of patients receiving prescriptions for all alosetron hydrochloride products. This trend is attributed to the availability of approved therapeutic alternatives[4].

Cost and Pricing

The financial trajectory of LOTRONEX is influenced by its pricing and the availability of generic alternatives. The introduction of generic versions has likely impacted the pricing strategy, making the drug more competitive in the market.

Patient and Prescriber Awareness

Despite the challenges, surveyed prescribers and patients generally understand the risks and benefits associated with LOTRONEX. Prescribers are aware of the indicated patient population and the need to counsel patients about potential risks. However, there are concerns about the oversight of the risk management program, particularly since it is administered by the drug's manufacturer, GlaxoSmithKline[3][4].

Key Takeaways

• Market Growth: The alosetron market is expected to grow at a CAGR of 3.50% from 2021 to 2028.
• Geographical Dominance: North America holds the largest market share, while the Asia-Pacific region is the fastest-growing.
• Drivers and Restraints: Increasing IBS prevalence, health expenditure, and existing drug presence drive the market, while strict regulations, side effects, and supply chain issues are restraints.
• Regulatory Changes: LOTRONEX was reintroduced with a REMS program, which has been modified over time.
• Financial Trends: There is a downward trend in prescription numbers due to the availability of therapeutic alternatives.

FAQs

What is LOTRONEX used for?

LOTRONEX (alosetron hydrochloride) is used to treat irritable bowel syndrome (IBS) in women whose predominant bowel symptom is diarrhea.

Why was LOTRONEX withdrawn from the market initially?

LOTRONEX was withdrawn in November 2000 due to serious adverse events, including ischemic colitis and complications of constipation.

What are the common side effects of LOTRONEX?

Common side effects include constipation, abdominal discomfort and pain, nausea, and gastrointestinal discomfort. Serious complications can include ischemic colitis and severe constipation[2][4].

How has the REMS program for LOTRONEX evolved?

The REMS program has been modified to make prescriber training voluntary and remove the prescription sticker requirement. Despite these changes, the reporting of adverse events has remained stable[4].

What is the current market trend for LOTRONEX?

There is an ongoing downward trend in the estimated total number of patients receiving prescriptions for all alosetron hydrochloride products due to the availability of approved therapeutic alternatives[4].

Sources

1. Data Bridge Market Research: Alosetron Market Share, Size, Scope, Industry Trends & Forecast 2028.
2. FDA: LOTRONEX (alosetron hydrochloride) Tablets.
3. Public Citizen: Press Release: Don't Allow Alosetron (Lotronex) Back on the Market.
4. FDA: Lotronex (alosetron hydrochloride) Information.