LUBIPROSTONE - Generic Drug Details

What are the generic drug sources for lubiprostone and what is the scope of freedom to operate?

Lubiprostone is the generic ingredient in two branded drugs marketed by Sucampo Pharma Llc, Amneal, Dr Reddys, Endo Operations, Teva Pharms Usa Inc, and Zydus Pharms, and is included in six NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lubiprostone has seventy-two patent family members in nineteen countries.

There are ten drug master file entries for lubiprostone. Sixteen suppliers are listed for this compound.

Summary for LUBIPROSTONE

International Patents:	72
US Patents:	5
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	47
Patent Applications:	1,898
Drug Prices:	Drug price trends for LUBIPROSTONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LUBIPROSTONE
What excipients (inactive ingredients) are in LUBIPROSTONE?	LUBIPROSTONE excipients list
DailyMed Link:	LUBIPROSTONE at DailyMed

See drug prices for LUBIPROSTONE

Recent Clinical Trials for LUBIPROSTONE

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

Sponsor	Phase
Alexandria University	Phase 3
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Phase 4
Helwan University	Phase 3

See all LUBIPROSTONE clinical trials

Pharmacology for LUBIPROSTONE

Drug Class	Chloride Channel Activator
Mechanism of Action	Chloride Channel Activators

Medical Subject Heading (MeSH) Categories for LUBIPROSTONE

Chloride Channel Agonists

Anatomical Therapeutic Chemical (ATC) Classes for LUBIPROSTONE

A06AX	Other drugs for constipation
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for LUBIPROSTONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AMITIZA	Capsules	lubiprostone	8 mcg and 24 mcg	021908	1	2012-08-20

US Patents and Regulatory Information for LUBIPROSTONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	LUBIPROSTONE	lubiprostone	CAPSULE;ORAL	201442-002	Jun 27, 2022		DISCN	No	No
Endo Operations	LUBIPROSTONE	lubiprostone	CAPSULE;ORAL	201442-001	Jun 27, 2022		DISCN	No	No
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	AB	RX	Yes	No			Y

Expired US Patents for LUBIPROSTONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006

International Patents for LUBIPROSTONE

Country	Patent Number	Title	Estimated Expiration
Japan	2018150354	胃腸障害処置用プロスタグランジン誘導体 (PROSTAGLANDIN DERIVATIVES FOR TREATING GASTROINTESTINAL DISORDER)
Brazil	PI0514891	composição contendo derivados de prostaglandina e uso da referida composição
Japan	2013049688	PROSTAGLANDIN DERIVATIVE FOR TREATING GASTROINTESTINAL DISORDER

Supplementary Protection Certificates for LUBIPROSTONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1315485	132016000025193	Italy		PRODUCT NAME: LUBIPROSTONE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(AMITIZA); AUTHORISATION NUMBER(S) AND DATE(S): PL 21341/0003, 20120910;043833019-021, 20150526
2298314	92826	Luxembourg		PRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910
1315485	2015C/048	Belgium		PRODUCT NAME: LUBIPROSTONE; AUTHORISATION NUMBER AND DATE: PL21341/0003 20150317

LUBIPROSTONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lubiprostone

Introduction to Lubiprostone

Lubiprostone, marketed under the brand name Amitiza, is a medication used to treat various gastrointestinal disorders, including chronic constipation, constipation induced by opioids (OIC), and irritable bowel syndrome with constipation (IBS-C) in women[5].

Market Size and Growth

The global lubiprostone market is poised for significant growth over the forecast period. It is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.5% from 2021 to 2030. This growth is driven by several key factors, including the increasing prevalence of chronic constipation and IBS, particularly among the elderly population, and rising awareness about the benefits of lubiprostone in treating these conditions[1][4].

Market Segmentation

By Type

The lubiprostone market is segmented into two main dosage forms: 8 mcg capsules and 24 mcg capsules. The 8 mcg capsules segment held the largest share in the market due to its higher efficacy compared to other dosage forms. However, the 24 mcg capsules segment is expected to grow at a CAGR of 6% during the forecast period, driven by its higher efficacy in treating specific conditions[1][4].

By Application

The market is also segmented by application into Chronic Idiopathic Constipation (CIC) and Opioid-Induced Constipation (OIC), as well as Irritable Bowel Syndrome with Constipation (IBS-C). These segments are expected to see significant growth due to the increasing need for effective treatments for these conditions[1][3].

Regional Analysis

The lubiprostone market is analyzed across several regions, including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America is expected to dominate the market due to high healthcare spending and a large patient population suffering from gastrointestinal disorders. Europe is the second-largest market, followed by the Asia-Pacific region, which is expected to grow rapidly due to increasing healthcare awareness and infrastructure[1][3][4].

Key Drivers

Increasing Prevalence of Gastrointestinal Disorders

The rising prevalence of chronic constipation and IBS, particularly among the elderly, is a significant driver for the lubiprostone market. As the global population ages, the demand for effective treatments for these conditions is expected to increase[1][3].

Clinical Trials and Research

The market is also driven by ongoing clinical trials and research on lubiprostone. These trials aim to expand the indications for lubiprostone and improve its efficacy in treating various gastrointestinal disorders. The repurposing of existing drugs for new indications is another trend that is expected to boost the market[1][2].

Awareness and Adoption

Increasing awareness among healthcare providers and patients about the benefits of lubiprostone is another key driver. As more patients and healthcare professionals become aware of the efficacy and safety of lubiprostone, its adoption is expected to increase[1].

Market Restraints

High Development Costs

The development of new pharmaceuticals is a costly and time-consuming process. The median capitalized research and development investment to bring a new drug to market was estimated at $985.3 million in 2018. This high cost can deter pharmaceutical companies from investing in new drug development, leading them to focus on repurposing existing drugs instead[2].

Regulatory Challenges

Regulatory approvals are a significant hurdle for any new or repurposed drug. The process is lengthy and involves rigorous testing, which can delay market entry and impact the financial trajectory of the drug[2].

Financial Trajectory

Revenue Forecast

The global lubiprostone market is expected to generate significant revenue over the forecast period. With a CAGR of 5.5%, the market is projected to grow substantially, driven by the increasing demand for effective treatments for gastrointestinal disorders[1][4].

Key Players

Companies like Takeda Pharmaceuticals are major players in the lubiprostone market. These companies invest heavily in research and development, marketing, and distribution, which helps in driving the market growth[1][3].

Competitive Landscape

The lubiprostone market is competitive, with several other drugs available for treating gastrointestinal disorders. Linaclotide, for example, is a significant competitor in the IBS treatment market, accounting for the largest market share by drug type[3].

Emerging Trends

Repurposing of Drugs

There is a growing trend towards repurposing existing drugs for new indications. This approach reduces development costs and timelines, making it an attractive option for pharmaceutical companies. Lubiprostone, initially approved for CIC, has also been approved for OIC and IBS-C, exemplifying this trend[2].

Technological Innovations

Advancements in pharmaceutical technologies, such as improved formulations and delivery systems, are expected to enhance the efficacy and patient compliance of lubiprostone. These innovations can further drive the market growth[2].

Consumer Behavior and Preferences

Patients with gastrointestinal disorders often prefer treatments that offer significant improvements in their quality of life. Lubiprostone, by increasing the fluid secretion in the bowels and easing the passage of stool, addresses this need effectively. Consumer preference for such treatments is a key factor driving the market[5].

Conclusion

The lubiprostone market is poised for significant growth driven by increasing prevalence of gastrointestinal disorders, ongoing clinical trials, and rising awareness about the drug's benefits. Despite challenges such as high development costs and regulatory hurdles, the market is expected to expand substantially over the forecast period.

Key Takeaways

• The global lubiprostone market is expected to grow at a CAGR of 5.5% from 2021 to 2030.
• The 8 mcg capsules segment currently holds the largest market share, but the 24 mcg capsules segment is expected to grow at a CAGR of 6%.
• North America is expected to dominate the market, followed by Europe and the Asia-Pacific region.
• Increasing prevalence of chronic constipation and IBS, along with rising awareness and ongoing clinical trials, are key drivers of the market.
• High development costs and regulatory challenges are significant restraints.

FAQs

What is lubiprostone used for?

Lubiprostone is used to treat long-lasting constipation in adults, constipation caused by opioids, and irritable bowel syndrome with constipation (IBS-C) in women[5].

What are the main dosage forms of lubiprostone?

The main dosage forms of lubiprostone are 8 mcg capsules and 24 mcg capsules[1][4].

Which region is expected to dominate the lubiprostone market?

North America is expected to dominate the lubiprostone market due to high healthcare spending and a large patient population suffering from gastrointestinal disorders[1][3][4].

What are the key drivers of the lubiprostone market?

Key drivers include the increasing prevalence of gastrointestinal disorders, ongoing clinical trials, and rising awareness about the drug's benefits[1][3].

What are the main restraints for the lubiprostone market?

High development costs and regulatory challenges are significant restraints for the lubiprostone market[2].

Sources

1. Industry Growth Insights: "Lubiprostone Market Report | Global Forecast To 2028"
2. BMJ Innovations: "Scanning the horizon using late-stage clinical trial"
3. Taiwan News: "Irritable Bowel Syndrome (IBS) Market Dynamics with Top Players"
4. Cognitive Market Research: "Global Lubiprostone Market Report 2024 Edition"
5. Mayo Clinic: "Lubiprostone (oral route) - Mayo Clinic"