AMITIZA Drug Patent Profile

When do Amitiza patents expire, and when can generic versions of Amitiza launch?

Amitiza is a drug marketed by Sucampo Pharma Llc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-two patent family members in nineteen countries.

The generic ingredient in AMITIZA is lubiprostone. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the lubiprostone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Amitiza

A generic version of AMITIZA was approved as lubiprostone by AMNEAL on November 30^th, 2021.

Summary for AMITIZA

International Patents:	72
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	28
Patent Applications:	1,380
Drug Prices:	Drug price information for AMITIZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMITIZA
What excipients (inactive ingredients) are in AMITIZA?	AMITIZA excipients list
DailyMed Link:	AMITIZA at DailyMed

See drug prices for AMITIZA

See drug sales revenues for AMITIZA

Recent Clinical Trials for AMITIZA

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

Sponsor	Phase
Takeda	Phase 2
Sucampo Pharma Americas, LLC	Phase 2
Sucampo AG	Phase 2

See all AMITIZA clinical trials

Pharmacology for AMITIZA

Drug Class	Chloride Channel Activator
Mechanism of Action	Chloride Channel Activators

Paragraph IV (Patent) Challenges for AMITIZA

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 AMITIZA

AMITIZA is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	AB	RX	Yes	No
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	AB	RX	Yes	Yes			Y
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	AB	RX	Yes	No			Y
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	AB	RX	Yes	Yes			Y
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	AB	RX	Yes	No
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	AB	RX	Yes	No			Y
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	AB	RX	Yes	Yes

Expired US Patents for AMITIZA

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
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008

International Patents for AMITIZA

When does loss-of-exclusivity occur for AMITIZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

European Patent Office

Israel

Japan

Mexico

New Zealand

Portugal

Russian Federation

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AMITIZA around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	03041716
Japan	2003511445
Brazil	0212233
Canada	1312014	PURGATIF CONTENANT DES DERIVES DE PROSTAGLANDINE (CATHARTICS CONTAINING PROSTAGLANDIN DERIVATIVES)
World Intellectual Property Organization (WIPO)	0127099
Germany	60010913
South Korea	100901102

Supplementary Protection Certificates for AMITIZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1315485	49/2015	Austria		PRODUCT NAME: LUBIPROSTON UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; NAT. REGISTRATION NO/DATE: 136176 20150508; FIRST REGISTRATION: GB PL 21341/0003 20120910
1315485	2015/028	Ireland		PRODUCT NAME: LUBIPROSTONE AND PHARMACEUTICALLY ACCEPTABLE SALTS FOR LUBIPROSTONE.; NAT REGISTRATION NO/DATE: PA148/002/001 20150213; FIRST REGISTRATION NO/DATE: PL21341/0003-0001 20120910
1315485	C01315485/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
1315485	300757	Netherlands		PRODUCT NAME: LUBIPROSTON; NATIONAL REGISTRATION NO/DATE: RVG 115891; FIRST REGISTRATION NO/DATE: PL21341/0003 20120910
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	122015000080	Germany		PRODUCT NAME: LUBIPROSTON, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: 92699.00.00 20150519; FIRST REGISTRATION: VEREINIGTES KOENIGREICH PL 21341/0003 20120910

AMITIZA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: AMITIZA

Introduction

AMITIZA, also known as lubiprostone, is a medication used to treat constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation. Here, we will delve into the market dynamics and financial trajectory of AMITIZA, highlighting its competitive landscape, market performance, and future outlook.

Market Overview

The global therapeutics market for Irritable Bowel Syndrome (IBS) has been growing steadily, driven by increasing prevalence and the introduction of new treatments. AMITIZA, developed by Sucampo Pharmaceuticals (now part of Mallinckrodt), is one of the key players in this market[1][4].

Competitive Landscape

AMITIZA competes directly with other IBS-C treatments, most notably Linzess (linaclotide) in the US market. While AMITIZA is primarily indicated for women with IBS-C, Linzess is approved for both men and women. In the US, AMITIZA and Linzess are the main competitors for IBS-C treatment, with Linzess having a stronger market potential due to its broader patient base and favorable dosing regimen[4].

Market Performance

As of the mid-2010s, AMITIZA had a significant presence in the US market. However, its market share has been influenced by the rise of Linzess. Despite this, AMITIZA remains a viable option, particularly for women with IBS-C. The drug's performance is reflected in the overall revenue of its parent company. For instance, Mallinckrodt, which acquired Sucampo Pharmaceuticals, reported strong sales across its product portfolio, although specific figures for AMITIZA are not always detailed in their financial reports[2].

Financial Trajectory

The financial performance of AMITIZA is closely tied to the overall financial health of its parent company. Here are some key points:

Revenue Contribution

While AMITIZA contributes to the revenue of Mallinckrodt, the exact figures are often bundled with other products. However, it is known that AMITIZA generates substantial revenue. For example, in the context of the broader IBS market, AMITIZA's sales are significant but lower than those of Linzess, which is forecasted to generate around $307 million by 2023[1][4].

Market Growth

The IBS therapeutics market is expected to grow, driven by increasing prevalence and the introduction of new treatments. However, AMITIZA's growth is somewhat hindered by the competition from Linzess and other emerging treatments. The market expansion from $589.6 million in 2013 to $1.5 billion by 2023 indicates a high Compound Annual Growth Rate (CAGR) of almost 9.9%, but AMITIZA's share within this growth is expected to be less dominant compared to Linzess[1].

Challenges and Barriers

Several challenges affect the financial trajectory of AMITIZA:

Low Diagnosis Rate

One of the significant barriers is the low diagnosis rate of IBS, which is less than 50% in all major markets. This results in fewer patients seeking medical attention and pharmacological treatments, impacting the overall sales of AMITIZA and other IBS treatments[1].

Competition from New Treatments

The introduction of new treatments, such as eluxadoline and tenapanor, further complicates the competitive landscape. Eluxadoline, for instance, is expected to generate significant revenues by 2023 and will compete directly with AMITIZA in certain markets[1][4].

Future Outlook

The future outlook for AMITIZA is mixed:

Continued Market Presence

Despite the competition, AMITIZA is expected to maintain its market presence due to its established patient base and continued marketing efforts by its parent company.

Clinical Trial Data

Indirect comparisons of clinical trial data suggest that while AMITIZA is effective, it may have a less favorable safety profile compared to Linzess, which could impact its long-term market share[4].

Regulatory Environment

Changes in regulatory environments and healthcare policies can also influence the market dynamics and financial performance of AMITIZA. For example, any changes in formulary listings or reimbursement policies could affect patient access and sales.

Key Takeaways

• Market Competition: AMITIZA competes with Linzess and other emerging treatments in the IBS-C market.
• Financial Performance: AMITIZA contributes to the revenue of Mallinckrodt, but its growth is hindered by competition.
• Challenges: Low IBS diagnosis rates and competition from new treatments are significant barriers.
• Future Outlook: AMITIZA will likely maintain its market presence but face continued competition.

FAQs

1. What is AMITIZA used for? AMITIZA (lubiprostone) is used to treat constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation.

2. Who are the main competitors of AMITIZA in the IBS-C market? The main competitors of AMITIZA in the IBS-C market are Linzess (linaclotide) and other emerging treatments like plecanatide and tenapanor.

3. What is the expected market size for IBS therapeutics by 2023? The global therapeutics market for IBS is expected to rise to $1.5 billion by 2023, with a CAGR of almost 9.9%[1].

4. Why is the diagnosis rate of IBS a significant barrier for AMITIZA? The low diagnosis rate of IBS (less than 50% in all major markets) results in fewer patients seeking medical attention and pharmacological treatments, impacting the overall sales of AMITIZA and other IBS treatments[1].

5. How does AMITIZA compare to Linzess in terms of efficacy and safety? AMITIZA appears to be less effective than Linzess in some clinical trials and has a less favorable safety profile, causing more diarrhea[4].

Sources

1. GlobalData: "Treatment Market for Irritable Bowel Syndrome Could Hit $1.5 Billion"
2. Mallinckrodt: "Mallinckrodt plc Reports Strong Fourth Quarter and 2019 Results"
3. Ardelyx INC: "Form 10-Q for Ardelyx INC filed 11/03/2022"
4. Managed Healthcare Executive: "Irritable bowel syndrome therapeutics market dynamics"