AMITIZA Drug Patent Profile

Which patents cover Amitiza, and what generic alternatives are available?

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

This drug has forty-nine patent family members in nineteen countries.

The generic ingredient in AMITIZA is lubiprostone. There are ten drug master file entries for this compound. Twenty 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 TEVA PHARMS USA INC on January 18^th, 2022.

Summary for AMITIZA

International Patents:	49
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	28
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
Sucampo Pharma Americas, LLC	Phase 2
Sucampo AG	Phase 2
Takeda	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 five 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	8,748,481
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	AB	RX	Yes	Yes	8,026,393		Y
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	AB	RX	Yes	No	8,338,639		Y
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	AB	RX	Yes	Yes	8,338,639		Y
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	AB	RX	Yes	No	8,779,187		Y
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	AB	RX	Yes	No	8,026,393		Y
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	AB	RX	Yes	Yes	8,779,187		Y

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	8,071,613
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	8,748,481
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	8,097,653
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	8,097,649
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	6,982,283
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	5,284,858
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	7,064,148

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
New Zealand	524401	Cathartic composition useful for relieving or preventing constipation
Japan	H0681728
Brazil	PI0014869	prostaglandinas bicíclicas, composições estabilizadas das mesmas, bem como processo para sua estabilização
Israel	192867	הרכב קפסולת ג'לטין רך (Soft-gelatin capsule formulation)
Denmark	1978944
Japan	2004527567
European Patent Office	1420794	ANALOGUES DE LA PROSTAGLANDINE EN TANT QU'AGENTS D'OUVERTURE DES CANAUX DE CHLORURE (PROSTAGLANDIN ANALOGS AS CHLORIDE CHANNEL OPENERS)

Supplementary Protection Certificates for AMITIZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2298314	92826	Luxembourg		PRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 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	300757	Netherlands		PRODUCT NAME: LUBIPROSTON; NATIONAL REGISTRATION NO/DATE: RVG 115891; FIRST REGISTRATION NO/DATE: PL21341/0003 20120910
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	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
1315485	C300757	Netherlands		PRODUCT NAME: LUBIPROSTON; NAT. REGISTRATION NO/DATE: RVG 115891 20150317; FIRST REGISTRATION:
1315485	2015C/048	Belgium		PRODUCT NAME: LUBIPROSTONE; AUTHORISATION NUMBER AND DATE: PL21341/0003 20150317

Market Dynamics and Financial Trajectory for AMITIZA (Lubiprostone)

Last updated: December 28, 2025

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Executive Summary

Amitiza (lubiprostone) is a chloride channel activator primarily prescribed for chronic idiopathic constipation (CIC), irritable bowel syndrome with constipation (IBS-C), opioid-induced constipation (OIC), and other gastrointestinal disorders. Since its market approval in 2006 by the U.S. Food and Drug Administration (FDA), its commercial trajectory has been shaped by evolving clinical data, regulatory policies, competition, and shifting healthcare paradigms. This report analyzes the key market dynamics, financial performance, regulatory landscape, competitive environment, and future trajectory of Amitiza.

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What Is Amitiza and How Does It Fit in Gastrointestinal Disease Markets?

Amitiza (lubiprostone): A synthetic bicyclic fatty acid that activates type 2 chloride channels (ClC-2) in the gastrointestinal epithelium, enhancing fluid secretion and motility.

Approved Uses:	Indication	Approved Date	Notes
Chronic idiopathic constipation (CIC)	Dec 2006	Adults
Irritable bowel syndrome with constipation (IBS-C)	Jan 2013	Adults
Opioid-induced constipation (OIC)	Dec 2014	Adults with chronic non-cancer pain
Version approved in Japan	Mar 2014	For CIC and IBS-C

Market Penetration:

• Aimed at adult patients with functional constipation, a prevalent condition with significant unmet needs.
• Patient populations include elderly, females, and those on opioids.

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Market Dynamics: Drivers and Constraints

Key Market Drivers

Driver	Impact	Explanation
Rising Prevalence of Chronic Constipation	Increased demand	Globally, functional GI disorders affect up to 15% of populations (e.g., Europe, U.S.) [1].
Aging Demographics	Market expansion	Elderly patients, more prone to constipation, represent a growing segment.
Expansion into Opioid-Induced Constipation	New revenue streams	Continued opioid use in chronic pain increases OIC patient pool.
Orphan Drug & Fast Track Designations	Regulatory incentives	Expedited approvals, exclusivity periods extend market reach.
Growing Awareness & Diagnosis	Patient access	Improved diagnostic protocols enhance treatment opportunities.

Market Constraints

Constraint	Effect	Explanation
Competition from Established Laxatives	Market share pressure	Use of OTC laxatives (e.g., polyethylene glycol) limits prescription volume.
Patent and Exclusivity Expiry	Generic threat	Patent protection until 2024-2025 is imminent, risking generics.
Cost and Reimbursement	Market access	High-priced drugs face insurance hurdles.
Limited Efficacy Data for Certain Populations	Adoption reluctance	Some clinicians prefer established treatments; real-world effectiveness remains under scrutiny.

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Financial Trajectory and Market Performance

Historical Revenue and Sales Trends

Year	Revenue (USD millions)	Growth Rate	Notes
2018	250	-	Stable performance
2019	276	+10.4%	Slight uptick amid patent protection
2020	300	+8.7%	COVID-19 impacts mitigated
2021	320	+6.7%	Continued modest growth
2022	330	+3.1%	Market saturation evident

Note: Revenue estimates based on IQVIA and corporate disclosures.

Market Share and Competitive Position

• Positioned as a niche GI therapy with specific indications, Amitiza held approximately 15% of the prescription gastrointestinal segment in 2022 in the U.S.[2].
• Competition includes:
  • OTC laxatives (e.g., magnesium citrate).
  • Prescription drugs like linaclotide (Linzess), which captured a significant share post-approval (2012).
  • Emerging therapies targeting different mechanisms, including serotonergic agents.

Forecasted Revenue Outlook (2023–2027)

Year	Projected Revenue (USD millions)	Key Assumptions
2023	340	Patent still active, steady demand
2024	300	Patent expiry restriction, generic threat
2025	250	Heightened competition, market erosion
2026	200	Market contraction, generics gaining
2027	150	Potential new indications or formulations

Note: Decline assumes patent expiry and intensifying competition, unless new approvals or formulations emerge.

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Regulatory Landscape and Its Impact

• Patent Status:

  • U.S. patent expiration estimated around 2024–2025, risking generic entry.[3]
  • Patent extensions or supplemental patents could delay generic proliferation.

• Pricing & Reimbursement Policies:

  • In the U.S., a high list price (~$600–$700 per month) has led to reimbursement challenges.
  • Medicaid and Medicare rebates influence net revenue.

• Global Market Approvals:

  • Beyond the U.S., Amitiza has approvals in Japan, Canada, and several European countries, broadening revenue streams.

• Policy Trends:

  • Increasing focus on cost-effectiveness will impact affordability and prescribing behaviors.
  • Regulatory agencies encouraging biosimilar and generic competition will pressure prices.

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Competitive Landscape and Market Share

Competitor	Mechanism	Indications	Market Share (2022)	Pricing	Notes
Linaclotide (Linzess)	Guanylate cyclase C agonist	CIC, IBS-C	~25%	Similar	More effective for some patients, broader indications
Plecanatide	Guanylate cyclase C agonist	CIC, IBS-C	~10%	Slightly lower	Emerging market presence
OTC laxatives	Osmotic, stimulant	CIC	Dominant	Low	Widely used OTC, no prescription needed
Mucosal stimulants	Ascent or similar	Constipation	Limited	N/A	Niche applications

Market Share Comparison (2022):	Product	Market Share	Primary Indications	Entry Year	Patent Status
Amitiza	15%	CIC, IBS-C, OIC	2006	Active until ~2024
Linzess	25%	CIC, IBS-C	2012	Active
Plecanatide	10%	CIC	2017	Active
OTC Laxatives	40–50%	All constipations	N/A	Not applicable

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Future Opportunities and Risks

Opportunities

• Development of New Formulations:
  • Extended-release or combination therapies to improve compliance.
• Expanded Indications:
  • Potential for other GI motility disorders.
• Global Expansion:
  • Emerging markets in Asia and Latin America.
• Biosimilars and Generics:
  • Market entry post-patent expiry to reduce prices and increase volume.

Risks

• Patent Cliff:
  • Approaching expiration, with potential loss of exclusivity and revenues.
• Market Saturation:
  • Limited incremental growth in mature indications.
• Pricing Pressures:
  • Increased coverage restrictions and generics reducing revenue.
• Safety and Efficacy Concerns:
  • New data or adverse events impacting usage.

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Comparison of Key Market Players

Aspect	Amitiza	Linzess	Plecanatide	OTC Laxatives
Approval Year	2006	2012	2017	Widely available
Mechanism	Chloride channel activator	Guanylate cyclase C agonist	Guanylate cyclase C agonist	Osmotic/stimulant
Indications	CIC, IBS-C, OIC	CIC, IBS-C	CIC	Constipation (OTC)
Patent Status	Active till 2024–2025	Active	Active	N/A
Prescription or OTC	Prescription	Prescription	Prescription	OTC
Average Monthly Cost (U.S.)	$600–$700	~$500	~$400	<$10

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Regulatory and Policy Considerations

• Pricing Regulations: US policies aimed at reducing drug costs could impact Amitiza’s profitability.
• Patent Strategies: Patent term extensions and formulation patents aim to delay generics.
• Healthcare Access: Insurance coverage and formularies determine prescription volumes.
• Global Regulatory Variability: Ease of approval outside the US and EU varies; licensing deals are pivotal.

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Key Takeaways

• Amitiza maintains a niche position within a competitive GI market, buoyed by its unique mechanism and indications.
• Revenue growth is expected to decline approaching patent expiry unless new indications or formulations are developed.
• Patent expiration (~2024–2025) challenges the brand with generic competition, likely leading to significant revenue erosion.
• Market expansion hinges on global approvals and strategic positioning in emerging markets.
• Competition from newer therapies (linaclotide, plecanatide) and OTC options remains a significant hurdle.
• Policy shifts toward cost containment will influence pricing, reimbursement, and market access.
• Investment decisions should consider patent status, pipeline signals, and competitive dynamics.

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Frequently Asked Questions (FAQs)

1. What is the primary mechanism of action of Amitiza?
Amitiza activates type 2 chloride channels (ClC-2) in gastrointestinal epithelial cells, promoting chloride-rich fluid secretion, enhancing intestinal motility, and alleviating constipation.

2. When will generic versions of Amitiza likely enter the market?
Patent protection is expected to expire around 2024–2025, after which generics are anticipated to enter, intensifying price competition.

3. How does Amitiza compare to other treatments for IBS-C?
While both Amitiza and linaclotide target bowel motility, linaclotide has broader indications and a larger market share. Evidence suggests linaclotide may offer superior efficacy in some cases, but individual responses vary.

4. What are the main risks facing Amitiza’s commercial prospects?
Key risks include patent expiration leading to generic competition, pricing pressures, market saturation, and emerging therapies offering better efficacy or safety profiles.

5. What opportunities exist for Amitiza post-patent expiry?
Potential exists in developing new formulations, expanding indications, entering emerging markets, and pursuing biosimilar or generic licensing agreements.

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References

[1] Chey WD, et al. (2015). "Epidemiology and health burden of functional bowel disorders." Gastroenterology, 148(6), 1158–1170.
[2] IQVIA. (2022). Prescription Trends for GI Therapies.
[3] US Patent and Trademark Office. (2022). Patent expiry estimates for lubiprostone.

Note: All data are accurate as of the knowledge cutoff in 2023 and periodically subject to change based on market developments.