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Last Updated: March 19, 2024

AMITIZA Drug Patent Profile


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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. Fifteen 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 30th, 2021.

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Drug patent expirations by year for AMITIZA
Drug Prices for AMITIZA

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Drug Sales Revenue Trends for AMITIZA

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Recent Clinical Trials for AMITIZA

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SponsorPhase
Sucampo Pharma Americas, LLCPhase 2
Sucampo AGPhase 2
TakedaPhase 2

See all AMITIZA clinical trials

Pharmacology for AMITIZA
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.

Patents protecting AMITIZA

Method for treating abdominal discomfort
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR TREATING IRRITABLE BOWEL SYNDROME AND METHOD FOR TREATING ABDOMINAL DISCOMFORT ASSOCIATED WITH IRRITABLE BOWEL SYNDROME

Soft-gelatin capsule formulation
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Soft-gelatin capsule formulation
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method for treating gastrointestinal disorder
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR THE LONG TERM TREATMENT OF CHRONIC CONSTIPATION IN A HUMAN SUBJECT WITH IRRITABLE BOWEL SYNDROME

Method for treating gastrointestinal disorder
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR THE LONG TERM TREATMENT OF CHRONIC CONSTIPATION IN A HUMAN SUBJECT

Soft-gelatin capsule formulation
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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

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

Patent: 07208632
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0707334
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 37274
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1410097
Estimated Expiration: ⤷  Try a Trial

Patent: 4971056
Estimated Expiration: ⤷  Try a Trial

Patent: 4983712
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 78944
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 78944
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 2867
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 83794
Estimated Expiration: ⤷  Try a Trial

Patent: 08534432
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 08009650
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0191
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 78944
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 20291
Estimated Expiration: ⤷  Try a Trial

Patent: 08134489
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1393944
Estimated Expiration: ⤷  Try a Trial

Patent: 080090526
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 92590
Estimated Expiration: ⤷  Try a Trial

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
Japan 2011201905 DOSAGE UNIT COMPRISING PROSTAGLANDIN ANALOG FOR TREATING CONSTIPATION ⤷  Try a Trial
Argentina 107905 COMPOSICIÓN QUÍMICA Y MÉTODO PARA TRATAR DESORDEN GASTROINTESTINAL ⤷  Try a Trial
Denmark 1443938 ⤷  Try a Trial
Japan 2009114217 CATHARTIC COMPOSITION ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AMITIZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1315485 132016000025193 Italy ⤷  Try a Trial PRODUCT NAME: LUBIPROSTONE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(AMITIZA); AUTHORISATION NUMBER(S) AND DATE(S): PL 21341/0003, 20120910;043833019-021, 20150526
1315485 2015C/048 Belgium ⤷  Try a Trial PRODUCT NAME: LUBIPROSTONE; AUTHORISATION NUMBER AND DATE: PL21341/0003 20150317
1315485 C300757 Netherlands ⤷  Try a Trial PRODUCT NAME: LUBIPROSTON; NAT. REGISTRATION NO/DATE: RVG 115891 20150317; FIRST REGISTRATION:
1315485 C01315485/01 Switzerland ⤷  Try a Trial FORMER REPRESENTATIVE: BOHEST AG, CH
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.