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Last Updated: November 12, 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. 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 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 AGPhase 2
TakedaPhase 2
Sucampo Pharma Americas, LLCPhase 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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD FOR TREATING IRRITABLE BOWEL SYNDROME AND METHOD FOR TREATING ABDOMINAL DISCOMFORT ASSOCIATED WITH IRRITABLE BOWEL SYNDROME

Soft-gelatin capsule formulation
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Patent Expiration: ⤷  Sign Up

Soft-gelatin capsule formulation
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Patent Expiration: ⤷  Sign Up

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

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

Soft-gelatin capsule formulation
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Patent Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-002 Apr 29, 2008 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-002 Apr 29, 2008 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-002 Apr 29, 2008 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 ⤷  Sign Up ⤷  Sign Up
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 ⤷  Sign Up ⤷  Sign Up
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 ⤷  Sign Up ⤷  Sign Up
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 ⤷  Sign Up ⤷  Sign Up
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-002 Apr 29, 2008 ⤷  Sign Up ⤷  Sign Up
>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
Patent: Soft-gelatin capsule formulation
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0707334
Patent: formulação de cápsula de gelatila mole e método para estabilização de um composto 15-cetoprostaglandina
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 37274
Patent: FORMULATION DE CAPSULE GELATINEUSE MOLLE (SOFT-GELATIN CAPSULE FORMULATION)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1410097
Patent: Soft-gelatin capsule formulation
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Patent: 4971056
Patent: Soft-gelatin Capsule Formulation
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Patent: 4983712
Patent: SOFT-GELATIN CAPSULE FORMULATION
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Denmark

Patent: 78944
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European Patent Office

Patent: 78944
Patent: FORMULATION DE CAPSULE GELATINEUSE MOLLE (SOFT-GELATIN CAPSULE FORMULATION)
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Israel

Patent: 2867
Patent: הרכב קפסולת ג'לטין רך (Soft-gelatin capsule formulation)
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Japan

Patent: 83794
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Patent: 08534432
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Mexico

Patent: 08009650
Patent: FORMULACION DE CAPSULA DE GELATINA SUAVE. (SOFT-GELATIN CAPSULE FORMULATION.)
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New Zealand

Patent: 0191
Patent: Soft-gelatin capsule formulation comprising a keto-prostaglandin compound
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Portugal

Patent: 78944
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 20291
Patent: СОСТАВ В МЯГКОЙ ЖЕЛАТИНОВОЙ КАПСУЛЕ (COMPOSITION IN SOFT GELATIN CAPSULE)
Estimated Expiration: ⤷  Sign Up

Patent: 08134489
Patent: СОСТАВ В МЯГКОЙ ЖЕЛАТИНОВОЙ КАПСУЛЕ
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1393944
Estimated Expiration: ⤷  Sign Up

Patent: 080090526
Patent: SOFT-GELATIN CAPSULE FORMULATION
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 92590
Estimated Expiration: ⤷  Sign Up

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
European Patent Office 1392318 DES 15-CETO-PROSTAGLANDINES POUR LE TRAITEMENT DE LA CONSTIPATION D'ORIGINE MEDICAMENTEUSE (15-KETO-PROSTAGLANDINS FOR TREATING DRUG-INDUCED CONSTIPATION) ⤷  Sign Up
Australia 2002330747 ⤷  Sign Up
Argentina 030609 COMPOSICION CATARTICA ⤷  Sign Up
Russian Federation 2007111908 ПРОИЗВОДНЫЕ ПРОСТАГЛАНДИНОВ ДЛЯ ЛЕЧЕНИЯ ЖЕЛУДОЧНО-КИШЕЧНОГО НАРУШЕНИЯ ⤷  Sign Up
Brazil 0209327 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 03041716 ⤷  Sign Up
>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 ⤷  Sign Up PRODUCT NAME: LUBIPROSTONE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(AMITIZA); AUTHORISATION NUMBER(S) AND DATE(S): PL 21341/0003, 20120910;043833019-021, 20150526
1315485 C01315485/01 Switzerland ⤷  Sign Up FORMER REPRESENTATIVE: BOHEST AG, CH
1315485 49/2015 Austria ⤷  Sign Up PRODUCT NAME: LUBIPROSTON UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; NAT. REGISTRATION NO/DATE: 136176 20150508; FIRST REGISTRATION: GB PL 21341/0003 20120910
2298314 92826 Luxembourg ⤷  Sign Up PRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910
1315485 2015C/048 Belgium ⤷  Sign Up PRODUCT NAME: LUBIPROSTONE; AUTHORISATION NUMBER AND DATE: PL21341/0003 20150317
1315485 300757 Netherlands ⤷  Sign Up PRODUCT NAME: LUBIPROSTON; NATIONAL REGISTRATION NO/DATE: RVG 115891; FIRST REGISTRATION NO/DATE: PL21341/0003 20120910
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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