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Last Updated: May 27, 2022

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 nine patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty patent family members in twenty-four countries.

The generic ingredient in AMITIZA is lubiprostone. There are ten drug master file entries for this compound. Four 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

See drug prices for AMITIZA

Drug Sales Revenue Trends for AMITIZA

See drug sales revenues for AMITIZA

Recent Clinical Trials for AMITIZA

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

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

See all AMITIZA clinical trials

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 fourteen US patents.

Patents protecting AMITIZA

Method for treating drug-induced constipation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR TREATING OPIOID-INDUCED CONSTIPATION

Chloride channel opener
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL SYNDROME BY OPENING CHLORIDE CHANNELS (CIC)

Chloride channel opener
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR TREATING CONSTIPATION BY OPENING CIC CHANNELS IN A MAMMALIAN SUBJECT

Chloride channel opener
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR TREATING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION BY OPENING CIC CHANNELS

Method for treating abdominal discomfort
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dosage unit comprising a prostaglandin analog for treating constipation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR RELIEVING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION THAT COMPRISES ADMINISTERING TO THE PATIENT A DOSAGE UNIT COMPRISING(I)24MICROG+/- 10% OF A DRUG SUBSTANCE AND (II) A PHARMACEUTICALLY SUITABLE EXCIPIENT

Dosage unit comprising a prostaglandin analog for treating constipation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR RELIEVING CONSTIPATION IN A HUMAN PATIENT THAT COMPRISES ADMINISTERING TO THE PATIENT A DOSAGE UNIT COMPRISING (I) 24MCG+/- 10% OF A DRUG SUBSTANCE AND (II) A PHARMACEUTICALLY SUITABLE EXCIPIENT

Soft-gelatin capsule formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dosage unit comprising a prostaglandin analog for treating constipation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN PATIENT WITH A DOSAGE UNIT COMPRISING 24MICROG+/- 10% OF A DRUG SUBSTANCE AND A PHARMACEUTICALLY SUITABLE EXCIPIENT

Dosage unit comprising a prostaglandin analog for treating constipation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN RELIEVING OR PREVENTING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION WITH A DOSAGE UNIT COMPRISING 24MICROG +/- 10% OF A DRUG SUBSTANCE AND A PHARMACEUTICALLY SUITABLE EXCIPIENT

Method for treating gastrointestinal disorder
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR THE LONG TERM TREATMENT OF CHRONIC CONSTIPATION IN A HUMAN SUBJECT

Soft-gelatin capsule formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-002 Apr 29, 2008 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 See Plans and Pricing See Plans and Pricing
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-002 Apr 29, 2008 See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Brazil

Patent: 0707334
Estimated Expiration: See Plans and Pricing

Canada

Patent: 37274
Estimated Expiration: See Plans and Pricing

China

Patent: 1410097
Estimated Expiration: See Plans and Pricing

Patent: 4971056
Estimated Expiration: See Plans and Pricing

Patent: 4983712
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 78944
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 78944
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2867
Estimated Expiration: See Plans and Pricing

Japan

Patent: 83794
Estimated Expiration: See Plans and Pricing

Patent: 08534432
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 08009650
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0191
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 78944
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 20291
Estimated Expiration: See Plans and Pricing

Patent: 08134489
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1393944
Estimated Expiration: See Plans and Pricing

Patent: 080090526
Estimated Expiration: See Plans and Pricing

Spain

Patent: 92590
Estimated Expiration: See Plans and Pricing

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
Brazil PI0514891 composição contendo derivados de prostaglandina e uso da referida composição See Plans and Pricing
South Korea 100886598 See Plans and Pricing
Mexico PA03001959 COMPOSICION CATARTICA. (CATHARTIC COMPOSITION.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AMITIZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2298314 92826 Luxembourg See Plans and Pricing PRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910
1315485 132016000025193 Italy See Plans and Pricing PRODUCT NAME: LUBIPROSTONE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(AMITIZA); AUTHORISATION NUMBER(S) AND DATE(S): PL 21341/0003, 20120910;043833019-021, 20150526
1315485 300757 Netherlands See Plans and Pricing 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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