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Last Updated: October 22, 2020

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AMITIZA Drug Profile

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Which patents cover Amitiza, 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 sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and sixteen patent family members in twenty-eight countries.

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

US ANDA Litigation and Generic Entry Outlook for Amitiza

Amitiza was eligible for patent challenges on January 31, 2010.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 25, 2027. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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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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Generic Entry Opportunity Date for AMITIZA
Generic Entry Date for AMITIZA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for AMITIZA

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

SponsorPhase
Sucampo Pharmaceuticals, Inc.Phase 3
TakedaPhase 2
Sucampo AGPhase 2

See all AMITIZA clinical trials

Pharmacology for AMITIZA
Paragraph IV (Patent) Challenges for AMITIZA
Tradename Dosage Ingredient NDA Submissiondate
AMITIZA CAPSULE;ORAL lubiprostone 021908 2012-08-20

US Patents and Regulatory Information for AMITIZA

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

Supplementary Protection Certificates for AMITIZA

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