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Serving leading biopharmaceutical companies globally:

Accenture
Moodys
Dow
Baxter
Novartis
Chinese Patent Office
US Department of Justice
QuintilesIMS
UBS
Teva

Generated: January 21, 2018

DrugPatentWatch Database Preview

AMITIZA Drug Profile

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When do Amitiza patents expire, and what generic alternatives are available?

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 eight patent family members in twenty-eight countries.

The generic ingredient in AMITIZA is lubiprostone. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the lubiprostone profile page.
Summary for AMITIZA
International Patents:208
US Patents:16
Applicants:1
NDAs:1
Suppliers / Packagers: 7
Bulk Api Vendors: 67
Clinical Trials: 25
Patent Applications: 461
Drug Prices:see details
DailyMed Link:AMITIZA at DailyMed
Drug patent expirations by year for AMITIZA
Pharmacology for AMITIZA
Medical Subject Heading (MeSH) Categories for AMITIZA

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

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

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Paragraph IV (Patent) Challenges for AMITIZA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Capsules 8 mcg and 24 mcg ➤ Subscribe 8/20/2012

Non-Orange Book US Patents for AMITIZA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,610,732 Anti-constipation composition ➤ Subscribe
8,748,454 Anti-constipation composition ➤ Subscribe
7,253,295 Chloride channel opener ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for AMITIZA

Supplementary Protection Certificates for AMITIZA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1315485/01 Switzerland ➤ Subscribe FORMER REPRESENTATIVE: BOHEST AG, CH
0757 Netherlands ➤ Subscribe PRODUCT NAME: LUBIPROSTON; NATIONAL REGISTRATION NO/DATE: RVG 115891; FIRST REGISTRATION NO/DATE: PL21341/0003 20120910
/2015 Austria ➤ Subscribe PRODUCT NAME: LUBIPROSTON UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; NAT. REGISTRATION NO/DATE: 136176 20150508; FIRST REGISTRATION: GB PL 21341/0003 20120910
00757 Netherlands ➤ Subscribe PRODUCT NAME: LUBIPROSTON; NAT. REGISTRATION NO/DATE: RVG 115891 20150317; FIRST REGISTRATION:
2015000080 Germany ➤ Subscribe 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
826 Luxembourg ➤ Subscribe PRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910
15/028 Ireland ➤ Subscribe 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

US Department of Justice
Julphar
Baxter
Harvard Business School
Novartis
Mallinckrodt
Dow
Deloitte
Cipla

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