BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Teva
Julphar
Harvard Business School
Chubb
Daiichi Sankyo
Mallinckrodt
Farmers Insurance
Deloitte
Cerilliant
Baxter

Generated: January 22, 2018

DrugPatentWatch Database Preview

Lubiprostone - Generic Drug Details

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What are the generic drug sources for lubiprostone and what is the scope of lubiprostone patent protection?

Lubiprostone
is the generic ingredient in one branded drug marketed by Sucampo Pharma Llc and is included in one NDA. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lubiprostone has two hundred and eight patent family members in twenty-eight countries.

There are nine drug master file entries for lubiprostone. Seven suppliers are listed for this compound.
Summary for lubiprostone
International Patents:208
US Patents:16
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 9
Suppliers / Packagers: 7
Bulk Api Vendors: 67
Clinical Trials: 43
Patent Applications: 735
Drug Prices:see low prices
DailyMed Link:lubiprostone at DailyMed
Pharmacology for lubiprostone
Medical Subject Heading (MeSH) Categories for lubiprostone

US Patents and Regulatory Information for lubiprostone

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 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 ➤ 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 021908-001 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 ➤ 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 lubiprostone

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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Non-Orange Book US Patents for lubiprostone

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

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International Patents for lubiprostone

Supplementary Protection Certificates for lubiprostone

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
826 Luxembourg ➤ Subscribe PRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 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
1315485/01 Switzerland ➤ Subscribe FORMER REPRESENTATIVE: BOHEST AG, CH
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
0757 Netherlands ➤ Subscribe PRODUCT NAME: LUBIPROSTON; NATIONAL REGISTRATION NO/DATE: RVG 115891; FIRST REGISTRATION NO/DATE: PL21341/0003 20120910
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Novartis
Johnson and Johnson
Accenture
Teva
UBS
Dow
Chinese Patent Office
Farmers Insurance

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 verifification 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.

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