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Last Updated: October 20, 2020

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 freedom to operate?

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 sixteen patent family members in twenty-eight countries.

There are ten drug master file entries for lubiprostone. Two suppliers are listed for this compound.

Recent Clinical Trials for LUBIPROSTONE

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

SponsorPhase
Rajavithi HospitalPhase 4
Braintree LaboratoriesPhase 3
TakedaPhase 2

See all LUBIPROSTONE clinical trials

Pharmacology for LUBIPROSTONE
Medical Subject Heading (MeSH) Categories for LUBIPROSTONE
Paragraph IV (Patent) Challenges for LUBIPROSTONE
Tradename Dosage Ingredient NDA Submissiondate
AMITIZA CAPSULE;ORAL lubiprostone 021908 2012-08-20

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 021908-002 Apr 29, 2008 RX Yes No   Start Trial   Start Trial   Start Trial
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 RX Yes Yes   Start Trial   Start Trial   Start Trial
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 RX Yes Yes   Start Trial   Start Trial   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 LUBIPROSTONE

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 LUBIPROSTONE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 C300757 Netherlands   Start Trial PRODUCT NAME: LUBIPROSTON; NAT. REGISTRATION NO/DATE: RVG 115891 20150317; FIRST REGISTRATION:
1315485 122015000080 Germany   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
Johnson and Johnson
Baxter
McKinsey
Mallinckrodt

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