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Last Updated: March 8, 2021

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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. Four suppliers are listed for this compound.

Summary for lubiprostone
International Patents:216
US Patents:16
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 10
Suppliers / Packagers: 4
Bulk Api Vendors: 87
Clinical Trials: 44
Patent Applications: 1,860
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for lubiprostone
What excipients (inactive ingredients) are in lubiprostone?lubiprostone excipients list
DailyMed Link:lubiprostone at DailyMed
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 021908-001 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 021908-002 Apr 29, 2008 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-002 Apr 29, 2008 RX Yes No   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 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   Start Trial   Start Trial
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
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
1315485 2015/028 Ireland   Start Trial 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
1315485 300757 Netherlands   Start Trial PRODUCT NAME: LUBIPROSTON; NATIONAL REGISTRATION NO/DATE: RVG 115891; FIRST REGISTRATION NO/DATE: PL21341/0003 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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