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Last Updated: February 26, 2021

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Lubiprostone - Generic Drug Details

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What are the generic sources for lubiprostone and what is the scope of 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 sixteen patent family members in twenty-eight countries.

There are ten drug master file entries for lubiprostone. Four 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
Sucampo Pharma Americas, LLCPhase 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 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 021908-001 Jan 31, 2006   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 021908-001 Jan 31, 2006   Start Trial   Start Trial
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-002 Apr 29, 2008   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 49/2015 Austria   Start Trial PRODUCT NAME: LUBIPROSTON UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; NAT. REGISTRATION NO/DATE: 136176 20150508; FIRST REGISTRATION: GB PL 21341/0003 20120910
1315485 C01315485/01 Switzerland   Start Trial FORMER REPRESENTATIVE: BOHEST AG, CH
1315485 132016000025193 Italy   Start Trial PRODUCT NAME: LUBIPROSTONE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(AMITIZA); AUTHORISATION NUMBER(S) AND DATE(S): PL 21341/0003, 20120910;043833019-021, 20150526
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:

Moodys
Medtronic
Colorcon
Johnson and Johnson
AstraZeneca
McKesson

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