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Last Updated: May 18, 2024

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 two branded drugs marketed by Sucampo Pharma Llc, Amneal, Anchen Pharms, Dr Reddys, Teva Pharms Usa Inc, and Zydus Pharms, and is included in six NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lubiprostone has seventy-two patent family members in nineteen countries.

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

Drug Prices for lubiprostone

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Recent Clinical Trials for lubiprostone

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

SponsorPhase
Alexandria UniversityPhase 3
Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshPhase 4
Helwan UniversityPhase 3

See all lubiprostone clinical trials

Pharmacology for lubiprostone
Medical Subject Heading (MeSH) Categories for lubiprostone
Paragraph IV (Patent) Challenges for LUBIPROSTONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AMITIZA Capsules lubiprostone 8 mcg and 24 mcg 021908 1 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
Teva Pharms Usa Inc LUBIPROSTONE lubiprostone CAPSULE;ORAL 209920-002 Jan 18, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys LUBIPROSTONE lubiprostone CAPSULE;ORAL 206994-001 Feb 8, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-002 Apr 29, 2008 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 ⤷  Try a Trial ⤷  Try a Trial
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 ⤷  Try a Trial ⤷  Try a 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 2015C/048 Belgium ⤷  Try a Trial PRODUCT NAME: LUBIPROSTONE; AUTHORISATION NUMBER AND DATE: PL21341/0003 20150317
1315485 2015/028 Ireland ⤷  Try a 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 132016000025193 Italy ⤷  Try a Trial PRODUCT NAME: LUBIPROSTONE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(AMITIZA); AUTHORISATION NUMBER(S) AND DATE(S): PL 21341/0003, 20120910;043833019-021, 20150526
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.