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Last Updated: November 21, 2024

LUBIPROSTONE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Lubiprostone

A generic version of LUBIPROSTONE was approved as lubiprostone by AMNEAL on November 30th, 2021.

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Drug patent expirations by year for LUBIPROSTONE
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Recent Clinical Trials for LUBIPROSTONE

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

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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
Amneal LUBIPROSTONE lubiprostone CAPSULE;ORAL 209450-001 Nov 30, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa Inc LUBIPROSTONE lubiprostone CAPSULE;ORAL 209920-001 Jan 18, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys LUBIPROSTONE lubiprostone CAPSULE;ORAL 206994-002 Feb 8, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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