Lubiprostone

For chronic. Sold as Amitiza. Every FDA application for this active ingredient: 1 branded and 7 generic.

As of Nov 14, 2026, FDA lists 8 applications for Lubiprostone (sold as Amitiza), first approved Jan 31, 2006, with 3 new uses approved and 0 published complete response letters.

First approved: Jan 31, 2006
Applications: 8
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $64.7M
First approved in Japan: Jun 29, 2012

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Lubiprostone	Part D	$62.9M	+12%	153,093
Amitiza	Part D	$1.8M	-38%	1,354

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

LUBIPROSTONE 24 MCG CAPSULE: $0.646 per unitGeneric · -20% in a year
LUBIPROSTONE 8 MCG CAPSULE: $0.567 per unitGeneric · -19% in a year
AMITIZA 24 MCG CAPSULE: $6.45 per unitBrand · +4% in a year
AMITIZA 8 MCG CAPSULE: $6.47 per unitBrand · +0% in a year

Approvals in Japan (PMDA)

First approved in Japan 77 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Amitiza, new ingredientA drug with a new active ingredient indicated for the treatment of chronic constipation (excluding constipation due to organic diseases). · Sucampo Pharma. Ltd. · Jun 29, 2012

Clinical Trials

3 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal CancerColorectal Cancer Metastatic, Peritoneal (Metastatic) Cancer · Sun Yat-sen University	Phase 2	Not yet recruiting	Feb 12, 2026
Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit ConstipationSlow Transit Constipation, Pharmacotherapy · Third Military Medical University	Phase 3	Recruiting	Dec 11, 2025
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced ConstipationOpioid-induced Constipation · BioDelivery Sciences International	—	Recruiting	Oct 25, 2018

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jan 31, 2006	AmitizaNDA 21908 · New molecular entity	Sucampo Pharma LLC	10	Marketed
Nov 30, 2021	LubiprostoneANDA 209450	Amneal	1	Marketed
Jan 18, 2022	LubiprostoneANDA 209920	Teva Pharms USA Inc	0	Marketed
Feb 8, 2022	LubiprostoneANDA 206994	Dr Reddys	0	Marketed
Jun 27, 2022	LubiprostoneANDA 201442	Ph Health	0	Discontinued
Mar 23, 2023	LubiprostoneANDA 214131	Zydus Pharms	0	Marketed
Jan 2, 2025	LubiprostoneANDA 218640	Ascent Pharms Inc	0	Marketed
Oct 14, 2026	LubiprostoneANDA 221049	Humanwell Puracap	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA