Lubiprostone - Generic Drug Details

✉ Email this page to a colleague

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, Dr Reddys, Endo Operations, 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.

Summary for lubiprostone

International Patents:	72
US Patents:	5
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	47
Patent Applications:	1,898
Drug Prices:	Drug price trends for lubiprostone
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

See drug prices for lubiprostone

Recent Clinical Trials for lubiprostone

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

Sponsor	Phase
Alexandria University	Phase 3
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Phase 4
Helwan University	Phase 3

See all lubiprostone clinical trials

Pharmacology for lubiprostone

Drug Class	Chloride Channel Activator
Mechanism of Action	Chloride Channel Activators

Medical Subject Heading (MeSH) Categories for lubiprostone

Chloride Channel Agonists

Anatomical Therapeutic Chemical (ATC) Classes for lubiprostone

A06AX	Other drugs for constipation
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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
Amneal	LUBIPROSTONE	lubiprostone	CAPSULE;ORAL	209450-002	Nov 30, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa Inc	LUBIPROSTONE	lubiprostone	CAPSULE;ORAL	209920-002	Jan 18, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys	LUBIPROSTONE	lubiprostone	CAPSULE;ORAL	206994-001	Feb 8, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Zydus Pharms	LUBIPROSTONE	lubiprostone	CAPSULE;ORAL	214131-002	Mar 23, 2023	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

Expired US Patents for lubiprostone

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	⤷ Sign Up	⤷ Sign Up
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	⤷ Sign Up	⤷ Sign Up
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	⤷ Sign Up	⤷ Sign Up
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	⤷ Sign Up	⤷ Sign Up
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	⤷ Sign Up	⤷ Sign Up
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for lubiprostone

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Japan	2008511541		⤷ Sign Up
China	1753680	Derivatives of prostaglandins for treating abdominal discomfort	⤷ Sign Up
Russian Federation	2008134489	СОСТАВ В МЯГКОЙ ЖЕЛАТИНОВОЙ КАПСУЛЕ	⤷ Sign Up
Japan	2006513232		⤷ Sign Up
Mexico	PA05006981	DERIVADOS DE PROSTAGLANDINAS PARA EL TRATAMIENTO DE LA MOLESTIA ABDOMINAL. (DERIVATIVES OF PROSTAGLANDINS FOR TREATING ABDOMINAL DISCOMFORT.)	⤷ Sign Up
Norway	20053623		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for lubiprostone

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1315485	132016000025193	Italy	⤷ Sign Up	PRODUCT NAME: LUBIPROSTONE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(AMITIZA); AUTHORISATION NUMBER(S) AND DATE(S): PL 21341/0003, 20120910;043833019-021, 20150526
1315485	2015/028	Ireland	⤷ Sign Up	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	2015C/048	Belgium	⤷ Sign Up	PRODUCT NAME: LUBIPROSTONE; AUTHORISATION NUMBER AND DATE: PL21341/0003 20150317
2298314	92826	Luxembourg	⤷ Sign Up	PRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.