LUBIPROSTONE - Generic Drug Details

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What are the generic drug sources for lubiprostone and what is the scope of freedom to operate?

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

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Glossary

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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	209450-002	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
Zydus Pharms	LUBIPROSTONE	lubiprostone	CAPSULE;ORAL	214131-001	Mar 23, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for LUBIPROSTONE

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Country	Patent Number	Title	Estimated Expiration
Argentina	107905	COMPOSICIÓN QUÍMICA Y MÉTODO PARA TRATAR DESORDEN GASTROINTESTINAL	⤷ Sign Up
South Korea	20140019006	PROSTAGLANDIN DERIVATIVES FOR TREATING GASTROINTESTINAL DISORDER	⤷ Sign Up
Israel	192867	הרכב קפסולת ג'לטין רך (Soft-gelatin capsule formulation)	⤷ Sign Up
Norway	340989		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LUBIPROSTONE

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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

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