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Lubiprostone - Generic Drug Details

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What are the generic drug sources for lubiprostone and what is the scope of lubiprostone patent protection?

Lubiprostone is the generic ingredient in one branded drug marketed by Sucampo Pharma Llc and is included in one NDA. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lubiprostone has two hundred and nine patent family members in twenty-eight countries.

There are nine drug master file entries for lubiprostone. Six suppliers are listed for this compound.

Summary for lubiprostone

International Patents:	209
US Patents:	16
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	9
Suppliers / Packagers:	6
Bulk Api Vendors:	66
Clinical Trials:	43
Patent Applications:	770
Drug Prices:	see low prices
DailyMed Link:	lubiprostone at DailyMed

Pharmacology for lubiprostone

Drug Class	Chloride Channel Activator
Mechanism of Action	Chloride Channel Activators

Medical Subject Heading (MeSH) Categories for lubiprostone

Chloride Channel Agonists

Synonyms for lubiprostone

(-)-7-((2R,4aR,5R,7aR)-2-(1,1-Difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta (b)pyran-5-yl)heptanoic acid

(-)-7-((2R,4aR,5R,7aR)-2-(1,1-Difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta(b)pyran-5-yl)heptanoic acid

(2R,4aR,5R,7aR)-2-(1,1-Difluoropentyl)-2-hydroxy-6-oxo-3,4,4a,5,7,7a-hexahydrocyclopenta[b]pyran-5-heptanoic acid

1263283-38-0

136790-76-6

333963-40-9

7-((1R,4R,6R,9R)-4-(1,1-difluoropentyl)-4-hydroxy-8-oxo-5-oxabicyclo(4.3.0)non-9-yl)heptanoic acid

7-((2R,4aR,5R,7aR)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl)heptanoic acid

7-((2R,4aR,5S,7aR)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl)heptanoic acid

7-[(1R,4R,6R,9R)-4-(1,1-Difluoropentyl)-4-hydroxy-8-oxo-5-oxabicyclo[4.3.0]non-9-yl]heptanoic acid

7-[(2R,4aR,5R,7aR)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxo-3,4,4a,5,7,7a-hexahydrocyclopenta[b]pyran-5-yl]heptanoic acid

7-[(2R,4aR,5R,7aR)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxo-3,4,4a,5,7,7a-hexahydrocyclopenta[e]pyran-5-yl]heptanoic acid

7-[(2R,4aR,5S,7aR)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxo-3,4,4a,5,7,7a-hexahydrocyclopenta[b]pyran-5-yl]heptanoic acid

7-[(2R,4aR,5S,7aR)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxo-octahydrocyclopenta[b]pyran-5-yl]heptanoic acid

7-[2-(1,1-DIFLUOROPENTYL)-2-HYDROXY-6-OXO-HEXAHYDROCYCLOPENTA[B]PYRAN-5-YL]HEPTANOIC ACID

89248-EP2275419A2

89248-EP2305652A2

963L409

AC-1863

AC1L4IXH

AC1LCVGZ

AK341743

AKOS015896617

AKOS015896639

AKOS030241065

Amitiza

Amitiza (TN)

Amitiza, RU-0211, SPI-0211, Lubiprostone

AN-6562

API0003227

BC677681

Bicyclic lubiprostone

C13707

C20H32F2O5

C28H28F2O5

CAS-136790-76-6

CHEBI:34945

CHEMBL1201134

CHEMBL3348939

CTK8E7624

D00CTS

D04790

DB01046

DSSTox_CID_28565

DSSTox_GSID_48639

DSSTox_RID_82837

DTXSID5048639

FT-0670870

FT-0697010

GTPL4242

HE335962

I06-2314

I06-2319

J-006909

J-521658

KS-00000XLM

LP012735

LP012736

LS-186535

LS-187360

Lubiprostone (JAN/USAN/INN)

Lubiprostone [USAN]

Lubiprostone hemiketal

Lubiprostone related compound 3

MFCD08444045

MolPort-006-666-405

N917

NCGC00183105-01

Prostan-1-oic acid, 11,15-epoxy-16,16-difluoro-15-hydroxy-9-oxo-, (11alpha,15R)-

RL03218

RP17713

RT-013602

RU-0211

RU0211

SC-20086

SC-99699

SCHEMBL12173275

SCHEMBL217184

SCHEMBL454016

SPI 0211

SPI-0211

SPI0211

Tox21_112986

WGFOBBZOWHGYQH-MXHNKVEKSA-N

X6870

YF10093

Z6115

ZINC4217732

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
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008		RX	Yes	No			Y
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006		RX	Yes	Yes			Y
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008		RX	Yes	No
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006		RX	Yes	Yes

Expired US Patents for lubiprostone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008

Non-Orange Book US Patents for lubiprostone

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,253,295	Chloride channel opener
6,610,732	Anti-constipation composition
8,748,454	Anti-constipation composition

International Patents for lubiprostone

Country	Document Number	Estimated Expiration
Austria	522218
Japan	2011201905
Canada	2419741
Netherlands	300757

Supplementary Protection Certificates for lubiprostone

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1315485/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0757	Netherlands		PRODUCT NAME: LUBIPROSTON; NATIONAL REGISTRATION NO/DATE: RVG 115891; FIRST REGISTRATION NO/DATE: PL21341/0003 20120910
2015000080	Germany		PRODUCT NAME: LUBIPROSTON, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: 92699.00.00 20150519; FIRST REGISTRATION: VEREINIGTES KOENIGREICH PL 21341/0003 20120910
00757	Netherlands		PRODUCT NAME: LUBIPROSTON; NAT. REGISTRATION NO/DATE: RVG 115891 20150317; FIRST REGISTRATION: