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Lubiprostone - Generic Drug Details

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 ten drug master file entries for lubiprostone. Five 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:	10
Suppliers / Packagers:	5
Bulk Api Vendors:	69
Clinical Trials:	43
Patent Applications:	770
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lubiprostone
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

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

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.

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