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Last Updated: October 18, 2019

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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 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 sixteen patent family members in twenty-eight countries.

There are ten drug master file entries for lubiprostone. Three suppliers are listed for this compound.

Summary for lubiprostone

International Patents:	216
US Patents:	16
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	10
Suppliers / Packagers:	3
Bulk Api Vendors:	77
Clinical Trials:	43
Patent Applications:	909
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lubiprostone
DailyMed Link:	lubiprostone at DailyMed

Recent Clinical Trials for lubiprostone

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Sponsor	Phase
Braintree Laboratories	Phase 3
Sucampo Pharma Americas, LLC	Phase 2
Takeda	Phase 2

See all lubiprostone clinical trials

Recent Litigation for lubiprostone

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District Court Litigation

Case Name	Date
SUCAMPO AG v. SUN PHARMACEUTICAL INDUSTRIES, LTD.	2018-10-30
SUCAMPO AG v. TEVA PHARMACEUTICAL INDUSTRIES LTD.	2017-09-25
SUCAMPO PHARMA, LLC v. AMNEAL PHARMACEUTICALS LLC	2017-04-13

See all lubiprostone litigation

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
136790-76-6
333963-40-9
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
89248-EP2275419A2
89248-EP2305652A2
963L409
AC-1863
AC1L4IXH
AC1LCVGZ
AK341743
AKOS015896617
AKOS015896639
AKOS030241065
Amitiza
Amitiza (TN)
AN-6562
API0003227
AS-39360
BC677681
Bicyclic lubiprostone
C13707
C20H32F2O5
C28H28F2O5
CAS-136790-76-6
CHEBI:34945
CHEMBL1201134
CHEMBL3348939
CTK8E7624
D04790
DB01046
DSSTox_CID_28565
DSSTox_GSID_48639
DSSTox_RID_82837
DTXSID5048639
EX-A1771
FT-0670870
FT-0697010
GTPL4242
I06-2314
I06-2319
J-006909
J-521658
KS-00000XLM
LS-186535
LS-187360
Lubiprostone (JAN/USAN/INN)
Lubiprostone [USAN]
Lubiprostone hemiketal
MolPort-006-666-405
N917
NCGC00183105-01
NCGC00485410-01
Prostan-1-oic acid, 11,15-epoxy-16,16-difluoro-15-hydroxy-9-oxo-, (11alpha,15R)-
RL03218
RP17713
RT-013602
RU-0211
SC-20086
SC-99699
SCHEMBL12173275
SCHEMBL217184
SCHEMBL454016
SPI-0211
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	Start Trial	Start Trial	Y			Start Trial
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008		RX	Yes	No	Start Trial	Start Trial				Start Trial
>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	Start Trial	Start Trial
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	Start Trial	Start Trial
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	Start Trial	Start Trial
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for lubiprostone

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Country	Patent Number	Estimated Expiration
South Korea	100886598	Start Trial
Russian Federation	2007111908	Start Trial
World Intellectual Property Organization (WIPO)	2004060377	Start Trial
Mexico	PA03010019	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for lubiprostone

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1315485	2015C/048	Belgium	Start Trial	PRODUCT NAME: LUBIPROSTONE; AUTHORISATION NUMBER AND DATE: PL21341/0003 20150317
1315485	C300757	Netherlands	Start Trial	PRODUCT NAME: LUBIPROSTON; NAT. REGISTRATION NO/DATE: RVG 115891 20150317; FIRST REGISTRATION:
1315485	122015000080	Germany	Start Trial	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
1315485	300757	Netherlands	Start Trial	PRODUCT NAME: LUBIPROSTON; NATIONAL REGISTRATION NO/DATE: RVG 115891; FIRST REGISTRATION NO/DATE: PL21341/0003 20120910
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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 verifification 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.

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