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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.

Recent Clinical Trials for lubiprostone

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

SponsorPhase
Braintree LaboratoriesPhase 3
Sucampo Pharma Americas, LLCPhase 2
TakedaPhase 2

See all lubiprostone clinical trials

Recent Litigation for lubiprostone

Identify potential future generic entrants

District Court Litigation
Case NameDate
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 LLC2017-04-13

See all lubiprostone litigation

Pharmacology for lubiprostone
Medical Subject Heading (MeSH) Categories for lubiprostone
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

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

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

Supplementary Protection Certificates for lubiprostone

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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Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
Merck
Express Scripts
Dow
Harvard Business School

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