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Generated: December 10, 2018

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AMITIZA Drug Profile

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When do Amitiza patents expire, and when can generic versions of Amitiza launch?

Amitiza is a drug marketed by Sucampo Pharma Llc and is included in one NDA. There are sixteen patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in AMITIZA is lubiprostone. There are ten drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the lubiprostone profile page.

Drug patent expirations by year for AMITIZA
Generic Entry Opportunity Date for AMITIZA
Generic Entry Date for AMITIZA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for AMITIZA
Medical Subject Heading (MeSH) Categories for AMITIZA
Synonyms for AMITIZA
(-)-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 (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
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 AMITIZA

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 021908-001 Jan 31, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 RX Yes Yes ➤ 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

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Expired US Patents for AMITIZA

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 021908-002 Apr 29, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for AMITIZA
Drugname Dosage Strength RLD Date
➤ Subscribe Capsules 8 mcg and 24 mcg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for AMITIZA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0757 Netherlands ➤ Sign Up PRODUCT NAME: LUBIPROSTON; NATIONAL REGISTRATION NO/DATE: RVG 115891; FIRST REGISTRATION NO/DATE: PL21341/0003 20120910
/2015 Austria ➤ Sign Up PRODUCT NAME: LUBIPROSTON UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; NAT. REGISTRATION NO/DATE: 136176 20150508; FIRST REGISTRATION: GB PL 21341/0003 20120910
826 Luxembourg ➤ Sign Up PRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Merck
Colorcon
Federal Trade Commission
US Department of Justice
AstraZeneca
Citi
Queensland Health
Moodys

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