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AMITIZA Drug Profile

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When do Amitiza patents expire, and what generic alternatives are available?

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. Five suppliers are listed for this compound. Additional details are available on the lubiprostone profile page.

Summary for AMITIZA

International Patents:	209
US Patents:	16
Applicants:	1
NDAs:	1
Suppliers / Packagers:	5
Bulk Api Vendors:	51
Clinical Trials:	25
Patent Applications:	452
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMITIZA
DailyMed Link:	AMITIZA at DailyMed

Pharmacology for AMITIZA

Drug Class	Chloride Channel Activator
Mechanism of Action	Chloride Channel Activators

Medical Subject Heading (MeSH) Categories for AMITIZA

Chloride Channel Agonists

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

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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
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008

Paragraph IV (Patent) Challenges for AMITIZA

Drugname	Dosage	Strength	RLD	Submissiondate
	Capsules	8 mcg and 24 mcg		2012-08-20

Non-Orange Book US Patents for AMITIZA

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
6,610,732	Anti-constipation composition
7,253,295	Chloride channel opener
8,748,454	Anti-constipation composition

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International Patents for AMITIZA

Country	Document Number	Estimated Expiration
South Korea	20040008168
Denmark	1392318
Czech Republic	20021037
Austria	267189

Supplementary Protection Certificates for AMITIZA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
15/028	Ireland		PRODUCT NAME: LUBIPROSTONE AND PHARMACEUTICALLY ACCEPTABLE SALTS FOR LUBIPROSTONE.; NAT REGISTRATION NO/DATE: PA148/002/001 20150213; FIRST REGISTRATION NO/DATE: PL21341/0003-0001 20120910
/2015	Austria		PRODUCT NAME: LUBIPROSTON UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; NAT. REGISTRATION NO/DATE: 136176 20150508; FIRST REGISTRATION: GB PL 21341/0003 20120910
826	Luxembourg		PRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910
00757	Netherlands		PRODUCT NAME: LUBIPROSTON; NAT. REGISTRATION NO/DATE: RVG 115891 20150317; FIRST REGISTRATION: