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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 sixteen patent family members in twenty-eight countries.

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

Summary for AMITIZA

International Patents:	216
US Patents:	16
Applicants:	1
NDAs:	1
Suppliers / Packagers:	3
Bulk Api Vendors:	57
Clinical Trials:	25
Patent Applications:	538
Drug Prices:	Drug price information for AMITIZA
Drug Sales Revenues:	Drug sales revenues for AMITIZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMITIZA
DailyMed Link:	AMITIZA at DailyMed

See drug prices for AMITIZA

See drug sales revenues for AMITIZA

Generic Entry Opportunity Date for AMITIZA

NDA:

021908

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.

Recent Clinical Trials for AMITIZA

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

Sponsor	Phase
Sucampo Pharmaceuticals, Inc.	Phase 3
Takeda	Phase 2
Sucampo AG	Phase 2

See all AMITIZA clinical trials

Recent Litigation for AMITIZA

Identify potential future generic entrants

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 AMITIZA litigation

Pharmacology for AMITIZA

Drug Class	Chloride Channel Activator
Mechanism of Action	Chloride Channel Activators

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

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-[(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

963L409

AC-1863

AC1L4IXH

AK341743

AKOS015896639

Amitiza (TN)

AN-6562

API0003227

AS-39360

BC677681

Bicyclic lubiprostone

C13707

C20H32F2O5

C28H28F2O5

CAS-136790-76-6

CHEMBL1201134

D04790

DB01046

DSSTox_CID_28565

DSSTox_GSID_48639

DSSTox_RID_82837

DTXSID5048639

EX-A1771

FT-0670870

GTPL4242

I06-2319

J-006909

LS-186535

LS-187360

Lubiprostone

Lubiprostone (JAN/USAN/INN)

Lubiprostone [USAN]

Lubiprostone hemiketal

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

RU-0211

SC-20086

SC-99699

SCHEMBL217184

SPI-0211

Tox21_112986

WGFOBBZOWHGYQH-MXHNKVEKSA-N

X6870

YF10093

Z6115

ZINC4217732

Paragraph IV (Patent) Challenges for AMITIZA

Tradename	Dosage	Ingredient	NDA	Submissiondate
AMITIZA	CAPSULE;ORAL	lubiprostone	021908	2012-08-20

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
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006		RX	Yes	Yes
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008		RX	Yes	No			Y
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006		RX	Yes	Yes			Y

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

International Patents for AMITIZA

Country	Patent Number	Estimated Expiration
Mexico	PA03010019
South Korea	20050086950
European Patent Office	1791545
Mexico	PA05006981

Supplementary Protection Certificates for AMITIZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1315485	122015000080	Germany		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	2015C/048	Belgium		PRODUCT NAME: LUBIPROSTONE; AUTHORISATION NUMBER AND DATE: PL21341/0003 20150317
1315485	C300757	Netherlands		PRODUCT NAME: LUBIPROSTON; NAT. REGISTRATION NO/DATE: RVG 115891 20150317; FIRST REGISTRATION:
2298314	92826	Luxembourg		PRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910