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AMITIZA Drug Profile
When do Amitiza patents expire, and what generic alternatives are available?
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. Six 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: | 6 |
Bulk Api Vendors: | 45 |
Clinical Trials: | 25 |
Patent Applications: | 452 |
Drug Prices: | see details |
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
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 | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free 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 AMITIZA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-002 | Apr 29, 2008 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-002 | Apr 29, 2008 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for AMITIZA
Drugname | Dosage | Strength | RLD | Submissiondate |
---|---|---|---|---|
➤ Subscribe | Capsules | 8 mcg and 24 mcg | ➤ Subscribe | 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 |
---|---|---|
7,253,295 | Chloride channel opener | ➤ Try a Free Trial |
6,610,732 | Anti-constipation composition | ➤ Try a Free Trial |
8,748,454 | Anti-constipation composition | ➤ Try a Free Trial |
Patent No. | Title | Estimated Patent Expiration |
International Patents for AMITIZA
Country | Document Number | Estimated Expiration |
---|---|---|
Austria | 522218 | ➤ Try a Free Trial |
Japan | 2011201905 | ➤ Try a Free Trial |
Canada | 2419741 | ➤ Try a Free Trial |
Netherlands | 300757 | ➤ Try a Free Trial |
Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for AMITIZA
Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|
1315485/01 | Switzerland | ➤ Try a Free Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
0757 | Netherlands | ➤ Try a Free Trial | PRODUCT NAME: LUBIPROSTON; NATIONAL REGISTRATION NO/DATE: RVG 115891; FIRST REGISTRATION NO/DATE: PL21341/0003 20120910 |
2015000080 | Germany | ➤ Try a Free 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 |
00757 | Netherlands | ➤ Try a Free Trial | PRODUCT NAME: LUBIPROSTON; NAT. REGISTRATION NO/DATE: RVG 115891 20150317; FIRST REGISTRATION: |
Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |