DrugPatentWatch Database Preview
AMITIZA Drug Profile
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. Four 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: | 4 |
| Bulk Api Vendors: | 55 |
| Clinical Trials: | 25 |
| Patent Applications: | 484 |
| Drug Prices: | Drug price information for AMITIZA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AMITIZA |
| DailyMed Link: | AMITIZA at DailyMed |
Generic Entry Opportunity Date for AMITIZA
*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
| 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 | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-002 | Apr 29, 2008 | RX | Yes | No | ➤ 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 | ➤ Sign Up | ||||
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-002 | Apr 29, 2008 | RX | Yes | No | ➤ 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 | ➤ Sign Up | ||||
| 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 | 021908-002 | Apr 29, 2008 | ➤ Sign Up | ➤ Sign Up |
| 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 | 021908-001 | Jan 31, 2006 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for AMITIZA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Capsules | 8 mcg and 24 mcg | ➤ Subscribe | ➤ Sign Up |
International Patents for AMITIZA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Australia | 2005278323 | ➤ Sign Up |
| Norway | 20034864 | ➤ Sign Up |
| Denmark | 1443938 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2004060377 | ➤ Sign Up |
| Germany | 60010913 | ➤ Sign Up |
| China | 104983712 | ➤ Sign Up |
| South Korea | 100901102 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for AMITIZA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 826 | Luxembourg | ➤ Sign Up | PRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910 |
| 1315485/01 | Switzerland | ➤ Sign Up | FORMER REPRESENTATIVE: BOHEST AG, CH |
| 0757 | Netherlands | ➤ Sign Up | PRODUCT NAME: LUBIPROSTON; NATIONAL REGISTRATION NO/DATE: RVG 115891; FIRST REGISTRATION NO/DATE: PL21341/0003 20120910 |
| 15/028 | Ireland | ➤ Sign Up | 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 | ➤ Sign Up | PRODUCT NAME: LUBIPROSTON UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; NAT. REGISTRATION NO/DATE: 136176 20150508; FIRST REGISTRATION: GB PL 21341/0003 20120910 |
| 2015000080 | Germany | ➤ Sign Up | 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 | ➤ Sign Up | PRODUCT NAME: LUBIPROSTON; NAT. REGISTRATION NO/DATE: RVG 115891 20150317; FIRST REGISTRATION: |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
