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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. Two suppliers are listed for this compound. Additional details are available on the lubiprostone profile page.
US ANDA Litigation and Generic Entry Outlook for Amitiza
Amitiza was eligible for patent challenges on January 31, 2010.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 25, 2027. This may change due to patent challenges or generic licensing.
Annual sales in 2017 were $482mm indicating the motivation for generic entry.
There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for AMITIZA
| International Patents: | 216 |
| US Patents: | 16 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 59 |
| Clinical Trials: | 25 |
| Patent Applications: | 555 |
| 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 |
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.
Recent Clinical Trials for AMITIZA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sucampo Pharmaceuticals, Inc. | Phase 3 |
| Sucampo AG | Phase 2 |
| Sucampo Pharma Americas, LLC | Phase 2 |
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 |
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 | Start Trial | Start Trial | Y | Start Trial | |||
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-002 | Apr 29, 2008 | RX | Yes | No | Start Trial | Start Trial | Start 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 | 021908-002 | Apr 29, 2008 | Start Trial | Start Trial |
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | Start Trial | Start Trial |
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | Start Trial | Start Trial |
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-002 | Apr 29, 2008 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AMITIZA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Argentina | 104392 | Start Trial |
| World Intellectual Property Organization (WIPO) | 02089812 | Start Trial |
| Canada | 2464420 | Start Trial |
| Germany | 60010913 | Start Trial |
| China | 101410097 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AMITIZA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1315485 | 2015/028 | Ireland | Start Trial | 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 |
| 1315485 | C01315485/01 | Switzerland | Start Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
| 1315485 | 2015C/048 | Belgium | Start Trial | PRODUCT NAME: LUBIPROSTONE; AUTHORISATION NUMBER AND DATE: PL21341/0003 20150317 |
| 1315485 | C300757 | Netherlands | Start Trial | PRODUCT NAME: LUBIPROSTON; NAT. REGISTRATION NO/DATE: RVG 115891 20150317; FIRST REGISTRATION: |
| 1315485 | 122015000080 | Germany | Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
