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Lubiprostone - Generic Drug Details
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What are the generic drug sources for lubiprostone and what is the scope of lubiprostone patent protection?
Lubiprostone
is the generic ingredient in one branded drug marketed by Sucampo Pharma Llc and is included in one NDA. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Lubiprostone has two hundred and nine patent family members in twenty-eight countries.
There are ten drug master file entries for lubiprostone. Four suppliers are listed for this compound.
Summary for lubiprostone
| International Patents: | 209 |
| US Patents: | 16 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 10 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 69 |
| Clinical Trials: | 43 |
| Patent Applications: | 770 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for lubiprostone |
| DailyMed Link: | lubiprostone at DailyMed |
Pharmacology for lubiprostone
| Drug Class | Chloride Channel Activator |
| Mechanism of Action | Chloride Channel Activators |
Medical Subject Heading (MeSH) Categories for lubiprostone
Synonyms for lubiprostone
| (-)-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 |
| 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 (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 lubiprostone
| 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 | Y | ➤ Sign Up | |||
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-002 | Apr 29, 2008 | RX | Yes | No | ➤ 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 | 021908-002 | Apr 29, 2008 | RX | Yes | No | ➤ 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 | Y | ➤ Sign Up | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Expired US Patents for lubiprostone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | ➤ 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 | 021908-002 | Apr 29, 2008 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for lubiprostone
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 | ➤ Sign Up |
| 8,748,454 | Anti-constipation composition | ➤ Sign Up |
| 7,253,295 | Chloride channel opener | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for lubiprostone
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Hungary | 0203746 | ➤ Sign Up |
| Russian Federation | 2275368 | ➤ Sign Up |
| Argentina | 100291 | ➤ Sign Up |
| Taiwan | I298256 | ➤ Sign Up |
| New Zealand | 529187 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for lubiprostone
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 00757 | Netherlands | ➤ Sign Up | PRODUCT NAME: LUBIPROSTON; NAT. REGISTRATION NO/DATE: RVG 115891 20150317; FIRST REGISTRATION: |
| /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 |
| 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 |
| 0757 | Netherlands | ➤ Sign Up | PRODUCT NAME: LUBIPROSTON; NATIONAL REGISTRATION NO/DATE: RVG 115891; FIRST REGISTRATION NO/DATE: PL21341/0003 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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