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AMITIZA Drug Profile
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This drug has one hundred and eighty patent family members in twenty-six countries.
The generic ingredient in AMITIZA is lubiprostone. There are seven 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 Tradename: AMITIZA
| Patents: | 16 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 6 |
| Drug Prices: : | see details |
Pharmacology for Tradename: AMITIZA
| Drug Class | Chloride Channel Activator |
| Mechanism of Action | Chloride Channel Activators |
Clinical Trials for: AMITIZA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | RX | Yes | 6,583,174 | Oct 16, 2020 | Y | |||||||||||||||||||
Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | RX | Yes | 8,026,393 | Oct 25, 2027 | Y | |||||||||||||||||||
Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | RX | Yes | 8,114,890 | Sep 5, 2020 | Y | |||||||||||||||||||
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Expired Patents for Tradename: AMITIZA
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-002 | Apr 29, 2008 | 5,284,858 | <disabled> | ||||||||||||||||||||||
Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | 5,284,858 | <disabled> | ||||||||||||||||||||||
Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | 5,317,032 | <disabled> | ||||||||||||||||||||||
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Paragraph IV activity for: AMITIZA
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| lubiprostone | Capsules | 8 mcg and 24 mcg | Amitiza | 8/20/2012 |
Non-Orange Book Patents for Tradename: 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,610,732 | Anti-constipation composition | <disabled in preview> | |||||||||||||||||||||||||||
| 7,371,069 | Manikin and eye device apparatus, methods and articles of manufacture | <disabled in preview> | |||||||||||||||||||||||||||
| 7,253,295 | Chloride channel opener | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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International Patent Family for Tradename: AMITIZA
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Argentina | 037524 | <disabled in preview> | |||||||||||||||||||||||||||
| Denmark | 1220849 | <disabled in preview> | |||||||||||||||||||||||||||
| European Patent Office | 1978944 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Supplementary Protection Certificates for Tradename: AMITIZA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1315485/01 | Switzerland | <disabled> | FORMER REPRESENTATIVE: BOHEST AG, CH | ||||||||||||||||||||||||||
| 826 | Luxembourg | <disabled> | PRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910 | ||||||||||||||||||||||||||
| 00757 | Netherlands | <disabled> | PRODUCT NAME: LUBIPROSTON; NAT. REGISTRATION NO/DATE: RVG 115891 20150317; FIRST REGISTRATION: | ||||||||||||||||||||||||||
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