AMITIZA Drug Patent Profile
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When do Amitiza patents expire, and when can generic versions of Amitiza launch?
Amitiza is a drug marketed by Sucampo Pharma Llc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has twenty patent family members in fifteen countries.
The generic ingredient in AMITIZA is lubiprostone. There are ten drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the lubiprostone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Amitiza
A generic version of AMITIZA was approved as lubiprostone by AMNEAL on November 30th, 2021.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for AMITIZA?
- What are the global sales for AMITIZA?
- What is Average Wholesale Price for AMITIZA?
Summary for AMITIZA
| International Patents: | 20 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 87 |
| Clinical Trials: | 28 |
| Drug Prices: | Drug price information for AMITIZA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AMITIZA |
| What excipients (inactive ingredients) are in AMITIZA? | AMITIZA excipients list |
| DailyMed Link: | AMITIZA at DailyMed |
Recent Clinical Trials for AMITIZA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Takeda | Phase 2 |
| Sucampo Pharma Americas, LLC | Phase 2 |
| Sucampo AG | Phase 2 |
Pharmacology for AMITIZA
| Drug Class | Chloride Channel Activator |
| Mechanism of Action | Chloride Channel Activators |
Paragraph IV (Patent) Challenges for AMITIZA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| AMITIZA | Capsules | lubiprostone | 8 mcg and 24 mcg | 021908 | 1 | 2012-08-20 |
US Patents and Regulatory Information for AMITIZA
AMITIZA is protected by three US patents.
| 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 | 021908-002 | Apr 29, 2008 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-002 | Apr 29, 2008 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-002 | Apr 29, 2008 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ 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 | 021908-001 | 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 | 021908-001 | 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
See the table below for patents covering AMITIZA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 2008009650 | FORMULACION DE CAPSULA DE GELATINA SUAVE. (SOFT-GELATIN CAPSULE FORMULATION.) | ⤷ Start Trial |
| Portugal | 1220849 | ⤷ Start Trial | |
| Taiwan | I302100 | ⤷ Start Trial | |
| Japan | S6452753 | PROSTAGLANDIN E AND ANTIULCER AGENT CONTAINING SAME | ⤷ Start Trial |
| Japan | 2009114217 | CATHARTIC COMPOSITION | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AMITIZA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 1315485 | 300757 | Netherlands | ⤷ Start Trial | PRODUCT NAME: LUBIPROSTON; NATIONAL REGISTRATION NO/DATE: RVG 115891; FIRST REGISTRATION NO/DATE: PL21341/0003 20120910 |
| 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 | 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 |
| >Patent Number | >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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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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