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AMITIZA Drug Profile
» See Plans and Pricing
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 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. Four 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.
There have been seven 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: | 4 |
| Bulk Api Vendors: | 61 |
| Clinical Trials: | 25 |
| Patent Applications: | 1,250 |
| 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 |
| What excipients (inactive ingredients) are in AMITIZA? | AMITIZA excipients list |
| 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 |
Pharmacology for AMITIZA
| Drug Class | Chloride Channel Activator |
| Mechanism of Action | Chloride Channel Activators |
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 | |||
| >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 | 021908-002 | 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 |
|---|---|---|
| Japan | 2011201905 | Start Trial |
| Spain | 2296786 | Start Trial |
| South Africa | 200202312 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AMITIZA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1315485 | 2015C/048 | Belgium | Start Trial | PRODUCT NAME: LUBIPROSTONE; AUTHORISATION NUMBER AND DATE: PL21341/0003 20150317 |
| 2298314 | 92826 | Luxembourg | Start Trial | PRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910 |
| 1315485 | 132016000025193 | Italy | Start Trial | PRODUCT NAME: LUBIPROSTONE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(AMITIZA); AUTHORISATION NUMBER(S) AND DATE(S): PL 21341/0003, 20120910;043833019-021, 20150526 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
