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 nine patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and thirty patent family members in twenty-four 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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Amitiza
A generic version of AMITIZA was approved as lubiprostone by AMNEAL on November 30th, 2021.
Summary for AMITIZA
| International Patents: | 130 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 74 |
| Clinical Trials: | 28 |
| Patent Applications: | 1,507 |
| 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 |
|---|---|
| Sucampo AG | Phase 2 |
| Takeda | Phase 2 |
| Sucampo Pharma Americas, LLC | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for AMITIZA
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 fourteen US patents.
Patents protecting AMITIZA
Method for treating drug-induced constipation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR TREATING OPIOID-INDUCED CONSTIPATION
Chloride channel opener
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL SYNDROME BY OPENING CHLORIDE CHANNELS (CIC)
Chloride channel opener
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR TREATING CONSTIPATION BY OPENING CIC CHANNELS IN A MAMMALIAN SUBJECT
Chloride channel opener
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR TREATING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION BY OPENING CIC CHANNELS
Method for treating abdominal discomfort
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR TREATING IRRITABLE BOWEL SYNDROME AND METHOD FOR TREATING ABDOMINAL DISCOMFORT ASSOCIATED WITH IRRITABLE BOWEL SYNDROME
Soft-gelatin capsule formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Dosage unit comprising a prostaglandin analog for treating constipation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR RELIEVING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION THAT COMPRISES ADMINISTERING TO THE PATIENT A DOSAGE UNIT COMPRISING(I)24MICROG+/- 10% OF A DRUG SUBSTANCE AND (II) A PHARMACEUTICALLY SUITABLE EXCIPIENT
Dosage unit comprising a prostaglandin analog for treating constipation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR RELIEVING CONSTIPATION IN A HUMAN PATIENT THAT COMPRISES ADMINISTERING TO THE PATIENT A DOSAGE UNIT COMPRISING (I) 24MCG+/- 10% OF A DRUG SUBSTANCE AND (II) A PHARMACEUTICALLY SUITABLE EXCIPIENT
Soft-gelatin capsule formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Dosage unit comprising a prostaglandin analog for treating constipation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN PATIENT WITH A DOSAGE UNIT COMPRISING 24MICROG+/- 10% OF A DRUG SUBSTANCE AND A PHARMACEUTICALLY SUITABLE EXCIPIENT
Dosage unit comprising a prostaglandin analog for treating constipation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN RELIEVING OR PREVENTING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION WITH A DOSAGE UNIT COMPRISING 24MICROG +/- 10% OF A DRUG SUBSTANCE AND A PHARMACEUTICALLY SUITABLE EXCIPIENT
Method for treating gastrointestinal disorder
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR THE LONG TERM TREATMENT OF CHRONIC CONSTIPATION IN A HUMAN SUBJECT WITH IRRITABLE BOWEL SYNDROME
Method for treating gastrointestinal disorder
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR THE LONG TERM TREATMENT OF CHRONIC CONSTIPATION IN A HUMAN SUBJECT
Soft-gelatin capsule formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-002 | Apr 29, 2008 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| >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 | See Plans and Pricing | See Plans and Pricing |
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | See Plans and Pricing | See Plans and Pricing |
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-002 | Apr 29, 2008 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AMITIZA
When does loss-of-exclusivity occur for AMITIZA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 07208632
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 0707334
Estimated Expiration: See Plans and Pricing
Canada
Patent: 37274
Estimated Expiration: See Plans and Pricing
China
Patent: 1410097
Estimated Expiration: See Plans and Pricing
Patent: 4971056
Estimated Expiration: See Plans and Pricing
Patent: 4983712
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 78944
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 78944
Estimated Expiration: See Plans and Pricing
Israel
Patent: 2867
Estimated Expiration: See Plans and Pricing
Japan
Patent: 83794
Estimated Expiration: See Plans and Pricing
Patent: 08534432
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 08009650
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 0191
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 78944
Estimated Expiration: See Plans and Pricing
Russian Federation
Patent: 20291
Estimated Expiration: See Plans and Pricing
Patent: 08134489
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1393944
Estimated Expiration: See Plans and Pricing
Patent: 080090526
Estimated Expiration: See Plans and Pricing
Spain
Patent: 92590
Estimated Expiration: See Plans and Pricing
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering AMITIZA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Brazil | PI0514891 | composição contendo derivados de prostaglandina e uso da referida composição | See Plans and Pricing |
| South Korea | 100886598 | See Plans and Pricing | |
| Mexico | PA03001959 | COMPOSICION CATARTICA. (CATHARTIC COMPOSITION.) | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AMITIZA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2298314 | 92826 | Luxembourg | See Plans and Pricing | PRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910 |
| 1315485 | 132016000025193 | Italy | See Plans and Pricing | PRODUCT NAME: LUBIPROSTONE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(AMITIZA); AUTHORISATION NUMBER(S) AND DATE(S): PL 21341/0003, 20120910;043833019-021, 20150526 |
| 1315485 | 300757 | Netherlands | See Plans and Pricing | PRODUCT NAME: LUBIPROSTON; NATIONAL REGISTRATION NO/DATE: RVG 115891; FIRST REGISTRATION NO/DATE: PL21341/0003 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. 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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