Amitiza is a drug owned by Sucampo Pharma Americas Llc. It is protected by 17 US drug patents filed from 2013 to 2014. Out of these, 5 drug patents are active and 12 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 25, 2027. Details of Amitiza's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5284858 | Prostaglandins E and anti ulcers containing same |
Jul, 2014
(10 years ago) |
Expired
|
| US8071613 | Anti-constipation composition |
Sep, 2020
(3 years ago) |
Expired
|
| US6414016 | Anti-constipation composition |
Sep, 2020
(3 years ago) |
Expired
|
| US8114890 | Anti-constipation composition |
Sep, 2020
(3 years ago) |
Expired
|
| US8097649 | Composition and method for stabilizing the same |
Oct, 2020
(3 years ago) |
Expired
|
| US6583174 | Composition and method for stabilizing the same |
Oct, 2020
(3 years ago) |
Expired
|
| US7417067 | Composition and method for stabilizing the same |
Oct, 2020
(3 years ago) |
Expired
|
| US8088934 | Composition and method for stabilizing the same |
May, 2021
(3 years ago) |
Expired
|
| US7064148 | Chloride channel opener |
Aug, 2022
(1 year, 10 months ago) |
Expired
|
| US8097653 | Dosage unit comprising a prostaglandin analog for treating constipation |
Nov, 2022
(1 year, 8 months ago) |
Expired
|
| US8389542 | Dosage unit comprising a prostaglandin analog for treating constipation |
Nov, 2022
(1 year, 8 months ago) |
Expired
|
| US6982283 | Method for treating drug-induced constipation |
Dec, 2022
(1 year, 7 months ago) |
Expired
|
| US7795312 | Method for treating abdominal discomfort |
Sep, 2024
(a month from now) | Active |
| US8748481 | Method for treating gastrointestinal disorder |
Sep, 2025
(1 year, 1 month from now) | Active |
| US8338639 | Soft-gelatin capsule formulation |
Jan, 2027
(2 years from now) | Active |
| US8779187 | Soft-gelatin capsule formulation |
Jan, 2027
(2 years from now) | Active |
| US8026393 | Soft-gelatin capsule formulation |
Oct, 2027
(3 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Amitiza's patents.
Latest Legal Activities on Amitiza's Patents
Given below is the list of recent legal activities going on the following patents of Amitiza.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 25 Jun, 2024 | US8338639 (Litigated) |
| Expire Patent | 08 Jan, 2024 | US8071613 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Aug, 2023 | US8114890 |
| Maintenance Fee Reminder Mailed | 24 Jul, 2023 | US8071613 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 17 Jul, 2023 | US8097653 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 17 Jul, 2023 | US8097649 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 Jul, 2023 | US8088934 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 27 Mar, 2023 | US8026393 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Mar, 2022 | US7795312 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Jan, 2022 | US8779187 |
FDA has granted several exclusivities to Amitiza. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Amitiza, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Amitiza.
Exclusivity Information
Amitiza holds 2 exclusivities. All of its exclusivities have expired in 2021. Details of Amitiza's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-670) | Apr 19, 2016 |
| M(M-225) | Apr 26, 2021 |
US patents provide insights into the exclusivity only within the United States, but Amitiza is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Amitiza's family patents as well as insights into ongoing legal events on those patents.
Amitiza's family patents
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Generic Launch
Generic Release Date:
Amitiza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 25, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Amitiza Generics:
Lubiprostone is the generic name for the brand Amitiza. 5 different companies have already filed for the generic of Amitiza, with Amneal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Amitiza's generic
How can I launch a generic of Amitiza before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Amitiza's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Amitiza's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Amitiza -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 8 mcg and 24 mcg | 20 Aug, 2012 | 1 | 27 Jun, 2022 | 30 Aug, 2022 | Extinguished |
About Amitiza
Amitiza is a drug owned by Sucampo Pharma Americas Llc. It is used for treating constipation, irritable bowel syndrome, and abdominal discomfort associated with irritable bowel syndrome. Amitiza uses Lubiprostone as an active ingredient. Amitiza was launched by Sucampo Pharma Llc in 2008.
Market Authorisation Date:
Amitiza was approved by FDA for market use on 29 April, 2008.
Active Ingredient:
Amitiza uses Lubiprostone as the active ingredient. Check out other Drugs and Companies using Lubiprostone ingredient
Treatment:
Amitiza is used for treating constipation, irritable bowel syndrome, and abdominal discomfort associated with irritable bowel syndrome.
Dosage:
Amitiza is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 24MCG | CAPSULE | Prescription | ORAL |
| 8MCG | CAPSULE | Prescription | ORAL |