Xifaxan is a drug owned by Salix Pharmaceuticals Inc. It is protected by 34 US drug patents filed from 2013 to 2023. Out of these, 22 drug patents are active and 12 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 02, 2029. Details of Xifaxan's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8193196 | Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations |
Sep, 2027
(2 years from now) | Active |
| US8741904 | Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations |
Feb, 2026
(1 year, 2 months from now) | Active |
| US7906542 | Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin |
Jun, 2025
(5 months from now) | Active |
| US7045620 | Polymorphous forms of rifaximin, processes for their production and use thereof in medicinal preparations |
Jun, 2024
(5 months ago) |
Expired
|
| US8835452 | Polymorphic forms α, β and γ of rifaximin |
Jun, 2024
(5 months ago) |
Expired
|
| US8158781 | Polymorphic forms α, β and γ of rifaximin |
Jun, 2024
(5 months ago) |
Expired
|
| US7612199 | Polymorphic forms α, β, and γ of rifaximin |
Jun, 2024
(5 months ago) |
Expired
|
| US7902206 | Polymorphic forms α, β and γ of rifaximin |
Jun, 2024
(5 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8642573 | Methods of treating hepatic encephalopathy |
Oct, 2029
(4 years from now) | Active |
| US8969398 | Methods of treating hepatic encephalopathy |
Oct, 2029
(4 years from now) | Active |
| US10314828 | Methods of treating hepatic encephalopathy |
Jul, 2029
(4 years from now) | Active |
| US8829017 | Methods of treating traveler's diarrhea and hepatic encephalopathy |
Jul, 2029
(4 years from now) | Active |
| US10709694 | Methods of treating hepatic encephalopathy |
Jul, 2029
(4 years from now) | Active |
| US9421195 | Methods of treating hepatic encephalopathy |
Jul, 2029
(4 years from now) | Active |
| US9629828 | Methods of treating traveler's diarrhea and hepatic encephalopathy |
Jul, 2029
(4 years from now) | Active |
| US8946252 | Methods of treating traveler's diarrhea and hepatic encephalopathy |
Jul, 2029
(4 years from now) | Active |
| US10335397 | Methods of treating hepatic encephalopathy |
Jul, 2029
(4 years from now) | Active |
| US7928115 | Methods of treating travelers diarrhea and hepatic encephalopathy |
Jul, 2029
(4 years from now) | Active |
| US8309569 | Methods for treating diarrhea-associated irritable bowel syndrome |
Jul, 2029
(4 years from now) | Active |
| US10765667 | Methods for treating irritable bowel syndrome (IBS) |
Feb, 2029
(4 years from now) | Active |
| US11779571 | Methods for treating irritable bowel syndrome (IBS) |
Feb, 2029
(4 years from now) | Active |
| US11564912 | Methods for treating irritable bowel syndrome (IBS) |
Feb, 2029
(4 years from now) | Active |
| US10456384 | Methods for treating irritable bowel syndrome (IBS) |
Feb, 2029
(4 years from now) | Active |
| US8193196 | Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations |
Sep, 2027
(2 years from now) | Active |
| US9271968 | Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations |
Feb, 2026
(1 year, 2 months from now) | Active |
| US10703763 | Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations |
Feb, 2026
(1 year, 2 months from now) | Active |
| US8518949 | Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations |
Feb, 2026
(1 year, 2 months from now) | Active |
| US7906542 | Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin |
Jun, 2025
(5 months from now) | Active |
| US7915275 | Use of polymorphic forms of rifaximin for medical preparations |
Feb, 2025
(2 months from now) | Active |
| US7045620 | Polymorphous forms of rifaximin, processes for their production and use thereof in medicinal preparations |
Jun, 2024
(5 months ago) |
Expired
|
| US8853231 | Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin |
Jun, 2024
(5 months ago) |
Expired
|
| US7612199 | Polymorphic forms α, β, and γ of rifaximin |
Jun, 2024
(5 months ago) |
Expired
|
| US8158644 | Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin |
Jun, 2024
(5 months ago) |
Expired
|
| US8158781 | Polymorphic forms α, β and γ of rifaximin |
Jun, 2024
(5 months ago) |
Expired
|
| US7902206 | Polymorphic forms α, β and γ of rifaximin |
Jun, 2024
(5 months ago) |
Expired
|
| US7605240 | Methods of treating diarrhea and bloating caused by small intestinal bacterial overgrowth |
Aug, 2019
(5 years ago) |
Expired
|
| US6861053 | Methods of diagnosing or treating irritable bowel syndrome and other disorders caused by small intestinal bacterial overgrowth |
Aug, 2019
(5 years ago) |
Expired
|
| US7718608 | Methods of treating a subject suffering from irritable bowel syndrome |
Aug, 2019
(5 years ago) |
Expired
|
| US7935799 | Methods of treating diarrhea caused by small intestinal bacterial overgrowth |
Aug, 2019
(5 years ago) |
Expired
|
| US7452857 | Methods of treating irritable bowel syndrome and other disorders caused by small intestinal bacterial overgrowth |
Aug, 2019
(5 years ago) |
Expired
|
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 Xifaxan's patents.
Latest Legal Activities on Xifaxan's Patents
Given below is the list of recent legal activities going on the following patents of Xifaxan.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 18 Apr, 2024 | US8309569 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Feb, 2024 | US10765667 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Jan, 2024 | US9421195 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Dec, 2023 | US10703763 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 Dec, 2023 | US10709694 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Nov, 2023 | US8193196 (Litigated) |
| Email Notification Critical | 11 Oct, 2023 | US11779571 |
| Mail Patent eGrant Notification | 10 Oct, 2023 | US11779571 |
| Patent eGrant Notification | 10 Oct, 2023 | US11779571 |
| Recordation of Patent eGrant | 10 Oct, 2023 | US11779571 |
FDA has granted several exclusivities to Xifaxan. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xifaxan, 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 Xifaxan.
Exclusivity Information
Xifaxan holds 3 exclusivities. All of its exclusivities have expired in 2018. Details of Xifaxan's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Mar 24, 2013 |
| Orphan Drug Exclusivity(ODE) | Mar 24, 2017 |
| New Indication(I-709) | May 27, 2018 |
Several oppositions have been filed on Xifaxan's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Xifaxan's generic, the next section provides detailed information on ongoing and past EP oppositions related to Xifaxan patents.
Xifaxan's Oppositions Filed in EPO
Xifaxan has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 08, 2008, by Interquim, S.A. De C.V.. This opposition was filed on patent number EP04005541A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP09818544A | Sep, 2020 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Granted and Under Opposition |
| EP09818544A | Sep, 2020 | Hollatz, Christian | Granted and Under Opposition |
| EP09818544A | Sep, 2020 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP09818544A | Sep, 2020 | Accord Healthcare Ltd | Granted and Under Opposition |
| EP09818544A | Sep, 2020 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP09818544A | Sep, 2020 | Aera A/S | Granted and Under Opposition |
| EP09818544A | Aug, 2020 | Lederer & Keller Patentanwälte Partnerschaft mbB | Granted and Under Opposition |
| EP09818544A | Aug, 2020 | CMS Cameron McKenna Nabarro Olswang LLP | Granted and Under Opposition |
| EP09715020A | Dec, 2019 | Lederer & Keller Patentanwälte Partnerschaft mbB | Granted and Under Opposition |
| EP09715020A | Dec, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP09715020A | Dec, 2019 | Sandoz GmbH | Granted and Under Opposition |
| EP05004695A | Jun, 2015 | Sandoz GmbH | Revoked |
| EP04005541A | Feb, 2008 | Interquim, S.A. De C.V. | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Xifaxan 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 Xifaxan's family patents as well as insights into ongoing legal events on those patents.
Xifaxan's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xifaxan's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 02, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xifaxan Generics:
There are no approved generic versions for Xifaxan as of now.
How can I launch a generic of Xifaxan before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Xifaxan's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Xifaxan'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 Xifaxan -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 550 mg | 18 Dec, 2015 | 1 | 02 Oct, 2029 | Non-Forfeiture | |
| 200 mg | 28 Jan, 2019 | 1 | 24 Jul, 2029 |
Alternative Brands for Xifaxan
Xifaxan which is used for treating travelers' diarrhea, reducing risk of hepatic encephalopathy episodes, and managing symptoms of irritable bowel syndrome with diarrhea., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Eli Lilly And Co |
| |||
About Xifaxan
Xifaxan is a drug owned by Salix Pharmaceuticals Inc. It is used for treating travelers' diarrhea, reducing risk of hepatic encephalopathy episodes, and managing symptoms of irritable bowel syndrome with diarrhea. Xifaxan uses Rifaximin as an active ingredient. Xifaxan was launched by Salix Pharms in 2010.
Approval Date:
Xifaxan was approved by FDA for market use on 24 March, 2010.
Active Ingredient:
Xifaxan uses Rifaximin as the active ingredient. Check out other Drugs and Companies using Rifaximin ingredient
Treatment:
Xifaxan is used for treating travelers' diarrhea, reducing risk of hepatic encephalopathy episodes, and managing symptoms of irritable bowel syndrome with diarrhea.
Dosage:
Xifaxan is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 550MG | TABLET | Prescription | ORAL |
| 200MG | TABLET | Prescription | ORAL |