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Last Updated: April 11, 2025

Eluxadoline - Generic Drug Details


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What are the generic drug sources for eluxadoline and what is the scope of patent protection?

Eluxadoline is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Eluxadoline has one hundred and fifty-two patent family members in forty countries.

There are two drug master file entries for eluxadoline. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for eluxadoline
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for eluxadoline
Generic Entry Date for eluxadoline*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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 eluxadoline

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AllerganPhase 3
Temple UniversityPhase 2/Phase 3
University of North Carolina, Chapel HillPhase 2

See all eluxadoline clinical trials

Generic filers with tentative approvals for ELUXADOLINE
Applicant Application No. Strength Dosage Form
⤷  Try for Free⤷  Try for Free100MGTABLET;ORAL
⤷  Try for Free⤷  Try for Free75MGTABLET;ORAL
⤷  Try for Free⤷  Try for Free75MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for eluxadoline
Paragraph IV (Patent) Challenges for ELUXADOLINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VIBERZI Tablets eluxadoline 75 mg and 100 mg 206940 6 2019-05-28

US Patents and Regulatory Information for eluxadoline

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Abbvie VIBERZI eluxadoline TABLET;ORAL 206940-001 May 27, 2015 RX Yes No 9,205,076 ⤷  Try for Free ⤷  Try for Free
Abbvie VIBERZI eluxadoline TABLET;ORAL 206940-001 May 27, 2015 RX Yes No 10,188,632 ⤷  Try for Free Y ⤷  Try for Free
Abbvie VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 RX Yes Yes 8,344,011 ⤷  Try for Free ⤷  Try for Free
Abbvie VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 RX Yes Yes 11,007,179 ⤷  Try for Free Y ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Expired US Patents for eluxadoline

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Abbvie VIBERZI eluxadoline TABLET;ORAL 206940-001 May 27, 2015 8,344,011 ⤷  Try for Free
Abbvie VIBERZI eluxadoline TABLET;ORAL 206940-001 May 27, 2015 9,700,542 ⤷  Try for Free
Abbvie VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 9,700,542 ⤷  Try for Free
Abbvie VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 8,609,709 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 4 of 4 entries

EU/EMA Drug Approvals for eluxadoline

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing Refusal
Allergan Pharmaceuticals International Limited Truberzi eluxadoline EMEA/H/C/004098
Truberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS D).
Withdrawn no no no 2016-09-19
>Company>Drugname>Inn>Product Number / Indication>Status>Generic>Biosimilar>Orphan>Marketing Authorisation>Marketing Refusal
Showing 1 to 1 of 1 entries

International Patents for eluxadoline

CountryPatent NumberTitleEstimated Expiration
Cyprus 1114167 ⤷  Try for Free
Eurasian Patent Organization 031559 ⤷  Try for Free
Montenegro 02221 Postupak za proizvodnju intermedijara jedinjenja korisnih kao modulatori opioidnih receptora (Process for preparing intermediates of compounds useful as opioid receptor modulators) ⤷  Try for Free
Portugal 2968351 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 4 of 4 entries

Supplementary Protection Certificates for eluxadoline

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
2176234 132017000028056 Italy ⤷  Try for Free PRODUCT NAME: ELUXADOLINA(TRUBERZI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1126, 20160921
1725537 17C1006 France ⤷  Try for Free PRODUCT NAME: ELUXADOLINE,SES ENANTIOMERES,SES DIASTEREOISOMERES,SES RACEMATES ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/16/1126 20160921
1725537 C 2017 006 Romania ⤷  Try for Free PRODUCT NAME: ELUXADOLINA SAU UN ENANTIOMER, UN DIASTEREOMER, UN RACEMAT SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1126; DATE OF NATIONAL AUTHORISATION: 20160919; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1126; DATE OF FIRST AUTHORISATION IN EEA: 20160919
1725537 LUC00007 Luxembourg ⤷  Try for Free PRODUCT NAME: ELUXADOLINE OU UN ENANTIOMERE, UN DIASTEREOMERE, UNRACEMATE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/16/1126 20160921
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 4 of 4 entries

Market Dynamics and Financial Trajectory for Eluxadoline

Introduction

Eluxadoline, a mixed μ-opioid and κ-opioid receptor agonist and δ-opioid receptor antagonist, has been a significant player in the treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D) since its approval in 2015. Here, we delve into the market dynamics and financial trajectory of this drug.

Approval and Launch

Eluxadoline was approved by the FDA in 2015 for the treatment of adults with IBS-D. It was launched in the United States in 2015, followed by launches in the 5EU (five major European markets) in 2016 and Japan in 2018[1][4].

Market Position

Eluxadoline is anticipated to generate significant revenue in the IBS-D treatment market. GlobalData forecasts that eluxadoline will be one of the top-selling products for IBS-D, with expected revenues of around $236.9 million by 2023. This makes it a key player in the market, particularly because it is the first treatment for both male and female IBS-D patients in the US without prescribing restrictions and the first product indicated for IBS-D in the 5EU[1][4].

Competitive Landscape

In the IBS-D market, eluxadoline faces competition from other therapies, although its unique profile gives it a competitive edge. For instance, Xifaxan, an antibiotic used off-label for IBS-D, is expected to see increased uptake following its label expansion, but its high price and safety concerns limit its market potential. Ibodutant, another IBS-D therapy, targets only women and has modest efficacy, making eluxadoline a more favorable option for a broader patient population[4].

Clinical Efficacy and Safety

Eluxadoline has demonstrated significant clinical efficacy in treating IBS-D. In phase 3 clinical trials, it showed improvements in abdominal and bowel symptoms and enhanced health-related quality of life (HRQOL) compared to placebo. It is particularly effective for patients who have had inadequate responses to loperamide, a commonly prescribed treatment for diarrhea[2].

Economic Impact

The treatment with eluxadoline has substantial economic benefits. It reduces work productivity losses and the number of unhealthy days, translating into significant cost savings for employers and payers. For example, treatment with eluxadoline reduced overall work productivity loss by 2.4 hours per patient per week, which equates to indirect costs of $4,503 per patient per year that could be avoided[2].

Market Growth and Projections

The global IBS treatment market, which includes eluxadoline, is expected to grow significantly. The market is projected to reach $2,988.6 million by 2023 from $1,890.9 million in 2017, with a Compound Annual Growth Rate (CAGR) of 7.58% during the forecast period from 2018 to 2023. The Americas, particularly North America, hold the largest share of this market, followed by Europe and Asia-Pacific[3].

Regional Analysis

Eluxadoline's market performance varies by region. In the US, it is expected to be a leading treatment for IBS-D due to its lack of prescribing restrictions. In the 5EU, it will be the first product indicated for IBS-D, giving it a competitive advantage. In Japan, while it will face competition from other treatments like Irribow, its unique mechanism of action is likely to maintain its market share[1][4].

Barriers to Growth

Despite the positive outlook, several barriers could hinder the growth of the IBS treatment market, including eluxadoline. The low diagnosis rate of IBS, which is less than 50% in major markets, results in fewer patients seeking medical attention and pharmacological treatments. Additionally, the high cost of some treatments and safety concerns associated with long-term use of certain drugs can impact market growth[1].

Key Takeaways

  • Market Leadership: Eluxadoline is expected to be one of the top-selling products for IBS-D by 2023.
  • Clinical Efficacy: It has shown significant improvements in abdominal and bowel symptoms and HRQOL.
  • Economic Benefits: Reduces work productivity losses and unhealthy days, leading to substantial cost savings.
  • Market Growth: The global IBS treatment market is projected to grow at a CAGR of 7.58% from 2018 to 2023.
  • Regional Performance: Strong market presence in the US, 5EU, and Japan.

FAQs

Q: What is eluxadoline used for? A: Eluxadoline is used for the treatment of adults with Irritable Bowel Syndrome with Diarrhea (IBS-D).

Q: When was eluxadoline approved? A: Eluxadoline was approved by the FDA in 2015.

Q: What are the expected revenues for eluxadoline by 2023? A: GlobalData forecasts that eluxadoline will generate revenues of around $236.9 million by 2023.

Q: How does eluxadoline compare to other IBS-D treatments? A: Eluxadoline has a competitive edge due to its lack of prescribing restrictions and its efficacy in treating both male and female patients.

Q: What are the economic benefits of treating IBS-D with eluxadoline? A: Treatment with eluxadoline reduces work productivity losses and the number of unhealthy days, leading to significant cost savings for employers and payers.

Sources

  1. Treatment Market for Irritable Bowel Syndrome Could Hit $1.5 Billion - Drug Development.
  2. Improved work productivity and health-related quality of life in ... - Journal of Managed Care & Specialty Pharmacy.
  3. Irritable Bowel Syndrome (IBS) Market Dynamics with Top Players ... - Taiwan News.
  4. Irritable bowel syndrome therapeutics market dynamics - Managed Healthcare Executive.

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