Eluxadoline - Generic Drug Details

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

Eluxadoline is the generic ingredient in two branded drugs marketed by Zydus Pharms and Abbvie, and is included in two NDAs. 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

International Patents:	152
US Patents:	21
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	9
Patent Applications:	320
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for eluxadoline
What excipients (inactive ingredients) are in eluxadoline?	eluxadoline excipients list
DailyMed Link:	eluxadoline at DailyMed

Recent Clinical Trials for eluxadoline

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

Sponsor	Phase
Allergan	Phase 3
Temple University	Phase 2/Phase 3
University of North Carolina, Chapel Hill	Phase 2

See all eluxadoline clinical trials

Generic filers with tentative approvals for ELUXADOLINE

Applicant	Application No.	Strength	Dosage Form
		100MG	TABLET;ORAL
		75MG	TABLET;ORAL
		100MG	TABLET; 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

Drug Class	mu-Opioid Receptor Agonist
Mechanism of Action	Opioid mu-Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for eluxadoline

A07DA	Antipropulsives
A07D	ANTIPROPULSIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015	AB	RX	Yes	No	7,786,158			Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	AB	RX	Yes	Yes	9,115,091		Y	Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	AB	RX	Yes	Yes	9,205,076
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015	AB	RX	Yes	No	8,344,011
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	AB	RX	Yes	Yes	8,344,011
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015	AB	RX	Yes	No	9,675,587		Y

Expired US Patents for eluxadoline

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015	8,344,011
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	9,205,076
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015	10,213,415
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	7,786,158
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015	9,205,076
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	9,700,542

EU/EMA Drug Approvals for eluxadoline

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing 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

International Patents for eluxadoline

Country	Patent Number	Title	Estimated Expiration
Slovenia	2968351
Cyprus	1111927
Japan	6666975
Japan	2018123144	５−（｛［２−アミノ−３−（４−カルバモイル−２，６−ジメチル−フェニル）−プロピオニル］−［１−（４−フェニル−１Ｈ−イミダゾール−２−イル）−エチル］−アミノ｝−メチル）−２−メトキシ−安息香酸の新規な結晶及び製造方法 (NOVEL CRYSTALS AND PRODUCTION PROCESSES 5-({[2-AMINO-3-(4-CARBAMOYL-2,6-DIMETHYL-PHENYL)-PROPIONYL]-[1-(4-PHENYL-1H-IMIDAZOL-2-YL)-ETHYL]-AMINO}-METHYL)-2-METHOXY-BENZOIC ACID)
Hong Kong	1105967	NOVEL COMPOUNDS AS OPIOID RECEPTOR MODULATORS
Japan	5702140

Supplementary Protection Certificates for eluxadoline

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725537	309 6-2017	Slovakia		PRODUCT NAME: ELUXADOLIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1126 20160921
1725537	17C1006	France		PRODUCT NAME: ELUXADOLINE,SES ENANTIOMERES,SES DIASTEREOISOMERES,SES RACEMATES ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/16/1126 20160921
1725537	C20170005 00225	Estonia		PRODUCT NAME: ELUKSADOLIIN;REG NO/DATE: EU/1/16/1126 21.09.2016
1725537	C01725537/01	Switzerland		PRODUCT NAME: ELUXADOLIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66549 07.02.2018
1725537	PA2017005,C1725537	Lithuania		PRODUCT NAME: ELUKSADOLINAS ARBA JO FARMACINIU POZIURIU PRIIMTINAS ENANTIOMERAS, DIASTEREOMERAS, RACEMATAS ARBA DRUSKA; REGISTRATION NO/DATE: EU/1/16/1126 20160919
1725537	SPC/GB17/020	United Kingdom		PRODUCT NAME: ELUXADOLINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/16/1126/001-006 20160921

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.

Last updated: 2024-12-17