Eluxadoline - Generic Drug Details

What are the generic drug 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 fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Eluxadoline has one hundred and fifty-three 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:	153
US Patents:	14
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	10
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
Devintec Sagl	NA
Allergan	Phase 3
Temple University	Phase 2/Phase 3

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		RX	Yes	No			Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes			Y	Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015		RX	Yes	No			Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes			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
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015

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/004098Truberzi 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
Hungary	S1700011
Singapore	185941	NOVEL CRYSTALS AND PROCESS OF MAKING 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
Eurasian Patent Organization	201591768
Norway	338203

Supplementary Protection Certificates for eluxadoline

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725537	2017/007	Ireland		PRODUCT NAME: ELUXADOLINE OR A PHARMACEUTICALLY ACCEPTABLE ENANTIOMER, DIASTEREOMER, RACEMATE OR SALT THEREOF; 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
1725537	309 6-2017	Slovakia		PRODUCT NAME: ELUXADOLIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1126 20160921
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

Market Dynamics and Financial Trajectory of Eluxadoline

Last updated: March 5, 2026

What is the current market position of Eluxadoline?

Eluxadoline is a peripherally acting opioid receptor modulator approved by the U.S. Food and Drug Administration (FDA) in 2016 for irritable bowel syndrome with diarrhea (IBS-D). Its market presence remains limited due to competition, safety concerns, and prescribing patterns. The drug's global sales trajectory reflects modest growth, primarily driven by the North American market.

What are the key market drivers?

Prevalence of IBS-D

• Estimated global IBS prevalence ranges from 5% to 15%, with IBS-D comprising approximately 40% of cases.
• In the U.S., more than 7 million adults experience IBS-D symptoms annually (Lacy et al., 2021).

Unmet Medical Need

• Limited effective treatments with acceptable safety profiles.
• Eluxadoline presents an alternative to traditional antispasmodics and antidepressants used off-label.

Regulatory Landscape

• FDA approval in 2016.
• Market access varies; some regions have off-label restrictions due to safety concerns.

What are the current market challenges?

Safety and Side Effects

• Risks of pancreatitis, particularly in patients without a gallbladder.
• Black box warning issued in 2017; restricted use.

Market Penetration and Physician Adoption

• Limited by safety concerns and risk management programs.
• Prescriptions in the U.S. peaked at approximately 600,000 units in 2018 and declined afterward (IQVIA data, 2022).

Competitive Environment

• Availability of other IBS-D treatments: rifaximin, eluxadoline faces competition.
• Emerging drugs with better safety profiles or novel mechanisms in development.

What is the financial trajectory?

Year	Estimated U.S. Sales	Global Sales	Notes
2017	$150 million	$200 million	Launch year; initial adoption
2018	$160 million	$210 million	Sales plateaued due to safety warnings
2019	$120 million	$170 million	Decline in prescriptions; safety concerns persist
2020	$110 million	$160 million	Slight decrease as prescribing remains cautious
2021	$100 million	$150 million	Continued cautious outlook

Growth Outlook

• Limited growth expected without new formulations or expanded indications.
• Potential revival depends on safety profile improvements or additional labeling for new indications.

What are future market prospects?

Development of Next-Gen Formulations

• Modified formulations aiming to reduce adverse effects.
• Extended-release versions or combination therapies.

Regulatory Expansion

• Investigations into additional indications such as opioid-induced bowel dysfunction.
• Filing of new indications could expand the market.

Market Expansion

• Entering European, Asian, and Latin American markets remains slow, constrained by regulatory hurdles and safety concerns.

What is the impact of patent periods and generic entry?

• Patent protection expires in 2024.
• Expected generic competition could significantly reduce prices, impacting sales volume and revenue.
• Similar drugs' market trends suggest substantial price erosion after patent expiry.

Key takeaways

• Eluxadoline has carved a niche in IBS-D treatment but faces limited growth due to safety issues, market penetration barriers, and competition.
• Revenue peaked early, with a gradual decline reflecting prescribing hesitations.
• Future growth hinges on addressing safety concerns and expanding indications.
• Patent expiration in 2024 suggests potential revenue decline unless new formulations or indications emerge.
• Market expansion outside the U.S. remains contingent on regulatory approvals and safety profile considerations.

FAQs

1. What factors limit Eluxadoline's market growth?
Safety concerns, particularly pancreatitis risk, and a restricted prescribing scope significantly limit growth.

2. How does Eluxadoline compare with other IBS-D treatments?
It offers a unique mechanism but faces competition from rifaximin and emerging drugs with better safety profiles.

3. What is the expected impact of patent expiration?
Generic entry in 2024 is likely to lead to price erosion and reduced sales unless new indications or formulations are approved.

4. Are there ongoing clinical trials for new indications?
Yes, trials are underway for opioid-induced bowel dysfunction and other off-label uses, which could impact future market potential.

5. What strategic options exist for companies marketing Eluxadoline?
Focus on safety profile improvements, pursue additional indications, and explore international regulatory pathways.

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References

1. Lacy, B. E., et al. (2021). Diagnosis and management of irritable bowel syndrome in adults. UpToDate.
2. IQVIA, (2022). Pharmaceutical sales analysis.
3. U.S. Food and Drug Administration. (2016). FDA approves Eluxadoline for IBS-D.
4. U.S. Food and Drug Administration. (2017). Black box warning for Eluxadoline.