ELUXADOLINE Drug Patent Profile

Which patents cover Eluxadoline, and when can generic versions of Eluxadoline launch?

Eluxadoline is a drug marketed by Aurobindo Pharma and Zydus Pharms and is included in two NDAs.

The generic ingredient in ELUXADOLINE is eluxadoline. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eluxadoline profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Eluxadoline

A generic version of ELUXADOLINE was approved as eluxadoline by AUROBINDO PHARMA on June 2^nd, 2026.

Summary for ELUXADOLINE

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	10
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ELUXADOLINE
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

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
Aurobindo Pharma	ELUXADOLINE	eluxadoline	TABLET;ORAL	213511-001	Jun 2, 2026	AB	RX	No	No
Zydus Pharms	ELUXADOLINE	eluxadoline	TABLET;ORAL	213522-002	Mar 14, 2025		DISCN	No	No
Aurobindo Pharma	ELUXADOLINE	eluxadoline	TABLET;ORAL	213511-002	Jun 2, 2026	AB	RX	No	No
Zydus Pharms	ELUXADOLINE	eluxadoline	TABLET;ORAL	213522-001	Mar 14, 2025		DISCN	No	No

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	Withdrawn	no	no	no	2016-09-19

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.

DrugChatter Q&A for ELUXADOLINE

Eluxadoline viberzi patent status?
Generic eluxadoline approved?