US Patent 9,205,076: Scope, Claims, Expiration, Orange Book Status and Eluxadoline Patent Landscape

US Patent No. 9,205,076 protects methods of using eluxadoline, the active ingredient in Viberzi, to treat or ameliorate diarrhea, visceral pain, and diarrhea-predominant irritable bowel syndrome. The patent is use-specific rather than a basic composition-of-matter patent. Its strongest commercial claims cover oral solid dosage forms containing approximately 50 mg to 200 mg of eluxadoline, particularly 75 mg or 100 mg tablets administered once or twice daily.

The patent was granted on December 8, 2015, and has a reported expiration date of March 26, 2030, subject to the patent-term calculation recorded in the USPTO file history. It is one component of the U.S. patent estate protecting Viberzi (eluxadoline). FDA approval of Viberzi was granted on May 27, 2015. The product also received five-year new chemical entity exclusivity, which expired in May 2020. Patent protection, rather than FDA exclusivity, is the primary remaining barrier to a conventional generic launch. [1-4]

What drug does US Patent 9,205,076 protect?

The compound identified in the claims is eluxadoline, a peripherally acting mixed opioid receptor ligand developed for irritable bowel syndrome with diarrhea, or IBS-D. Viberzi is the U.S. branded product.

The patent claims the compound by its chemical name rather than by the international nonproprietary name. The claimed molecule is:

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

The claims are directed to therapeutic administration of this compound in a pharmaceutical composition. They do not independently claim every possible use of eluxadoline, every manufacturing process, or the molecule as a chemical composition.

Key patent data

Item	Data
U.S. patent	US 9,205,076 B2
Title	Methods of treating diarrhea and visceral pain
Grant date	December 8, 2015
Applicant/assignee history	Furiex Pharmaceuticals and successors, including Allergan-related entities
Active ingredient	Eluxadoline
Branded product	Viberzi
Principal indication	IBS-D
FDA approval	May 27, 2015
Regulatory exclusivity	Five-year NCE exclusivity, expired May 2020
Reported patent expiration	March 26, 2030
Dosage forms emphasized	Solid dosage forms, especially tablets
Doses emphasized	Approximately 50 mg to 200 mg; specifically 75 mg and 100 mg
Dosing frequency	One to four administrations daily; specifically once or twice daily

What does claim 1 of US 9,205,076 cover?

Claim 1 covers a method of treating or ameliorating diarrhea or visceral pain by administering a pharmaceutical composition containing eluxadoline to a subject in need of treatment.

The claim has four core limitations:

A method of treatment.
A subject in need of treatment.
Administration of a pharmaceutical composition.
The composition contains the specified eluxadoline molecule.

The claim does not expressly require IBS-D, a tablet, a particular dose, or a particular administration frequency. Those limitations appear in dependent claims.

Claim 1 infringement theory

A product could potentially implicate claim 1 if it is marketed with instructions to administer eluxadoline for diarrhea or visceral pain. Direct infringement would generally focus on performance of the claimed method. Induced infringement risk would be more significant for a generic manufacturer whose labeling instructs patients or healthcare professionals to use eluxadoline for the patented indication.

A generic product containing eluxadoline would not necessarily infringe claim 1 merely because it contains the same active ingredient. The use instructions, promotional materials, and approved labeling would be central to the analysis.

How do claims 2 through 6 narrow the patent scope?

Claims 2 and 3 divide the treatment objective into diarrhea and visceral pain. Claims 4 through 6 narrow the patient population and indication to diarrhea-predominant irritable bowel syndrome.

Claim	Limitation
1	Diarrhea or visceral pain treated with an eluxadoline-containing composition
2	Treatment or amelioration of diarrhea
3	Treatment or amelioration of visceral pain
4	Subject has diarrhea-predominant IBS
5	Treatment of diarrhea in a subject with IBS-D
6	Treatment of visceral pain in a subject with IBS-D

Claims 4 through 6 are commercially important because Viberzi was approved for IBS-D. A generic applicant seeking a narrow label that omits IBS-D could reduce, but not automatically eliminate, method-of-use risk. The practical effect depends on the remaining indication language, prescribing behavior, promotional conduct, and any other listed patents.

What is the significance of the IBS-D limitations?

The IBS-D claims align closely with the FDA-approved use of Viberzi. That alignment gives the patent holder a stronger induced-infringement position against a generic label that expressly includes IBS-D.

The claims are narrower than a patent covering all uses of eluxadoline for gastrointestinal disorders. They do not expressly cover constipation-predominant IBS, inflammatory bowel disease, opioid-induced bowel dysfunction, or unrelated pain conditions.

What dosage and formulation features are protected?

Claims 8 through 24 create a layered formulation and dosing structure. The claims cover the active ingredient in a solid dosage form, tablets, specified dose ranges, excipient categories, specific excipients, and administration frequency.

Dosage-form claims

Claim 8 covers a solid dosage form.
Claim 9 narrows the solid dosage form to a tablet.
Claims 10 through 12 cover compositions containing approximately 50 mg to 200 mg, with specific claims to approximately 75 mg and 100 mg.

These claims map closely to the commercial Viberzi strengths of 75 mg and 100 mg tablets. [2]

Excipient and carrier claims

Claims 13 through 21 cover conventional oral solid-dose excipients, including:

Mannitol
Microcrystalline cellulose
Cross-linked polyvinylpyrrolidone
Silica
Magnesium stearate
Film coating
Starches
Lactose and sucrose-based diluents
Cellulosic binders
Sodium starch glycolate
Cross-linked sodium carboxymethylcellulose
Talc and silica glidants

Claim 21 is the most product-specific formulation claim. It covers a composition containing eluxadoline together with mannitol, microcrystalline cellulose, cross-linked polyvinylpyrrolidone, silica, magnesium stearate, and a film coating.

The excipient claims are narrower than claim 1, but they may be relevant to an ANDA applicant whose formulation materially tracks the branded tablet. A generic manufacturer can potentially design around a narrow excipient combination while still facing the broader method claims and other Orange Book-listed patents.

Dosing-frequency claims

Claim 22 covers one to four administrations per day.
Claim 23 covers once-daily administration.
Claim 24 covers twice-daily administration.

Viberzi labeling generally instructs administration twice daily before meals, subject to dose modification and patient-specific restrictions. [2] Claim 24 therefore has direct commercial relevance.

What is the scope of claim 7?

Claim 7, as reproduced, states that the eluxadoline compound “is” followed by no apparent additional limitation. On the supplied claim text, claim 7 is incomplete and does not provide a meaningful narrowing limitation.

The issued patent should be analyzed using the official USPTO patent document and prosecution history. If the issued version contains a completed chemical or stereochemical limitation that is missing from the supplied text, that limitation could materially affect claim scope. Based solely on the text provided, claim 7 is not independently interpretable as a complete substantive claim.

When does US Patent 9,205,076 lose exclusivity?

The reported expiration date for US 9,205,076 is March 26, 2030. The patent therefore extends beyond the May 2020 expiration of Viberzi’s five-year NCE exclusivity.

Exclusivity layer	Date
FDA approval of Viberzi	May 27, 2015
NCE exclusivity begins	May 27, 2015
NCE exclusivity ends	May 27, 2020
Reported expiration of US 9,205,076	March 26, 2030

The patent expiration date is not the same as the earliest possible ANDA approval date. A generic applicant could file an ANDA after the NCE exclusivity period ended, but approval and launch would depend on Orange Book-listed patents, Paragraph IV litigation, settlement terms, and any applicable 30-month stay.

What is the Orange Book status of Viberzi?

Viberzi is an FDA-approved small-molecule drug subject to the ANDA pathway. Its relevant patent estate has included composition, therapeutic-use, formulation, and related patent claims. FDA Orange Book listings are the operative source for determining which patents are formally listed against the reference product at a given time. [3]

The existence of a patent in the broader Viberzi family does not establish that every patent is currently Orange Book-listed. Conversely, an Orange Book-listed patent may create an ANDA certification and litigation risk even if it does not claim the active ingredient itself.

Orange Book and ANDA implications

A generic applicant generally must address each listed patent through one of the following:

Paragraph I certification, where no patent information is listed.
Paragraph II certification, where the patent has expired.
Paragraph III certification, where the applicant will wait for patent expiration.
Paragraph IV certification, where the applicant asserts that the patent is invalid, unenforceable, or not infringed.

For US 9,205,076, a Paragraph III certification would ordinarily delay approval until patent expiration if no successful challenge or settlement applies. A Paragraph IV certification could trigger patent litigation and a statutory 30-month stay under the Hatch-Waxman framework. [4]

Which companies are challenging Viberzi patents?

The public competitive risk is driven by ANDA applicants seeking approval for generic eluxadoline tablets. Generic development has involved the customary Hatch-Waxman issues: bioequivalence, label design, listed-patent certifications, and potential litigation involving the branded product owner and its patent portfolio.

A definitive company-by-company challenge list requires current FDA ANDA records and federal docket review. The claim set alone does not identify which applicants filed Paragraph IV certifications, whether litigation was commenced, or whether any settlement permits an earlier launch. On the information provided, the record supports analysis of the statutory challenge pathway but does not establish a complete current list of challengers or a final adjudication involving US 9,205,076.

What patent litigation affects US 9,205,076?

The principal litigation risk is a Hatch-Waxman action following a Paragraph IV certification. The likely issues would include:

Whether the ANDA label induces use for diarrhea or IBS-D.
Whether the generic product satisfies the claimed composition limitations.
Whether a tablet contains the claimed dose or excipient combination.
Whether the patent is valid under sections 102, 103, and 112.
Whether the patent is enforceable, including inequitable-conduct defenses.
Whether the patent owner can obtain a 30-month stay of approval.

The strongest infringement case would generally involve a generic label that expressly recites IBS-D, diarrhea treatment, 75 mg or 100 mg tablets, and twice-daily administration. A narrower label that omits the patented indication could reduce method-of-use exposure, but the risk may remain through other listed patents or induced-use evidence.

How strong is the patent estate for eluxadoline?

The estate is stronger as a layered portfolio than as a single-patent barrier. US 9,205,076 provides meaningful method-of-use protection, but it does not alone block every manufacture, sale, or use of eluxadoline.

Strengths

The core treatment claims track the approved IBS-D indication.
Dependent claims cover commercial strengths and twice-daily dosing.
Formulation claims may cover the branded tablet architecture.
The patent extends to 2030, well beyond NCE exclusivity.
Generic labeling creates potential induced-infringement exposure.

Limitations

The patent is not a pure composition-of-matter patent.
Claims are directed to methods involving administration.
Formulation claims may be designed around by changing excipients.
A generic applicant may pursue a restricted label.
The commercial product may be exposed to separate validity and noninfringement challenges against other family members.

The estate’s practical strength depends on the combination of Orange Book listings, claim differentiation among family members, prosecution-history estoppel, and the scope of any Paragraph IV settlement.

What generic launch scenarios exist for Viberzi?

Scenario 1: Launch after patent expiration

A generic manufacturer waits until the relevant listed patents expire. Under the reported timeline, US 9,205,076 would not block approval after March 26, 2030, although other listed patents must also be assessed.

Scenario 2: Paragraph IV launch after litigation

An ANDA applicant challenges the patent and prevails on invalidity, unenforceability, or noninfringement. Approval can occur before the nominal expiration date, subject to FDA requirements and any other unexpired patents.

Scenario 3: Settlement with an agreed entry date

The brand owner and generic applicant resolve litigation through a settlement establishing a permitted launch date. The settlement may include restrictions involving dosage strengths, indications, or authorized-generic arrangements.

Scenario 4: Carve-out or skinny label

The applicant removes patented indication language from the labeling. This approach may reduce liability under claims directed to IBS-D, but it must be consistent with FDA labeling rules and cannot eliminate liability if the marketed product encourages the patented use.

Does eluxadoline have biosimilar risk?

No. Eluxadoline is a chemically synthesized small molecule, not a biologic. The relevant competitive pathway is an ANDA for a generic drug under section 505(j) of the Federal Food, Drug, and Cosmetic Act, not a biosimilar application under the Biologics Price Competition and Innovation Act.

The commercial risk is therefore driven by generic entry, patent certifications, formulation design, and substitution rules rather than biosimilar interchangeability.

What manufacturing and geographic barriers remain?

US 9,205,076 does not principally protect the manufacture of eluxadoline. It protects specified therapeutic administration. A separate composition-of-matter, process, polymorph, salt, or formulation patent could create manufacturing barriers.

Geographically, this patent is enforceable only in the United States. Foreign patent families may contain different claims, expiration dates, prosecution histories, and regulatory linkages. A manufacturer with freedom to operate outside the United States could still face U.S. liability for importing, selling, or inducing use of the product in the United States.

Key Takeaways

US 9,205,076 is a method-of-use patent for eluxadoline, marketed as Viberzi.
Its central indication is diarrhea and visceral pain, particularly IBS-D.
Claims 8 through 24 add solid dosage, tablet, dose, excipient, and dosing-frequency limitations.
The commercial core is 75 mg and 100 mg oral tablets administered once or twice daily.
The reported patent expiration date is March 26, 2030.
Viberzi’s five-year NCE exclusivity expired in May 2020.
Generic competition proceeds through the ANDA and Paragraph IV framework, not the biosimilar pathway.
The patent is significant for induced-infringement risk but does not independently cover every manufacture or sale of eluxadoline.
Claim 7, as supplied, is incomplete and cannot be assigned a reliable narrowing scope without the complete issued text.
Generic launch timing will depend on the complete Orange Book portfolio, any Paragraph IV litigation, and settlement terms.

FAQs

Is US 9,205,076 a composition-of-matter patent for eluxadoline?

No. It is principally a method-of-treatment patent. It covers administration of an eluxadoline-containing pharmaceutical composition for diarrhea, visceral pain, and IBS-D.

Does a generic eluxadoline tablet automatically infringe US 9,205,076?

No. Infringement depends on the generic product, proposed labeling, dosage instructions, indication language, promotional conduct, and the specific claim limitations.

Are 75 mg and 100 mg eluxadoline tablets expressly covered?

Yes. Claims 11 and 12 expressly address compositions containing approximately 75 mg and approximately 100 mg of eluxadoline.

Can a generic manufacturer avoid the patent by using different excipients?

Potentially for the narrow formulation claims, but changing excipients would not necessarily avoid the broader method-of-use claims or other patents in the Viberzi estate.

Is Viberzi protected by FDA exclusivity after 2020?

No. The five-year NCE exclusivity period expired in May 2020. Continuing protection depends on patents and any applicable regulatory or litigation-related restrictions.

References

U.S. Patent and Trademark Office. (2015). U.S. Patent No. 9,205,076: Methods of treating diarrhea and visceral pain.
U.S. Food and Drug Administration. (2015). Viberzi prescribing information. Allergan USA, Inc.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
U.S. Food and Drug Administration. (2017). ANDA submissions: Amendments and supplements to ANDAs, approvals, and postapproval changes.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1725537	⤷ Start Trial	CA 2017 00008	Denmark	⤷ Start Trial
European Patent Office	1725537	⤷ Start Trial	300865	Netherlands	⤷ Start Trial
European Patent Office	1725537	⤷ Start Trial	PA2017005	Lithuania	⤷ Start Trial
European Patent Office	1725537	⤷ Start Trial	122017000009	Germany	⤷ Start Trial
European Patent Office	1725537	⤷ Start Trial	1790007-7	Sweden	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 9,205,076

Summary for Patent: 9,205,076