List of Excipients in Branded Drug OMVOH

« Back to Dashboard

Last updated: September 25, 2026

ecutive summary: Omvoh (mirikizumab-mrkz), Eli Lilly’s IL-23p19 monoclonal antibody, has a two-stage commercial formulation strategy: intravenous induction and subcutaneous maintenance. Its approved formulations use conventional excipients, including sucrose, polysorbate 80, histidine buffers, citrate buffers, and water for injection. The strongest commercial opportunities are therefore in qualified excipient supply, low-particle biologic processing, ready-to-use fill-finish, injection devices, and lifecycle reformulation rather than standalone excipient patent licensing. U.S. biologic exclusivity runs from Omvoh’s first licensure on October 26, 2023, to approximately October 26, 2035, before any pediatric extension. Patent expiry dates require a current, claim-level review of Lilly’s U.S. and foreign filings.

Omvoh Excipient Strategy, Formulation Patents, Exclusivity, and Commercial Opportunities

What is Omvoh and how is it formulated?

Omvoh is mirikizumab-mrkz, a humanized IgG4 monoclonal antibody targeting the p19 subunit of interleukin-23. Eli Lilly markets it for adults with moderately to severely active ulcerative colitis and Crohn’s disease who have had an inadequate response or intolerance to conventional or biologic treatment.[1,2]

The product uses intravenous induction followed by subcutaneous maintenance. The regimen differs by indication.

Indication	Induction	Maintenance	Main commercial implication
Ulcerative colitis	300 mg IV at Weeks 0, 4, and 8	200 mg SC every 4 weeks from Week 12	Lower-dose maintenance device and presentation
Crohn’s disease	900 mg IV at Weeks 0, 4, and 8	300 mg SC every 4 weeks from Week 12	Higher-dose induction and larger maintenance requirement

The U.S. label identifies the following excipient systems:

Presentation	Key excipients identified in the U.S. prescribing information	Formulation role
IV solution	Citric acid anhydrous, sodium citrate dihydrate, polysorbate 80, sucrose, water for injection	pH control, surfactant protection, tonicity and stabilization
SC injection	L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, water for injection	Histidine buffering, interfacial stabilization, protein protection and tonicity

The labeled SC product is supplied in single-dose prefilled syringes and prefilled pens. The IV product is supplied as a single-dose vial for dilution and infusion.[1]

What excipients are used in Omvoh?

Sucrose

Sucrose is a standard biologic stabilizer. It helps reduce antibody aggregation and protects the protein during freezing, thawing, shipping and storage. Its commercial value is tied less to chemical novelty than to pharmaceutical-grade supply, low bioburden, low endotoxin, traceability and consistent lot performance.

For Omvoh, a supplier competing for sucrose volume would need to satisfy Lilly’s qualified supplier system and demonstrate consistency across development and commercial lots. A technically equivalent food-grade or laboratory-grade material would not be sufficient.

Polysorbate 80

Polysorbate 80 reduces adsorption of mirikizumab to manufacturing equipment, containers and delivery-device surfaces. It also limits agitation-induced aggregation.

Polysorbate 80 is a major risk-control excipient for antibody products, but it has recognized degradation pathways, including hydrolysis and oxidation. Degradation can generate subvisible particles, free fatty acids and changes in product quality. Suppliers with strong control over peroxide levels, fatty-acid distribution, hydrolysis profile and batch-to-batch variability have a commercial advantage.

Potential opportunities include:

• Low-peroxide polysorbate 80 grades.
• Characterized and traceable pharmaceutical-grade material.
• Analytical packages for oxidation and hydrolysis.
• Supply agreements tied to commercial biologics manufacturing.
• Stabilization systems that reduce reliance on polysorbate 80.

A substitute surfactant would face a high regulatory barrier because any change could affect aggregation, immunogenicity, container compatibility and device performance.

Histidine buffer

The SC formulation uses histidine and histidine hydrochloride monohydrate as the buffer system. Histidine is common in monoclonal antibody formulations because it provides buffering near mildly acidic pH and can support protein stability.

The commercial opportunity is concentrated in high-purity, low-endotoxin histidine and histidine hydrochloride with validated pharmaceutical manufacturing controls. Histidine itself is unlikely to create a strong composition-of-matter barrier. The defensible value lies in specification control, supply reliability and qualification status.

Citrate buffer

The IV presentation uses citric acid and sodium citrate. Citrate is a conventional buffer for biologics and may support pH control during storage and dilution.

Citrate can create compatibility issues with some proteins, containers or administration systems. Any alternative buffer would require comparative stability, aggregation, particulate, potency and infusion-tolerability data.

Water for injection

Water for injection is a standard compendial component. It is essential to manufacturing but does not create meaningful product-level exclusivity. Commercial differentiation is limited to validated utility systems, quality compliance and manufacturing reliability.

What formulation strategy does Omvoh use?

Omvoh separates induction and maintenance into different delivery pathways:

1. A diluted IV solution for high-dose induction.
2. A ready-to-use SC injection for recurring maintenance.
3. A prefilled syringe and pen platform for home administration.

This strategy addresses the clinical need for rapid induction dosing while shifting long-term treatment to self-injection. It also creates several lifecycle-management options:

• Higher-concentration SC presentations.
• Fewer-device maintenance regimens.
• Larger-volume or lower-volume injection formats.
• Improved injection-force performance.
• Device systems designed for patients with inflammatory bowel disease-related dexterity limitations.
• Container-closure systems that reduce extractables, leachables and particle formation.
• Formulations with improved room-temperature handling, if supported by stability data.

The current excipient system is conservative and consistent with established monoclonal antibody practice. A competing excipient platform would need to deliver a clear benefit, such as improved stability, reduced injection volume, improved device compatibility or lower manufacturing cost.

What patents protect Omvoh and its formulation?

Omvoh’s protection is expected to involve several patent categories:

Patent category	Likely subject matter	Commercial relevance
Antibody composition	Mirikizumab sequence, structural variants or binding characteristics	Primary biologic protection
Target binding	Binding to IL-23 p19 or defined epitopes	May constrain biosimilar design-around strategies
Therapeutic use	Treatment of ulcerative colitis, Crohn’s disease or related inflammatory disorders	Method-of-use protection
Formulation	Stabilized antibody composition, pH, excipient concentration or storage conditions	May delay formulation substitution
Manufacturing	Cell culture, purification, viral clearance or product-quality control	Can raise biosimilar development costs
Delivery device	Pen, syringe, cartridge or administration system	Relevant to commercial substitution
Dosing regimen	Induction and maintenance schedules	Relevant to label-conforming competition

The FDA prescribing information does not provide a complete patent list. Because Omvoh is a biologic, its principal U.S. patent information is not presented through the small-molecule Orange Book framework. Biosimilar applicants follow the Biologics Price Competition and Innovation Act process, including the confidential patent-information exchange and related litigation procedures.[3]

A current patent-family search is required to identify individual U.S. patent numbers, earliest priority dates, terminal disclaimers, patent term adjustments, patent term extensions and foreign expiry dates. The public FDA sources cited here do not establish a reliable claim-level expiration table.

When does Omvoh lose regulatory exclusivity?

Omvoh received its first U.S. biologics license approval on October 26, 2023. The reference product therefore receives 12 years of reference-product exclusivity under the BPCIA, subject to statutory adjustments and any pediatric extension.[3,4]

Milestone	Date
First U.S. approval for ulcerative colitis	October 26, 2023
Earliest ordinary reference-product exclusivity endpoint	October 26, 2035
Crohn’s disease U.S. approval	January 15, 2025
New 12-year biologic exclusivity from Crohn’s expansion	No
Pediatric extension	Not included in the base date

The Crohn’s disease approval expands the label but does not restart the 12-year reference-product exclusivity period. Patent protection may extend beyond or expire before the regulatory exclusivity date, depending on the relevant patent families.

What is the Orange Book and Purple Book status of Omvoh?

Omvoh is a biologic, not a conventional small-molecule drug. It is therefore not expected to have a conventional Orange Book listing with small-molecule patent certifications.

Its relevant regulatory reference is the FDA Purple Book, which identifies licensed biological products and biosimilar or interchangeable relationships. The Purple Book does not function as a complete public substitute for a claim-by-claim patent register.[3]

Are Paragraph IV challenges available for Omvoh?

A conventional Paragraph IV abbreviated new drug application challenge is not the normal pathway for Omvoh. A biosimilar applicant would generally pursue a 351(k) application and address patent issues through the BPCIA framework.

That distinction affects generic-entry timing:

• Small-molecule generic applicants can file ANDAs with Paragraph IV certifications.
• Biosimilar applicants rely on comparative analytical, nonclinical and clinical evidence.
• Patent litigation may occur through BPCIA procedures rather than the standard Hatch-Waxman pattern.
• Interchangeability is a separate regulatory designation and is not automatic upon biosimilar approval.

What formulation patents could affect Omvoh competition?

Formulation patents could be important if they claim a specific combination of:

• Mirikizumab concentration.
• Histidine or citrate buffer concentration.
• Sucrose concentration.
• Polysorbate 80 level.
• pH range.
• Storage temperature.
• Container-closure system.
• Freeze-thaw stability.
• Aggregation or particle limits.
• SC injection volume or administration conditions.

These claims are commercially relevant even when the underlying excipients are old. A biosimilar sponsor may reproduce the active antibody while using a different formulation, provided the resulting product meets biosimilarity and product-quality requirements. A narrow formulation patent may therefore be design-aroundable, while a broad composition or antibody patent may present a greater barrier.

The strongest formulation claims would combine multiple parameters with demonstrated stability or administration advantages. A patent claiming only the use of sucrose, polysorbate 80 or histidine in conventional ranges would face greater validity and obviousness pressure than a claim tied to a specific antibody, concentration and unexpected stability result.

How strong is the Omvoh patent estate?

The estate should be assessed in layers rather than by patent count.

Stronger protection

The most commercially important layers are likely to be:

• Antibody sequence and binding claims.
• Claims covering the specific IL-23 p19 epitope.
• Broad therapeutic-use claims with clinically relevant patient populations.
• Manufacturing claims that are difficult to avoid without changing process performance.
• Long-dated patents with meaningful remaining term after regulatory approval.

More vulnerable protection

The following categories generally face higher design-around or validity risk:

• Conventional excipient combinations.
• Broad pH or concentration ranges.
• Routine buffer substitutions.
• Generic prefilled-pen architecture.
• Method-of-use claims that overlap heavily with known IL-23 treatment regimens.

Patent strength depends on claim scope, written description, enablement, prosecution history and prior art. Patent count alone is not a useful measure of entry risk.

Which companies are challenging Omvoh?

No Paragraph IV challenger is expected because Omvoh is a biologic. The relevant competitive threat is from biosimilar developers and from branded IL-23 competitors.

The competitive landscape includes:

Product	Sponsor	Mechanism or class	Competitive relevance
Omvoh	Eli Lilly	IL-23p19 antibody	IV induction plus SC maintenance
Skyrizi	AbbVie	IL-23p19 antibody	Major IBD and immunology competitor
Tremfya	Johnson & Johnson	IL-23p19 antibody	Competing IL-23 product with IBD expansion
Stelara	Johnson & Johnson	IL-12/23 antibody	Established biologic with biosimilar pressure
Entyvio	Takeda	Gut-selective integrin inhibitor	Alternative biologic for IBD
Rinvoq	AbbVie	JAK inhibitor	Oral small-molecule alternative

The largest commercial pressure is likely to come from branded products with established IBD positioning and from future biosimilar entrants targeting the broader IL-23 and IBD market.

What commercial opportunities exist in Omvoh excipients?

Excipient supply and qualification

The most immediate opportunity is supply into Lilly’s qualified commercial chain. Attractive products include pharmaceutical-grade:

• Polysorbate 80 with controlled peroxide and fatty-acid profiles.
• Sucrose with low endotoxin and strong lot consistency.
• Histidine and histidine hydrochloride with validated impurity controls.
• Citrate components with robust compendial compliance.

Supplier qualification can create recurring revenue, but switching barriers are high once a biologic process is validated.

Alternative surfactants

A low-particle, oxidation-resistant surfactant could have value if it improves stability without reducing potency or increasing immunogenicity. The commercial route would require comparability and likely a major formulation-development program.

Drug-device systems

Omvoh’s recurring SC maintenance regimen supports demand for:

• Prefilled syringes.
• Autoinjectors and pens.
• Low-force injection systems.
• Human-factors engineering.
• Device-compatible container-closure systems.
• Connected adherence platforms, subject to regulatory and privacy requirements.

The Crohn’s disease 300 mg maintenance dose creates a specific opportunity for higher-dose or lower-volume delivery systems.

Fill-finish and cold-chain services

A contract manufacturer with validated handling of monoclonal antibodies could compete for:

• IV vial filling.
• SC syringe and pen assembly.
• Labeling and packaging.
• Device combination-product operations.
• Temperature-controlled logistics.
• Particulate and container-closure testing.

Manufacturing barriers are operational rather than solely patent-based. Lilly’s process controls, analytics, release specifications and supplier qualification requirements are likely more important than the cost of the excipients themselves.

What litigation and settlement risks affect Omvoh?

A biologic entrant could face:

• BPCIA patent litigation.
• Antibody sequence or epitope disputes.
• Formulation patent claims.
• Manufacturing-process claims.
• Device patent disputes.
• Patent settlements that establish a delayed biosimilar launch date.

No settlement date or public Paragraph IV litigation framework should be assumed for Omvoh. The relevant launch analysis requires review of issued patents, BPCIA notices, district-court filings, Federal Circuit decisions and any licensed-entry agreements.

What is the generic or biosimilar launch risk?

The near-term risk is limited by Omvoh’s 12-year reference-product exclusivity, which reaches its base endpoint in 2035. Biosimilar launch timing could occur later if relevant patents remain enforceable or if a settlement delays entry.

The risk profile is:

Period	Entry risk	Main driver
Before 2035	Low from regulatory exclusivity alone	Patent litigation remains possible
Around 2035	Increasing	Biosimilar applications and patent challenges
After patent resolution	Material	Price competition and payer substitution
After interchangeability designation	Higher substitution risk	Pharmacy-level substitution may improve, subject to state law and payer policy

Biosimilar erosion may be slower than small-molecule generic erosion because biologics have complex manufacturing, payer controls, physician adoption issues and interchangeability requirements.

What is the geographic coverage of Omvoh protection?

The United States is the most important market for exclusivity analysis because of the BPCIA framework and Lilly’s U.S. launch. Europe, Japan, Canada and other jurisdictions apply different regulatory and patent rules.

A global excipient or formulation strategy should assess:

• U.S. biologic exclusivity.
• European supplementary protection certificate opportunities.
• National patent validation and opposition risk.
• Pediatric extensions.
• Data and market exclusivity outside the United States.
• Device and combination-product requirements.
• Local cold-chain and fill-finish capacity.

A formulation patent may have materially different enforceability and expiry dates across jurisdictions.

Key Takeaways

• Omvoh uses sucrose and polysorbate 80 in both product pathways, with histidine buffering in the SC formulation and citrate buffering in the IV formulation.
• The excipient system is conventional, so the main commercial value lies in quality, supply continuity, analytical control and qualification.
• The strongest adjacent opportunities are low-peroxide polysorbate 80, biologic-grade stabilizers, ready-to-use fill-finish, prefilled devices and higher-dose SC delivery.
• Omvoh’s first U.S. approval was October 26, 2023. Base reference-product exclusivity therefore runs to approximately October 26, 2035.
• Omvoh does not follow the conventional Orange Book and Paragraph IV pathway. Future competition will primarily involve 351(k) biosimilars and patent litigation under the BPCIA.
• Crohn’s disease approval does not restart the 12-year biologic exclusivity period.
• Exact patent expiry dates cannot be inferred from the FDA label. They require a current patent-family and claim-level analysis.

FAQs About Omvoh Excipients, Patents, and Market Entry

Does Omvoh contain polysorbate 80?

Yes. The IV and SC formulations use polysorbate 80 as a surfactant to reduce protein adsorption and aggregation.

What buffer is used in the Omvoh prefilled pen?

The SC formulation uses histidine and histidine hydrochloride monohydrate as the buffer system.

Can a biosimilar use different excipients from Omvoh?

Yes, a biosimilar may use a different formulation if it satisfies regulatory requirements and does not infringe enforceable patents. Any change must support comparability, stability, safety and device performance.

Is Omvoh interchangeable with another IL-23 biologic?

No. Biosimilarity or interchangeability is product-specific. Omvoh cannot be treated as interchangeable with another IL-23 antibody without the relevant regulatory designation.

Could Omvoh receive a new exclusivity period for Crohn’s disease?

No. The Crohn’s disease approval expands the indication but does not create a new 12-year reference-product exclusivity period.

References

1. U.S. Food and Drug Administration. (2025). Omvoh (mirikizumab-mrkz) prescribing information. Eli Lilly and Company.

2. U.S. Food and Drug Administration. (2025, January 15). FDA approves first treatment for moderately to severely active Crohn’s disease in adults: Omvoh (mirikizumab-mrkz).

3. U.S. Food and Drug Administration. (2024). Purple Book: Database of licensed biological products.

4. Biologics Price Competition and Innovation Act of 2009, 42 U.S.C. § 262.