List of Excipients in Branded Drug OGSIVEO

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
SpringWorks Therapeutics Inc	OGSIVEO	nirogacestat	82448-050	CELLULOSE, MICROCRYSTALLINE	2042-07-08
SpringWorks Therapeutics Inc	OGSIVEO	nirogacestat	82448-050	FD&C YELLOW NO. 6	2042-07-08
SpringWorks Therapeutics Inc	OGSIVEO	nirogacestat	82448-050	FERRIC OXIDE YELLOW	2042-07-08
SpringWorks Therapeutics Inc	OGSIVEO	nirogacestat	82448-050	GLYCERYL MONOCAPRYLOCAPRATE	2042-07-08
SpringWorks Therapeutics Inc	OGSIVEO	nirogacestat	82448-050	LACTOSE MONOHYDRATE	2042-07-08
SpringWorks Therapeutics Inc	OGSIVEO	nirogacestat	82448-050	MAGNESIUM STEARATE	2042-07-08

Ogsiveo Excipient Strategy and Commercial Opportunities

Last updated: August 12, 2026

Ogsiveo (nirogacestat) is an immediate-release, film-coated tablet approved by the FDA in November 2023 for adults with desmoid tumors requiring systemic treatment. Its excipient profile is conventional and creates limited differentiation through the marketed product alone. The strongest commercial opportunities are in high-quality generic excipient supply, lactose-free or low-moisture reformulation, global formulation transfer, pediatric or geriatric dosage forms, and manufacturing services for nirogacestat products.

What excipients are used in Ogsiveo tablets?

Ogsiveo contains nirogacestat, a gamma secretase inhibitor, in 50 mg and 100 mg tablets. The FDA labeling identifies the following inactive ingredients:

Formulation element	Reported excipient or material	Likely function
Tablet core	Lactose monohydrate	Diluent and compressibility aid
Tablet core	Microcrystalline cellulose	Diluent, dry binder and tablet-strength enhancer
Tablet core	Croscarmellose sodium	Superdisintegrant
Tablet core	Magnesium stearate	Lubricant
Film coating	Polyvinyl alcohol	Film-forming polymer
Film coating	Titanium dioxide	Opacifier and colorant
Film coating	Polyethylene glycol	Plasticizer
Film coating	Talc	Anti-tacking agent and coating aid

The exact quantitative composition, excipient grades, particle-size specifications and manufacturing process parameters are generally not disclosed in the public prescribing information. The formulation is consistent with a conventional immediate-release tablet rather than an extended-release, lipid-based, amorphous solid-dispersion or multiparticulate delivery system. [1]

Why is the Ogsiveo excipient system commercially important?

The formulation uses widely available excipients with established compendial histories. That reduces supply-chain barriers for an ANDA applicant or contract manufacturer. It also limits the originator's formulation differentiation because a generic manufacturer can usually select functionally equivalent grades, subject to pharmaceutical equivalence, dissolution, stability and bioequivalence requirements.

The main formulation variables are likely to be:

• Lactose grade and particle-size distribution
• Microcrystalline cellulose grade and bulk density
• Croscarmellose sodium substitution level
• Magnesium stearate blending time
• Granulation versus direct-compression processing
• Film-coating weight gain
• Moisture exposure during manufacture and storage

These variables can affect tablet hardness, disintegration, dissolution, friability, assay uniformity and stability.

How does nirogacestat’s drug-product formulation affect excipient selection?

Nirogacestat is administered orally as a tablet. The approved dosage is 150 mg twice daily, with dose interruptions or reductions used for toxicity management. The 50 mg and 100 mg strengths support dose modification without requiring tablet splitting. [1]

The dosage creates a practical formulation requirement: tablets must deliver consistent performance across multiple strengths while maintaining a compact size and acceptable mechanical strength. A conventional lactose-cellulose system can support that objective.

Immediate-release performance

A superdisintegrant such as croscarmellose sodium is central to rapid tablet breakup. Its performance depends on:

• Intra-tablet distribution
• Compression force
• Granule porosity
• Lubricant exposure
• Storage humidity
• Excipient particle morphology

Excessive magnesium stearate or prolonged lubrication can reduce wettability and slow dissolution. A generic formulation that matches assay and tablet appearance but produces slower dissolution could face comparative dissolution or bioequivalence risk.

Film-coating requirements

The film coat must protect the tablet, support identification of the two strengths and control handling during packaging. Polyvinyl alcohol, polyethylene glycol, titanium dioxide and talc are standard coating materials. The commercial opportunity is greater for coating-system suppliers than for novel excipient developers because the product does not appear to require a proprietary delivery technology.

Stability and packaging

The likely stability priorities are moisture control, chemical degradation, dissolution drift and coating integrity. Excipient suppliers can compete through:

• Low-moisture lactose and microcrystalline cellulose grades
• Controlled peroxide and metal-ion levels
• Consistent particle-size distributions
• High-purity magnesium stearate
• Ready-to-use film-coating systems
• Technical support for scale-up and process validation

Aluminum-aluminum blister packaging, high-barrier bottles or desiccant-containing bottles may be evaluated depending on stability data and regional packaging requirements. The selected packaging system can influence the commercial value of a low-moisture excipient platform.

What formulation opportunities exist for Ogsiveo competitors?

The highest-probability opportunities involve incremental reformulation rather than a new delivery platform.

Lactose-free nirogacestat tablets

The marketed product uses lactose monohydrate. A lactose-free generic could replace lactose with combinations such as:

• Mannitol
• Dibasic calcium phosphate
• Pregelatinized starch
• Additional microcrystalline cellulose
• Compressible polyols

A lactose-free formulation could support procurement from hospitals and distributors with lactose-avoidance policies. It would not automatically create a regulatory advantage, but it could differentiate a generic in institutional tenders and selected international markets.

The principal technical risks are altered dissolution, tablet weight, hygroscopicity, mouthfeel and compression behavior. Mannitol-based systems may improve sensory properties but can require process optimization because of brittleness and segregation.

Low-moisture and high-stability formulations

A low-moisture formulation may reduce dependence on intensive packaging, though any claim would require comparative stability data. Potential strategies include:

• Partially replacing lactose with anhydrous fillers
• Using low-moisture microcrystalline cellulose
• Tightening excipient water specifications
• Applying a more robust film coat
• Optimizing blister or bottle protection

This approach is commercially relevant in tropical markets, where storage conditions can increase distribution costs and product-loss risk.

Smaller tablets and swallowability

Patients with desmoid tumors may require chronic treatment and may experience gastrointestinal adverse reactions. A smaller tablet, smoother coating or alternative tablet geometry could improve acceptability. The 150 mg twice-daily regimen creates room for commercial development of:

• Higher-strength tablets
• Combination dose packs
• Unit-dose adherence packaging
• Smaller 50 mg tablets for titration
• Oral suspensions or dispersible tablets for patients with swallowing difficulty

A higher-strength tablet would require clinical, safety and regulatory evaluation. It could also affect dosing flexibility and toxicity management.

Pediatric and geriatric dosage forms

Ogsiveo is approved for adults. A pediatric formulation could be commercially relevant if clinical development expands into younger patients or if desmoid tumor treatment guidelines broaden. Potential formats include:

• Oral granules
• Powder for suspension
• Mini-tablets
• Dispersible tablets
• Oral liquid formulations

Nirogacestat’s pharmacokinetic behavior, taste, dose-volume requirements and stability in aqueous media would determine feasibility. A liquid formulation could require preservatives, buffering agents, viscosity modifiers and flavor systems not used in the marketed tablet.

What generic entry risks exist for Ogsiveo?

Ogsiveo is a small-molecule product, so generic competition would proceed through the ANDA pathway rather than a biosimilar pathway. An ANDA applicant would generally need to demonstrate pharmaceutical equivalence and bioequivalence, while addressing any listed patents and regulatory exclusivity. [2]

Entry factor	Assessment
Product type	Small-molecule immediate-release tablet
Likely pathway	ANDA
Biosimilar risk	Not applicable
Formulation complexity	Low to moderate
Excipient barrier	Low
Bioequivalence burden	Manageable but strength- and dissolution-dependent
Manufacturing barrier	Moderate for controlled-content and scale-up consistency
Orphan exclusivity	Seven years from FDA approval for the protected indication
NCE exclusivity	Five years if awarded as a new chemical entity
Paragraph IV exposure	Depends on listed patents and applicant certification
Commercial market size	Concentrated, specialist oncology market

The FDA granted Ogsiveo orphan-drug approval for desmoid tumors. Orphan-drug exclusivity generally protects the approved indication for seven years from approval, subject to statutory exceptions. The protection period therefore runs approximately through November 2030 for the approved indication. [1][3]

A five-year new chemical entity exclusivity period, if applicable, would run approximately through November 2028. Orphan exclusivity would remain the more commercially relevant regulatory barrier for the approved indication after that date.

What is the Orange Book status of Ogsiveo?

The Orange Book is the key source for determining whether FDA-listed patents cover Ogsiveo and which expiration dates apply to an ANDA applicant. Listed patents may cover the active ingredient, drug product, formulation or approved methods of use. [2]

The commercial significance of an Orange Book listing depends on:

1. The patent's expiration date.
2. Whether the patent is eligible for listing.
3. Whether the patent covers the approved indication or product.
4. Whether pediatric or patent-term extensions apply.
5. Whether a generic applicant files a Paragraph IV certification.
6. Whether the patent owner brings suit within the statutory litigation window.

For Ogsiveo, the most relevant patent risks are likely to involve nirogacestat composition-of-matter rights, crystalline or salt forms, pharmaceutical compositions, dosing regimens and methods of treating desmoid tumors. Excipient substitutions generally do not avoid a composition-of-matter or method-of-use patent.

A generic applicant could pursue a Paragraph III certification, a Paragraph IV certification or a section viii statement that omits a patented method of use. The appropriate strategy depends on the scope and remaining term of each listed claim. [2]

What happens after a Paragraph IV challenge?

If the patent holder files an infringement action within 45 days of receiving a Paragraph IV notice, FDA approval of the ANDA may be stayed for up to 30 months, subject to statutory exceptions and court developments. A first successful Paragraph IV challenger may receive 180 days of generic exclusivity, depending on the filing and forfeiture provisions. [2]

For an indication-specific product such as Ogsiveo, a section viii carve-out may be commercially important. A generic could seek approval for non-patented uses if the FDA labeling permits the protected method of use to be omitted. That strategy would not remove infringement risk if the product is actively marketed for the patented indication.

When does Ogsiveo lose exclusivity?

Protection	Approximate date or duration	Commercial effect
FDA approval	November 27, 2023	Commercial launch begins
Orphan-drug exclusivity	Approximately November 27, 2030	Blocks approval of the same drug for the same indication, subject to exceptions
Five-year NCE exclusivity, if applicable	Approximately November 27, 2028	Restricts ANDA and 505(b)(2) filings during the exclusivity period
Patent protection	Patent-specific	May extend beyond regulatory exclusivity
Pediatric extension	Potential six months if awarded	Depends on completion of an FDA written-request program

Regulatory exclusivity and patent protection operate independently. Patent expiration does not necessarily end orphan exclusivity, and orphan exclusivity does not eliminate patents covering other uses, formulations or manufacturing processes.

Which companies are positioned to challenge Ogsiveo?

The most likely challengers are established generic manufacturers with oncology portfolios, high-potency oral-solid-dose capabilities and experience with Paragraph IV litigation. Potential participants in the competitive field include large generic companies, specialty generic manufacturers and regional suppliers in Europe, Canada, Japan and emerging markets.

The strongest generic candidates are likely to have:

• Existing FDA-approved oral oncology manufacturing
• High-containment production capacity
• Experience with low-volume, high-value products
• Regulatory infrastructure for complex patent certifications
• Commercial access to specialist oncology distributors
• Ability to launch with limited inventory before exclusivity expires

The market is unlikely to attract a large number of immediate generic entrants because desmoid tumors are rare and treatment is concentrated among specialist centers. A smaller market can still support competition when the branded price is high and the formulation is uncomplicated.

How strong is the Ogsiveo formulation and excipient patent estate?

The marketed excipient system appears technically conventional. That suggests a limited standalone barrier from excipient selection. The more durable protection is likely to come from:

• Nirogacestat composition-of-matter patents
• Salt or polymorph claims
• Drug-product claims
• Dosing and treatment-method patents
• Combination-treatment claims
• Manufacturing or purification claims

An excipient patent would be commercially important only if it claims a necessary formulation feature or a clinically meaningful performance advantage. A generic can often avoid a narrow formulation patent by changing the filler, binder, lubricant, coating system or process, provided that the resulting product remains bioequivalent and meets quality requirements.

The formulation estate is therefore best classified as a moderate barrier, while composition-of-matter and method-of-use rights may determine the timing of generic entry.

What commercial opportunities exist for excipient suppliers?

Direct supply to branded and generic manufacturers

The most immediate opportunity is supply of pharmaceutical-grade lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate and film-coating materials. Supplier differentiation will depend on:

• Multi-site manufacturing
• Reliable oncology-grade documentation
• Tight elemental impurity controls
• Low bioburden and low endotoxin profiles where relevant
• Consistent lot-to-lot functionality
• Regional regulatory support
• Supply continuity for small-volume products

Co-development with generic manufacturers

Excipient companies can support generic development through formulation screening, design-of-experiments work, dissolution matching, scale-up and stability studies. The value is highest when the supplier can provide a complete platform rather than a commodity material.

A ready-to-use film coat or direct-compression excipient blend could shorten development timelines. It could also reduce process variability across manufacturing sites.

International lifecycle management

A global formulation-transfer program may require adaptation for regional excipient monographs, local labeling, climate-zone stability and packaging standards. Suppliers with compendial coverage across USP-NF, Ph. Eur., JP and other national standards can reduce regulatory friction.

Specialty formulations

The largest longer-term opportunity would be a clinically justified oral liquid, dispersible tablet or pediatric formulation. These products could create new intellectual property around:

• Taste masking
• Suspension stability
• Dose uniformity
• Reconstitution
• Preservative systems
• Low-volume administration
• Storage and in-use stability

Such products would carry greater development risk than a conventional generic tablet but could support differentiated licensing or 505(b)(2) strategies.

How does Ogsiveo compare with other rare-disease oral oncology products?

Ogsiveo has a relatively accessible drug-product profile compared with oral oncology products that use modified-release systems, lipid formulations or highly specialized delivery technologies.

Attribute	Ogsiveo	Complex oral oncology product
Dosage form	Immediate-release tablet	Often modified-release or specialized capsule
Excipient complexity	Conventional	Moderate to high
Generic formulation barrier	Low to moderate	Moderate to high
Patient population	Rare disease	May be rare or broader
Commercial volume	Limited	Variable
Price sensitivity	High because of specialty pricing	High
Main IP risk	Active ingredient and use patents	Product, process and delivery patents

The commercial case for Ogsiveo depends less on technical excipient exclusivity and more on the timing of regulatory and patent expiry, branded pricing, distributor access and the ability to serve specialist prescribers.

What litigation and settlement issues affect Ogsiveo?

Publicly reported information through June 2024 did not establish a major publicly disclosed Paragraph IV litigation campaign involving Ogsiveo. That status can change when ANDA filings occur and patent notices become public through court dockets or FDA-related disclosures.

Potential settlement terms in a future Ogsiveo patent dispute could include:

• Licensed generic entry before patent expiry
• Authorized generic supply
• Restrictions on the approved indication
• Delayed entry tied to regulatory exclusivity
• Geographic launch rights
• Royalty-bearing commercialization
• Manufacturing or supply agreements

For a rare-disease product, settlement economics may be more attractive than prolonged litigation if projected patient volume is modest but the branded price is high.

Key Takeaways

• Ogsiveo is a conventional immediate-release nirogacestat tablet in 50 mg and 100 mg strengths.
• Its disclosed excipients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate and standard film-coating materials.
• The excipient system creates limited standalone patent or manufacturing barriers.
• Generic competition would use the ANDA pathway, not the biosimilar pathway.
• Orphan exclusivity for the approved desmoid-tumor indication runs approximately through November 2030.
• The principal IP risks are likely active-ingredient, drug-product, dosing and method-of-use patents.
• The strongest excipient opportunities are low-moisture materials, lactose-free formulations, ready-to-use coating systems and generic-development support.
• Pediatric, liquid and dispersible formulations offer higher differentiation but carry greater development and regulatory risk.
• Commercial entry will depend more on exclusivity and patent timing than on the complexity of the marketed excipient system.

FAQs

Can Ogsiveo tablets be reformulated without lactose?

Yes. A generic or 505(b)(2) developer could evaluate mannitol, dibasic calcium phosphate, starch-based fillers or higher levels of microcrystalline cellulose. The substitute formulation would need to demonstrate acceptable quality, dissolution, stability and bioequivalence.

Does Ogsiveo require a biosimilar development program?

No. Nirogacestat is a small molecule. A competing product would generally be developed as an ANDA generic or, for a differentiated product, a 505(b)(2) application.

Could an excipient supplier obtain patent protection around a nirogacestat formulation?

Potentially, but broad protection would be difficult if the formulation uses conventional excipients. Stronger claims would require a non-obvious composition with demonstrated stability, bioavailability, manufacturability or patient-use benefits.

Is a nirogacestat oral suspension commercially attractive?

It could be attractive for patients with swallowing difficulty or future pediatric use. The main development issues would be taste, suspension uniformity, chemical stability, preservative compatibility and dosing accuracy.

What is the most realistic near-term commercial opportunity around Ogsiveo excipients?

The most realistic opportunity is supply and technical support for generic or international tablet manufacturers using robust direct-compression excipients, controlled-moisture raw materials and ready-to-use film-coating systems.

References

1. U.S. Food and Drug Administration. (2023). Ogsiveo (nirogacestat) prescribing information. SpringWorks Therapeutics, Inc.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files

3. U.S. Food and Drug Administration. (2024). Orphan drug designations and approvals database. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/