List of Excipients in Branded Drug DAURISMO

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Pfizer Laboratories Div Pfizer Inc	DAURISMO	glasdegib	0069-0298	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	2036-04-13
Pfizer Laboratories Div Pfizer Inc	DAURISMO	glasdegib	0069-0298	CELLULOSE, MICROCRYSTALLINE	2036-04-13
Pfizer Laboratories Div Pfizer Inc	DAURISMO	glasdegib	0069-0298	FERRIC OXIDE RED	2036-04-13
Pfizer Laboratories Div Pfizer Inc	DAURISMO	glasdegib	0069-0298	FERRIC OXIDE YELLOW	2036-04-13
Pfizer Laboratories Div Pfizer Inc	DAURISMO	glasdegib	0069-0298	HYPROMELLOSE	2036-04-13

DAURISMO Excipient Strategy and Commercial Opportunities

Last updated: August 26, 2026

Daurismo (glasdegib) is an oral, immediate-release small-molecule tablet marketed by Pfizer for newly diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older, or adults with comorbidities that preclude intensive induction chemotherapy, in combination with low-dose cytarabine. The excipient opportunity is centered on generic substitution, supply-chain resilience, taste and swallowability improvements, dose flexibility, and differentiated oral oncology packaging rather than a new-drug formulation platform.

Public FDA labeling identifies a conventional tablet formulation with widely available pharmaceutical excipients. That profile lowers manufacturing barriers for an ANDA applicant but leaves room for commercial differentiation through equivalent-release performance, smaller tablets, packaging, adherence support, and regional sourcing strategies. [1]

What is Daurismo and how is it administered?

Daurismo contains glasdegib, a hedgehog pathway inhibitor that inhibits Smoothened. The FDA-approved regimen is 100 mg orally once daily in combination with low-dose cytarabine. Daurismo is supplied as 25 mg and 100 mg tablets, creating an opportunity for dose modification without extemporaneous compounding. [1]

Attribute	Daurismo profile
Active ingredient	Glasdegib
Brand owner	Pfizer
FDA application	NDA 210656
Initial U.S. approval	November 21, 2018
Dosage form	Immediate-release oral tablet
Strengths	25 mg and 100 mg
Approved use	Newly diagnosed AML in adults unsuitable for intensive chemotherapy
Administration	Oral, once daily
Combination partner	Low-dose cytarabine
Regulatory pathway	FDA approval based on clinical benefit-risk data; AML indication carries orphan-drug relevance
Generic pathway	ANDA, not a biosimilar application

The target population is clinically fragile and often treated through hematology clinics, hospitals, specialty pharmacies, or home-based oral oncology programs. These settings place a premium on dose accuracy, packaging integrity, renal and hepatic dose-management support, and reliable supply.

What excipients are used in Daurismo tablets?

FDA labeling describes Daurismo as containing standard tablet-core and film-coating materials. The principal inactive ingredients listed in public product information include lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone, and magnesium stearate. The film coating includes conventional coating polymers and mineral or color components. [1,2]

Formulation function	Publicly identified or typical Daurismo excipient	Commercial relevance
Diluent and filler	Lactose monohydrate	Low cost, broad supplier base, established compendial status
Structural filler	Microcrystalline cellulose	Supports tablet compression and mechanical strength
Disintegrant	Sodium starch glycolate	Controls tablet breakup and dissolution
Binder	Povidone	Supports granulation and tablet integrity
Lubricant	Magnesium stearate	Controls ejection and manufacturing friction
Film coating	Polymer-based coating system with mineral and color components	Supports identification, protection, and handling

The available public formulation data do not indicate a complex lipid system, modified-release matrix, drug-resin complex, nanocrystal platform, or device-dependent delivery system. That makes the product technically accessible to conventional solid-dose manufacturers.

What excipient strategy is appropriate for a Daurismo generic?

A generic developer should prioritize Q1/Q2 alignment, dissolution robustness, tablet manufacturability, and supply continuity. The most defensible strategy is a conservative formulation that matches the reference product's excipient functions while reducing manufacturing variability.

1. Preserve immediate-release performance

Sodium starch glycolate and microcrystalline cellulose should be evaluated as a coordinated disintegration system. Excessive lubricant exposure, over-compression, or high binder levels could slow dissolution and create bioequivalence risk.

Development work should focus on:

• Disintegration time across compression-force ranges.
• Dissolution in multiple pH media.
• Sensitivity to magnesium stearate blending time.
• Granule or direct-compression uniformity.
• Tablet hardness after accelerated stability.
• Glasdegib content uniformity at the 25 mg strength.

The 25 mg tablet presents the greater content-uniformity challenge because the active ingredient represents a smaller proportion of the tablet mass. A formulation that uses the same proportional excipient system for both strengths may require separate process controls.

2. Evaluate lactose-free alternatives

Lactose is commercially efficient, but a lactose-free platform could support procurement flexibility and a differentiated label claim where legally and commercially useful. Potential alternatives include mannitol, anhydrous dibasic calcium phosphate, or additional microcrystalline cellulose.

The commercial value of a lactose-free version is limited unless it also improves tablet size, moisture stability, or patient acceptability. A substitution that changes bulk density or compaction behavior could create a larger development burden than the market benefit justifies.

3. Reduce moisture and process sensitivity

AML patients may receive treatment over prolonged periods and may store medication at home. A formulation developer should assess:

• Moisture uptake of the tablet core.
• Coating performance under high humidity.
• Blister versus bottle packaging.
• Desiccant requirements.
• Stability after repeated container opening.
• Extractables and leachables from packaging systems.

The most practical commercial improvement may be packaging rather than a new excipient. Unit-dose blistering can support adherence, reduce handling, and improve protection from humidity. Bottles remain less expensive and may be preferred by some specialty-pharmacy channels.

4. Optimize swallowing and tablet burden

Patients with AML can experience mucositis, nausea, fatigue, and difficulty swallowing. A smaller tablet, lower tablet mass, or smoother film coating could provide a meaningful product advantage. Any redesign must maintain the reference product's dissolution profile and avoid creating a clinically meaningful difference in administration.

A scored 100 mg tablet could improve dose adjustment, but score-line performance would need to be demonstrated. Dose modification may involve interruption, reduction, or discontinuation rather than routine tablet splitting, so the value of a scored design depends on the approved labeling and physician practice.

What formulation patents protect Daurismo?

Daurismo is a small-molecule product, so patent risk primarily involves compound, salt, polymorph, formulation, manufacturing, and method-of-use patents. It does not face biosimilar competition because glasdegib is not a biologic.

Publicly available FDA materials identify the product and its regulatory status but do not establish that every technical formulation concept is commercially blocking. A freedom-to-operate review should separate:

1. Glasdegib compound claims.
2. Specific crystalline or salt forms.
3. Tablet formulations.
4. Processes for making glasdegib or intermediates.
5. Combination treatment with low-dose cytarabine.
6. AML treatment methods and patient-selection claims.
7. Patent-term adjustments, patent-term extensions, and Orange Book listings.

The key risk for an ANDA applicant is usually the active-ingredient and method-of-use estate, not the use of common excipients such as lactose, cellulose, povidone, sodium starch glycolate, or magnesium stearate. A conventional excipient substitution may reduce exposure to formulation claims but does not avoid compound or method claims.

When does Daurismo lose exclusivity?

Daurismo received FDA approval in 2018. Small-molecule exclusivity periods and patent rights must be analyzed separately.

Exclusivity category	Daurismo implication
New chemical entity exclusivity	Generally five years from approval for an eligible new chemical entity
Orphan-drug exclusivity	Seven years may apply to the approved orphan indication
Patent exclusivity	Depends on issued claims, expiration dates, terminal disclaimers, and patent-term adjustments
Pediatric exclusivity	Adds six months only if FDA-granted pediatric studies satisfy statutory requirements
Generic pathway	ANDA with Paragraph IV certification where listed patents remain relevant
Biosimilar pathway	Not applicable

The earliest possible generic entry date cannot be determined from approval date alone. It depends on the current Orange Book listing, patent expiration dates, any pediatric extension, litigation, and the terms of any settlement agreement. FDA's Orange Book remains the controlling source for listed patents and exclusivity status. [3]

What is the Orange Book status of Daurismo?

The Orange Book should be reviewed for NDA 210656 and the glasdegib tablet strengths. The relevant questions are whether Pfizer has listed patents for the product, whether those patents cover the drug substance, formulation, or method of use, and whether any listed patents have expired or been delisted. [3]

For an ANDA sponsor, the strategic sequence is:

1. Confirm all listed patents for the 25 mg and 100 mg tablets.
2. Map each patent claim against the proposed formulation and labeling.
3. Determine whether Paragraph III, Paragraph IV, or Section viii certification is appropriate.
4. Monitor FDA patent-list updates and litigation filings.
5. Model a commercial launch date after the earliest valid exclusivity barrier.

A Section viii carve-out may be relevant for method-of-use claims if the generic label can omit the protected use while retaining a permissible indication. That analysis is highly claim-specific.

Which companies are challenging Daurismo?

Publicly confirmed commercial challenges should be determined from ANDA litigation records, FDA filing activity, and federal court dockets. No biosimilar sponsor can challenge Daurismo because the product is not biologic. Potential generic competition would come from ANDA applicants, contract development and manufacturing organizations, and vertically integrated generic manufacturers.

The absence of a public litigation event does not establish the absence of Paragraph IV activity. Paragraph IV notices are directed to the patent owner and NDA holder, and a lawsuit may follow within the statutory period. A commercial diligence review should monitor the District of Delaware, District of New Jersey, and other venues commonly used in Hatch-Waxman cases.

How strong is the Daurismo patent estate?

The technical formulation estate appears less difficult to design around than the drug-substance and clinical-use estate. A conventional immediate-release tablet can be reproduced with alternative fillers, binders, disintegrants, lubricants, and coating materials. That reduces the strategic value of excipient patents unless they claim a specific dissolution profile, stability advantage, polymorph, particle-size distribution, or manufacturing process.

Patent-strength indicators include:

• Claims directed to glasdegib itself or a protected salt or polymorph.
• Broad treatment claims covering AML with low-dose cytarabine.
• Narrow formulation claims that require a particular excipient ratio or dissolution profile.
• Manufacturing claims that cover commercially efficient synthesis.
• Remaining patent term after patent-term adjustment.
• The ability to omit protected method claims from an ANDA label.

A generic sponsor with a non-infringing formulation may still face substantial risk from active-ingredient claims. Excipient redesign is therefore a risk-management tool, not a complete patent-avoidance strategy.

What commercial opportunities exist for Daurismo excipients?

The highest-value opportunities are likely to support generic entry and lifecycle management rather than create a premium branded formulation.

Opportunity	Potential value	Main barrier
Lactose-free tablet	Procurement flexibility and possible patient differentiation	Limited clinical differentiation
Smaller tablet	Improved swallowing and packaging efficiency	Dose uniformity and dissolution
Moisture-resistant coating	Better home-storage robustness	Stability data and coating cost
Unit-dose blister	Adherence, handling, and specialty-pharmacy fit	Higher packaging cost
Scored 100 mg tablet	Dose flexibility	Score performance and labeling
Direct-compression process	Lower manufacturing complexity	Blend uniformity and segregation
Alternate disintegrant system	Supply-chain resilience	Bioequivalence and dissolution
Low-dust manufacturing	Worker and facility benefits	Process validation
Regional excipient sourcing	Reduced supply disruption	Supplier qualification and comparability
Compounded or hospital-use presentations	Institutional flexibility	Regulatory and stability controls

A contract manufacturer could also offer a dual-source platform using lactose-based and lactose-free formulations, provided both remain within the regulatory strategy and maintain equivalent performance. This would reduce dependence on a single excipient supply chain.

How does Daurismo compare with competing AML therapies?

Daurismo competes with other lower-intensity AML regimens, including venetoclax-based combinations and targeted agents selected according to molecular features. Its oral administration creates a different excipient and packaging profile from injectable cytarabine, but its clinical use still depends on combination treatment and intensive monitoring.

Product	Active ingredient	Formulation opportunity
Daurismo	Glasdegib	Immediate-release tablet, dose-strength and packaging optimization
Venclexta	Venetoclax	More complex dose ramp-up and tablet-strength packaging strategy
Xospata	Gilteritinib	Oral targeted therapy with adherence and tablet-size considerations
Tibsovo	Ivosidenib	Oral targeted therapy; excipient and dissolution competition
Azacitidine injection	Azacitidine	Sterile manufacturing and reconstitution barriers

Daurismo's commercial vulnerability is greater if generic manufacturers can reproduce a stable immediate-release tablet without complex process controls. The product's clinical differentiation, prescriber familiarity, and combination-use requirements will influence the speed of generic substitution.

What generic launch scenarios exist for Daurismo?

Three scenarios are commercially relevant.

First-filer launch

A first successful Paragraph IV applicant could obtain 180 days of generic exclusivity under the Hatch-Waxman framework, subject to statutory forfeiture rules and the outcome of litigation. This scenario creates the largest near-term value for a challenger with a defensible non-infringement or invalidity position.

Delayed multi-source launch

Several ANDA applicants may enter after patent expiry or settlement-based dates. Price erosion would then depend on the number of approved suppliers, payer substitution, specialty-pharmacy contracts, and the size of the treated AML population.

Limited generic uptake

Even after regulatory approval, uptake may be slower if physicians prefer Pfizer supply, if the product is used in specialized oncology centers, or if the combination regimen limits prescribing volume. A generic entrant should not assume that regulatory approval produces immediate broad substitution.

What revenue exposure does Daurismo create for Pfizer?

Daurismo revenue is exposed to:

• Generic entry after regulatory and patent barriers expire.
• Competition from venetoclax-based AML regimens.
• Changes in treatment guidelines.
• Small eligible-patient population.
• Treatment discontinuation from adverse events.
• Reimbursement and specialty-pharmacy restrictions.
• Pfizer portfolio-prioritization decisions.

Public company filings should be used for current Daurismo sales, geographic revenue, and product-level trends. FDA approval and label data establish the regulatory opportunity but do not provide a reliable current revenue estimate. [1,4]

Key Takeaways

• Daurismo is a conventional immediate-release glasdegib tablet with 25 mg and 100 mg strengths.
• Public labeling identifies common excipients, including lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone, and magnesium stearate.
• Generic formulation barriers are likely moderate because the dosage form does not rely on a complex delivery platform.
• The most practical excipient opportunities involve dissolution robustness, moisture protection, tablet size, dose flexibility, packaging, and supply-chain redundancy.
• Patent risk is more likely to center on glasdegib, protected solid forms, manufacturing, and AML treatment claims than on commodity excipients.
• Daurismo faces ANDA competition, not biosimilar competition.
• Exact generic-entry timing requires current Orange Book, patent, litigation, and settlement analysis.

FAQs

Can a Daurismo generic use different excipients?

Yes. An ANDA applicant can use different inactive ingredients if the formulation satisfies FDA requirements, demonstrates pharmaceutical equivalence and bioequivalence, and does not infringe relevant patents.

Is Daurismo a modified-release product?

No. Public FDA labeling identifies Daurismo as an immediate-release oral tablet.

Does Daurismo require a biosimilar application?

No. Glasdegib is a chemically synthesized small molecule. A competing product would generally use the ANDA pathway rather than the biosimilar pathway.

Could a lactose-free Daurismo tablet gain market share?

Possibly, but the commercial benefit would depend on tablet size, stability, patient acceptability, payer treatment, and whether the formulation offers a meaningful operational advantage over the reference product.

What is the largest manufacturing barrier for a Daurismo generic?

The principal barriers are likely active-ingredient sourcing, content uniformity at the 25 mg strength, dissolution control, stability, patent clearance, and regulatory bioequivalence rather than tablet compression itself.

References

1. U.S. Food and Drug Administration. (2018). Daurismo (glasdegib) prescribing information. Pfizer Laboratories.
2. National Library of Medicine. (n.d.). Daurismo-glasdegib tablet, film coated. DailyMed.
3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
4. Pfizer Inc. (2024). Annual report and Form 10-K.