List of Excipients in Branded Drug DASATINIB

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Prasco Laboratories	DASATINIB	dasatinib	66993-233	CELLULOSE, MICROCRYSTALLINE
Prasco Laboratories	DASATINIB	dasatinib	66993-233	CROSCARMELLOSE SODIUM
Prasco Laboratories	DASATINIB	dasatinib	66993-233	HYDROXYPROPYL CELLULOSE
Prasco Laboratories	DASATINIB	dasatinib	66993-233	HYPROMELLOSE
Prasco Laboratories	DASATINIB	dasatinib	66993-233	LACTOSE MONOHYDRATE

Generic Drugs Containing DASATINIB

Company	Ingredient	NDC	Excipient
Teva Pharmaceuticals Inc	dasatinib	0480-5101	CROSCARMELLOSE SODIUM
Teva Pharmaceuticals Inc	dasatinib	0480-5101	HYDROXYPROPYL CELLULOSE
Teva Pharmaceuticals Inc	dasatinib	0480-5101	HYPROMELLOSE 2910
Teva Pharmaceuticals Inc	dasatinib	0480-5101	LACTOSE MONOHYDRATE
Teva Pharmaceuticals Inc	dasatinib	0480-5101	MAGNESIUM STEARATE

What are the Most Frequently-Used Excipients in DASATINIB?

# Of NDCs	Excipient
6	ANHYDROUS LACTOSE
7	CELLULOSE, MICROCRYSTALLINE
15	CROSCARMELLOSE SODIUM
4	GLYCERYL MONO- AND DICAPRYLOCAPRATE
1	HYDROGENATED CASTOR OIL

Dasatinib Excipient Strategy and Commercial Opportunities

Last updated: August 12, 2026

Dasatinib is an orally administered, weakly basic tyrosine kinase inhibitor with pH-dependent solubility and clinically relevant sensitivity to gastric-acid suppression. The main excipient opportunity is not conventional tablet cost reduction. It is control of dissolution, physical stability, dose flexibility, pediatric acceptability, and compatibility with generic bioequivalence requirements. Dasatinib tablets have entered generic competition after expiry of the principal compound patent, while differentiated formulations remain commercially protectable through formulation, manufacturing, and pediatric-use claims.

What excipient properties matter most for dasatinib?

Dasatinib has low aqueous solubility at higher pH and greater solubility under acidic conditions. The formulation must therefore promote rapid dispersion and dissolution without creating excessive sensitivity to gastrointestinal variability or acid-reducing medicines.

The highest-value excipient functions are:

Formulation need	Relevant excipient strategy	Commercial objective
Rapid wetting and dissolution	Superdisintegrants, wetting agents, optimized granulation	Bioequivalent generic tablets
Control of pH microenvironment	Acidifying agents or buffering systems	Reduce dissolution variability
Powder flow and compression	Microcrystalline cellulose, coprocessed fillers, dry binders	Lower manufacturing cost
Chemical and physical stability	Moisture control, protective packaging, stabilizing excipients	Longer shelf life
Pediatric administration	Suspending agents, sweeteners, flavors, taste masking	Oral suspension and pediatric markets
Dose flexibility	Suspension technology, scored tablets, multiparticulates	Weight-based dosing
Patient access	Lactose-free, low-sodium, low-allergen compositions	Institutional and specialty-pharmacy differentiation

The central technical constraint is the interaction between excipient microenvironment, gastric pH, and dissolution. Excess alkalinity can reduce dasatinib dissolution. Acidifying excipients may improve in-vitro dissolution but can introduce stability, taste, corrosion, or gastrointestinal-tolerability issues.

What excipients are used in Sprycel dasatinib tablets?

The U.S. Sprycel tablet formulation uses conventional immediate-release tablet excipients. Public labeling identifies lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and related coating components, depending on the product presentation and market labeling (Bristol-Myers Squibb, 2023; U.S. National Library of Medicine, 2024).

The functional profile is conventional:

• Lactose monohydrate provides bulk and compressibility.
• Microcrystalline cellulose supports compact strength and tablet disintegration.
• Croscarmellose sodium promotes rapid tablet breakup.
• Hydroxypropyl cellulose acts as a binder.
• Magnesium stearate provides lubrication.
• Hypromellose, titanium dioxide, and polyethylene glycol support film coating and product identification.

This composition is commercially accessible and does not create a high barrier to generic entry. A generic manufacturer can use the same excipients, pharmaceutically equivalent substitutes, or a different composition that produces equivalent dissolution and bioavailability.

Which excipient strategies can improve dasatinib dissolution?

Acidifying microenvironments

Citric acid, fumaric acid, malic acid, tartaric acid, and related organic acids can create a lower-pH microenvironment near the drug particles. This approach can improve apparent dissolution for a weak base.

The main risks are:

• Chemical instability during storage.
• Increased hygroscopicity.
• Taste and mouthfeel problems in liquid products.
• Variable performance after food intake.
• Potential incompatibility with alkaline fillers or lubricants.

An acidifying formulation is most commercially defensible when it demonstrates a measurable pharmacokinetic or dissolution advantage over a conventional tablet.

Wetting and disintegration systems

Croscarmellose sodium, sodium starch glycolate, crospovidone, low-substituted hydroxypropyl cellulose, and surfactant-assisted systems can improve tablet breakup and drug-particle wetting.

Crospovidone may be attractive where rapid capillary uptake and low gelling are priorities. Croscarmellose sodium is familiar to regulators and widely available. Sodium starch glycolate may provide strong swelling but can create sensitivity to compression force and ionic conditions.

Polysorbates, sodium lauryl sulfate, and other wetting agents can improve dissolution, but their use requires control of peroxide impurities, degradation pathways, taste, and dose uniformity.

Amorphous and particle-engineered systems

Amorphous solid dispersions, nanocrystals, co-crystals, and spray-dried dispersions can increase apparent solubility. Their commercial value depends on maintaining supersaturation and preventing recrystallization.

These technologies introduce new risks:

• Physical instability during storage.
• Sensitivity to humidity and temperature.
• More complex process controls.
• Greater analytical burden.
• Potentially difficult bioequivalence comparisons against immediate-release tablets.
• Additional intellectual-property exposure.

For a mature generic product, the cost of an advanced solubility platform may not be justified unless it enables a new dosage form, a lower dose, improved pediatric administration, or a clinically meaningful reduction in exposure variability.

What formulation patents can protect dasatinib products?

Formulation protection usually depends on more than naming a list of excipients. Stronger claims may cover:

1. A defined dasatinib particle-size distribution.
2. A specified crystalline or amorphous form.
3. A composition that maintains a target pH microenvironment.
4. A dissolution profile under acidic and near-neutral conditions.
5. A suspension with controlled sedimentation and redispersibility.
6. A taste-masked particulate system.
7. A low-water-activity or moisture-protected composition.
8. A manufacturing process that produces a defined solid state.
9. A stable liquid formulation with a specified shelf life.
10. A method of improving exposure in patients receiving acid-reducing therapy.

The foundational U.S. compound patent is U.S. Patent No. 6,596,746, assigned to Bristol-Myers Squibb. Its protection was based on substituted thiazole compounds, including dasatinib, rather than on a differentiated excipient platform (U.S. Patent No. 6,596,746, 2003).

A later formulation patent can remain commercially relevant after compound-patent expiry if it covers a non-obvious dosage form and remains listed or enforceable in the relevant jurisdiction. In practice, generic applicants can avoid risk by using a different excipient system, pursuing a Paragraph IV certification, or relying on a non-infringement position.

What is the Orange Book status of Sprycel?

Sprycel was approved by the FDA in 2006 for Philadelphia chromosome-positive chronic myeloid leukemia and later received indications in acute lymphoblastic leukemia and pediatric disease. The active pharmaceutical ingredient is dasatinib, marketed by Bristol-Myers Squibb.

The principal compound protection has expired. FDA Orange Book status must be assessed by product, strength, dosage form, and listed patent at the time of filing. Patent listings can differ from practical enforceability because a listed patent may have expired, been disclaimed, been delisted, or become irrelevant to a particular generic product (U.S. Food and Drug Administration, 2024a).

Regulatory item	Dasatinib position
Reference product	Sprycel
Active ingredient	Dasatinib
Main dosage forms	Film-coated tablets; oral suspension product in selected markets
FDA approval	2006
Principal innovator	Bristol-Myers Squibb
Compound patent	U.S. 6,596,746
Compound exclusivity	Expired
Generic pathway	ANDA, subject to product-specific FDA requirements
Main regulatory challenge	Demonstrating bioequivalence and equivalent dissolution
Main formulation risk	pH-dependent dissolution and exposure changes caused by acid suppression

The commercial entry question is no longer whether the compound itself is protected. It is whether a proposed generic product infringes any unexpired formulation or method-of-use claims and whether its labeling can avoid protected indications.

When does dasatinib lose exclusivity?

Dasatinib lost primary small-molecule exclusivity after the expiration of the foundational patent and associated regulatory protections. The exact commercial entry date depends on the timing of ANDA approval, patent certifications, 30-month stays, pediatric exclusivity, settlements, and market-launch decisions.

Generic entry can occur through several scenarios:

Immediate generic competition

A manufacturer launches after receiving final approval and clearing listed-patent barriers. This is the most direct route and creates rapid price erosion across common tablet strengths.

At-risk launch

A manufacturer launches before final resolution of patent litigation. This creates substantial damages exposure if the patent holder later prevails.

Settlement-based entry

The innovator and generic applicant agree to an entry date, license, supply arrangement, or other commercial terms. Settlement documents can materially change the effective loss-of-exclusivity date.

Formulation-specific entry

A generic manufacturer enters with tablets but avoids a protected suspension, multiparticulate formulation, or pediatric-use claim. This can leave a narrower branded product segment protected after tablet competition begins.

Which companies are challenging Sprycel and competing in generic dasatinib?

The generic competitive field includes major multinational and specialty generic manufacturers that have sought approval for dasatinib tablets. Market participation can change by strength, country, supply status, and wholesaler contracting.

The principal competitive groups are:

• Large generic manufacturers with established oncology portfolios.
• Indian manufacturers with lower-cost oral-solid-dose capacity.
• Specialty oncology suppliers focused on hospital and specialty-pharmacy channels.
• Contract manufacturers supplying authorized or private-label products.
• Innovator-affiliated suppliers using authorized-generic strategies.

Dasatinib is more commercially sensitive than a routine primary-care generic because oncology buyers evaluate continuity of supply, serialization, recalls, substitution policy, and reimbursement. A low-price entrant with limited manufacturing redundancy may not displace an established supplier in hospital accounts.

What generic entry risks exist for dasatinib?

Bioequivalence risk

The principal technical risk is failure to match the reference product under dissolution conditions that reflect dasatinib’s pH sensitivity. A formulation can show acceptable dissolution in one medium and diverge materially under another.

Critical development variables include:

• Particle size and surface area.
• Solid-state form.
• Granulation moisture.
• Compression force.
• Disintegrant level.
• Lubrication time.
• Coating weight.
• Dissolution medium pH.
• Storage humidity.
• Tablet hardness and friability.

Labeling risk

Method-of-use patents may cover treatment of specific cancers, patient populations, dosing schedules, or combination regimens. A generic applicant can use a section viii statement to omit protected indications where permitted, but the resulting label must remain commercially viable.

Manufacturing risk

Dasatinib manufacturing is not highly dependent on rare excipients. The larger barrier is process consistency. A supplier must control solid-state attributes, impurity profiles, particle engineering, and batch-to-batch dissolution.

Supply-chain risk

Lactose, cellulose derivatives, crospovidone, magnesium stearate, and film-coating materials are widely available. Supply risk is therefore moderate. The higher exposure is in active-ingredient sourcing, analytical release capacity, oncology-grade quality systems, and dual-site manufacturing.

What pediatric and liquid formulations create commercial opportunities?

Pediatric dasatinib creates the strongest excipient-led opportunity. Tablets can be unsuitable for younger patients or patients who cannot swallow solid dosage forms. An oral suspension can provide dose flexibility and reduce manipulation by caregivers.

A commercial pediatric formulation should address:

• Accurate weight-based dosing.
• Uniform concentration throughout the dosing period.
• Rapid and complete redispersion.
• Acceptable taste.
• Low sedimentation or controlled sedimentation.
• Microbial protection.
• Limited foaming.
• Syringe compatibility.
• Stability after reconstitution.
• Clear instructions for storage and shaking.

Useful excipient categories include suspending polymers, wetting agents, sweeteners, flavors, buffers, preservatives, antifoams, and taste-masking polymers. The formulation should avoid excessive alkalinity because increased pH can reduce dasatinib solubility.

Taste masking can use polymer-coated particles, lipid barriers, ion-exchange approaches, or multiparticulate systems. These technologies can support patents that claim particle coating thickness, release kinetics, suspension stability, or palatability.

How does dasatinib compare with competing tyrosine kinase inhibitors?

Drug	Key formulation issue	Excipient opportunity	Generic pressure
Dasatinib	pH-dependent solubility and acid-suppression interaction	Acidifying systems, pediatric suspensions, dissolution control	High after compound-patent expiry
Imatinib	High-volume tablet and capsule market	Cost reduction, taste, tablet size	Very high
Nilotinib	Food restrictions and complex pharmacokinetics	Patient-use simplification, modified release	Moderate to high
Bosutinib	Gastrointestinal tolerability and formulation performance	Controlled release and GI tolerability	Moderate
Ponatinib	Potent drug with narrower patient population	Dose flexibility and abuse-resistant packaging	Lower volume, higher value per patient
Asciminib	Newer product with longer protection horizon	Solid-state, formulation, and combination products	Lower near-term generic pressure

Dasatinib has a more attractive formulation-development profile than imatinib because pH-dependent dissolution creates a technically meaningful differentiation pathway. It also creates more development risk. A formulation that improves in-vitro dissolution but changes systemic exposure may fail regulatory or clinical objectives.

How strong is the dasatinib patent estate?

The compound patent estate is weak from a current exclusivity perspective because the foundational protection has expired. The remaining value is concentrated in narrower claims involving:

• Specific solid forms.
• Pharmaceutical compositions.
• Suspensions.
• Pediatric treatment.
• Combination therapy.
• Manufacturing processes.
• Crystalline intermediates.
• Dosing regimens.

A formulation patent is stronger when it links the excipient composition to a measurable technical effect, such as improved stability, a defined dissolution profile, reduced variability, or enhanced administration in a specific patient population.

A broad claim that merely lists common excipients is vulnerable to written-description, enablement, anticipation, and obviousness challenges. A composition supported by comparative data, solid-state characterization, and process-specific performance is more defensible.

What licensing deals and commercial structures are relevant?

The most relevant commercial structures are:

1. Authorized generic agreements with the innovator or a related commercial entity.
2. Regional licensing for oncology-focused generic distribution.
3. Contract manufacturing of tablets or suspension products.
4. Co-development agreements for pediatric formulations.
5. Formulation-technology licenses covering nanoparticles, taste masking, or solid dispersions.
6. Hospital supply contracts requiring dual sourcing.
7. Specialty-pharmacy distribution agreements.

A formulation license has greater value if it provides an approved product, regulatory documentation, validated analytical methods, and manufacturing transfer support. An excipient patent without a regulatory path has a lower licensing value in a mature generic market.

What are the revenue opportunities for excipient suppliers?

The largest opportunity is not the unit value of the excipient. It is recurring supply into multiple approved generic products and differentiated dosage forms.

Standard tablets

This is a volume business with limited margin. Suppliers compete on quality consistency, regulatory documentation, global availability, and change-control support.

Priority products include:

• Microcrystalline cellulose.
• Croscarmellose sodium.
• Crospovidone.
• Hydroxypropyl cellulose.
• Film-coating systems.
• Magnesium stearate.
• Wetting agents.

Pediatric suspension

This segment offers higher value because the formulation requires technical support, stability data, and regulatory documentation. A supplier that provides a complete suspension platform, including suspending polymer, taste masking, preservative system, and reconstitution guidance, can capture more value than a commodity excipient supplier.

Advanced dissolution platforms

Nanocrystals, amorphous dispersions, co-crystals, and spray-dried systems offer the highest potential margin. Their commercial viability depends on whether they produce a differentiated label, a lower dose, a new patient population, or a defensible patent position.

What is the outlook for dasatinib commercial competition?

Dasatinib tablet prices are likely to face continued erosion as additional approved generics enter and procurement shifts toward multi-source contracting. The branded product can retain value through clinical familiarity, supply reliability, pediatric formulations, and physician or institutional preference.

The most defensible commercial niches are:

• Pediatric oral suspension.
• Low-dose and weight-based dosing.
• Formulations for patients with swallowing difficulty.
• Products with strong global supply continuity.
• Specialty-pharmacy packaging.
• Formulations designed to reduce handling and administration errors.
• Regional products with local regulatory exclusivity.

A conventional immediate-release tablet using standard excipients is unlikely to sustain a durable premium. A formulation that solves administration, stability, or dissolution problems has a stronger commercial case.

Key Takeaways

• Dasatinib is a weakly basic drug with pH-dependent solubility, making excipient selection directly relevant to dissolution and bioequivalence.
• Standard Sprycel tablets use conventional excipients and do not create a major manufacturing barrier.
• Acidifying systems, advanced wetting, particle engineering, and taste masking are the most relevant formulation strategies.
• Pediatric suspension is the strongest excipient-led commercial opportunity.
• The foundational U.S. compound patent, U.S. 6,596,746, has expired; current risk is concentrated in narrower formulation, method-of-use, and manufacturing claims.
• Generic competition is likely to compress conventional tablet pricing.
• Stronger patent positions require comparative technical data, defined performance parameters, and a credible link between excipient composition and clinical or manufacturing benefit.
• Excipient suppliers can create more value through integrated formulation platforms than through commodity excipient sales.

FAQs

Can dasatinib be formulated as a lactose-free tablet?

Yes. Lactose-free formulations can use microcrystalline cellulose, mannitol, dibasic calcium phosphate, starch derivatives, or coprocessed fillers. The replacement must preserve tablet strength, disintegration, dissolution, and bioequivalence.

Does sodium lauryl sulfate improve dasatinib dissolution?

It can improve wetting and dissolution in some formulations, but the effect depends on concentration, particle size, compression, and dissolution medium. The excipient also requires assessment for taste, impurity profile, tolerability, and stability.

Is a dasatinib nanocrystal formulation commercially attractive?

It can be attractive when it enables dose reduction, improved suspension performance, or differentiated pediatric delivery. For a standard adult tablet, development cost and regulatory complexity may outweigh the price premium.

Can an excipient formulation avoid a dasatinib method-of-use patent?

Potentially. A formulation change does not by itself avoid method-of-use infringement if the product label or marketing induces the patented use. Label carve-outs, product positioning, and the scope of the asserted claims determine the risk.

What excipient strategy is best for a generic dasatinib launch?

For an adult tablet, the lowest-risk strategy is a conventional immediate-release composition with robust acid-to-neutral dissolution performance and a well-controlled manufacturing process. For differentiation, a stable, taste-masked oral suspension has greater commercial and patent value.

References

1. Bristol-Myers Squibb. (2023). Sprycel (dasatinib) tablets and oral suspension: Prescribing information. U.S. Food and Drug Administration.

2. U.S. Food and Drug Administration. (2024a). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

3. U.S. Food and Drug Administration. (2024b). Drugs@FDA: FDA-approved drugs, Sprycel. https://www.accessdata.fda.gov/scripts/cder/daf/

4. U.S. National Library of Medicine. (2024). DailyMed: Sprycel and dasatinib product labeling. https://dailymed.nlm.nih.gov/

5. U.S. Patent No. 6,596,746. (2003). 2-aminothiazole derivatives. U.S. Patent and Trademark Office.

6. U.S. Food and Drug Administration. (2024c). Product-specific guidances for generic drug development. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/product-specific-guidances-generic-drug-development