List of Excipients in Branded Drug DAPAGLIFLOZIN AND SAXAGLIPTIN

« Back to Dashboard

Generic Drugs Containing DAPAGLIFLOZIN AND SAXAGLIPTIN

Company	Ingredient	NDC	Excipient
Novadoz Pharmaceuticals LLC	dapagliflozin and saxagliptin	72205-438	CELLULOSE, MICROCRYSTALLINE
Novadoz Pharmaceuticals LLC	dapagliflozin and saxagliptin	72205-438	CROSCARMELLOSE SODIUM
Novadoz Pharmaceuticals LLC	dapagliflozin and saxagliptin	72205-438	FERRIC OXIDE RED
Novadoz Pharmaceuticals LLC	dapagliflozin and saxagliptin	72205-438	FERRIC OXIDE YELLOW
Novadoz Pharmaceuticals LLC	dapagliflozin and saxagliptin	72205-438	HYPROMELLOSE
Novadoz Pharmaceuticals LLC	dapagliflozin and saxagliptin	72205-438	MAGNESIUM STEARATE

What are the Most Frequently-Used Excipients in DAPAGLIFLOZIN AND SAXAGLIPTIN?

# Of NDCs	Excipient
1	CELLULOSE, MICROCRYSTALLINE
1	CROSCARMELLOSE SODIUM
1	FERRIC OXIDE RED
1	FERRIC OXIDE YELLOW
1	HYPROMELLOSE
1	MAGNESIUM STEARATE

Dapagliflozin and Saxagliptin Excipient Strategy and Commercial Opportunities

Last updated: November 3, 2026

Dapagliflozin and saxagliptin are co-formulated in Qtern, a once-daily oral tablet developed by AstraZeneca for adults with type 2 diabetes. The product combines an SGLT2 inhibitor with a DPP-4 inhibitor. Its commercial opportunity is concentrated in fixed-dose combination convenience, adherence, cardiometabolic positioning, and regional generic or licensed-product development.

The principal excipient strategy is conventional immediate-release tablet design: a lactose- and cellulose-based core, superdisintegrant-assisted breakup, magnesium stearate lubrication, colloidal silica for flow, and a protective film coating. This platform is technically accessible to generic manufacturers, but regulatory bridging, bioequivalence, stability, patent status, and commercial differentiation remain material barriers.

What is Qtern and how is the dapagliflozin-saxagliptin combination formulated?

Qtern contains dapagliflozin propanediol and saxagliptin hydrochloride in a fixed-dose, immediate-release tablet. The U.S. strengths are:

Product	Dapagliflozin component	Saxagliptin component	Administration
Qtern 10/5 mg	Dapagliflozin equivalent to 10 mg	Saxagliptin equivalent to 5 mg	Once daily
Qtern 10/10 mg	Dapagliflozin equivalent to 10 mg	Saxagliptin equivalent to 10 mg	Once daily

The product is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both components is appropriate. It is not indicated for type 1 diabetes because of ketoacidosis risk associated with SGLT2 inhibition (AstraZeneca, 2023a).

Qtern uses an immediate-release design rather than an extended-release matrix. The formulation objective is rapid tablet disintegration and dissolution for two low-dose, highly potent active ingredients. The product does not require gastro-retentive technology, enteric protection, osmotic delivery, or modified-release polymer systems.

What excipients are used in Qtern?

The U.S. prescribing information identifies the following excipient classes for Qtern:

Formulation function	Excipient or excipient class
Diluent and compressibility aid	Anhydrous lactose
Filler and dry-binder	Microcrystalline cellulose
Disintegrant	Croscarmellose sodium
Lubricant	Magnesium stearate
Glidant and anti-agglomeration aid	Colloidal silicon dioxide
Film former	Polyvinyl alcohol
Opacifier	Titanium dioxide
Plasticizer	Polyethylene glycol
Anti-tacking agent	Talc
Colorant	Iron oxide yellow

The excipient system is designed for conventional high-speed tablet manufacturing. Anhydrous lactose and microcrystalline cellulose provide bulk and compressibility. Croscarmellose sodium supports rapid water uptake and tablet breakup. Magnesium stearate reduces ejection force, while colloidal silicon dioxide improves powder flow. The film coat controls appearance, handling, and moisture exposure rather than modifying release (AstraZeneca, 2023a).

Why is the excipient platform commercially attractive?

The formulation has several commercial advantages:

1. It relies on widely available compendial excipients.
2. It does not depend on a proprietary drug-delivery device.
3. It uses a conventional immediate-release manufacturing process.
4. It avoids the formulation complexity of metformin extended-release combinations.
5. It can be manufactured by standard direct-compression or wet-granulation equipment, subject to process development.

This creates opportunities for generic manufacturers, contract development and manufacturing organizations, and regional licensees. The main opportunity is not a novel excipient system. It is a bioequivalent, stable, cost-efficient tablet with acceptable appearance, dissolution, and manufacturing yield.

What formulation challenges exist for dapagliflozin and saxagliptin?

The main technical challenge is achieving consistent content uniformity and dissolution for a low-dose combination containing two chemically distinct active ingredients.

Dose uniformity

Saxagliptin is present at 5 mg or 10 mg, while dapagliflozin is present at a 10 mg equivalent dose. Both active ingredients represent a relatively small percentage of total tablet mass. Blend uniformity, segregation control, sampling strategy, and compression consistency are therefore important.

A generic manufacturer may need to evaluate:

• particle-size distribution of each active ingredient;
• bulk density and flowability;
• electrostatic behavior;
• ordered mixing or geometric dilution;
• granulation versus direct compression;
• blend segregation during hopper discharge;
• assay uniformity at beginning, middle, and end of compression runs.

The selected excipients must provide sufficient bulk without increasing tablet size beyond a commercially acceptable format.

Chemical and physical stability

Dapagliflozin is supplied as a propanediol monohydrate form, while saxagliptin is supplied as a hydrochloride salt. Their salt and solvate characteristics influence water activity, hygroscopicity, crystallinity, and dissolution.

A development program should evaluate:

• polymorphic or solvated-form control;
• moisture uptake;
• assay and degradation products;
• interaction between active ingredients and lactose;
• lubricant sensitivity;
• coating-related moisture exposure;
• stability under ICH long-term and accelerated conditions.

Lactose-containing formulations can require compatibility testing because reducing sugars may react with amine-containing drug substances under some conditions. The relevance depends on the chemical form, water activity, process temperature, and storage environment. A lactose-free version using mannitol, dibasic calcium phosphate, or an alternative cellulose-based filler could create a differentiated product, but it would require a new formulation-development and bioequivalence package.

Dissolution and disintegration

The formulation should provide rapid and reproducible release of both active ingredients across physiologic pH conditions. Excessive magnesium stearate or over-lubrication can reduce wettability and slow dissolution. Croscarmellose sodium level and distribution can affect disintegration time, especially after compression-force changes.

A generic product should compare dissolution profiles for both actives using multiple media, including acidic and near-neutral conditions. A matching profile for one active is not sufficient if the second active has a different release behavior.

What excipient opportunities exist for generic and licensed products?

Lactose-free Qtern alternatives

A lactose-free version could address patients with lactose intolerance, procurement requirements, or excipient restrictions. Potential fillers include:

• mannitol;
• microcrystalline cellulose;
• dibasic calcium phosphate;
• pregelatinized starch;
• silicified microcrystalline cellulose.

The commercial value is likely incremental rather than transformative because lactose intolerance does not generally make a small amount of tablet lactose clinically significant. The product could still appeal to hospital formularies, selected markets, and manufacturers seeking a differentiated label.

Reduced-moisture formulations

A lower-moisture formulation may improve stability in hot and humid markets. Options include:

• low-moisture excipient grades;
• optimized film-coating weight;
• high-barrier blister packaging;
• desiccant-containing bottles;
• moisture-control manufacturing environments.

Packaging may provide a stronger commercial benefit than changing the core excipients. A manufacturer can preserve a familiar tablet process while improving shelf life through alu-alu blistering or high-density polyethylene bottles with desiccants.

Smaller tablets

Reducing tablet size can improve swallowability and manufacturing economics. The tradeoff is lower excipient volume for maintaining compressibility, content uniformity, and mechanical strength. Direct compression with silicified microcrystalline cellulose or a highly functional co-processed excipient may support tablet-size reduction, but the resulting dissolution and stability profile must be demonstrated.

Color and coating differentiation

Iron oxide colorants and film-coating systems provide a low-cost method to distinguish strengths and reduce dispensing errors. A generic manufacturer should avoid unnecessary visual similarity that could create medication-error concerns, while maintaining sufficient color differentiation between 10/5 mg and 10/10 mg strengths.

Excipient substitutions and regulatory strategy

A generic product does not necessarily need to duplicate every inactive ingredient. It must satisfy applicable FDA requirements for inactive ingredients, demonstrate pharmaceutical equivalence where required, and establish bioequivalence. Differences in excipients can trigger additional comparative studies if they affect absorption, dissolution, stability, or safety.

The most defensible development strategy is usually a close qualitative and quantitative match to the reference product, followed by a differentiated second-generation version only after the core product is established.

What FDA regulatory pathway applies to a dapagliflozin-saxagliptin generic?

A U.S. generic applicant would generally pursue an abbreviated new drug application under section 505(j) of the Federal Food, Drug, and Cosmetic Act. The product must demonstrate pharmaceutical equivalence and bioequivalence to the reference listed drug.

Key requirements include:

Requirement	Commercial relevance
Same active ingredients	Both dapagliflozin and saxagliptin must be present in the approved strength
Same dosage form	Immediate-release tablet
Same route	Oral
Bioequivalence	Exposure and, where applicable, comparative dissolution must support approval
Labeling	Generally must align with the reference product, subject to permitted differences
Manufacturing controls	Blend uniformity, assay, dissolution, impurities, and stability must be controlled
Inactive ingredients	Must comply with FDA safety and regulatory requirements

FDA’s product-specific guidance should be reviewed before study design because the agency may specify pharmacokinetic comparison requirements for fixed-dose combinations and recommend fed or fasting conditions (FDA, 2024a).

What patents and exclusivity affect commercial entry?

Qtern’s U.S. market protection must be evaluated through current FDA Orange Book entries, patent declarations, and litigation records. The relevant analysis should separate:

• patents covering dapagliflozin;
• patents covering saxagliptin;
• patents covering the fixed-dose combination;
• formulation patents;
• method-of-use patents;
• pediatric exclusivity;
• regulatory exclusivity attached to the reference product.

The Qtern product itself was approved by FDA in 2017. FDA approval does not establish a single market-exclusivity date. Entry timing depends on listed patents, certification strategy, any Paragraph IV litigation, settlement terms, and the regulatory status of the reference products.

A Paragraph IV applicant may challenge an Orange Book-listed patent by asserting that the patent is invalid, unenforceable, or not infringed. The first substantially complete ANDA with a qualifying Paragraph IV certification may obtain 180-day generic exclusivity under the Hatch-Waxman framework, subject to statutory forfeiture provisions (FDA, 2024b).

Because patent listings and litigation outcomes can change, commercial diligence should use the current Orange Book rather than historical launch assumptions. A fixed-dose combination may face a different entry profile from either single-agent product.

What is the Orange Book status of Qtern?

Qtern is a prescription fixed-dose combination product listed by FDA. Orange Book analysis should confirm:

• reference listed drug designation;
• active ingredient descriptions;
• dosage-form listing;
• strength-specific entries;
• patent numbers and expiration dates;
• use codes for method-of-use patents;
• exclusivity codes;
• any approved generic applicants.

The Orange Book may not capture every commercial barrier. Unlisted process know-how, formulation trade secrets, regulatory delays, supply agreements, and manufacturing scale can affect launch timing even when patent protection is weak (FDA, 2024c).

How strong is the patent estate for dapagliflozin and saxagliptin?

The patent estate is likely stronger for the individual active ingredients than for a conventional fixed-dose tablet excipient platform. Dapagliflozin and saxagliptin each originated from separate discovery programs and may have had composition-of-matter, salt, crystalline-form, preparation, and method-of-use patents.

For the combination product, the highest-value protection would generally come from:

• combination-treatment claims;
• specific dapagliflozin:saxagliptin ratios;
• dosage-regimen claims;
• treatment claims for patients inadequately controlled on monotherapy;
• formulation claims tied to defined dissolution or stability characteristics.

A conventional lactose-cellulose-croscarmellose tablet is more vulnerable to design-around than a proprietary extended-release or device-based system. Excipient substitution, altered coating composition, and process changes can reduce dependence on formulation claims, subject to infringement and bioequivalence analysis.

What commercial opportunities exist beyond the original Qtern tablet?

Generic fixed-dose combination

The clearest opportunity is a lower-cost generic or authorized-generic Qtern equivalent. Potential customers include:

• national health systems;
• managed-care formularies;
• diabetes clinics;
• private-label pharmaceutical distributors;
• markets where separate prescriptions create adherence or reimbursement friction.

The commercial case depends on whether the combination remains reimbursed and whether payers prefer separate dapagliflozin and saxagliptin products.

Regional licensing

A regional licensee could combine local manufacturing, tender access, and regulatory infrastructure with a finished product or technology package. This model is most attractive in markets with:

• high SGLT2 inhibitor uptake;
• rising demand for oral combination products;
• local-content requirements;
• price-sensitive diabetes formularies;
• established generic substitution.

Hospital and institutional supply

Institutional buyers may value a single tablet over co-prescribing two products, particularly where medication reconciliation and adherence are operational concerns. A supplier with reliable availability and competitive tender pricing may gain share even without substantial excipient differentiation.

Combination products with cardiometabolic positioning

Dapagliflozin has indications and clinical use extending beyond glycemic control, including heart failure and chronic kidney disease settings. Saxagliptin is primarily a glucose-lowering DPP-4 inhibitor. The combination’s commercial positioning must therefore remain within the approved labeling of the specific product and jurisdiction. It should not imply that the saxagliptin combination carries every cardiovascular or renal indication associated with dapagliflozin monotherapy.

Co-packaged alternatives

A co-packaged dapagliflozin tablet plus saxagliptin tablet could be easier to develop in some jurisdictions than a new fixed-dose combination. It would provide dose flexibility but would not deliver the same single-tablet adherence benefit. Co-packaging can also support separate product lifecycle management and reduce formulation-development complexity.

How does Qtern compare with competing diabetes combinations?

Product or strategy	Mechanism profile	Formulation complexity	Commercial advantage	Main limitation
Qtern	SGLT2 inhibitor plus DPP-4 inhibitor	Low to moderate	Single-tablet dual mechanism	Limited flexibility in dose adjustment
Separate dapagliflozin and saxagliptin	Two oral agents	Low per product	Independent titration and broader sourcing	Higher pill burden
Dapagliflozin plus metformin XR	SGLT2 inhibitor plus biguanide	Moderate to high	Established first-line combination logic	Extended-release manufacturing and metformin tolerability
Empagliflozin plus linagliptin	SGLT2 inhibitor plus DPP-4 inhibitor	Low to moderate	Direct class competition	Different patent and reimbursement position
SGLT2 inhibitor plus GLP-1 therapy	Oral plus injectable or oral incretin	High	Greater weight and metabolic positioning in some regimens	Higher cost and administration complexity

The main competitive risk is substitution with dapagliflozin plus metformin or another SGLT2/DPP-4 combination. The commercial opportunity is strongest where clinicians want dual oral therapy without metformin or where a patient is already receiving both actives separately.

What manufacturing and intellectual-property barriers remain?

The manufacturing process is not intrinsically high barrier. The stronger barriers are regulatory execution and supply-chain reliability.

A viable commercial program requires:

• qualified sources for both active ingredients;
• control of dapagliflozin solvate form;
• consistent saxagliptin hydrochloride quality;
• validated blend-uniformity controls;
• impurity and degradation monitoring;
• packaging suitable for target climate zones;
• scalable coating and compression processes;
• regulatory review of excipient differences;
• current freedom-to-operate analysis.

The most defensible excipient strategy is to begin with a close reference formulation, then pursue cost reduction through excipient sourcing, process optimization, tablet-size reduction, packaging efficiency, and yield improvement. A novel excipient claim is unlikely to be the primary value driver.

What generic launch scenarios exist?

Scenario	Description	Commercial impact
First generic after patent clearance	One or more applicants enter after litigation or patent expiry	Highest initial price erosion risk
Authorized generic	Reference-company product is supplied under a different label	Can reduce independent generic share
Multiple generic entrants	Several manufacturers launch in close succession	Rapid price compression
Regional launch only	Product enters selected non-U.S. markets	Lower development cost, limited scale
Co-packaged substitute	Separate tablets marketed together	Faster flexibility, weaker single-tablet differentiation
Reformulated product	Lactose-free, smaller, or climate-stable tablet	Potential niche premium, added development cost

Revenue exposure should be assessed at the portfolio level. Public company reporting generally separates major brands such as Farxiga and Onglyza more clearly than Qtern. Qtern revenue may therefore be embedded in broader diabetes-product reporting rather than disclosed as a standalone figure. Product-level revenue estimates should not be inferred by adding Farxiga and Onglyza sales because those figures include indications, countries, and patients outside the fixed-dose combination.

Key Takeaways

• Qtern combines dapagliflozin propanediol and saxagliptin hydrochloride in a once-daily immediate-release tablet.
• Its excipient platform uses conventional materials, including anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, and a polyvinyl alcohol film coat.
• The formulation is technically accessible to generic manufacturers, but content uniformity, dissolution, stability, and active-form control require careful development.
• The strongest product opportunities are generic entry, regional licensing, institutional supply, lactose-free reformulation, smaller tablets, and improved hot-climate packaging.
• Patent analysis must distinguish dapagliflozin patents, saxagliptin patents, fixed-dose combination patents, method-of-use claims, and current Orange Book listings.
• Qtern’s commercial value is linked to single-tablet convenience, but it competes with separate therapy, dapagliflozin-metformin combinations, and other SGLT2/DPP-4 products.
• No standalone Qtern revenue conclusion should be drawn from reported Farxiga or Onglyza sales.
• The highest-return development path is usually a close reference formulation followed by process, packaging, and supply-chain optimization.

FAQs About Dapagliflozin and Saxagliptin Excipient Strategy

Can lactose be removed from a dapagliflozin-saxagliptin tablet?

Yes. Lactose can potentially be replaced with mannitol, additional microcrystalline cellulose, dibasic calcium phosphate, or another suitable filler. The replacement requires new compatibility, dissolution, stability, and bioequivalence assessment.

Is Qtern an extended-release product?

No. Qtern is an immediate-release film-coated tablet. This distinguishes it from certain dapagliflozin-metformin products that use extended-release metformin technology.

Can a generic manufacturer use different coating colors?

Potentially. Color and appearance may differ within applicable regulatory and labeling requirements. The manufacturer must prevent strength confusion and demonstrate that the coating change does not affect stability or performance.

Does dapagliflozin-saxagliptin require cold-chain distribution?

No. Qtern is an oral solid dosage form stored under labeled room-temperature conditions. Packaging and humidity controls remain important, particularly in hot and humid markets.

Is a co-packaged product easier to develop than a fixed-dose tablet?

Often, yes. A co-packaged product can use already approved tablets and preserve dose flexibility. It sacrifices the single-tablet convenience of a fixed-dose combination and may face separate reimbursement or substitution rules.

References

1. AstraZeneca. (2023a). Qtern: U.S. prescribing information. U.S. Food and Drug Administration.

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

3. U.S. Food and Drug Administration. (2024b). Hatch-Waxman letters. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/hatch-waxman-letters

4. U.S. Food and Drug Administration. (2024c). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

5. U.S. Food and Drug Administration. (2023). Guidance for industry: ANDAs for certain highly soluble, highly permeable, and rapidly dissolving drug products. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/andAs-certain-highly-soluble-highly-permeable-and-rapidly-dissolving-drug-products