List of Excipients in Branded Drug QTERN

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
AstraZeneca Pharmaceuticals LP	QTERN	dapagliflozin and saxagliptin	0310-6780	ANHYDROUS LACTOSE
AstraZeneca Pharmaceuticals LP	QTERN	dapagliflozin and saxagliptin	0310-6780	CELLULOSE, MICROCRYSTALLINE
AstraZeneca Pharmaceuticals LP	QTERN	dapagliflozin and saxagliptin	0310-6780	CROSCARMELLOSE SODIUM
AstraZeneca Pharmaceuticals LP	QTERN	dapagliflozin and saxagliptin	0310-6780	FERROUS OXIDE
AstraZeneca Pharmaceuticals LP	QTERN	dapagliflozin and saxagliptin	0310-6780	MAGNESIUM STEARATE

QTERN Excipient Strategy and Commercial Opportunities

Last updated: August 24, 2026

QTERN is a once-daily fixed-dose combination tablet containing dapagliflozin 10 mg and saxagliptin 5 mg. Its excipient platform is conventional for an immediate-release, film-coated oral tablet: lactose, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, and a polyvinyl alcohol-based coating system. The commercial opportunity is strongest in generic fixed-dose combinations, lactose-free reformulation, low-cost direct compression, and differentiated tablets for patients with excipient sensitivities or regional formulation requirements.

What is QTERN and which excipients does it contain?

QTERN is AstraZeneca’s fixed-dose combination of the SGLT2 inhibitor dapagliflozin and the DPP-4 inhibitor saxagliptin. The U.S. product is a 10 mg/5 mg immediate-release tablet administered once daily, generally as an adjunct to diet and exercise for glycemic control in adults with type 2 diabetes [1].

The U.S. prescribing information identifies the following inactive ingredients:

Formulation component	QTERN excipient	Primary function
Diluent	Anhydrous lactose	Adds bulk and supports tablet compressibility
Filler and binder	Microcrystalline cellulose	Improves compactibility and mechanical strength
Disintegrant	Crospovidone	Promotes tablet breakup and drug release
Glidant	Colloidal silicon dioxide	Improves powder flow and blend uniformity
Lubricant	Magnesium stearate	Reduces ejection friction during compression
Film former	Polyvinyl alcohol	Forms the tablet coating
Opacifier and pigment	Titanium dioxide and yellow iron oxide	Controls appearance and light protection
Plasticizer and processing aid	Polyethylene glycol	Improves coating flexibility
Anti-tacking agent	Talc	Reduces coating adhesion during processing

QTERN does not use a novel excipient or a specialized delivery technology. Its formulation is based on established oral solid-dose materials listed in FDA’s Inactive Ingredient Database and commonly used in immediate-release tablets [1, 2].

How does the QTERN excipient platform support manufacturing?

The formulation is compatible with a conventional high-volume tablet manufacturing process. The likely process sequence is material dispensing, blending, lubrication, compression, film coating, inspection, and packaging.

The excipient combination supports several manufacturing objectives:

• Microcrystalline cellulose and lactose provide a balanced filler system for tablet weight control and compact strength.
• Crospovidone supports rapid disintegration without requiring a prolonged swelling step.
• Colloidal silicon dioxide improves flow for a low-dose blend containing two active pharmaceutical ingredients.
• Magnesium stearate enables efficient tablet ejection but requires control of blending time because over-lubrication can reduce hardness or slow dissolution.
• Polyvinyl alcohol film coating supports a thin, robust coat suitable for high-speed coating equipment.

The principal formulation risk is blend uniformity. Dapagliflozin and saxagliptin are present at different drug loads, and saxagliptin represents a relatively small fraction of the total tablet mass. Particle-size distribution, segregation behavior, order of addition, and lubricant blending therefore have direct implications for content uniformity.

A generic manufacturer can use direct compression if the selected active pharmaceutical ingredients have suitable flow and compactibility. Roller compaction or dry granulation may be used if the blend shows poor flow, segregation, or compression defects. Wet granulation is technically possible but can increase process complexity and introduce additional moisture and drying controls.

What formulation attributes are commercially valuable?

The strongest commercial formulation attributes are low manufacturing cost, robust dissolution, predictable content uniformity, and broad excipient tolerability.

Lactose-free QTERN alternatives

QTERN contains anhydrous lactose. A lactose-free version could replace lactose with one or more of the following:

• Mannitol
• Dibasic calcium phosphate
• Pregelatinized starch
• Additional microcrystalline cellulose
• Spray-dried or co-processed cellulose systems

A lactose-free product could target patients with lactose intolerance, hospital formularies with excipient restrictions, and markets where lactose-free labeling has commercial value. The change would require comparative dissolution, stability, manufacturability, and bioequivalence work. It would not automatically create patent protection, because excipient substitution alone generally does not produce a strong composition-of-matter barrier.

Low-cost direct-compression formulations

A formulation that uses a single multifunctional filler, such as a co-processed cellulose-based excipient, could reduce manufacturing steps and improve scale-up. The commercial value depends on whether the excipient reduces:

• Tablet weight
• Compression force
• Coating time
• Batch failure rates
• Blend segregation
• Cleaning and changeover requirements

A low-cost formulation is more defensible if it delivers a measurable process advantage, such as improved content uniformity at commercial scale or a narrower dissolution profile across manufacturing sites.

Modified tablet size and swallowability

QTERN is a combination product with two pharmacologically active ingredients. A smaller tablet could improve adherence, particularly for patients already taking metformin, insulin, antihypertensive agents, or lipid-lowering therapy. Tablet miniaturization must preserve dose uniformity and mechanical strength.

A smaller tablet may require higher-density excipients, more efficient compression, or a multilayer design. It could support a formulation patent if the claims cover a defined composition and performance profile, although patentability would depend on unexpected technical effects.

Moisture and stability control

Dapagliflozin and saxagliptin formulations require stability evaluation under ICH conditions. Excipient water activity, packaging permeability, and coating integrity can influence degradation and dissolution over shelf life.

Commercially relevant approaches include:

• Low-moisture excipients
• High-barrier blister packaging
• Desiccant-equipped bottles
• Moisture-protective film coatings
• Control of residual solvents and peroxide impurities

Excipient suppliers with low-peroxide grades of povidone, crospovidone, or polyethylene glycol may have an opportunity where oxidative degradation affects stability. Any such advantage must be demonstrated in the finished product rather than inferred from raw-material specifications.

What regulatory pathway applies to generic QTERN?

A generic QTERN product would generally be pursued through an abbreviated new drug application under section 505(j) of the Federal Food, Drug, and Cosmetic Act. The product would need to match the reference listed drug in active ingredients, dosage form, strength, route of administration, and conditions of use, while demonstrating bioequivalence [3].

For an immediate-release tablet, the generic sponsor would normally evaluate:

• Pharmacokinetic bioequivalence for dapagliflozin and saxagliptin
• Comparative dissolution across relevant media
• Assay and content uniformity
• Degradation products
• Stability
• Impurity controls
• Container-closure performance
• Inactive-ingredient safety

FDA’s inactive-ingredient framework does not require every generic tablet to duplicate the reference product’s excipients. A different excipient system may be acceptable if it is permitted for the dosage form and route, does not affect safety or efficacy, and does not prevent demonstration of bioequivalence [2, 3].

What is the Orange Book and patent status of QTERN?

QTERN is an FDA-approved drug product regulated as a small-molecule combination, not a biologic. Biosimilar legislation therefore does not apply. The relevant competitive pathway is an ANDA, not a biosimilar application.

The Orange Book is the controlling source for current reference-product status, listed patents, exclusivity, and patent certification requirements [4]. A generic applicant must evaluate whether listed patents require:

• Paragraph III certification, accepting launch after patent expiration
• Paragraph IV certification, asserting that a listed patent is invalid, unenforceable, or not infringed
• A section viii statement, where the applicant omits a patented method of use

The original active-ingredient patent estates for dapagliflozin and saxagliptin arose before the QTERN combination. The commercial risk is therefore more likely to center on combination, formulation, dosing, and method-of-use patents than on new chemical-entity protection for the individual ingredients.

QTERN received FDA approval in 2017. Any three-year regulatory exclusivity associated with new clinical investigations would not normally remain a current barrier to an ANDA. The relevant launch constraints are current Orange Book-listed patents, pediatric extensions if applicable, litigation stays, and any settlement terms [1, 4].

Which QTERN patent claims are most relevant to excipient strategy?

Excipient development is most exposed to patents in four claim categories:

Fixed-dose composition claims

These claims may define a tablet containing specified quantities of dapagliflozin and saxagliptin, with or without a defined excipient group. A generic manufacturer should assess whether a lactose-free or co-processed excipient formulation avoids the claim language.

Formulation-performance claims

Claims may specify dissolution, disintegration, particle size, stability, or impurity limits. A formulation that uses different excipients may still infringe if the claims are performance-based rather than ingredient-based.

Method-of-use claims

QTERN-related claims may cover treatment of type 2 diabetes, particular patient populations, combination therapy, or dosing schedules. A section viii strategy may be relevant if patented indications can be carved out without undermining the approved generic label.

Manufacturing-process claims

Claims may cover blending, granulation, compression, coating, or control of polymorphic or particle-size attributes. These claims can create manufacturing barriers even when the final product composition is outside a composition patent.

The strength of an excipient-focused design-around depends on claim construction, prosecution history, written-description support, enablement, and whether the formulation change produces a meaningful technical result. Substituting lactose with mannitol is usually a weak patent strategy by itself. A formulation that improves stability, reduces tablet mass, or produces a specific dissolution profile has greater potential for defensible protection.

When does QTERN lose exclusivity and when could generic entry occur?

QTERN’s regulatory exclusivity period has expired based on its 2017 approval date. Generic entry timing depends on the current Orange Book patent listings and any Paragraph IV litigation.

Milestone	Commercial relevance
2017 FDA approval	Established QTERN as the reference product
2020 onward	Three-year exclusivity, if applicable, would generally no longer block ANDA approval
Patent expiration dates	Determine whether a Paragraph III launch is required
Paragraph IV notice	Can trigger patent litigation and a potential 30-month stay
Settlement agreement	May establish an earlier authorized or licensed generic entry date
ANDA approval	Does not guarantee immediate launch if patents or settlements remain operative

The most attractive generic launch scenario is an ANDA supported by a non-infringing formulation, a complete section viii labeling strategy where available, and a Paragraph IV position against remaining blocking patents. A less aggressive route is Paragraph III certification with launch after the latest enforceable patent expiration.

What commercial opportunities exist for excipient suppliers?

Excipient suppliers can pursue QTERN-related opportunities in five areas.

1. Lactose-free excipient systems

A co-processed mannitol-cellulose or cellulose-starch system could replace the lactose-cellulose base while preserving compressibility and rapid disintegration.

2. Direct-compression platforms

Suppliers can position high-functionality excipients around improved flow, lower compression force, and reduced blend segregation. The value proposition should be supported by comparative tabletability and content-uniformity data.

3. Low-peroxide grades

Low-peroxide crospovidone, povidone, polyethylene glycol, and related materials may support stability-sensitive formulations. The strongest evidence would be reduced degradation under accelerated conditions.

4. Film-coating systems

Ready-to-use polyvinyl alcohol coating systems can reduce development time and simplify color matching across manufacturing sites. A coating that improves moisture protection without increasing disintegration time has direct value.

5. Pediatric and geriatric dosage forms

A dispersible tablet, mini-tablet, orally disintegrating tablet, or sprinkle formulation could broaden the product concept. Such products would require new clinical, labeling, and bioequivalence assessments and may fall outside a standard ANDA strategy.

How does QTERN compare with QTERNMET XR?

QTERN and QTERNMET XR address different formulation problems.

Attribute	QTERN	QTERNMET XR
Active ingredients	Dapagliflozin and saxagliptin	Dapagliflozin, saxagliptin, and extended-release metformin
Release profile	Immediate release	Includes extended-release metformin
Excipient challenge	Blend uniformity and rapid disintegration	Matrix or controlled-release performance plus multi-drug compatibility
Generic complexity	Moderate	Higher
Primary commercial opportunity	Low-cost fixed-dose immediate-release tablet	Controlled-release design-around and dose flexibility
Bioequivalence risk	Conventional pharmacokinetic comparison	More complex release and pharmacokinetic evaluation

QTERN is more accessible for conventional generic development. QTERNMET XR offers greater technical differentiation but carries higher development, analytical, and regulatory risk.

What generic entry risks exist for QTERN?

The principal risks are formulation bioequivalence, patent certification, and market size.

A generic sponsor may face:

• Failure to match dapagliflozin or saxagliptin exposure
• Dissolution divergence caused by excipient substitution
• Content-uniformity failure from low-dose saxagliptin distribution
• Coating-related changes in disintegration
• Patent litigation after Paragraph IV notice
• Limited reimbursement preference for the fixed-dose combination
• Competition from separate dapagliflozin and saxagliptin products
• Prescriber preference for newer GLP-1 and dual-incretin therapies
• Weak commercial uptake if QTERN pricing is already discounted

The product has a practical adherence advantage because it combines two oral agents in one tablet. That advantage is offset by competition from generic single-agent products and newer diabetes therapies with stronger weight-loss or cardiovascular positioning.

Key Takeaways

• QTERN is an immediate-release 10 mg/5 mg dapagliflozin-saxagliptin tablet using conventional excipients.
• The core excipient platform consists of lactose, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, and a polyvinyl alcohol film coat.
• The best formulation opportunities are lactose-free tablets, lower-mass direct-compression products, low-peroxide systems, and moisture-protective coatings.
• QTERN is a small-molecule combination product. Biosimilar competition is not relevant.
• Generic entry depends primarily on current Orange Book patents, Paragraph IV litigation, settlements, and any applicable method-of-use carve-outs.
• A technically credible excipient design-around should demonstrate a measurable advantage in stability, dissolution, manufacturability, or tablet size.
• QTERN is less technically complex than QTERNMET XR and is more suitable for conventional ANDA development.

FAQs About QTERN Excipient and Generic Opportunities

Can a generic QTERN tablet use different excipients?

Yes. FDA generally permits inactive-ingredient differences in an ANDA if the formulation is safe, supports bioequivalence, and complies with inactive-ingredient requirements.

Is QTERN protected by a biologic patent or biosimilar pathway?

No. QTERN contains small-molecule active ingredients and competes through the generic drug framework rather than the biosimilar pathway.

Is a lactose-free QTERN formulation commercially attractive?

It can be attractive in markets that value lactose-free labeling or where excipient restrictions affect prescribing. Its success depends on preserving tabletability, dissolution, stability, and bioequivalence.

Which excipient is most important for QTERN dissolution?

Crospovidone is the principal disintegrant, but dissolution depends on the combined effects of particle size, compression force, lubricant level, filler selection, and coating characteristics.

Can an excipient supplier obtain patent protection around a QTERN formulation?

Potentially. Protection is stronger when the formulation produces a demonstrated technical effect, such as improved stability, reduced tablet size, or a defined dissolution profile, rather than merely replacing one routine filler with another.

References

1. U.S. Food and Drug Administration. (n.d.). QTERN (dapagliflozin and saxagliptin) tablets, prescribing information. AstraZeneca Pharmaceuticals LP.

2. U.S. Food and Drug Administration. (n.d.). Inactive Ingredient Database. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm

3. U.S. Food and Drug Administration. (2014). ANDA submissions: Content and format of an abbreviated new drug application. https://www.fda.gov

4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm