List of Excipients in Branded Drug STEGLUJAN

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Merck Sharp & Dohme LLC	STEGLUJAN	ertugliflozin and sitagliptin	0006-5367	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	2030-10-21
Merck Sharp & Dohme LLC	STEGLUJAN	ertugliflozin and sitagliptin	0006-5367	CARNAUBA WAX	2030-10-21
Merck Sharp & Dohme LLC	STEGLUJAN	ertugliflozin and sitagliptin	0006-5367	CELLULOSE, MICROCRYSTALLINE	2030-10-21
Merck Sharp & Dohme LLC	STEGLUJAN	ertugliflozin and sitagliptin	0006-5367	CROSCARMELLOSE SODIUM	2030-10-21
Merck Sharp & Dohme LLC	STEGLUJAN	ertugliflozin and sitagliptin	0006-5367	FERRIC OXIDE RED	2030-10-21
Merck Sharp & Dohme LLC	STEGLUJAN	ertugliflozin and sitagliptin	0006-5367	FERRIC OXIDE YELLOW	2030-10-21
Merck Sharp & Dohme LLC	STEGLUJAN	ertugliflozin and sitagliptin	0006-5367	FERROSOFERRIC OXIDE	2030-10-21

Steglujan Excipient Strategy and Commercial Opportunities

Last updated: October 25, 2026

Steglujan is a fixed-dose combination tablet containing ertugliflozin and sitagliptin, marketed for adults with type 2 diabetes mellitus. Its commercial opportunity is concentrated in generic and lifecycle development after loss of core active-ingredient exclusivity, with excipient differentiation available through bioequivalent immediate-release tablets, improved manufacturability, packaging stability, and patient-specific formulations. The reference product uses a conventional tablet platform with lactose, microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, magnesium stearate, and a film coating system.[1]

What is Steglujan and how is it formulated?

Steglujan combines two oral antihyperglycemic mechanisms:

Attribute	Steglujan detail
Active ingredients	Ertugliflozin and sitagliptin
US strengths	5 mg/100 mg and 15 mg/100 mg
Dosage form	Immediate-release, film-coated tablet
Administration	Once daily, generally in the morning
Therapeutic class	SGLT2 inhibitor plus DPP-4 inhibitor
Reference sponsor	Merck Sharp & Dohme LLC, with Pfizer development and commercialization history
FDA approval	December 2017
Primary indication	Glycemic control in adults with type 2 diabetes, as an adjunct to diet and exercise
Key reference	FDA Prescribing Information and DailyMed labeling

Steglujan is not an extended-release product. The formulation challenge is therefore conventional but commercially important: the manufacturer must reproduce dissolution, assay, content uniformity, impurity profile, tablet strength, coating performance, and stability within the applicable abbreviated new drug application, or ANDA, framework.[1][2]

What excipients are used in Steglujan tablets?

The core Steglujan tablet uses common direct-compression and film-coating excipients.

Formulation component	Function in Steglujan
Microcrystalline cellulose	Diluent, compressibility aid, tablet structure
Lactose monohydrate	Diluent and bulking agent
Croscarmellose sodium	Superdisintegrant
Sodium stearyl fumarate	Lubricant
Magnesium stearate	Lubricant and ejection aid
Polyvinyl alcohol	Film-forming coating polymer
Titanium dioxide	Opacifier and pigment
Macrogol 3350	Plasticizer and coating flexibility aid
Talc	Anti-tacking and coating-process aid
Iron oxide pigments	Tablet color and strength differentiation

The combination of microcrystalline cellulose and lactose is a standard platform for immediate-release tablets. Croscarmellose sodium supports rapid tablet breakup. Sodium stearyl fumarate and magnesium stearate reduce sticking and improve ejection during compression, although excessive lubrication can slow disintegration or reduce dissolution.

The film coat provides color coding, handling protection, and improved swallowability. It also helps distinguish the 5 mg/100 mg and 15 mg/100 mg strengths.

How can generic manufacturers reproduce the Steglujan formulation?

A generic manufacturer does not necessarily need to duplicate every excipient in the same quantity. The product must meet FDA requirements for pharmaceutical equivalence and bioequivalence, while the formulation must demonstrate acceptable quality, stability, dissolution, and manufacturability.[2]

The most commercially practical approach is a conventional immediate-release formulation with:

1. A lactose-cellulose diluent system.
2. Croscarmellose sodium or an equivalent superdisintegrant.
3. A low-risk lubricant system.
4. An aqueous or nonaqueous film coating.
5. Strength-specific color coding.

Potential formulation substitutions include:

Reference excipient	Potential alternative	Commercial rationale
Lactose monohydrate	Mannitol, anhydrous lactose, dibasic calcium phosphate	Lactose-free positioning, moisture control, or improved flow
Microcrystalline cellulose	Spray-dried lactose, silicified MCC, coprocessed fillers	Better flow, compactibility, and high-speed compression
Croscarmellose sodium	Crospovidone, sodium starch glycolate	Dissolution and disintegration optimization
Magnesium stearate	Sodium stearyl fumarate, calcium stearate	Reduced hydrophobic lubrication or improved process robustness
Polyvinyl alcohol coating	Hypromellose or other immediate-release coating systems	Supplier flexibility and coating-process optimization
Iron oxide pigments	Alternative approved color systems	Supply continuity and product identification

The highest-value formulation work is unlikely to involve a novel excipient. It is more likely to involve process control, excipient grade selection, particle-size engineering, lubrication time, coating uniformity, and dissolution matching.

What excipient risks affect Steglujan generic development?

Lactose and hypersensitivity positioning

The reference product contains lactose monohydrate. A lactose-free or low-lactose generic could target patients and prescribers who prefer to avoid lactose, although the clinical value of this positioning would need to be supported by market research. Removing lactose may require changes to tablet density, compactibility, friability, and dissolution.

Mannitol is a plausible replacement, but it can alter tablet strength, hygroscopicity, mouthfeel, and cost. Dibasic calcium phosphate may improve compressibility but can introduce different disintegration and dissolution behavior.

Lubricant sensitivity

Magnesium stearate is widely used but can cause dissolution changes when concentration or blending time is poorly controlled. Sodium stearyl fumarate is already present in the reference formulation and may offer a differentiated lubricant strategy. A generic manufacturer could use one lubricant or a controlled combination, but the dissolution profile must remain comparable.

Coating supply and color control

The film coating is operationally important because Steglujan has two strengths. A manufacturer can simplify its coating system, but color and imprint differences must preserve strength identification and meet labeling requirements. Titanium dioxide and iron oxide supply controls can affect cost, lead time, and geographic availability.

Moisture and packaging

Sitagliptin and ertugliflozin products require stability assessment under ICH conditions. Excipient moisture, packaging permeability, tablet coating integrity, and impurity growth should be evaluated together. High-barrier blister packaging may provide a commercial advantage where bottle packaging creates greater exposure to humidity after opening.

What patent and exclusivity issues affect Steglujan?

Steglujan has two active pharmaceutical ingredients with different patent histories. Sitagliptin was commercialized earlier than ertugliflozin, while the fixed-dose combination and ertugliflozin-related rights were developed later.

Exclusivity category	Relevance to Steglujan
Sitagliptin compound patents	Historically protected the DPP-4 inhibitor component
Ertugliflozin compound patents	Protected the SGLT2 inhibitor component
Combination patents	May cover ertugliflozin plus sitagliptin combinations
Method-of-use patents	May cover treatment of type 2 diabetes and combination use
Formulation patents	May cover particular tablet compositions or manufacturing processes
Regulatory exclusivity	Depends on the approval pathway, labeling, and any pediatric or other statutory exclusivity
Orange Book listings	Determine listed patents and the scope of ANDA certification obligations

The relevant diligence source is the FDA Orange Book, together with the individual patent records and litigation docket.[3] A product-specific freedom-to-operate analysis must distinguish between:

• A patent covering the active ingredient.
• A patent covering a salt, polymorph, or crystalline form.
• A patent covering the fixed-dose combination.
• A patent covering a method of treatment.
• A patent covering a particular formulation or manufacturing process.

Excipient substitution can reduce risk from formulation claims, but it does not avoid patents covering the active ingredients or combination therapy. A generic applicant may still need Paragraph IV certifications against listed patents and may face a 30-month stay if the patent holder files suit within the statutory period under the Hatch-Waxman framework.[4]

When does Steglujan lose exclusivity?

The commercial timing is not defined by a single date. Steglujan exclusivity depends on the interaction of patent expiration, pediatric extensions, regulatory exclusivity, listed patents, litigation, and settlement terms.

For business planning, the following sequence is more useful than treating the product as having one exclusivity date:

1. Identify all Steglujan-related Orange Book patents.
2. Separate compound, combination, method-of-use, and formulation claims.
3. Determine expiration dates, terminal disclaimers, and patent-term adjustments.
4. Check whether pediatric exclusivity adds six months to relevant patents.
5. Review Paragraph IV certifications and litigation.
6. Assess whether a settlement permits an earlier generic launch.
7. Model launches by strength and indication.

Sitagliptin’s earlier patent history creates a potential asymmetry: the DPP-4 component may have less remaining protection than ertugliflozin or the fixed-dose combination. That asymmetry can support generic development of sitagliptin alone before a Steglujan-equivalent product becomes commercially available.

What is the FDA regulatory pathway for a Steglujan generic?

A conventional generic Steglujan product would generally be developed through an ANDA demonstrating pharmaceutical equivalence and bioequivalence to the reference listed drug. Key development requirements include:

• Same active ingredients.
• Same dosage form and route of administration.
• Equivalent strengths.
• Comparable labeling, subject to permissible generic modifications.
• In vitro dissolution testing.
• Bioequivalence studies where required.
• Impurity and degradation-product control.
• Stability data.
• Demonstration of adequate manufacturing controls.

Because Steglujan is an immediate-release tablet, a conventional formulation is more commercially attractive than an extended-release redesign. The combination product still presents analytical complexity because the assay, dissolution, and impurity methods must quantify two active ingredients in one dosage form.

A manufacturer should expect particular scrutiny around:

• Content uniformity at the lower ertugliflozin strength.
• Differential dissolution of the two active ingredients.
• Drug-excipient compatibility.
• Lubricant impact on release.
• Coating weight gain and color consistency.
• Tablet hardness, friability, and disintegration.
• Stability of both active ingredients in the finished product.

What formulation patents could affect Steglujan?

Formulation patent risk is generally narrower than active-ingredient patent risk but can still delay commercialization. Potential claim categories include:

Fixed-dose composition claims

These claims may specify ranges for ertugliflozin, sitagliptin, diluents, binders, disintegrants, lubricants, or coating materials. A formulation using the same excipients in materially different proportions may avoid some claims, but claim construction is required.

Dissolution or release claims

A patent may define dissolution at particular time points or under specified media conditions. Such claims can create risk even where the generic uses standard excipients.

Manufacturing-process claims

Claims may cover blending order, granulation, compression, coating, or particle-size control. A direct-compression process can reduce exposure to wet-granulation claims, although it must still satisfy product-quality requirements.

Solid-state claims

Separate patents may cover crystalline forms, hydrates, solvates, or particle-size distributions of ertugliflozin or sitagliptin. Excipient selection does not eliminate these risks.

How strong is the Steglujan patent estate?

The estate is potentially stronger where it combines active-ingredient rights with fixed-dose combination, method-of-use, solid-state, and manufacturing claims. Its practical strength depends on the number of unexpired claims, claim breadth, validity, enforceability, and whether a generic can design around formulation and process patents.

Patent category	Design-around potential	Commercial impact
Active ingredient	Low to moderate	Highest barrier
Salt or polymorph	Moderate	Can delay sourcing and development
Fixed-dose combination	Moderate	Directly relevant to Steglujan-equivalent products
Method of use	Moderate to high	May permit carve-outs, depending on labeling
Excipient composition	High to moderate	Often addressable through substitution
Manufacturing process	Moderate	Process redesign may be possible
Packaging or stability	Moderate to high	Usually less central to launch timing

Excipient strategy is most useful against composition and manufacturing claims. It has limited value against core compound claims.

What commercial opportunities exist for Steglujan excipients?

Generic fixed-dose combination tablets

The largest opportunity is a lower-cost Steglujan-equivalent product. A manufacturer that secures reliable ertugliflozin and sitagliptin supply can use standard excipients and compete on:

• Launch timing.
• Wholesale acquisition cost.
• Contract manufacturing efficiency.
• Pharmacy substitution.
• Formulary access.
• Supply reliability.

Lactose-free or low-lactose positioning

A lactose-free formulation could support a niche positioning strategy. The opportunity is limited by the size of the relevant patient population and by the fact that lactose in tablets is usually present at low quantities.

Improved moisture protection

A high-barrier blister or optimized bottle-closure system could support distribution in humid markets. Packaging differentiation may be more commercially defensible than excipient substitution alone.

Smaller tablet or improved swallowability

A higher-density excipient system could reduce tablet size. This may matter because Steglujan combines two active ingredients in a once-daily tablet, although the total active load is not large. A smaller tablet could improve adherence and reduce packaging volume.

Global supply-chain resilience

Second-source excipient qualification can reduce manufacturing interruptions. Preferred candidates should have multiple qualified suppliers, established compendial status, stable particle-size specifications, and low regulatory change risk.

Private-label and regional supply

Steglujan-equivalent products may support private-label, tender, and regional commercialization. Excipients with broad pharmacopeial acceptance and local availability are advantageous for multi-country registrations.

How does Steglujan compare with competing diabetes combinations?

Product category	Combination	Excipient opportunity
Steglujan	Ertugliflozin plus sitagliptin	Conventional immediate-release FDC; generic substitution and formulation design-around
Qtern	Dapagliflozin plus saxagliptin	Competing SGLT2/DPP-4 combination; different patent and formulation estate
Glyxambi	Empagliflozin plus linagliptin	Larger commercial comparator; potentially stronger branded-market presence
Synjardy	Empagliflozin plus metformin	High-volume SGLT2 combination; metformin creates larger tablet and tolerability constraints
Xigduo XR	Dapagliflozin plus metformin extended release	More complex release technology and excipient architecture

Steglujan’s immediate-release architecture may be easier to reproduce than extended-release combinations. Its commercial disadvantage is that ertugliflozin has had a smaller market position than empagliflozin and dapagliflozin in many markets. A generic strategy therefore depends heavily on price, contracting, and supply reliability rather than formulation novelty.

What generic launch risks exist for Steglujan?

The principal risks are:

• Unexpired patents covering ertugliflozin or the combination.
• Paragraph IV litigation and a possible 30-month stay.
• Difficulty obtaining bioequivalence with a substituted excipient system.
• Limited demand relative to higher-volume SGLT2 products.
• Active-ingredient supply constraints.
• Formulary exclusion or unfavorable rebate economics.
• Separate regulatory requirements across jurisdictions.
• Labeling restrictions arising from method-of-use patents.
• Manufacturing scale-up failures involving blend uniformity or coating.

A base-case launch model should distinguish between an at-risk launch, a launch after patent expiry, and a settlement-authorized entry. Revenue exposure for the originator is likely to be concentrated in the fixed-dose combination and any residual ertugliflozin franchise rather than in excipient-related differentiation.

Key Takeaways

• Steglujan is an immediate-release ertugliflozin/sitagliptin tablet in 5 mg/100 mg and 15 mg/100 mg strengths.
• Its reference formulation uses microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, magnesium stearate, and a polyvinyl alcohol-based film coat.
• Generic developers can likely pursue a conventional direct-compression platform with alternative fillers, disintegrants, lubricants, and coating systems.
• Excipient substitution is most valuable for formulation-patent design-around, supply-chain resilience, lactose-free positioning, moisture protection, and tablet-size reduction.
• Excipient strategy does not eliminate active-ingredient, solid-state, combination, or method-of-use patent risk.
• Commercial success depends more on launch timing, ertugliflozin and sitagliptin sourcing, reimbursement, and contracting than on a novel excipient.
• FDA Orange Book review, patent-family analysis, and litigation monitoring are essential to determine actual generic entry timing.

FAQs

Is Steglujan an immediate-release or extended-release product?

Steglujan is an immediate-release, film-coated tablet taken once daily.

Does Steglujan contain lactose?

Yes. The reference formulation contains lactose monohydrate.

Can a generic Steglujan product replace lactose with mannitol?

Potentially. The substitution would require formulation development, comparative dissolution work, stability testing, and bioequivalence support.

Are Steglujan excipients likely to be the main barrier to generic entry?

No. Active-ingredient, combination, solid-state, method-of-use, and listed formulation patents are more likely to control timing. Excipients mainly affect design-around strategy and manufacturing performance.

Which excipient is most important for Steglujan dissolution?

Croscarmellose sodium is the principal disintegrant, while the amount and blending history of magnesium stearate and sodium stearyl fumarate can materially affect tablet wetting and dissolution.

References

1. U.S. Food and Drug Administration. (2017). Steglujan prescribing information. Merck Sharp & Dohme LLC.

2. U.S. Food and Drug Administration. (2023). Guidance for industry: ANDAs for certain highly soluble, highly permeable drugs. Center for Drug Evaluation and Research.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.

4. U.S. Congress. (1984). Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585.