List of Excipients in Branded Drug JARDIANCE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Cardinal Health 107 LLC	JARDIANCE	empagliflozin	55154-0411	CELLULOSE, MICROCRYSTALLINE	2029-02-01
Cardinal Health 107 LLC	JARDIANCE	empagliflozin	55154-0411	CROSCARMELLOSE SODIUM	2029-02-01
Cardinal Health 107 LLC	JARDIANCE	empagliflozin	55154-0411	FERRIC OXIDE YELLOW	2029-02-01

Last updated: August 4, 2026

ecutive summary: Jardiance (empagliflozin) uses a conventional immediate-release tablet platform built around lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide and magnesium stearate, with a hypromellose-based film coating. The formulation is technically reproducible and commercially efficient, but it creates opportunities for generic manufacturers and excipient suppliers in lactose-free versions, low-cost direct-compression platforms, fixed-dose combinations, pediatric products and differentiated delivery systems. The strongest commercial strategy is an FDA-compliant 505(j) generic that matches the reference product’s qualitative and quantitative composition closely while avoiding unnecessary formulation complexity.

Jardiance Excipient Strategy and Commercial Opportunities

What excipients are used in Jardiance tablets?

Jardiance is an immediate-release, film-coated tablet containing either 10 mg or 25 mg of empagliflozin. The core formulation uses standard oral solid-dose excipients rather than a novel controlled-release or lipid-based delivery system.

Formulation component	Function in Jardiance
Lactose monohydrate	Diluent and tablet bulk
Microcrystalline cellulose	Diluent, compression aid and structural matrix
Hydroxypropyl cellulose	Binder
Croscarmellose sodium	Superdisintegrant
Colloidal silicon dioxide	Glidant and powder-flow aid
Magnesium stearate	Lubricant
Hypromellose	Film-coating polymer
Titanium dioxide	Opacifier and color modifier
Talc	Coating aid and anti-tacking agent
Yellow ferric oxide	Tablet-colorant component

The exact inactive-ingredient declaration, strength-specific color system and manufacturing controls are set out in the FDA-approved prescribing information and product labeling. [1]

The formulation objective is straightforward: provide rapid tablet disintegration, consistent dissolution and robust manufacturability at a low drug load. Empagliflozin is present at 10 mg or 25 mg per tablet, so the excipient system carries most of the tablet mass and controls blend uniformity, compression and disintegration.

Why is the Jardiance excipient platform commercially attractive?

The excipient platform has several characteristics that reduce generic development risk:

1. It uses widely available, compendial materials.
2. It avoids specialized modified-release polymers.
3. It is compatible with conventional wet-granulation or direct-compression manufacturing, subject to the manufacturer’s process design.
4. The tablet does not require a complex delivery device.
5. The core excipients are familiar to contract development and manufacturing organizations.

For a generic sponsor, this supports a relatively low-cost formulation-development program. The primary CMC risks are not excipient novelty. They are blend uniformity, dissolution matching, film-coating consistency, impurity control, polymorph management and stability.

Empagliflozin is a potent small-molecule drug with a low tablet dose. Low-dose products require particular attention to content uniformity because a small weighing or segregation error can materially affect dose accuracy. Microcrystalline cellulose and colloidal silicon dioxide can improve flow, but excessive glidant or lubricant levels can alter tablet hardness and dissolution.

What formulation opportunities exist for Jardiance generics?

Lactose-free Jardiance alternatives

The clearest excipient opportunity is replacement of lactose monohydrate with a lactose-free diluent. Potential alternatives include:

• Mannitol
• Anhydrous dibasic calcium phosphate
• Pregelatinized starch
• Additional microcrystalline cellulose
• Coprocessed cellulose-based excipients

A lactose-free version may address patient and prescriber preferences, supply-chain positioning or excipient-avoidance requirements. The commercial value is likely to be limited in a standard generic market unless the product also improves tablet size, tolerability, manufacturability or access in a defined market segment.

A lactose-free product may require new development work on compactability, disintegration, moisture sensitivity and dissolution. A substitute diluent can also affect the tablet’s density and appearance, creating a different product profile even when the active ingredient and strength remain unchanged.

Low-excipient and small-tablet formulations

A smaller tablet can improve swallowability and reduce packaging volume. The opportunity is constrained by the need to maintain adequate mechanical strength and dose uniformity. Empagliflozin’s low dose makes a small tablet technically feasible, but the commercial benefit must justify additional development and bioequivalence work.

A low-excipient strategy may use highly compressible microcrystalline cellulose, mannitol or a coprocessed excipient. The main risks are friability, punch sticking, lubricant sensitivity and variability in disintegration.

Direct-compression formulations

Direct compression can reduce process steps, solvent use and manufacturing cost. It may also simplify scale-up. However, direct compression depends on consistent powder flow and particle-size control. Empagliflozin particle properties, excipient grade and blend segregation must be controlled across commercial equipment sizes.

A direct-compression generic can compete on cost, but it generally does not create strong differentiation unless it also delivers a smaller tablet, improved stability or a recognized patient-use advantage.

Orally disintegrating tablets

An orally disintegrating tablet could target patients with dysphagia, older adults and certain cardiometabolic populations. Candidate excipients include mannitol, crospovidone, low-substituted hydroxypropyl cellulose and taste-masking agents.

The opportunity is commercially distinct from a conventional generic but faces higher development risk:

• Empagliflozin taste may require masking.
• ODTs can have higher moisture sensitivity.
• Packaging may need desiccant or unit-dose protection.
• Bioequivalence must be demonstrated under the applicable FDA pathway.
• The product may require a separate brand and promotional strategy.

An ODT is more likely to support an authorized generic-plus or 505(b)(2)-type commercial model than a simple commodity ANDA.

What formulation patents protect Jardiance?

Jardiance’s principal intellectual-property value has historically centered on empagliflozin and the broader C-glucoside/SGLT2 inhibitor patent family rather than on a highly distinctive excipient system.

The relevant patent categories include:

Patent category	Commercial relevance
Empagliflozin compound patents	Protect the active pharmaceutical ingredient
Crystalline or solid-state patents	May limit use of particular polymorphs or crystal forms
Pharmaceutical-composition patents	May cover dosage forms or composition ranges
Method-of-use patents	May cover diabetes, heart failure, kidney disease or related indications
Combination-product patents	May affect empagliflozin/metformin and other fixed-dose products
Manufacturing patents	May cover selected synthetic or purification processes

The FDA Orange Book is the controlling public source for patents listed against approved small-molecule products. Patent scope and expiry must be evaluated separately for Jardiance, Synjardy, Glyxambi and Trijardy XR because combination products and additional indications may carry different listed rights. [2]

An excipient substitution does not automatically avoid a patent. A generic sponsor must analyze claim language covering the active ingredient, dosage form, composition, process, method of use and any relevant polymorph. A formulation that replaces lactose may still infringe a composition claim if the claim covers the active ingredient with broad excipient categories or defined ranges.

When does Jardiance lose exclusivity?

Jardiance lost or will lose exclusivity through several separate mechanisms rather than one date.

Exclusivity element	Practical effect
New chemical entity exclusivity	Delayed ANDA approval for the initial approval period
Listed patents	Can delay approval or create Paragraph IV litigation
Pediatric exclusivity	Can add six months to applicable exclusivity or patent terms
Method-of-use protection	May restrict labeling for protected indications
Regulatory exclusivity for combinations	May affect products such as Synjardy or Trijardy XR
Patent settlements	Can establish an agreed generic-entry date

The key date for a generic manufacturer is the earliest legally available launch date after accounting for Orange Book patents, six-month pediatric exclusivity, court orders and any settlement agreement. A patent expiration date alone does not establish an unconditional launch date.

Jardiance is a small-molecule product. Biosimilar exclusivity rules do not apply. The relevant pathway is an ANDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act, or, for a materially differentiated product, potentially a 505(b)(2) application. [3]

What is the Orange Book status of Jardiance?

Jardiance is listed in the FDA Orange Book as a prescription small-molecule drug. The Orange Book identifies the reference listed drug, dosage forms, strengths and patents submitted by the sponsor.

An ANDA applicant may use one of four patent certifications:

• Paragraph I: no patent information is listed.
• Paragraph II: the listed patent has expired.
• Paragraph III: approval is requested after patent expiration.
• Paragraph IV: the listed patent is invalid, unenforceable or will not be infringed.

A Paragraph IV certification can trigger patent litigation if the innovator files suit within the statutory period. A first-filer may receive 180-day exclusivity if statutory requirements are met, although eligibility can be affected by forfeiture events and settlement terms. [4]

For Jardiance, the high-value risk is not usually the tablet excipient itself. It is the interaction between active-ingredient patents, method-of-use claims and the proposed generic label.

Which companies are challenging Jardiance exclusivity?

Publicly identifiable challenges can change as ANDAs are filed, Paragraph IV notices are served and cases settle. The key competitive groups are:

1. Large generic companies with cardiovascular and diabetes portfolios.
2. Regional manufacturers targeting price-sensitive markets.
3. Authorized-generic or supply partners linked to the reference-product sponsor.
4. Combination-product specialists developing empagliflozin/metformin or other SGLT2 combinations.

A company can challenge a patent without immediately launching. Litigation, settlement agreements, manufacturing readiness and regulatory approval must be assessed together. A patent settlement can preserve a later launch date while removing the risk of an adverse injunction or damages judgment.

How does Jardiance compare with competing SGLT2 inhibitors?

Product	Active ingredient	Main formulation opportunity
Jardiance	Empagliflozin	Lactose-free generic, ODT, low-cost immediate-release tablet, fixed-dose combinations
Farxiga/Forxiga	Dapagliflozin	Similar conventional tablet strategy, with competition across diabetes, heart failure and kidney disease
Invokana	Canagliflozin	Generic tablet and combination-product opportunities
Steglatro	Ertugliflozin	Smaller commercial base but potential niche generic opportunity

The competitive advantage of Jardiance is not a proprietary excipient technology. It is the strength of its clinical positioning across type 2 diabetes, heart failure and chronic kidney disease, together with broad prescriber familiarity. FDA expanded Jardiance’s approved uses beyond glycemic control, including heart-failure and chronic-kidney-disease indications. [1, 5]

A generic company that launches only a diabetes-labeled product may face a narrower commercial opportunity than the reference brand. Method-of-use patents and labeling restrictions can limit the indications that appear in the generic label.

What manufacturing and intellectual-property barriers affect Jardiance generics?

Active pharmaceutical ingredient supply

Empagliflozin API quality is a central barrier. Important controls include:

• Identity and assay
• Related substances
• Residual solvents
• Water content
• Particle-size distribution
• Solid-state form
• Elemental impurities
• Microbial quality where applicable

A generic manufacturer may use a non-infringing synthetic route, but process economics and impurity clearance can determine whether the product is commercially viable.

Solid-state and particle engineering

Empagliflozin’s particle size and morphology can affect blend uniformity and dissolution. A change in API supplier can require reformulation or additional comparative testing. Particle engineering can also create IP exposure if a patent claims a specific polymorph, particle-size range or manufacturing process.

Film coating

The film coat has limited therapeutic differentiation but affects appearance, stability and patient identification. Color matching is relevant to generic substitution and product quality. A substitute colorant may reduce cost but increase risk of visual mismatch or regulatory review questions.

Combination products

Synjardy combines empagliflozin with metformin hydrochloride. Trijardy XR combines empagliflozin, linagliptin and extended-release metformin. These products create more demanding excipient and process requirements than Jardiance because the formulation must manage multiple active ingredients and, in the case of Trijardy XR, modified release.

The commercial opportunity is larger in fixed-dose combinations, but formulation and patent complexity are also higher. A company that lacks modified-release manufacturing capability may be better positioned with Jardiance or Synjardy immediate-release products.

What FDA regulatory pathway applies to a Jardiance excipient strategy?

A conventional generic tablet normally uses the ANDA pathway. The applicant must demonstrate pharmaceutical equivalence and bioequivalence to the reference listed drug. Differences in inactive ingredients may be permissible, but they must not affect safety, efficacy, quality, performance or bioequivalence.

A 505(b)(2) strategy may be relevant where the sponsor proposes a new dosage form, route, formulation or clinical use that cannot be fully supported by an ANDA. This route can support an ODT, dispersible tablet or other differentiated product, but it generally involves greater regulatory and clinical expense.

FDA’s inactive-ingredient databases can support early excipient screening, but they do not replace product-specific compatibility, stability, dissolution and bioequivalence work. [6]

What licensing deals affect the Jardiance franchise?

Boehringer Ingelheim and Eli Lilly developed and commercialized Jardiance through their diabetes alliance. The alliance covers a broader portfolio of diabetes products and affects global commercialization, supply and economic rights. [7]

An excipient supplier is unlikely to license a core Jardiance patent merely by supplying lactose, cellulose, croscarmellose sodium or coating materials. Commercial opportunity is more likely to arise through:

• Preferred-supplier agreements
• Dual-sourcing programs
• Custom particle-size grades
• Coprocessed excipients
• Technical support for direct compression
• Regional supply contracts
• Contract development and manufacturing arrangements

The most defensible supplier position is a performance-based excipient platform that improves manufacturability or stability without requiring a clinically differentiated product.

How strong is the Jardiance formulation opportunity?

The opportunity is moderate for commodity generics and stronger for differentiated products.

Opportunity	Technical difficulty	Commercial potential
Standard immediate-release generic	Low to moderate	High volume, price pressure
Lactose-free tablet	Moderate	Moderate
Smaller tablet	Moderate	Moderate
ODT or dispersible tablet	High	Niche to moderate
Empagliflozin/metformin combination	Moderate to high	High
Extended-release combination	High	High but patent-sensitive
Pediatric-friendly formulation	Moderate to high	Niche
Excipient supplier platform	Moderate	Recurring B2B revenue

The preferred strategy depends on market timing. Before broad generic entry, a differentiated formulation can support higher margins. After generic competition becomes established, low-cost production and reliable supply usually matter more than minor excipient differentiation.

Key Takeaways

• Jardiance uses a conventional immediate-release, film-coated tablet platform.
• The main excipients are lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide and magnesium stearate.
• Lactose-free, smaller-tablet and direct-compression versions are the most practical formulation opportunities.
• ODT and pediatric products offer greater differentiation but require more development and regulatory work.
• Jardiance is a small molecule, so biosimilar risk does not apply.
• Generic entry depends on Orange Book patents, exclusivity, Paragraph IV activity, settlements and method-of-use restrictions.
• The primary IP risks concern empagliflozin, solid-state forms, methods of use, combinations and manufacturing processes, not routine excipients alone.
• Fixed-dose combinations offer greater commercial value but carry greater formulation and patent complexity.
• For excipient suppliers, performance, dual sourcing and process support are more attractive opportunities than ownership of routine inactive-ingredient patents.

FAQs

Can a Jardiance generic use different inactive ingredients?

Yes. An ANDA may use different inactive ingredients if the product remains pharmaceutically equivalent, bioequivalent and acceptable for safety, quality and performance. Differences that affect dissolution, stability or tolerability can create additional regulatory risk.

Is Jardiance lactose-free?

The reference Jardiance tablet contains lactose monohydrate according to FDA labeling. A generic manufacturer could develop a lactose-free version, but the alternative diluent system would require product-specific development and comparative testing.

Can an excipient patent block a Jardiance generic?

It can if a valid claim covers the proposed composition, excipient range, dosage form or manufacturing process. Routine use of a compendial excipient does not by itself eliminate patent risk.

Does Jardiance have an extended-release formulation?

Jardiance itself is an immediate-release tablet. Trijardy XR contains empagliflozin with linagliptin and extended-release metformin, creating a separate modified-release formulation and patent analysis.

Is a Jardiance ODT likely to receive generic approval through an ANDA?

An ODT that differs materially from the reference tablet may not qualify as a straightforward ANDA product. The appropriate pathway depends on dosage-form differences, FDA requirements and whether the applicant can establish the necessary equivalence. A 505(b)(2) pathway may be relevant for a substantially differentiated product.

References

1. U.S. Food and Drug Administration. (2023). Jardiance (empagliflozin) prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

3. U.S. Food and Drug Administration. (2024). Abbreviated new drug application ANDA process. https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda

4. U.S. Food and Drug Administration. (2024). Paragraph IV patent certifications and 180-day exclusivity. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/paragraph-iv-patent-certifications

5. U.S. Food and Drug Administration. (2023). FDA approves Jardiance to reduce the risk of cardiovascular death in adults with chronic kidney disease. https://www.fda.gov

6. U.S. Food and Drug Administration. (2024). Inactive ingredient database. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm

7. Eli Lilly and Company. (2024). Annual report 2023. https://investor.lilly.com/financial-information/annual-reports-and-proxy-statements