United States Patent 12,427,162: Empagliflozin Chronic Kidney Disease Claims, Scope and Patent Landscape
U.S. Patent 12,427,162 covers the use of empagliflozin to delay kidney-function decline, end-stage renal disease, kidney failure, or renal death in patients with stage 2 through stage 5 chronic kidney disease. Its strongest commercial coverage is directed to empagliflozin use in chronic kidney disease, particularly when combined with diabetes, albuminuria, cardiovascular risk, or renin-angiotensin-aldosterone-system therapy.
The patent is a method-of-use patent. It does not claim empagliflozin as a chemical compound, a specific crystalline form, or a particular tablet manufacturing process. Its infringement risk therefore depends primarily on the labeled or actual clinical use of empagliflozin, the indication included in a generic label, and the scope and validity of related patents in the same family.
What does U.S. Patent 12,427,162 protect?
Claim 1 establishes the central right:
- The active ingredient is empagliflozin.
- The patient must have stage 2, 3, 4, or 5 chronic kidney disease.
- Treatment must be directed to delaying loss of eGFR, delaying progression to end-stage renal disease or kidney failure, or delaying renal death.
- Empagliflozin may be administered alone or with one or more additional therapeutic substances.
The claim does not require:
- Diabetes;
- Albuminuria;
- Cardiovascular disease;
- A specific eGFR threshold within the stated CKD stage;
- A specific duration of treatment;
- A specified dose;
- A particular formulation;
- A requirement that the patient be receiving dialysis;
- A defined reduction in albuminuria.
The broadest reasonable reading of claim 1 reaches empagliflozin treatment across stages 2 through 5 CKD, provided the treatment is undertaken for one of the recited renal outcomes.
Claim-by-claim scope analysis
| Claim |
Subject matter |
Commercial and enforcement significance |
| 1 |
Empagliflozin for delaying eGFR loss, end-stage renal disease, kidney failure, or renal death in stage 2-5 CKD |
Core CKD method-of-use claim |
| 2 |
CKD with albuminuria |
Covers albuminuric patients without limiting the claim to a particular albumin-to-creatinine ratio |
| 3 |
Microalbuminuria or macroalbuminuria |
Narrows claim 2 by expressly identifying albuminuria categories |
| 4 |
Prediabetes, type 1 diabetes, or type 2 diabetes |
Extends coverage across diabetic and prediabetic populations |
| 5 |
Existing or potential cardiovascular disease |
Adds a broad cardiovascular-risk patient population |
| 6 |
Diabetes or prediabetes combined with cardiovascular disease or risk |
Overlaps the major cardiometabolic use population |
| 7 |
Stage 2, 3, or 4 CKD |
Excludes stage 5 and may be relevant to earlier-stage treatment |
| 8 |
Specific cardiovascular-risk factors and established vascular disease |
Patient-selection claim with detailed risk-factor limitations |
| 9 |
Combination with another antidiabetic agent |
Covers combination therapy generally |
| 10 |
Combination with metformin, linagliptin, or both |
Directly targets common diabetes regimens |
| 11 |
Combination with a RAAS inhibitor |
Covers concurrent nephroprotective therapy |
| 12 |
Direct renin inhibitor, ACE inhibitor, or ARB |
Defines the RAAS categories more specifically |
| 13 |
Empagliflozin plus any RAAS inhibitor |
Combination-use claim |
| 14 |
Empagliflozin plus direct renin inhibitor, ACE inhibitor, or ARB |
More specific RAAS combination claim |
| 15 |
Oral empagliflozin at 10 mg or 25 mg daily |
Covers standard Jardiance strengths and dosing |
| 16 |
Pharmaceutical composition containing 10 mg or 25 mg empagliflozin |
Product-use limitation directed to standard dose units |
How broad is the main CKD claim?
Claim 1 is broad in patient population but narrower in therapeutic purpose. A potential infringement theory would require more than dispensing empagliflozin to a person who happens to have CKD. The use must be connected to delaying eGFR decline, kidney failure, end-stage renal disease, or renal death.
That distinction matters for generic-label analysis. A generic company may attempt to omit the CKD indication from its labeling while retaining diabetes or heart-failure indications. The practical strength of that strategy depends on:
- Whether the generic is marketed for a use that physicians would understand to include CKD treatment;
- Whether the branded patent is listed in the FDA Orange Book;
- Whether the generic filing includes a Paragraph IV certification;
- Whether the patent holder can establish induced infringement based on prescribing, promotion, labeling, or distribution conduct;
- Whether the CKD indication is medically inseparable from the remaining label.
The claim also uses outcome-oriented language. “Delaying loss of eGFR” and “delaying progression to end stage renal disease/kidney failure” describe treatment objectives rather than a fixed numerical endpoint. That language may support a broad construction, but it can create enablement, written-description, indefiniteness, and proof-of-infringement disputes depending on the patent specification and prosecution history.
What patient populations are covered?
The claims cover a wide portion of the clinical CKD market.
CKD stage coverage
| CKD stage |
Claim coverage |
| Stage 2 |
Claims 1 and 7 |
| Stage 3 |
Claims 1 and 7 |
| Stage 4 |
Claims 1 and 7 |
| Stage 5 |
Claim 1 only |
Claim 7 narrows the population to stages 2 through 4. It may be relevant where stage 5 patients are excluded from a clinical protocol, label, or reimbursement policy.
Albuminuria coverage
Claims 2 and 3 cover CKD patients with albuminuria, including microalbuminuria and macroalbuminuria. The claims do not state a particular urinary albumin-to-creatinine ratio. The absence of a numerical threshold may increase population coverage but can create claim-construction disputes over how the terms are defined in the specification and relevant clinical practice.
Albuminuria is commercially important because it is commonly used for CKD risk stratification and treatment selection. It also creates overlap with earlier CKD treatment patents that may use albuminuria, proteinuria, or eGFR decline as patient-selection criteria.
Diabetes and cardiovascular risk
Claim 4 covers patients with prediabetes, type 1 diabetes, or type 2 diabetes. Claim 6 combines diabetes or prediabetes with cardiovascular disease or cardiovascular risk.
Claim 8 is more detailed and includes:
- Prior myocardial infarction;
- Coronary artery disease;
- Percutaneous coronary intervention;
- Coronary artery bypass grafting;
- Ischemic or hemorrhagic stroke;
- Congestive heart failure;
- Peripheral occlusive arterial disease;
- Hypertension;
- Smoking;
- Dyslipidemia;
- Obesity;
- Metabolic syndrome;
- Insulin resistance;
- Hyperuricemia;
- Erectile dysfunction;
- Polycystic ovary syndrome;
- Sleep apnea; and
- Family history of vascular disease or cardiomyopathy.
The drafting of claim 8 contains apparent formatting and structural problems, including repeated cardiovascular-disease categories and threshold language such as “advanced age>/=60-70 years” and “diabetes mellitus>10 years duration.” The patent specification and prosecution record would control how those provisions are construed.
What dosage forms and formulations are protected?
Claims 15 and 16 provide the clearest formulation and dosage coverage.
Claim 15 covers oral administration at a total daily dose of 10 mg or 25 mg. Claim 16 covers a pharmaceutical composition containing 10 mg or 25 mg of empagliflozin.
These claims align with the standard Jardiance tablet strengths identified in FDA labeling. They are narrower than claim 1 because they require oral administration and specific dose amounts. They may be useful against a generic product that uses the same strengths while carrying a CKD indication or promoting the product for CKD treatment.
The claims do not expressly require:
- A film-coated tablet;
- A particular excipient;
- A specific release profile;
- A fixed-dose combination tablet;
- A particular particle size;
- A specific polymorph;
- A manufacturing process; or
- A branded product configuration.
Claims 9 and 10 reach combinations with other antidiabetic agents, including metformin and linagliptin. Claims 11 through 14 reach combinations with RAAS inhibitors. These are method-of-use combinations, not necessarily claims to a physically co-formulated tablet.
How does the patent compare with compound and formulation patents?
The empagliflozin patent estate can be divided into four principal layers.
| Patent layer |
Typical subject matter |
Relevance to Patent 12,427,162 |
| Compound patents |
Empagliflozin molecule and related chemical genus |
Separate from the CKD-use claims |
| Solid-state and formulation patents |
Polymorphs, salts, tablet compositions, manufacturing methods |
May restrict generic product design after compound expiry |
| Method-of-use patents |
Diabetes, heart failure, cardiovascular-risk reduction, CKD, renal outcomes |
Closest competitive layer |
| Combination patents |
Empagliflozin with metformin, linagliptin, insulin, or RAAS therapy |
Overlap with claims 9-14 |
Patent 12,427,162 is most relevant to the fourth and third categories. It is not, based on the supplied claims, a basic molecule patent. A generic company could therefore face different barriers at different times: chemical-entity expiry, formulation expiry, and later method-of-use patents.
What is the FDA regulatory status of empagliflozin?
Empagliflozin is marketed in the United States as Jardiance by Boehringer Ingelheim and Eli Lilly. FDA approvals have expanded from type 2 diabetes to cardiovascular-risk reduction, heart failure, and chronic kidney disease indications. The current Jardiance labeling identifies use in adults with chronic kidney disease at risk of progression, subject to the approved labeling conditions and limitations. [2]
The CKD indication is commercially important because it converts empagliflozin from a glucose-lowering product into a broader renal and cardiovascular-risk-management product. The regulatory indication also creates the factual basis for method-of-use patent enforcement.
The FDA label should be compared with the patent claims rather than treated as identical to them. A label may contain narrower eligibility language, contraindications, renal-function restrictions, or dosing information than the patent claim.
What is the Orange Book status of U.S. Patent 12,427,162?
A patent is commercially significant against an ANDA only if it is listed in the FDA Orange Book or otherwise supports a legally available enforcement theory. Orange Book listing is distinct from patent validity and does not establish that a patent claim is enforceable.
For Patent 12,427,162, the relevant review points are:
- Whether the patent is listed against Jardiance;
- Whether the listing identifies a method-of-use code;
- Whether the patent covers an FDA-approved indication;
- The listed expiration date;
- Any pediatric exclusivity adjustment;
- Any patent-term adjustment;
- Whether the generic applicant files a Paragraph IV certification;
- Whether the branded sponsor brings suit within the statutory period.
The supplied claims alone do not establish the patent’s issue date, priority date, terminal disclaimer, patent-term adjustment, Orange Book listing status, or expiration date. Those facts control the exclusivity timeline and cannot be inferred from claim language.
When does empagliflozin lose exclusivity?
Empagliflozin exclusivity is not governed by a single date. The relevant timeline may include:
- New chemical entity exclusivity;
- Composition-of-matter patent expiry;
- Solid-form or formulation patent expiry;
- Cardiovascular method-of-use patent expiry;
- Heart-failure method-of-use patent expiry;
- CKD method-of-use patent expiry;
- Pediatric exclusivity;
- Patent-term adjustment or patent-term extension;
- Litigation settlements that permit an agreed generic launch date.
Patent 12,427,162 may delay CKD-labeled generic competition even after earlier compound or formulation rights expire. Conversely, a generic may enter with a label that omits the patented CKD indication if the remaining unpatented uses support an ANDA and the labeling strategy is legally effective.
The exact loss-of-exclusivity date requires the patent’s priority chain, issue data, terminal disclaimers, Orange Book entries, and any litigation settlement. The claims supplied do not contain those dates.
What Paragraph IV challenges and generic-entry risks exist?
A generic applicant seeking FDA approval for empagliflozin may use one of four principal certification strategies:
- Paragraph I: no relevant patent information has been submitted;
- Paragraph II: the listed patent has expired;
- Paragraph III: approval is deferred until patent expiry;
- Paragraph IV: the patent is invalid, unenforceable, or will not be infringed.
For this patent, the principal Paragraph IV arguments would likely target:
Noninfringement
A generic could argue that its proposed label omits CKD treatment and does not instruct use to delay eGFR loss, kidney failure, or renal death. The strength of that position would depend on the proposed label, prescribing context, promotional materials, and the scope of any remaining FDA-approved indications.
Invalidity
Potential invalidity theories could include:
- Lack of novelty;
- Obviousness based on earlier SGLT2 inhibitor renal data;
- Lack of written description for the full stage 2-5 CKD population;
- Lack of enablement across diabetic, prediabetic, and nondiabetic patients;
- Indefiniteness of outcome-based language;
- Indefiniteness or ambiguity in claim 8;
- Double patenting over earlier empagliflozin CKD or cardiovascular patents.
The clinical evidence supporting empagliflozin’s kidney-outcome benefits, including the EMPA-KIDNEY trial, may be relevant to written description, enablement, obviousness, and claim construction, although post-filing clinical evidence does not automatically cure a deficient disclosure. [3]
Carve-out or skinny-label strategy
A generic may seek approval for non-CKD indications while carving out the patented CKD use. This strategy reduces direct label-based infringement exposure but does not eliminate the risk of induced infringement if the product is marketed or distributed in a manner that encourages the patented use.
Is there biosimilar risk?
There is no conventional biosimilar pathway for empagliflozin because it is a chemically synthesized small molecule. The relevant competitive pathway is an ANDA for a generic drug, not a biologics-license application under the biosimilar provisions.
The main competitive risks are therefore:
- Paragraph IV litigation;
- Label carve-outs;
- Authorized generic entry;
- Non-infringing use of empagliflozin;
- Formulation redesign;
- Combination-product substitution; and
- Off-label prescribing after generic approval.
What patent litigation and settlement issues matter?
The most important litigation questions are not limited to whether Patent 12,427,162 has been challenged. The full assessment requires review of:
- Related patents in the same family;
- Continuation and divisional applications;
- Terminal disclaimers;
- ANDA litigation under the Hatch-Waxman Act;
- Claim-construction rulings;
- Invalidity decisions;
- Injunctions;
- License agreements;
- Authorized-generic arrangements;
- Settlement dates; and
- Any FTC or court review of reverse-payment provisions.
A settlement involving one empagliflozin patent may not resolve all CKD, heart-failure, formulation, or combination patents. A generic launch date must therefore be assessed at the patent-family level, not from one patent number alone.
How strong is the patent estate?
Patent 12,427,162 has several strengths:
- It covers the clinically important CKD indication;
- Claim 1 reaches stages 2 through 5;
- The claim includes major renal outcomes;
- Dependent claims target albuminuria, diabetes, cardiovascular risk, and RAAS therapy;
- Claims 15 and 16 correspond to the commercially standard 10 mg and 25 mg doses;
- The claims align with a regulatory indication supported by outcome-trial evidence.
The principal weaknesses and attack points are:
- Broad coverage across heterogeneous CKD stages;
- Broad outcome language without a numerical endpoint;
- Potential overlap with earlier CKD and cardiovascular-use patents;
- Claim 8’s drafting irregularities;
- Dependence on actual indication-specific use for infringement;
- Potential availability of a skinny-label generic strategy;
- No direct protection in the supplied claims for the molecule, polymorph, excipient system, or manufacturing process.
Key Takeaways
- U.S. Patent 12,427,162 is primarily a CKD method-of-use patent for empagliflozin.
- Claim 1 is broad across stage 2, 3, 4, and 5 CKD.
- The claims cover renal outcomes, not merely glucose lowering.
- Albuminuria, diabetes, cardiovascular disease, cardiovascular risk, RAAS therapy, and standard 10 mg or 25 mg oral dosing are covered by dependent claims.
- The patent does not, based on the supplied claims, protect empagliflozin as a molecule or a specific tablet manufacturing process.
- Generic risk will turn on Orange Book listing, the proposed ANDA label, Paragraph IV certifications, litigation, and the availability of a CKD indication carve-out.
- Empagliflozin has generic rather than biosimilar competition risk.
- The exact expiration date and exclusivity timeline cannot be derived from the claims alone.
- Patent-family analysis is necessary because related formulation, compound, cardiovascular, heart-failure, and CKD patents may produce different launch barriers.
Frequently Asked Questions
Does Patent 12,427,162 cover empagliflozin for diabetes alone?
No. The supplied claims require chronic kidney disease and a renal treatment objective. Diabetes is an additional limitation in claims 4 and 6, not a standalone substitute for CKD.
Does the patent cover patients without diabetes?
Yes. Claim 1 does not require diabetes. Claims 4 and 6 specifically add diabetic or prediabetic populations, but the independent claim is broader.
Does claim 1 require albuminuria?
No. Albuminuria appears in claims 2 and 3. It is not required by claim 1.
Can a generic launch empagliflozin before all related patents expire?
Potentially. A generic may pursue a Paragraph II, III, or IV certification, or seek approval with a carved-out label. The result depends on listed patents, litigation, settlement terms, and the final FDA-approved labeling.
Are Jardiance 10 mg and 25 mg tablets directly implicated?
Yes. Claims 15 and 16 expressly cover oral empagliflozin at 10 mg or 25 mg daily and compositions containing those amounts, subject to the claim’s CKD-use limitations.
References
- U.S. Patent No. 12,427,162, claims 1-16. United States Patent and Trademark Office.
- U.S. Food and Drug Administration. (2024). Jardiance (empagliflozin) prescribing information.
- The EMPA-KIDNEY Collaborative Group. (2023). Empagliflozin in patients with chronic kidney disease. New England Journal of Medicine, 388, 117-127. https://doi.org/10.1056/NEJMoa2204233
- U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
- U.S. Food and Drug Administration. (1984). Drug Price Competition and Patent Term Restoration Act, 21 U.S.C. § 355(j).
