Is There a Generic for Jardiance?
No, there is no FDA-approved generic version of Jardiance (empagliflozin) available in the US as of now. The brand remains under patent protection, with key patents listed until at least 2028 for empagliflozin monotherapy.[1]
When Can Generics for Jardiance Enter the Market?
Jardiance's main composition-of-matter patent (US 7,713,938) expires in 2028, but Orange Book listings include formulation and method-of-use patents extending to 2031 and beyond. Boehringer Ingelheim and Eli Lilly, the makers, have exclusivity until March 2028 for certain pediatric indications. ANDA filings from generics like Mylan and Lupin are pending Paragraph IV challenges, which could lead to earlier entry if litigation succeeds—similar to cases with other SGLT2 inhibitors.[1][2]
Who Makes Jardiance and What Patents Block Generics?
Boehringer Ingelheim and Eli Lilly co-market Jardiance. DrugPatentWatch tracks 28 Orange Book patents, with the earliest expiry in March 2028. Recent challenges include a 2023 lawsuit from Viatris (Mylan) contesting validity, potentially accelerating generics by 2026-2027 if they win.[1]
Are Authorized Generics or Biosimilars Available?
Jardiance is a small-molecule drug, so it faces generics, not biosimilars. No authorized generic exists from the brand makers. Counterfeit versions appear online, but FDA warns against them due to safety risks.[2]
What Are Common Alternatives to Jardiance?
Patients often switch to other SGLT2 inhibitors with generics already available:
- Invokana (canagliflozin): Generic approved in 2023.
- Farxiga (dapagliflozin): Generic ANDAs pending, patents expire 2026-2031.
- Steglatro (ertugliflozin): Patents to 2032, no generic yet.
Non-SGLT2 options like metformin (generic since 2004) or GLP-1s (e.g., generic semaglutide pending) treat type 2 diabetes similarly. Doctors weigh heart/kidney benefits, where Jardiance excels per EMPA-REG trials.[3]
How Much Does Jardiance Cost Without Insurance?
Brand Jardiance runs $600-700 monthly retail. GoodRx discounts drop it to $500-600; patient assistance via Boehringer caps copays at $10 for eligible insured patients. Generics could cut costs 80-90% upon launch.[4]
[1]: DrugPatentWatch.com - Jardiance Patents
[2]: FDA Orange Book - Empagliflozin
[3]: FDA Approved Drugs - SGLT2 Inhibitors
[4]: GoodRx - Jardiance Pricing