Generic Jardiance: Approved but Not Yet Available

Generic Jardiance (empagliflozin) received FDA approval in August 2022, but it is not yet widely available at pharmacies. Patent protections on Jardiance extend through 2033, which means the approved generic cannot launch for sale until those patents expire or are successfully challenged. So while a generic technically exists on paper, you can’t fill a prescription for generic empagliflozin today.

Why the Generic Is Approved but Not Available

The FDA granted Zydus Pharmaceuticals approval for generic empagliflozin tablets in both the 10 mg and 25 mg strengths on August 3, 2022. A generic version of the combination pill (empagliflozin plus metformin, the generic equivalent of Synjardy) was approved even earlier, on July 7, 2022. These approvals confirm that the FDA considers the generic versions bioequivalent to the brand-name drugs.

However, FDA approval alone doesn’t put a drug on pharmacy shelves. Jardiance is protected by patents that currently run through April 2033, with an additional six months of pediatric exclusivity pushing the effective date to October 2033. Until those patents expire, or unless the generic manufacturer reaches a licensing deal or wins a patent challenge in court, the generic version stays off the market. This gap between approval and availability is common with brand-name drugs that still have active patent protection.

What Jardiance Costs Without a Generic

The retail price of brand-name Jardiance is around $350 for a 30-day supply, though the exact amount varies by pharmacy and dosage. The 25 mg tablet typically costs more than the 10 mg tablet. Without insurance, that adds up to over $4,000 a year.

Boehringer Ingelheim, the manufacturer, offers a savings card that can bring the cost down to as little as $10 per month for eligible commercially insured patients. The card covers prescriptions of one to three months at a time and automatically re-enrolls you after 12 months if you still qualify. If you have Medicare or Medicaid, you typically don’t qualify for manufacturer savings cards, though Medicare Part D plans do cover Jardiance. Your out-of-pocket cost under Part D depends on which tier your specific plan places the drug in.

What Jardiance Is Prescribed For

Jardiance started as a type 2 diabetes medication, but its approved uses have expanded significantly. The FDA currently approves it for three purposes: improving blood sugar control (alongside diet and exercise) in adults and children 10 and older with type 2 diabetes, reducing the risk of cardiovascular death in adults with type 2 diabetes who also have heart disease, and reducing the risk of cardiovascular death and hospitalization in adults with heart failure. That last indication applies regardless of whether someone has diabetes, which has broadened the number of people who take it.

The generic approval from 2022 only covers the type 2 diabetes indication. It does not currently extend to the heart failure indication, which means even after patents expire, your doctor may need to specify brand-name Jardiance if you’re taking it for heart failure rather than diabetes.

What About Other Combination Generics

The combination of empagliflozin and metformin (brand name Synjardy) also has an approved generic from Zydus Pharmaceuticals, covering all four available dose combinations. Like standalone empagliflozin, this generic faces the same patent barriers and is not currently sold at pharmacies. Other empagliflozin combination products, such as Glyxambi (empagliflozin plus linagliptin), do not yet have approved generics.

Options While You Wait

If cost is a concern, a few practical options exist right now. The manufacturer savings card is the most straightforward path to lower prices if you have commercial insurance. Pharmacy discount programs and coupons from third-party sites can sometimes reduce the cash price, though savings vary. Your doctor may also consider alternative SGLT2 inhibitors in the same drug class. Dapagliflozin (Farxiga) does not yet have a generic either, but canagliflozin (Invokea) lost its patent exclusivity, and pricing may differ depending on your insurance formulary.

If you’re on Medicare, the Inflation Reduction Act’s $2,000 annual out-of-pocket cap on Part D drug spending (effective 2025) may reduce your total yearly cost for Jardiance, even without a generic available. Ask your pharmacist to calculate your expected annual spending under your specific plan.