Generic Cialis (Tadalafil): Approval History, Bioequivalence, and Cost
“Generic Cialis” refers to FDA-approved tadalafil tablets made by manufacturers other than the company that originally developed and patented the drug. This page explains when generic approval happened, what bioequivalence requires, who makes it, and how cost compares with the brand-name product.
When Did Generic Tadalafil Become Available?
The original patent covering tadalafil for erectile dysfunction expired in the United States in 2018. Following expiry, the FDA began approving Abbreviated New Drug Applications from other manufacturers, and generic tadalafil reached the US market that same year. Additional manufacturers have received approval since, and generic tadalafil is now widely stocked alongside the brand-name product at most pharmacies.
Key point: Generic tadalafil has been FDA-approved and available in the US since 2018, across both daily-dose and as-needed-dose strengths.
Bioequivalence for Both Dosing Patterns
Because tadalafil is approved for both daily use (2.5 mg and 5 mg) and as-needed use (10 mg and 20 mg), generic manufacturers must demonstrate bioequivalence across the relevant strengths they intend to market. The bioequivalence standard itself is the same as for any other generic drug: the product must deliver the same active ingredient, at the same dose, into the bloodstream at a rate and extent within an FDA-defined range compared to the brand-name product.
Inactive Ingredients and Appearance
As with generic sildenafil, inactive ingredients and tablet appearance can differ between manufacturers even though the active ingredient and dose must match. Generic tadalafil tablets are commonly a different shape or color from the brand-name product, with a manufacturer-specific imprint code. Patients with specific allergies to a particular inactive ingredient should mention this to their pharmacist.
Who Manufactures Generic Tadalafil?
Multiple manufacturers now produce FDA-approved generic tadalafil, and which one a pharmacy stocks depends on location and wholesaler contracts, similar to generic sildenafil. Pharmacies typically substitute the generic automatically unless a prescriber specifically requests the brand-name product. Patients can ask their pharmacist which manufacturer's version they've received, or check the imprint code against FDA pill-identification resources.
Cost Differences
Generic competition has brought tadalafil's per-tablet cost down substantially compared to when it was available only as the brand-name product. For the daily-dose strengths specifically, cost is often discussed as a monthly total rather than a per-tablet price, since it is taken every day rather than only as needed. Exact pricing varies by pharmacy and insurance formulary, so comparing cash-pay pricing directly after a prescription is written is a reasonable way to find the lowest price for a given strength and quantity.
Important: A valid prescription is required for generic tadalafil in the US, exactly as for the brand-name product, regardless of whether it is prescribed for daily or as-needed use.
Generic vs. Brand: Quick Comparison
| Factor | Brand-Name Tadalafil | Generic Tadalafil |
|---|---|---|
| Active ingredient | Tadalafil | Tadalafil (identical) |
| FDA approval pathway | Original New Drug Application | Abbreviated New Drug Application (bioequivalence) |
| Strengths | 2.5, 5, 10, 20 mg | Same strengths, varies by manufacturer |
| Typical cost | Higher | Substantially lower |
For a closer look at tablet appearance and daily-dosing routine tips, see our Cialis pills guide. For strengths and titration between daily and as-needed use, see our tadalafil dosage page.