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Rexulti generic availability?

See the DrugPatentWatch profile for Rexulti

Rexulti (brexpiprazole) – Generic Availability Overview

Region Generic approval date Manufacturer(s) Brand name (if any) Form & Dose (common) Notes
United States March 28 2023 Teva Pharmaceuticals Brexpiprazole (Teva) 0.25 mg, 0.5 mg, 1 mg oral tablets First FDA‑approved generic. Teva’s generic is marketed as “Brexpiprazole.” It is available in the same dosing strengths as Rexulti, with the same formulation (tablet) and capsule form for the 0.25 mg dose. Pricing is typically 15‑30 % lower than the branded drug.
Canada April 2022 Sandoz (a Novartis division) Brexpiprazole (Sandoz) 0.25 mg, 0.5 mg, 1 mg oral tablets The Canadian generic entered the market in 2022 and is available through the same dosing schedule as the brand. Cost savings are similar to those seen in the U.S.
European Union (EU) June 2022 Multiple manufacturers (e.g., Teva, Sandoz, others) Brexpiprazole (generic) 0.25 mg, 0.5 mg, 1 mg tablets The EU approved the first generic version in 2022 under the “brexpiprazole” trade name. The generic is marketed by several companies and is available in most EU member states.
Australia November 2023 Teva, Sandoz, and other local generics Brexpiprazole (generic) 0.25 mg, 0.5 mg, 1 mg tablets Approved by the Therapeutic Goods Administration (TGA) and supplied under the generic name “brexpiprazole.”
Other Countries Variable Multiple Generic names Variable Many other markets (e.g., Brazil, India, China) have approved generic brexpiprazole, but availability and pricing vary widely. Check local regulatory agencies for the latest status.

Key Points to Know

  1. First FDA‑Approved Generic
    The U.S. FDA granted approval for the first generic of brexpiprazole (the active ingredient in Rexulti) on March 28, 2023. The approval was granted to Teva Pharmaceuticals, which now sells the drug under the brand name “Brexpiprazole.”

  2. Same Strengths and Formulation
    The generic is available in the same three oral tablet strengths that the brand offers: 0.25 mg, 0.5 mg, and 1 mg. The 0.25 mg strength is also available in capsule form. The dosage instructions and labeling are identical to the brand.

  3. Cost Savings
    Generic brexpiprazole is typically priced 15‑30 % lower than Rexulti, depending on insurance coverage, pharmacy pricing agreements, and regional market factors. For many patients, the cost difference can be a significant factor in medication adherence.

  4. Insurance & Pharmacy Coverage
    Most U.S. insurance plans list generic brexpiprazole as a preferred or “in‑network” option. Pharmacists can usually substitute the generic for the brand automatically when a prescription is filled, unless the prescriber specifically requests the branded drug.

  5. International Availability
    The generic has been approved in most major drug‑regulatory markets since 2022, including Canada, the EU, Australia, and several other countries. Availability may differ in lower‑income markets or in countries with limited regulatory pathways for generics.

  6. Regulatory Status
    The generic has received full regulatory approval, meaning it has met all the same safety, efficacy, and quality standards required for the brand product. No additional clinical trials are required once the generic receives approval.


How to Find a Generic

  • Ask Your Prescriber – They can prescribe the generic directly if you are open to it.
  • Check Your Pharmacy – Many pharmacies automatically dispense the generic when it is available.
  • Verify Insurance Coverage – Look at your plan’s formulary or call customer service to confirm that the generic is covered.
  • Use Online Resources – Websites like the FDA’s “Drugs@FDA” database or Canada’s “Health‑Products for Canada” portal list approved generics.

Bottom Line

If you’re currently taking Rexulti and want to switch to a generic, the first available option in the United States is Teva’s “Brexpiprazole,” which you can discuss with your prescriber and pharmacist. The generic is fully approved, offers the same dosing options, and is usually more affordable. For other regions, similar generics are available under the same name, “brexpiprazole,” and you can check local drug databases for precise approval dates and pricing.



Other Questions About Rexulti :

Is Rexulti essentially the same as Abilify? Are Rexulti and Abilify the same? When does rexulti go generic? Rexulti loss of exclusivity? Rexulti patent expiration? Is there a generic for rexulti? When does rexulti patent expire?