interaction records 54 assistance programs 55 0 personal data stored
OmniRx › Tools › Generic competition check › Sotalol Hydrochloride

Generic competition · all medicines · read 12 November 2026

Is there a generic of Sotalol Hydrochloride, and who makes it?

Sotalol Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 7 generic makers listed as marketed across them. 2 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came 7.5 years after the first brand approval. This is the Orange Book's listing, not a forecast.

Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Sotalol Hydrochloride3 dosage-form groups in the Orange Book
7generic makers listed
  1. Sotalol Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 7 generic makers listed as marketed across them.
  2. 2 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
  3. Where both are dated, the first generic approval came 7.5 years after the first brand approval.
  4. Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.

Tablet, Oral

Four or more generic makers listed

Brand listed as marketed: Betapace and Betapace Af. 7 generic makers with 31 generic products listed as marketed; the first generic approval is dated 1 May 2000.

19901995200020052010201520202025203007brand 1992Teva Pharmaceuticals Usa Inc, first approval 1 May 2000Aiping Pharmaceutical Inc, first approval 27 April 2001Apotex Inc, first approval 26 September 2002Oxford Pharmaceuticals Llc, first approval 7 November 2003Epic Pharma Llc, first approval 4 November 2005Aurobindo Pharma Usa Inc, first approval 7 February 2007Regcon Holdings Llc, first approval 21 October 2016data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Teva Pharmaceuticals Usa Inc1 May 20004
Aiping Pharmaceutical Inc27 April 20014
Apotex Inc26 September 20027
Oxford Pharmaceuticals Llc7 November 20034
Epic Pharma Llc4 November 20053
Aurobindo Pharma Usa Inc7 February 20073
Regcon Holdings Llc21 October 20166

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Solution, Intravenous

Brand listed, no generic listed as marketed

Brand listed as marketed: Sotalol Hydrochloride. No generic is listed as marketed.

2005201020152020202520302035204001brand 2009data datePatent 12403109 listed to expire 14 August 2028Patent 10512620 listed to expire 14 August 2038Patent 12390431 listed to expire 14 August 2038Patent 11696902 listed to expire 14 August 2038Patent 12740947 listed to expire 14 August 2038Patent 10799138 listed to expire 5 April 2039Patent 12569183 listed to expire 5 April 2039Patent 11583216 listed to expire 21 August 2039
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 14 August 2028Patent 12403109
  • 14 August 2038Patent 10512620
  • 14 August 2038Patent 12390431
  • 14 August 2038Patent 11696902
  • 14 August 2038Patent 12740947
  • 5 April 2039Patent 10799138
  • 5 April 2039Patent 12569183
  • 21 August 2039Patent 11583216

Solution, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Sotylize. No generic is listed as marketed.

20102015202020252030203501brand 2014data datePatent 10206895 listed to expire 1 April 2034Patent 12290495 listed to expire 1 April 2034Patent 11013703 listed to expire 1 April 2034Patent 11850222 listed to expire 19 November 2034Patent 9724297 listed to expire 31 August 2035
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 1 April 2034Patent 10206895 drug product
  • 1 April 2034Patent 12290495
  • 1 April 2034Patent 11013703 drug product
  • 19 November 2034Patent 11850222
  • 31 August 2035Patent 9724297 drug product

US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.

Where can you go from this result?

Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.