There are currently several generic Betapace (sotalol) products licensed for sale. These products are manufactured by a few different drug companies, including Mylan Pharmaceuticals, Sandoz, and Apotex Corporation. All generic versions of Betapace currently available have been given an "AB" rating by the FDA, which means that they are equivalent to the brand-name medication.
Betapace® (sotalol hydrochloride) is a prescription drug used to treat irregular heart rhythms (arrhythmias). It is both a beta blocker and a Class III arrhythmia drug. There are two different forms: Betapace AF® is approved to treat atrial fibrillation or atrial flutter, while the regular version is approved to treat other arrhythmias. There are no important differences between the two, except Betapace AF comes with a special patient package insert with information for people with atrial fibrillation or atrial flutter.
Brand-name Betapace and Betapace AF are made by Bayer HealthCare Pharmaceuticals, Inc. The patents for these medications have expired, however, and generic versions of Betapace and Betapace AF are now available.
Generic Betapace tablets are available in the following strengths:
- Sotalol 80 mg
- Sotalol 120 mg
- Sotalol 160 mg
- Sotalol 240 mg (brand-name Betapace is no longer made in this strength).
It can be difficult to know if a particular sotalol medication is a generic version of Betapace or Betapace AF. Sometimes, pharmacies may distinguish between the two by using two different names ("Sotalol" and "Sotalol AF").
One particular medication, Sorine® could be considered both a brand-name and generic version of Betapace. It could be considered a brand-name drug because it has its own brand name and because it is made by a manufacturer that makes brand-name drugs (Upsher-Smith Laboratories). However, the U.S. Food and Drug Administration (FDA) considers Sorine to be a generic version of regular Betapace.