The first generic version of Cystadane® (betaine anhydrous for oral solution) Powder has been made available by Oakrum Pharma, LLC, in collaboration with ANI Pharmaceuticals.

Betaine Anhydrous Powder is a methylating agent indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations. Included within the category of homocystinuria are:

  • Cystathionine beta-synthase (CBS) deficiency;
  • 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency;
  • Cobalamin cofactor metabolism (cbl) defect.

The Food and Drug Administration approved the Abbreviated New Drug Application (ANDA) for Betaine Anhydrous Powder in a 180 gram bottle. The approval was granted Competitive Generic Therapy, meaning the Company will have 180 days of exclusivity to market the product.

“This is the third generic Orphan Drug that we have launched since starting this business, and we remain committed to bringing rare disease patients affordable options of pharmaceutical products that currently have few or no generic options,” said Marco Polizzi, CEO of Oakrum Pharma.


Oakrum Pharma and ANI Pharmaceuticals announce the launch of Betaine Anhydrous Powder, the first generic version of Cystadane® (betaine anhydrous for oral solution) Powder, including 180 days of exclusivity. News release. Oakrum Pharma, LLC. February 14, 2022. Accessed February 15, 2022.–powder-including-180-days-of-exclusivity-301481968.html