Syprine Generic Approved
February 7, 2018 – The U.S. FDA has approved an AB-rated generic, manufactured by Teva Pharmaceuticals, for Valeant’s Syprine® (trientine hydrochloride) 250mg capsules. Trientine hydrochloride is approved to treat patients with Wilson’s disease who are intolerant of penicillamine.
A genetic disorder that effects approximately one out of every 30,000 people worldwide, Wilson’s disease prevents the body from removing excess copper. The accumulation of copper over time leads to organ damage, which can be fatal.
Trientine hydrochloride, like penicillamine, is used as a chelating agent in treatment of Wilson’s disease. It helps to bind copper so that the body can remove the metal from the bloodstream. It is not considered interchangeable with penicillamine, and should be used only when the patient cannot tolerate penicillamine. Unlike penicillamine, trientine hydrochloride is indicated only for the treatment of Wilson’s disease.
IQVIA estimates that U.S. sales of Syprine tablets totaled $155 million in 2017. Teva’s generic has already been launched.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.