Teva launches generic of Syprine
Teva has introduced its generic Syprine (trientine hydrochloride) capsules. The drug was included on the Food and Drug Administration’s list of off-patent, off-exclusivity branded drugs that didn’t have generics.
“Teva filed our [abbreviated new drug application] more than two years ago and we are pleased that the FDA has now approved our applications and we are able to offer a lower-cost generic alternative to patients,” Teva executive vice president of global R&D Hafrun Fridriksdottir said. “We look forward to working closely with the FDA on their review of our many other generic applications.”
The drug is indicated to treat patients with Wilson’s disease — a genetic disorder that prevents the body from removing excess copper — who are intolerant of penicillamine. Teva’s generic Syprine will be available in 250-mg dosage strength.
Wilson’s disease is estimated to affect roughly 1-in-30,000 individuals. The drug had U.S. sales of roughly $155 million for the 12 months ended November 2018, according to IQVIA data.
“The launch of trientine hydrochloride capsules illustrates Teva’s commitment to serving patient populations in need—whether it’s a medicine that could be taken by millions of individuals or one focused on a rare condition disorder like Wilson’s disease,” Teava executive vice president and head of North America commercial Brendan O’Grady said.
“Teva filed our [abbreviated new drug application] more than two years ago and we are pleased that the FDA has now approved our applications and we are able to offer a lower-cost generic alternative to patients,” Teva executive vice president of global R&D Hafrun Fridriksdottir said. “We look forward to working closely with the FDA on their review of our many other generic applications.”
The drug is indicated to treat patients with Wilson’s disease — a genetic disorder that prevents the body from removing excess copper — who are intolerant of penicillamine. Teva’s generic Syprine will be available in 250-mg dosage strength.
Wilson’s disease is estimated to affect roughly 1-in-30,000 individuals. The drug had U.S. sales of roughly $155 million for the 12 months ended November 2018, according to IQVIA data.
“The launch of trientine hydrochloride capsules illustrates Teva’s commitment to serving patient populations in need—whether it’s a medicine that could be taken by millions of individuals or one focused on a rare condition disorder like Wilson’s disease,” Teava executive vice president and head of North America commercial Brendan O’Grady said.