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  1. pharmadog
  2. ›drugs
  3. ›Zurzuvae
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zuranolone

Marketedupdated 3mo ago
by Sage Therapeutics Inc
Approved
community read0 votes

all catalysts(0)

nothing on the calendar yet

Trials studying zuranolone

  • —A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolonerecruitingn=200
  • —A Study to Learn More About How Zuranolone Affects Postpartum Depression Symptoms in Participants Who Took it Within 1 Year After The End of Their Pregnancyrecruitingn=200
  • phase1Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)completedn=19

Patent cliff

source: FDA Orange Book
first barrier falls
Oct 31, 2028
~2.2 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (15)

  • Aug 23, 2037compositionUS 11236121
  • Aug 23, 2037compositionUS 11236121
  • Aug 23, 2037compositionUS 11236121
  • Aug 23, 2037method-of-use (U-2552)US 11884696
  • Aug 23, 2037method-of-use (U-2552)US 11884696
  • Aug 23, 2037method-of-use (U-2552)US 11884696
  • Apr 17, 2034method-of-use (U-2552)US 10172871
  • Apr 17, 2034method-of-use (U-2552)US 10172871
  • Apr 17, 2034method-of-use (U-2552)US 10172871
  • Apr 17, 2034method-of-use (U-2552)US 10342810
  • Apr 17, 2034method-of-use (U-2552)US 10342810
  • Apr 17, 2034method-of-use (U-2552)US 10342810
  • Apr 17, 2034compositionUS 9512165
  • Apr 17, 2034compositionUS 9512165
  • Apr 17, 2034compositionUS 9512165

FDA exclusivities (3)

  • Oct 31, 2028NCENew Chemical Entity (5y)2.2y
  • Oct 31, 2028NCENew Chemical Entity (5y)2.2y
  • Oct 31, 2028NCENew Chemical Entity (5y)2.2y

News(2)

  • Supernus and Indivior merge to create CNS mega-company with 11 approved drugs
    Supernus Pharmaceuticals and Indivior Pharmaceuticals are outlining a combined expected $2.2 billion in annual revenue, plus $125 million in cost savings that will include “natural redundancies.”
    biospace · 11d ago
  • Supernus, Indivior merge to beef up brain drug portfolio
    The transaction combines two companies marketing nearly a dozen neurological drugs that bring in steady, but not blockbuster sales for conditions such as opioid use disorder and Parkinson's.
    biopharma_dive · 11d ago
brand
Zurzuvae
generic
zuranolone
indication
Post Partum Depression (Maternal Depression / Postnatal Depression)
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 1m ago
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