Drug Insights > July 2013
Drug Pipeline Update → New Drug Information → Generic Drug Information Zubsolv® (buprenorphine and naloxone): Orexo received Trilipix® (fenofibric acid delayed-release): Multiple
Food and Drug Administration (FDA) approval for their
manufacturers received FDA approval for their generic
sublingual tablet for the maintenance treatment of
version of AbbVie’s Trilipix for the improvement of
opioid dependence. Zubsolv will compete against
cholesterol levels (including triglycerides). According to
IMS Health, Trilipix had approximately $554 million in annual U.S. sales. Brisdelle™ (paroxetine): The FDA approved Noven
Therapeutics’ Brisdelle, a non-hormonal treatment
Prandin® (repaglinide) and PrandiMet® (repaglinide and
option for hot flashes associated with menopause.
metformin): Sun Pharmaceuticals launched its generic
The low-dose formulation of paroxetine was not
versions of Novo Nordisk’s Prandin and PrandiMet for
recommended for approval by the FDA advisory panel
the treatment of diabetes and will have 180 days of
due to its lack of benefit compared to placebo.
marketing exclusivity. According to IMS, these products had approximately $200 million in annual U.S. sales. Suvorexant: Merck received a complete response
letter from the FDA regarding their new drug for the
Metrogel® (metronidazole gel, 1%): Generic
treatment of insomnia. According to the manufacturer,
manufacturers have launched their generic versions of
the FDA did not approve the drug because of safety and
Galderma’s Metrogel 1% for the treatment of rosacea.
According to IMS, Metrogel 1% had approximately $110 million in U.S. sales annually. Lamictal® ODT (lamotrigine orally disintegrating tablets): Actavis received approval to launch their generic versions of Lamictal ODT (GlaxoSmithKline) in 25 mg, 50 mg, 100 mg and 200 mg strengths. They will likely retain 180 days of marketing exclusivity. IMS reports U.S. annual sales of approximately $51 million.
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Prime therapeutics llC does not warrant that the information contained herein is free from error and it should be used only as an informational guide. nothing herein represents the promotion of any drugs or manufacturers by Prime therapeutics llC and no conclusions of formulary status shall be inferred from any discussion herein. Brand names are the property of their respective owners.
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