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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.
Some or all of the information contained in this document may contain confidential and/or proprietary information and should be treated accordingly. 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.
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.
2992-A1  Prime Therapeutics LLC 07/13

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