Vortioxetine API and Tablet Technology Transfer
Basic Information
Name: Vortioxetine (Hydrobromide)
Dosage Form: Tablet
Strengths: 5 mg, 10 mg
Indication: Treatment of Major Depressive Disorder (MDD)
Dosage and Administration:
Recommended starting dose: 10 mg once daily, orally, with or without food.
Dose may be increased to 20 mg/day if tolerated, or reduced to 5 mg/day for patients intolerant to higher doses.
Vortioxetine can be discontinued abruptly. However, if necessary, reduce the dose from 15 mg/day or 20 mg/day to 10 mg/day for one week before discontinuation.
For patients with known poor CYP2D6 metabolism, the maximum recommended dose is 10 mg/day.
Chemical Structure:
(Not provided in text)
Molecular Formula: C18H22N2S
Molecular Weight: 298.44
CAS Number: 508233-74-7
Originator: Co-developed by Takeda (Japan) and Lundbeck (Denmark)
Global Market Status:
Approved by U.S. FDA on September 30, 2013, marketed as Brintellix by Takeda in the U.S.
Approved by EMA on December 18, 2013, marketed as Brintellix by Lundbeck in Europe.
China: As of 2018, not yet approved. 22 companies have filed for approval, with Shandong Kangmeile Pharmaceutical Technology Co., Ltd. being the 10th, having received clinical trial approval.
Patent Status
Compound Patent:
International Patent: WO03029232
Chinese Equivalent: 02819025.4
Expiry Date: October 2, 2022
Legal Status: Valid (as of 2018)
Polymorph Patent:
International Patent: WO2007144005
Chinese Equivalent: 200880008903.7
Expiry Date: March 14, 2028
Legal Status: Under substantive examination
Use Patent:
International Patent: WO2009062517
Chinese Equivalent: 200880116463.7
Expiry Date: November 12, 2028
Legal Status: Under substantive examination
Market Prospects
In China, the antidepressant market reached 2.61 billion CNY in 2011, with a year-on-year growth of 19.45%. In 2012, the psychiatric drug market in 16 key cities’ sample hospitals reached 10.5 billion CNY, growing 25.19% from the previous year. The antidepressant market in China remains underdeveloped, but with significant growth potential, it is expected to experience explosive growth in the coming years.
Synthetic Route
