India’s Sun Pharma will soon launch low-cost generic version of depression drug venlafaxine in US with six months of sales exclusivity.
US FDA has granted approval for Sun Pharma abbreviated new drug application (ANDA) seeking to sell generic venlafaxine, the company informed in a press release.
Venlafaxine was originally developed by Wyeth and marketed by Pfizer under the brand name Effexor XR.
These generic extended release venlafaxine tablets are therapeutically equivalent to Osmotica’s venlafaxine hydrochloride extended release tablets and include three strengths: 37.5 mg (base), 75 mg (base), 150 mg (base), the release said.
Venlafaxine hydrochloride extended release tablets are indicated for the management of major depressive disorder, generalized anxiety disorder, panic disorder, etc.
Since Sun Pharma is the first to file for a generic version following the expiry of Effexor XR patents in US, the Indian generic company is entitled to get a 160-day exclusivity as well. During this 180-day period no other generic products of venlafaxine approved in the strengthss will be allowed for sales in the US market.
Sun Pharma’s generic version of venlafaxine hydrochloride extended release tablets is expected to reach the market shortly with 180-day marketing exclusivity.
Venlafaxine is an arylalkanolamine serotonin-norepinephrine reuptake inhibitor (SNRI).
Venlafaxine is one of most widely prescribed medications to treat depressive disorders in US.
Venlafaxine Hydrochloride has been studied for the treatment of panic disorder, post-traumatic stress disorder, and the treatment of hot flashes in patients who cannot or do not want to take hormone replacement therapy.
Venlafaxine Hydrochloride is an inhibitor with a double role- Venlafaxine Hydrochloride inhibits serotonin reuptake at select receptors and, unlike the pure selective serotonin reuptake inhibitors (SSRIs), inhibits the reuptake of norepinephrine.
Venlafaxine Hydrochloride appears to be effective in treating patients with melancholia, a severe form of depression. The side effect and drug interaction profile of Venlafaxine Hydrochloride is very similar to that of the SSRIs.
Venlafaxine Hydrochloride does not exhibit MAO inhibition activity, yet Venlafaxine Hydrochloride should not be used in patients who are receiving or have recently received MAOI therapy.