Traditional Drug Pipeline Update: July 2022

This monthly pipeline wrap-up provides a review of newly approved traditional drugs, recent drug launches, generic updates, new indications and news of note on drugs in the approval process.

See separate article for pipeline information on specialty drugs.

New Drug Information

• Venbysi™ XR (venlafaxine besylate): The U.S. Food and Drug Administration (FDA) has approved Almatica Pharma’s Venbysi XR for the treatment of major depressive disorder and generalized anxiety disorder. Venbysi XR was approved via the 505(b)2 pathway using venlafaxine as its reference product.¹ Venbysi XR launch and price are pending.
• Drospirenone™ Chewable Tablets (drospirenone): The FDA approved Exeltis’ Drospirenone Chewable Tablets as a progestin only tablet indicated for females of reproductive potential to prevent pregnancy. Drospirenone Chewable Tablets were approved via the 505(b)2 pathway using Exeltis’ Slynd^® as a reference product.² Drospirenone Chewable Tablets launch and price are pending.
• Zonisade™ (zonisamide): The FDA has granted approval of Azurity Pharmaceuticals’ Zonisade™ (zonisamide oral suspension), 100mg/5mL as adjunctive therapy for the treatment of partial seizures in adults and pediatric patients aged 16 years and older with epilepsy. Zonisade was approved via the 505(b)2 pathway using Dainippon Pharmaceutical Co’s Zonegran^® as a reference drug.³ Zonisade launch and price are pending.

GenerIc Drug Information

• Daytrana^® (methlphenidate): Mylan/Viatris has launched their generic version of Noven Pharmaceuticals’ Daytrana indicated for the treatment of attention deficit hyperactivity disorder. Daytrana generated $46 million in U.S. annual sales in 2021.
• Pradaxa^® (dabigatran etexilate mesylate): Alkem Labs has launched their generic version of Boehringer Ingelheim’s Pradaxa^® (dabigatran etexilate mesylate) which is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Multiple manufacturers are schedule to launch this year. Pradaxa generated $524 million in U.S. annual sales in 2021.
• Toviaz^® (fesoterodine fumarate): Multiple manufactures have launched their generic version of Pfizer’s Toviaz indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Toviaz generated $237 million in U.S. annual sales in 2021.

+Specialty medication

References

1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215429s000lbl.pdf
2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216285s000lbl.pdf

3. https://www.prnewswire.com/news-releases/azurity-pharmaceuticals-inc-announces-fda-approval-of-zonisade-zonisamide-oral-suspension-301587834.html