1. Generics Bulletin
  2. >>Products
  3. >>Generics

Slayback Exclusivity On Taytulla Does Not Bar Rival ANDA Product

US-Based Player Received Approval With CGT Designation

 
• By Dean Rudge

Slayback Pharma has now launched its Merzee generic version of Allergan’s Taytulla oral contraceptive with a CGT designation, several months after Xiromed moved first.

Virtual_Buttons
“CGT exclusivity is not applied retrospectively," Slayback told Generics Bulletin • Source: Shutterstock

No additional generic versions of Allergan’s Taytulla (norethindrone acetate/ethinyl capsules; ferrous fumarate capsules) will be approved before late July, after Slayback Pharma launched its AB-rated generic, Merzee, with an ‘effective’ 180-day market exclusivity period provided under the competitive generic therapy pathway.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Generics

More from Products

Kabi Pens Agreement To Launch Generic Exparel In 2030 – With A Volume Limit

 
• By Dean Rudge

With sales of $550m last year and a high barrier to entry, Exparel marks an intriguing target for abbreviated new drug application sponsors. Having shot down a US patent last year and won US FDA approval for its ANDA, Jiangsu Hengrui’s US eVenus Pharmaceutical Laboratories subsidiary and partner Fresenius Kabi have just reached a settlement agreement.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Spanish Authorities Investigate Sandoz Over Information-Sharing

 
• By Dave Wallace

Spanish competition regulator the CNMC has announced an investigation into Sandoz and its Bexal subsidiary – as well as Alliance Healthcare España and Bluetab Solutions – over sharing sensitive commercial information relating to pharmacy orders for generics.