Zydus Mounts Challenge To Novartis With Generic Nelarabine Injection

US Rival To Arranon Has Been Granted 180 Days Of CGT Exclusivity

Zydus Cadila’s single-dose nelarabine injection (250mg/50ml) will enjoy 180 days of competitive generic therapy market exclusivity following approval from the US FDA, as the first approved rival to Novartis’ Arranon brand.

US Flag Graph
Zydus is building up its US injectables business • Source: Alamy

Indian generics firm Zydus Cadila has received final approval from the US Food and Drug Administration to market its single-dose nelarabine injection (250mg/50ml), which will receive 180 days of market exclusivity under its competitive generic therapy designation.

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

More from Products

OGD’s Policy Office Cut To Have ‘Profound’ Impact On New Generic Approvals, Warns Former FDA Head Gottlieb

 

The elimination of the policy division at the Office of Generic Drugs, tariffs, the Section 232 investigation, and a new executive order to promote lower drug prices seem to both cause and purport to solve the same problem: supply chain disruption.

Sunshine Becomes Latest To Compete On Everolimus In Canada

 
• By 

Sunshine Biopharma is continuing to roll out generic launches in Canada, with its latest product challenging Afinitor and other everolimus rivals in the market.

Celltrion Celebrates Interchangeability Designation For Humira Biosimilar In The US

 

Celltrion’s adalimumab biosimilar was crowned as interchangeable by the FDA, at a time when the future of the designation is unknown.

Samsung Bioepis Reevaluating Approach To Biosimilars

 

The challenging US biosimilar market remains a persistent problem, leading the biosimilar developer to reconsider how it invests in the future while pushing for changes.

More from Generics Bulletin

Xbrane Approves Deal Giving Away Cimzia Rival To Alvotech

 
• By 

After announcing the agreement last month, Xbrane has now approved its deal with Alvotech as part of an extra general meeting.

Celltrion Celebrates Interchangeability Designation For Humira Biosimilar In The US

 

Celltrion’s adalimumab biosimilar was crowned as interchangeable by the FDA, at a time when the future of the designation is unknown.

Samsung Bioepis Reevaluating Approach To Biosimilars

 

The challenging US biosimilar market remains a persistent problem, leading the biosimilar developer to reconsider how it invests in the future while pushing for changes.