Sole Challenger HEC Beaten On US Gilenya Patent

Key Patent to December 2027 Upheld

Imminent generic competition to Novartis’ Gilenya blockbuster in the US now seems impossible after a US district court held that the company’s dosage-regimen patent was both valid and infringed by HEC’s ANDA product. The Chinese firm may yet appeal the decision.

Courtroom
HEC's dual challenge to Gilenya's dosage-regimen patent fell flat • Source: Shutterstock

Novartis’ US dosage-regimen patent 9,187,405 for Gilenya (fingolimod) 0.5mg capsules is not invalid and is also infringed by HEC Pharm’s proposed abbreviated new drug application product, a US district court has ordered, shooting down the potential for generic competition this year to the $1.8bn blockbuster.

The Chinese firm was “the only generic actively challenging the key Gilenya patent in a district court litigation,” Morgan Stanley...

Generics Bulletin Podcast

Stay ahead of every shift in generics and biosimilars.

Generics Bulletin brings you the latest updates that matter for the off-patent industry.

More from Legal & IP

ADHD

This is regarding ADHD.

GB-Leadership-Free: Article with 150 words (Time to read is < 1 min)

 
• By 

In the first cinematic chapter of J.K. Rowling’s wizarding world, young Harry Potter discovers his true identity and enters Hogwarts School of Witchcraft and Wizardry. This enchanting origin story sets the tone for a saga filled with magic, loyalty, and the power of choice.

MPP Finds Three More Partners On Key Hepatitis C Treatment

 
• By 

The Medicines Patent Pool has entered into a partnership with three companies for glecaprevir/pibrentasvir, a WHO-recommended treatment for people living with hepatitis C. The companies join previous generic licensee Mylan and originator AbbVie.

Troubled Teligent Enters Bankruptcy Proceedings As CEO Resigns

 
• By 

Teligent is pursuing an asset sale process to “maximize the value of the company” after entering into Chapter 11 bankruptcy proceedings in the US. The firm – which has also seen CEO Tim Sawyer resign – had been struggling of late with remediation issues to address a warning letter at its Buena manufacturing facility in New Jersey, as well as a recent recall.

More from Generics Bulletin

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C10

 
• By 

The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C9

 
• By 

The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C8

 
• By 

The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.