Sapropterin Approval Year
The FDA approved sapropterin dihydrochloride (Kuvan) on December 12, 2007, for treating hyperphenylalaninemia (PKU) in patients aged 4 and older responsive to the drug.[1][2]
What Is Sapropterin and What Does It Treat?
Sapropterin is a synthetic form of tetrahydrobiopterin (BH4), a cofactor that helps phenylalanine hydroxylase break down phenylalanine. It reduces blood phenylalanine levels in PKU patients who respond to it, often allowing relaxed dietary restrictions.[1]
Approval Timeline by Indication and Age Group
- Initial approval (2007): Ages 4+ with PKU responsive to sapropterin.[1]
- Expanded 2009: Ages 0-4 years.[2]
- 2018 label update: Confirmed efficacy across ages 1 month and older.[2]
No approvals outside the US prior to 2007; EU approval came in 2008 as Phenoptin.[3]
Who Makes Sapropterin?
BioMarin Pharmaceutical developed and originally marketed Kuvan. Endosa acquired US rights in 2023.[4]
When Do Key Patents Expire?
US Patent 6,410,539 (core composition) expires December 28, 2023. Pediatric exclusivity extends some protections to mid-2024. Multiple challenges from generics like Mylan and Apotex resolved via settlements.[5] Check DrugPatentWatch.com for latest status and ANDA filings.[5]
Are There Biosimilars or Generics Available?
No generics launched as of 2024 due to ongoing litigation and exclusivity. First ANDA approvals expected post-2024 patent cliffs.[5]
[1]: FDA Label, Kuvan (2007). https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022181lbl.pdf
[2]: FDA Approval History. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021959
[3]: EMA Summary. https://www.ema.europa.eu/en/medicines/human/EPAR/phenoptin
[4]: BioMarin Press Release (2023). https://investors.biomarin.com/news-releases/news-release-details/biomarin-announces-agreement-sell-us-rights-kuvanr
[5]: DrugPatentWatch.com, Kuvan. https://www.drugpatentwatch.com/p/tradename/KUVAN