Methylphenidate paten?

When Does the Patent for Methylphenidate Expire?

Methylphenidate, a central nervous system stimulant commonly used to treat attention deficit hyperactivity disorder (ADHD), has been the subject of various patent disputes [1]. According to the FDA, methylphenidate is still under patent protection in some forms, though the patents have expired, or are set to expire, over time. For example, the patent for methylphenidate hydrochloride was set to expire in 2015.

What Formulations Are Still Under Patent?

Methylphenidate is sold under various brand names such as Ritalin [2]. The patents protecting these formulations may still be in place. Companies like Novartis and Teva have held these patents at various points [3], though this situation has changed over time as patents expire [4].

Are Biosimilars Entering the Market?

Biosimilars can enter the market as soon as patent protection expires, allowing for generic or nearly generic formulations [5]. Biosimilar versions of methylphenidate are being developed. For instance, a biosimilar of Ritalin was submitted by companies Alphapharm and Arrow Pharma [6]. Their submissions reflect the ongoing process of developing lower-cost options, as patent barriers come down on the medication's higher-priced branded versions.

Sources

[1] https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm(fdaSAP)
[2] https://www.drugs.com/rilatine.html
[3] https://www.drugpatentwatch.com/drug/ritalin
[4]https://www.accessdata.fda.gov/drugsatfda_docs/nda/archive/2013/202654Orig1s000TOC.cfm
[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6321241/#:~:text=Generic%20versions,-Biosimilars.
[6] https://www.fda.gov/media/133511/download