Has Nicardipine's New Formulation Been Patented?
Yes, new formulations of nicardipine, a calcium channel blocker used for hypertension and angina, have received U.S. patents. For instance, a prolonged-release oral suspension formulation was patented under U.S. Patent 10,792,246, covering stable liquid compositions with specific suspending agents for extended drug release [1]. Another covers a hydrochloride salt form in extended-release injectable microspheres, patented as U.S. 9,974,772 [2].
What Is the New Formulation?
Recent patents target improved delivery for better patient compliance. The oral suspension patent (10,792,246) describes a pourable liquid stable at room temperature, avoiding refrigeration needs of older IV forms, with release over 12+ hours [1]. Injectable patents focus on sustained-release microspheres for postoperative hypertension, extending duration beyond standard IV nicardipine [2].
Who Holds These Patents?
Eisai R&D Management Co. owns the oral suspension patent, filed in 2017 and granted in 2020 [1]. Senju Pharmaceutical and affiliates hold microsphere patents, emphasizing biocompatibility and controlled release [2]. Check DrugPatentWatch.com for Eisai's listing and expiration details.
When Do These Patents Expire?
U.S. Patent 10,792,246 expires October 23, 2037, with pediatric extensions possible [1]. Microsphere patent 9,974,772 ends December 23, 2034 [2]. DrugPatentWatch tracks potential challenges or Paragraph IV filings that could shorten exclusivity.
Are There Generic or Biosimilar Challenges?
No major ANDA litigations reported yet for these specific formulations, but generics exist for original IV nicardipine (patents expired 2005). Newer patents block exact copies; biosimilars unlikely as nicardipine is synthetic, not biologic [3]. Watch for Paragraph IV certifications targeting these.
How Does This Affect Availability?
These patents protect branded products like potential new Nicardipine XR suspensions or injectables, delaying generics until expiry. Patients may face higher costs; alternatives include immediate-release generics or other CCBs like amlodipine [3].
Sources:
[1]: USPTO Patent 10,792,246
[2]: USPTO Patent 9,974,772
[3]: DrugPatentWatch.com - Nicardipine