Lyrica With Text Overlay

Overview

Lyrica is currently not available generically, although it should be soon.

The patent for Lyrica was originally set to expire December 30, 2018, but received a six-month patent extension when the FDA-approved it for a new indication, as an adjunctive (i.e. add-on) treatment of partial onset seizures in patients four years and older.[1]

Due to the new indication, the patent on Lyrica now is set to expire on June 30, 2019. You can, therefore, expect to see generic pregabalin products available at your pharmacy around July 1, 2019.[2][3]

Who Will Be Making Generic Pregabalin?

When the patent on Lyrica expires on June 30, 2019, there are multiple companies set to manufacture generic pregabalin.[4][5]

Thus far, the following manufacturers have been reported to be in the process of making and marketing pregabalin in preparation for release starting on July 1, 2019:

Pregabalin capsules:

  • Alembic
  • Alkem
  • Apotex
  • Aurobindo
  • Cadila
  • Lupi
  • Macleod
  • Mylan
  • Prinston
  • Sandoz
  • Teva
  • Wockhardt
  • Zydus

Pregabalin oral solution:

  • Apotex
  • Lupin
  • Novel

Is Lyrica CR Going Generic Too?

Lyrica CR, the 'controlled-release' version of Lyrica, will not be going generic at the same time as Lyrica.

Lyrica CR was approved by the FDA only recently, in October of 2017. Therefore, it won't be going generic until 2026 at the earliest.[6]

Summary

Lyrica is set to be available generically (as pregabalin) on July 1, 2019 as the patent for the drug expires June 30, 2019. Lyrica CR however, won't be available as a generic product until much later since it was only recently approved (in October of 2017).

References
  1. ^ LAUNCH OF GENERIC LYRICA DELAYED: PFIZER, INC. RECEIVES PATENT EXTENSION. MyMatrixx
  2. ^ Pfizer wins blockbuster Lyrica patent extension to safeguard sales till June FiercePharma
  3. ^ Approvals of FDA-Regulated Products: Lyrica Food and Drug Administration
  4. ^ Anticipated Availability of First-Time Generics. PharmacistsLetter (subscription required)
  5. ^ Corporate Pharmacy Services. Upcoming generic drugs Corporate Pharmacy
  6. ^ Approvals of FDA-Regulated Products: Lyrica Food and Drug Administration