When Is The Generic Lyrica (Pregabalin) Available?

In our latest question and answer, the pharmacist discusses the generic availability of Lyrica (pregabalin).

Question

Is there a generic for Lyrica yet?

Asked by 1962yaya On Mar 29, 2019

Answered by
Medical Content Reviewed By PharmacistAnswers Staff

On Mar 29, 2019
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

About the Pharmacist

Dr. Brian Staiger Pharm.D

Dr. Brian Staiger is a licensed pharmacist in New York State and the founder of PharmacistAnswers.com. He graduated from the University At Buffalo with a Doctor of Pharmacy degree in 2010. He has been featured in numerous publications including the Huffington Post as well as a variety of health and pharmacy-related blogs. Please feel free to reach out to him directly if you have any inquiries or want to connect! He's answered thousands of medication and pharmacy-related questions and he's ready to answer yours! Brian.Staiger@PharmacistAnswers.com Office: 716-389-3076

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