Generic Lyrica Availability

Lyrica is a brand name of pregabalin, approved by the FDA in the following formulation(s):

LYRICA (pregabalin - capsule;oral)

  • Manufacturer: PF PRISM
    Approval date: December 30, 2004
    Strength(s): 25MG [AB], 50MG [AB], 75MG [AB], 100MG [AB], 150MG [AB], 200MG [AB], 225MG [AB], 300MG [RLD] [AB]

LYRICA (pregabalin - solution;oral)

  • Manufacturer: PF PRISM
    Approval date: January 4, 2010
    Strength(s): 20MG/ML [RLD]

Has a generic version of Lyrica been approved?

A generic version of Lyrica has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Lyrica and have been approved by the FDA:

pregabalin capsule;oral

  • Manufacturer: LUPIN LTD
    Approval date: July 3, 2012
    Strength(s): 25MG [AB], 50MG [AB], 75MG [AB], 100MG [AB], 150MG [AB], 200MG [AB], 225MG [AB], 300MG [AB]
  • Manufacturer: TEVA PHARMS
    Approval date: July 3, 2012
    Strength(s): 25MG [AB], 50MG [AB], 75MG [AB], 100MG [AB], 150MG [AB], 200MG [AB], 225MG [AB], 300MG [AB]
  • Manufacturer: WATSON LABS INC
    Approval date: July 3, 2012
    Strength(s): 25MG [AB], 50MG [AB], 75MG [AB], 100MG [AB], 150MG [AB], 200MG [AB], 225MG [AB], 300MG [AB]

Note: No generic formulation of the following product is available.

  • pregabalin - solution;oral

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Lyrica. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • GABA and L-glutamic acid analogs for antiseizure treatment
    Patent 5,563,175
    Issued: October 8, 1996
    Inventor(s): Silverman; Richard B. & Andruszkiewicz; Ryszard & Yuen; Po-Wai & Sobieray; Denis M. & Franklin; Lloyd C. & Schwindt; Mark A.
    Assignee(s): Northwestern University Warner-Lambert Company
    A compound of the formula ##STR1## wherein R.sub.1 is a straight or branched alkyl group having from 1 to 6 carbon atoms, phenyl, or cycloalkyl having from 3 to 6 carbon atoms; R.sub.2 is hydrogen or methyl; and R.sub.3 is hydrogen, methyl or carboxyl; which is useful in the treatment of seizure disorders. Processes are disclosed for the preparation of the compound. Intermediates prepared during the synthesis of the compound are also disclosed.
    Patent expiration dates:
    • October 8, 2013
      ✓ 
      Patent use: TREATMENT OF SEIZURE DISORDER
  • Isobutylgaba and its derivatives for the treatment of pain
    Patent 6,001,876
    Issued: December 14, 1999
    Inventor(s): Singh; Lakhbir
    Assignee(s): Warner-Lambert Company
    The instant invention is a method of using certain analogs of glutamic acid and gamma-aminobutyric acid in pain therapy.
    Patent expiration dates:
    • December 30, 2018
      ✓ 
      Patent use: MANAGEMENT OF FIBROMYALGIA
      ✓ 
      Sponsor has requested patent be delisted
    • December 30, 2018
      ✓ 
      Patent use: TREATMENT OF PAIN
      ✓ 
      Sponsor has requested patent be delisted
  • Gamma amino butyric acid analogs and optical isomers
    Patent 6,197,819
    Issued: March 6, 2001
    Inventor(s): Silverman; Richard B. & Andruszkiewicz; Ryszard
    Assignee(s): Northwestern University
    A compound of the formula ##STR1## wherein R.sub.1 is a straight or branched alkyl group having from 1 to 6 carbon atoms, phenyl, or cycloalkyl having from 3 to 6 carbon atoms; R.sub.2 is hydrogen or methyl; and R.sub.3 is hydrogen, methyl or carboxyl; which is useful in the treatment of seizure disorders. Processes are disclosed for the preparation of the compound. Intermediates prepared during the synthesis of the compound are also disclosed.
    Patent expiration dates:
    • December 30, 2018
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Isobutylgaba and its derivatives for the treatment of pain
    Patent RE41920
    Issued: November 9, 2010
    Inventor(s): Singh; Lakhbir
    Assignee(s): Warner-Lambert Company LLC
    The instant invention is a method of using certain analogs of glutamic acid and gamma-aminobutyric acid in pain therapy.
    Patent expiration dates:
    • December 30, 2018
      ✓ 
      Patent use: TREATMENT OF PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY OR SPINAL CORD INJURY, POSTHERPETIC NEURALGIA, AND FIBROMYALGIA

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • June 20, 2015 - MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH SPINAL CORD INJURY

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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