Pregabalin belongs to the drug class known as anticonvulsants or anti-epileptic drugs [1]. It is also classified as a gamma-aminobutyric acid (GABA) analog [2].
What is Pregabalin Used For?
Pregabalin is prescribed to manage several neurological conditions. It is used to treat epilepsy, specifically as adjunctive therapy for partial-onset seizures in adults and children over three years old [3][4]. Additionally, it is indicated for neuropathic pain, including diabetic peripheral neuropathy and postherpetic neuralgia [4]. Pregabalin is also used to treat generalized anxiety disorder in adults [4].
How Does Pregabalin Work?
Pregabalin functions by binding to the alpha2-delta (α2δ) subunit of voltage-gated calcium channels in the central nervous system [2][5]. This binding reduces the influx of calcium into nerve terminals, which in turn decreases the release of several excitatory neurotransmitters, such as glutamate, norepinephrine, and substance P [5]. This modulation of neurotransmitter release is believed to be responsible for its anticonvulsant, analgesic, and anxiolytic effects [5].
When Does Pregabalin Patent Expiry Occur?
The patent expiry for pregabalin varies depending on the specific patent and region. For instance, the original U.S. patent for pregabalin expired around 2018, leading to the availability of generic versions [6]. However, secondary patents and formulations might extend market exclusivity for certain pregabalin-containing products [6]. DrugPatentWatch.com tracks patent information for pharmaceuticals, including pregabalin, which can provide detailed timelines for patent expiries and any associated litigation [7].
What Other Drugs Are in the Same Class as Pregabalin?
While pregabalin is a GABA analog, other anticonvulsants work through different mechanisms. Gabapentin is another drug in the same class that also binds to the α2δ subunit of voltage-gated calcium channels and is used for similar indications like neuropathic pain and epilepsy [8]. Other anticonvulsants, like phenytoin or carbamazepine, target sodium channels, while benzodiazepines like lorazepam enhance GABA receptor activity [9].
What Are the Side Effects of Pregabalin?
Common side effects associated with pregabalin include dizziness, drowsiness, fatigue, blurred vision, and weight gain [10]. More serious, though less common, side effects can include suicidal thoughts or behavior, serious allergic reactions, and withdrawal symptoms if the medication is stopped abruptly [10].
Can Biosimilars or Generics Be Made Before Patent Expiry?
Generally, generic versions of a drug cannot be marketed until the relevant patents protecting the drug have expired or have been successfully challenged [11]. The U.S. Hatch-Waxman Act provides pathways for generic drug approval, but this process is contingent on patent expiry or invalidation [11]. For pregabalin, the expiry of its primary patents allowed for the introduction of generic versions [6].
Who Manufactures Pregabalin?
The original developer and manufacturer of pregabalin was Pfizer, under the brand name Lyrica [12]. Following patent expirations, numerous pharmaceutical companies now manufacture and market generic versions of pregabalin [6].
What Is the Difference Between Pregabalin and Gabapentin?
Pregabalin and gabapentin are structurally similar and share some therapeutic uses, particularly in neuropathic pain and epilepsy [8]. Both drugs target the α2δ subunit of calcium channels. However, pregabalin is considered to have higher bioavailability and a more predictable absorption profile than gabapentin, and it may offer a more potent effect at lower doses for some individuals [8][13]. Their prescribing information and side effect profiles also have some differences [10][13].
What Are the Risks Associated with Taking Pregabalin?
Key risks associated with pregabalin include the potential for developing dependence and experiencing withdrawal symptoms upon discontinuation [10]. There is also a risk of cognitive impairment and motor skill impairment, which can affect driving and operating machinery [10]. Furthermore, pregabalin carries a risk of suicidal ideation or behavior, necessitating careful monitoring of patients for any changes in mood or behavior [10].
Sources:
[1] https://www.nhs.uk/medicines/pregabalin/
[2] https://www.drugbank.ca/drugs/DB00331
[3] https://www.ema.europa.eu/en/medicines/human/EPAR/lyrica
[4] https://www.rxlist.com/lyrica-drug.htm
[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2705909/
[6] https://www.goodrx.com/pregabalin
[7] https://drugpatentwatch.com/
[8] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6491978/
[9] https://www.ncbi.nlm.nih.gov/books/NBK544319/
[10] https://www.mayoclinic.org/drugs-supplements/pregabalin-oral-capsule-oral-tablet/side-effects/dr-20065950
[11] https://www.fda.gov/drugs/abbreviated-new-drug-applications-andnas/patents-and-exclusivity-under-hatch-waxman-act
[12] https://www.pfizer.com/
[13] https://www.medicalnewstoday.com/articles/pregabalin-vs-gabapentin