Keppra, an anti-epileptic drug, has been available since 2000 [1]. It was approved by the U.S. Food and Drug Administration (FDA) in November 2000 [1].
When did Keppra's patents start to expire?
The primary patents for Keppra began expiring around 2014 [2]. This timeframe is significant as it opened the door for generic versions of the drug to enter the market [3].
Who makes generic Keppra?
Following the expiration of Keppra's patents, several pharmaceutical companies began manufacturing and distributing generic versions of levetiracetam, the active ingredient in Keppra [3]. These include major generic drug manufacturers.
What are the active ingredients in Keppra and its generics?
The active ingredient in Keppra is levetiracetam [4]. Generic versions also contain levetiracetam as the sole active pharmaceutical ingredient [3].
How does levetiracetam work to treat seizures?
Levetiracetam is thought to work by binding to a protein in the brain called synaptic vesicle protein 2A (SV2A) [4]. This binding is believed to modulate the release of neurotransmitters, thereby inhibiting excessive neuronal firing that leads to seizures [4].
What are the differences between Keppra and generic levetiracetam?
While generic levetiracetam has the same active ingredient and is expected to have the same safety and efficacy as Keppra, minor differences may exist in inactive ingredients, such as binders, fillers, or coatings [3]. These inactive ingredients generally do not affect the drug's performance. Regulatory bodies like the FDA ensure that generic drugs are bioequivalent to their brand-name counterparts.
What is the typical cost of Keppra versus its generics?
Generally, generic versions of medications are significantly less expensive than their brand-name counterparts [3]. This cost difference is a primary reason patients and healthcare systems often opt for generics once they become available.
What are the potential side effects of levetiracetam?
Common side effects associated with levetiracetam include drowsiness, dizziness, fatigue, and behavioral changes such as irritability or aggression [5]. Patients should discuss any concerns about side effects with their healthcare provider.
What are the drug interactions associated with levetiracetam?
Levetiracetam may interact with other central nervous system depressants, potentially increasing their sedative effects. It is important for patients to inform their doctor about all medications, including over-the-counter drugs and supplements, they are taking [5].
When can new anti-epileptic drugs be expected?
The development of new anti-epileptic drugs is an ongoing process involving extensive research and clinical trials. Information on the timelines for specific new drug approvals can be tracked through regulatory agencies and pharmaceutical pipelines [6].
Sources:
[1] https://www.accessdata.fda.gov/drugsatfdadocs/appletter/2000/112251Keppra_prnt.pdf
[2] https://www.drugpatentwatch.com/
[3] https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/generics
[4] https://www.rxlist.com/script/main/prescriptiondrugsummary.htm?docid=16341&drugid=16341&txsid=34674
[5] https://www.mayoclinic.org/drugs-supplements/levetiracetam-oral-route-parenteral-route/side-effects/drg-20063124
[6] https://www.fda.gov/drugs