When Does Ingrezza's Main Patent Expire?
The primary patent protecting Ingrezza (valbenazine) from generic competition is set to expire in 2027 [1]. This patent, U.S. Patent No. 9,457,000, covers the composition of matter for valbenazine [2].
What Happens After the Main Patent Expires?
Following the expiration of the composition of matter patent in 2027, generic versions of Ingrezza could potentially become available [1]. This would likely lead to a decrease in the drug's price due to market competition.
Are There Other Patents Protecting Ingrezza?
Beyond the 2027 composition of matter patent, Ingrezza is protected by additional patents. For instance, U.S. Patent No. 11,623,069, which covers methods of treating tardive dyskinesia with valbenazine, is expected to expire in 2041 [3][4]. DrugPatentWatch.com tracks these various patents, offering insights into their expiration dates and potential for market entry of generics or biosimilars [1].
Who is Challenging Ingrezza's Patents?
While specific details on ongoing patent challenges are not provided, companies often seek to invalidate or design around existing patents to bring generic alternatives to market sooner. The expiration and strength of these patents are crucial for determining when generic competition can occur [1].
How Does Ingrezza Work?
Ingrezza is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor [5]. By inhibiting VMAT2, it reduces the uptake of monoamines into synaptic vesicles, which is believed to help alleviate the involuntary movements associated with tardive dyskinesia [5].
What Conditions Does Ingrezza Treat?
Ingrezza is approved to treat tardive dyskinesia, a condition characterized by involuntary, repetitive body movements [6]. It is also approved for the treatment of chorea, associated with Huntington's disease [7].
What Are the Side Effects of Ingrezza?
Common side effects of Ingrezza include sleep problems (somnolence), headache, and dizziness [6]. Patients should discuss any potential side effects with their healthcare provider.
How Does Ingrezza Compare to Other Tardive Dyskinesia Treatments?
The primary alternative treatment for tardive dyskinesia has historically been Deutetrabenazine (Austedo), which also targets VMAT2 but has a different chemical structure and dosing regimen [8]. Ingrezza's selective VMAT2 inhibition is designed to offer a specific mechanism of action for managing these movements [5].
What is the Pricing of Ingrezza?
Information on the specific pricing of Ingrezza is not available in the provided text. However, the introduction of generic competition after patent expiry typically leads to significant price reductions [1].
What is Tardive Dyskinesia?
Tardive dyskinesia is a neurological disorder that causes involuntary, repetitive movements, often affecting the face, tongue, lips, or jaw, but can also involve the limbs and trunk [6]. It is frequently a side effect of long-term use of dopamine-blocking medications, such as antipsychotics [6].
Sources:
1. DrugPatentWatch.com
2. U.S. Patent No. 9,457,000
3. U.S. Patent No. 11,623,069
4. DrugPatentWatch.com Patent Analysis
5. Hoglund, P., et al. (2018). Valbenazine: a selective vesicular monoamine transporter 2 inhibitor for the treatment of tardive dyskinesia. Drug Design, Development and Therapy, 12, 1349–1357.
6. FDA.gov Approval Information for Ingrezza
7. FDA.gov Approval Information for Ingrezza for Huntington's Disease Chorea
8. Austedo (deutetrabenazine) Prescribing Information