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Is there a generic auvelity?

See the DrugPatentWatch profile for auvelity

There is currently no generic version of Auvelity (dextromethorphan HBr-bupropion HBr) available [1].

What is Auvelity prescribed for?


Auvelity is a prescription medication approved for the treatment of major depressive disorder (MDD) in adults [1]. It works by combining dextromethorphan, an NMDA receptor antagonist and sigma-1 receptor agonist, with bupropion, an antidepressant that inhibits the reuptake of norepinephrine and dopamine [2].

When might a generic version of Auvelity become available?


The availability of a generic version of Auvelity depends on the expiration of its patents and any regulatory exclusivity periods. Drug patent information, including expirations and challenges, can be tracked on sites like DrugPatentWatch.com [3]. The specific patent landscape for Auvelity and its potential for generic entry would be detailed there.

How does Auvelity work in the brain?


Auvelity's dual mechanism involves dextromethorphan and bupropion. Dextromethorphan influences glutamate neurotransmission by acting on NMDA receptors and sigma-1 receptors. Bupropion, meanwhile, affects the levels of norepinephrine and dopamine, two key neurotransmitters implicated in mood regulation [2].

Are there any approved alternatives for major depressive disorder?


Yes, numerous other medications are approved for the treatment of major depressive disorder, including various selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and other classes of antidepressants [4]. These alternatives may have different efficacy, side effect profiles, and mechanisms of action compared to Auvelity.

What are the potential side effects of Auvelity?


Common side effects associated with Auvelity include dizziness, somnolence, diarrhea, nausea, vomiting, constipation, dry mouth, and decreased libido [1]. Serious side effects can include suicidal thoughts and behaviors, activation of mania or hypomania, seizures, and increased blood pressure [1].

What is the cost of Auvelity?


The cost of Auvelity can vary depending on insurance coverage and pharmacy. Information on drug pricing and potential savings programs can often be found through the manufacturer's website or patient assistance programs. The introduction of a generic version typically leads to significant price reductions.

What are the key patents protecting Auvelity?


Detailed information on the specific patents protecting Auvelity and their expiration dates is publicly available. Resources like DrugPatentWatch.com track these patents, which are crucial for understanding when generic competition might emerge [3].

Who manufactures Auvelity?


Auvelity is manufactured by Axsome Therapeutics [1].

---

Sources:

[1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216162s000lbl.pdf
[2] https://www.drugpatentwatch.com/blog/auvelity-dextromethorphan-hbr-bupropion-hbr-patent-information
[3] https://www.drugpatentwatch.com/
[4] https://www.fda.gov/consumers/consumer-updates/help-your-teen-avoid-depression-and-suicide



Other Questions About Auvelity :

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AI-Drug Label Prescribing Information Alignment Report

40
40%
Grade C

Partial

Partially Aligned

Patient Risk: Medium

Summary

Several scientific/mechanism and side-effect claims are not supported by the provided FDA label excerpts, which only include boxed warning/monitoring and pediatric non-approval for suicidal thoughts and behaviors. Some general claims are plausible but cannot be verified against the limited excerpts.


Category Scores

Indication
60
Good
Dosage
0
Poor
Warnings
70
Good
Indication
60
Good
AdverseReactions
20
Poor

Accurate Statements

Auvelity can cause serious side effects including suicidal thoughts and behaviors.
Supported in provided excerpts via boxed warning/monitoring language (Boxed Warning; sections 5.1 and 17).

Unsupported Statements

There is currently no generic version of Auvelity (dextromethorphan HBr-bupropion HBr) available.
No label excerpt provided addresses availability of generics.
Auvelity is a prescription medication approved for the treatment of major depressive disorder (MDD) in adults.
No indication text was provided in the supplied label excerpts to verify this claim.
Auvelity combines dextromethorphan and bupropion.
Ingredient information is not provided in the supplied label excerpts; label excerpts focus on suicidal thoughts/behaviors and pediatric use.
Dextromethorphan in Auvelity is an NMDA receptor antagonist.
No mechanism-of-action statements were provided in the supplied label excerpts.
Dextromethorphan in Auvelity is a sigma-1 receptor agonist.
No mechanism-of-action statements were provided in the supplied label excerpts.
Bupropion in Auvelity inhibits the reuptake of norepinephrine and dopamine.
No mechanism-of-action statements were provided in the supplied label excerpts.
Auvelity's dual mechanism involves dextromethorphan and bupropion.
No mechanism-of-action statements were provided in the supplied label excerpts.
Dextromethorphan in Auvelity influences glutamate neurotransmission by acting on NMDA receptors.
No mechanism-of-action statements were provided in the supplied label excerpts.
Dextromethorphan in Auvelity influences glutamate neurotransmission by acting on sigma-1 receptors.
No mechanism-of-action statements were provided in the supplied label excerpts.
Bupropion in Auvelity affects the levels of norepinephrine and dopamine.
No mechanism-of-action statements were provided in the supplied label excerpts.
Norepinephrine and dopamine are implicated in mood regulation.
No discussion of NE/DA in mood regulation was provided in the supplied label excerpts.
Auvelity is associated with common side effects including dizziness.
No adverse reaction list/excerpts were provided.
Auvelity is associated with common side effects including somnolence.
No adverse reaction list/excerpts were provided.
Auvelity is associated with common side effects including diarrhea.
No adverse reaction list/excerpts were provided.
Auvelity is associated with common side effects including nausea.
No adverse reaction list/excerpts were provided.
Auvelity is associated with common side effects including vomiting.
No adverse reaction list/excerpts were provided.
Auvelity is associated with common side effects including constipation.
No adverse reaction list/excerpts were provided.
Auvelity is associated with common side effects including dry mouth.
No adverse reaction list/excerpts were provided.
Auvelity is associated with common side effects including decreased libido.
No adverse reaction list/excerpts were provided.
Auvelity can cause serious side effects including activation of mania or hypomania.
No such warning text was provided in the supplied label excerpts.
Auvelity can cause serious side effects including seizures.
No such warning text was provided in the supplied label excerpts.
Auvelity can cause serious side effects including increased blood pressure.
No such warning text was provided in the supplied label excerpts.
Auvelity is manufactured by Axsome Therapeutics.
No manufacturer/manufactured-by statement was provided in the supplied label excerpts.

Contradictions


Important Omissions

Monitoring/education language specific to suicidal thoughts and behaviors (e.g., close monitoring during initial months and when doses are adjusted; instructing patients/caregivers to report symptoms) was not mentioned.
Importance: Moderate
Pediatric non-approval and that safety/effectiveness are not established in pediatric patients were not included in the set of claims.
Importance: Moderate

Safety Assessment

Potential Patient Risk: Medium
A boxed-warning-related serious risk (suicidal thoughts/behaviors) was correctly mentioned, but many other serious adverse-effect claims were made without support from the supplied label excerpts. Additionally, key label-directed monitoring/counseling details were omitted.

Regulatory Assessment

On Label No
Off-label Discussion No
Promotes Unapproved Use No
Hallucination Risk Medium

Recommendation

Partially Aligned

Primary Issue
Most mechanism-of-action and adverse-effect/side-effect assertions are not supported by the provided FDA label excerpts; only suicidal thoughts/behaviors content aligns with the supplied excerpts.

Suggested Improvement
Limit claims to what is present in the provided label excerpts (boxed warning/5.1/17 monitoring and pediatric non-approval), or supply additional FDA label sections (Indications, Dosage/Administration, Warnings/Precautions, Adverse Reactions, and specific sections for mechanisms, manufacturing, and other risks) for accurate evaluation.

Drug Brand Mention Assessment

Branding Score
55
Visibility
58
Mentioned
Ranking
#1
Sentiment
45
Recommendation Status
mentioned only
Brand Perception
Best Known For

Auvelity is a prescription medication approved for the treatment of major depressive disorder (MDD) in adults


Core Claims
  • There is currently no generic version of Auvelity available
  • Auvelity is a prescription medication approved for the treatment of major depressive disorder (MDD) in adults
  • Auvelity combines dextromethorphan with bupropion
  • Common side effects include dizziness, somnolence, diarrhea, nausea, vomiting, constipation, dry mouth, and decreased libido
  • The cost of Auvelity can vary depending on insurance coverage and pharmacy
Differentiators
  • Dual mechanism uses dextromethorphan and bupropion
  • Dextromethorphan acts on NMDA receptors and sigma-1 receptors
  • Bupropion inhibits reuptake of norepinephrine and dopamine

Pricing Perception: Mid Range
Competitors Mentioned
Company Visibility Sentiment Rank Recommended
DrugPatentWatch 30%
50 #3 No