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When does trazodone expire?

See the DrugPatentWatch profile for trazodone

Trazodone's primary patents have long expired, allowing for the widespread availability of generic versions.

When did trazodone patents first expire?


The original patents for trazodone hydrochloride, the active ingredient in Desyrel and other trazodone formulations, expired many years ago. This expiration allowed generic manufacturers to enter the market, significantly reducing the cost of the medication. For instance, Trazodone was first approved by the FDA in 1981 [1].

How does trazodone patent expiry affect drug availability?


Once a drug's patents expire, other companies can legally produce and market generic versions of the medication. This leads to increased competition, which typically drives down prices. Patients can then access the medication at a lower cost through generic formulations.

Are there still any active patents related to trazodone?


While the core patents for trazodone have expired, it is possible for new patents to be issued for specific formulations, delivery methods, or new uses of the drug. However, these do not typically affect the availability of the standard oral tablet generic versions. Information on specific patent statuses can often be found through resources like DrugPatentWatch.com [2].

What are the main uses of trazodone?


Trazodone is primarily prescribed to treat major depressive disorder. It is also frequently used off-label to manage insomnia, anxiety disorders, and other conditions [3].

What is the difference between brand-name trazodone and generic trazodone?


The main difference between brand-name trazodone (like Desyrel) and generic trazodone is the manufacturer and the cost. Both contain the same active ingredient, trazodone hydrochloride, and are required to meet the same strict standards for safety, quality, and effectiveness set by regulatory bodies like the FDA. Generic versions are generally less expensive due to market competition following patent expiration [4].

Who makes generic trazodone?


Numerous pharmaceutical companies manufacture generic trazodone. This includes companies like Teva Pharmaceuticals, Accord Healthcare, and Aurobindo Pharma, among others. The availability of multiple generic manufacturers contributes to competitive pricing [5].

What are common side effects of trazodone?


Common side effects associated with trazodone include drowsiness, dizziness, dry mouth, blurred vision, constipation, and nausea. More serious, though less common, side effects can include priapism (a prolonged erection), orthostatic hypotension (a sudden drop in blood pressure upon standing), and serotonin syndrome [3].

How does trazodone work?


Trazodone is an antidepressant that belongs to a class of drugs known as serotonin antagonist and reuptake inhibitors (SARIs). It works by affecting the levels of serotonin, a neurotransmitter in the brain, which helps to improve mood and sleep [3].

Sources:
1. FDA. (n.d.). Drug Approval Packages. https://www.accessdata.fda.gov/scripts/cder/daf/
2. DrugPatentWatch.com. (n.d.). Trazodone Patents. https://drugpatentwatch.com/search/trazodone
3. National Institute of Mental Health. (n.d.). Trazodone. https://www.nimh.nih.gov/health/topics/trazodone
4. U.S. Food and Drug Administration. (n.d.). Generic Drugs: Questions and Answers. https://www.fda.gov/drugs/generic-drugs/generic-drugs-questions-and-answers
5. GoodRx. (n.d.). Trazodone Prices, Coupons, and Patient Assistance Programs. https://www.goodrx.com/trazodone



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AI-Drug Label Prescribing Information Alignment Report

45
45%
Grade C

Partial

Needs Review

Patient Risk: Medium

Summary

Only a portion of the response can be assessed against the supplied FDA label excerpts (suicidal thoughts/behaviors in pediatric/young adults and not approved for pediatric use). The response includes many additional off-scope claims that are not supported or evaluated by the provided label text.

Category Scores

Indication
40
Poor
Warnings
60
Partial
SpecificPopulations
20
Poor

Accurate Statements

Unsupported Statements

Trazodone is primarily prescribed to treat major depressive disorder.
The supplied label excerpts include an indication statement for RALDESY (MDD in adults), but the AI response describes trazodone generally. This is not directly supported by the provided excerpts as a label-backed statement for trazodone overall (and the response does not specify RALDESY or adult indication).
Trazodone was first approved by the FDA in 1981.
No approval history details are present in the supplied label excerpts.
Trazodone is frequently used off-label to manage insomnia.
Off-label use statements are not present in the supplied label excerpts.
Trazodone is frequently used off-label to manage anxiety disorders.
Off-label use statements are not present in the supplied label excerpts.
Brand-name trazodone (e.g., Desyrel) and generic trazodone contain the same active ingredient, trazodone hydrochloride.
No brand/generic equivalence statements are present in the supplied label excerpts.
Generic versions are required to meet the same strict standards for safety, quality, and effectiveness set by regulatory bodies like the FDA.
No generic regulatory standards statements are present in the supplied label excerpts.
Generic versions are generally less expensive due to market competition following patent expiration.
No pricing/market competition statements are present in the supplied label excerpts.
Numerous pharmaceutical companies manufacture generic trazodone.
No manufacturer/market statements are present in the supplied label excerpts.
Teva Pharmaceuticals manufactures generic trazodone.
No manufacturer-specific statements are present in the supplied label excerpts.
Accord Healthcare manufactures generic trazodone.
No manufacturer-specific statements are present in the supplied label excerpts.
Aurobindo Pharma manufactures generic trazodone.
No manufacturer-specific statements are present in the supplied label excerpts.
Common side effects of trazodone include drowsiness, dizziness, dry mouth, blurred vision, constipation, nausea.
No adverse reaction/side effect lists are present in the supplied label excerpts.
More serious, less common side effects of trazodone can include priapism, orthostatic hypotension, serotonin syndrome.
No specific serious adverse reaction list is present in the supplied label excerpts.
Trazodone is an antidepressant.
The supplied label excerpts confirm RALDESY is an antidepressant in the context of suicidality boxed warning discussion, but the response claims this as a general property of trazodone; the provided excerpts do not explicitly state 'trazodone is an antidepressant' in a direct label sentence.
Trazodone belongs to the class of serotonin antagonist and reuptake inhibitors (SARIs).
No drug class description is present in the supplied label excerpts.
Trazodone works by affecting levels of serotonin.
No mechanism-of-action/serotonin statements are present in the supplied label excerpts.

Contradictions

Important Omissions

No statements in the provided AI response address RALDESY’s boxed warning or counseling/monitoring about suicidal thoughts and behaviors in pediatric/young adult patients, or the statement that RALDESY is not approved for pediatric use.
Importance: High
No monitoring language is provided (e.g., monitor patients for clinical worsening and emergence of suicidal thoughts/behaviors, especially during initial months and dosage changes).
Importance: Moderate

Safety Assessment

Potential Patient Risk: Medium
The supplied label excerpts contain important boxed-warning and pediatric-use information related to suicidality risk and lack of pediatric approval; the AI response does not include these label-specific warnings/limitations.

Regulatory Assessment

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

Recommendation

Needs Review

Primary Issue
Major omission of FDA label-required boxed warning/pediatric-use information about suicidal thoughts/behaviors and that RALDESY is not approved for pediatric patients.

Suggested Improvement
Include label-accurate boxed warning and pediatric-use statements from the provided excerpts (suicidal thoughts/behaviors risk; monitoring; not approved for pediatric use), and remove or clearly qualify non-label-supported statements not present in the supplied prescribing information excerpts.

Drug Brand Mention Assessment

Branding Score
78
Visibility
84
Mentioned
Ranking
#1
Sentiment
72
Recommendation Status
mentioned only
Brand Perception
Best Known For

Trazodone's primary patents have long expired

Core Claims
  • Trazodone's primary patents have long expired
  • The original patents for trazodone hydrochloride expired many years ago
  • Patent expiry allows generic manufacturers to enter the market
  • Once patents expire, other companies can legally produce and market generic versions
  • Generic versions are generally less expensive due to market competition following patent expiration
Differentiators
  • Brand-name trazodone (like Desyrel) vs generic trazodone differs in manufacturer and cost
  • Both contain the same active ingredient, trazodone hydrochloride
  • Both are required to meet the same strict standards for safety, quality, and effectiveness set by regulatory bodies like the FDA
  • Patent expiration drives increased competition and lower generic costs
Pricing Perception: Mid Range