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Last Updated: December 27, 2024

ETRAFON-A Drug Patent Profile


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When do Etrafon-a patents expire, and what generic alternatives are available?

Etrafon-a is a drug marketed by Schering and is included in one NDA.

The generic ingredient in ETRAFON-A is amitriptyline hydrochloride; perphenazine. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amitriptyline hydrochloride; perphenazine profile page.

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Summary for ETRAFON-A
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:ETRAFON-A at DailyMed
Drug patent expirations by year for ETRAFON-A

US Patents and Regulatory Information for ETRAFON-A

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schering ETRAFON-A amitriptyline hydrochloride; perphenazine TABLET;ORAL 014713-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ETRAFON-A Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Etrafon (Perphenazine/Amitriptyline)

Introduction

Etrafon, a combination of the antipsychotic perphenazine and the tricyclic antidepressant amitriptyline, is used to treat various mental health conditions, including depression, anxiety, and agitation. Understanding the market dynamics and financial trajectory of Etrafon involves examining its usage, side effects, regulatory environment, and the broader pharmaceutical market.

Uses and Indications

Etrafon is indicated for the treatment of patients with moderate to severe anxiety and/or agitation and depressed mood. It is also used for patients with depression associated with chronic physical disease and for schizophrenic patients with symptoms of depression[2].

Market Position and Competition

Etrafon operates in a market segment where both antipsychotic and antidepressant medications are crucial. However, its market position has evolved over time due to several factors:

Generic Competition

The brand name Etrafon is no longer available in the U.S., and generic versions of the combination are now prevalent. This shift to generic products has significantly impacted the pricing and profitability of Etrafon. Generic competition typically drives prices lower, reducing the revenue generated by the original branded product[1][4].

Regulatory Environment

The pharmaceutical industry is heavily regulated, and this affects the market dynamics of drugs like Etrafon. Regulations allow for a period of exclusivity for patented products, which can maintain higher price-cost margins to incentivize innovation. However, once patents expire, generic competition increases, leading to lower prices and reduced profitability[3].

Financial Trajectory

Development and Launch Costs

The development of Etrafon, like other pharmaceuticals, involved significant fixed costs related to research and development. These costs are a major factor in the pricing strategy of pharmaceutical companies. The high costs of bringing a drug to market are often justified by the potential for high returns during the period of patent protection[3].

Pricing Strategies

Pharmaceutical companies often employ differential pricing strategies, especially for drugs targeting small patient populations. For Etrafon, the pricing would have been influenced by its initial market exclusivity and the subsequent entry of generic competitors. As generic versions became available, the price of Etrafon would have decreased, impacting its financial trajectory[3].

Revenue and Profitability

The revenue generated by Etrafon would have peaked during its period of market exclusivity. As generic versions entered the market, revenue would have declined. The profitability of Etrafon is also affected by the costs associated with its production, marketing, and distribution, as well as any legal or regulatory challenges it may face.

Side Effects and Safety Profile

The side effects of Etrafon, including common and serious adverse reactions, can impact its market dynamics. Common side effects such as dizziness, drowsiness, and irregular heart rate, as well as serious side effects like tardive dyskinesia and neuroleptic malignant syndrome, can influence patient and physician preferences. A drug with a significant side effect profile may see reduced usage and revenue over time[1][5].

Long-Term Use and Maintenance

For patients requiring long-term therapy, Etrafon's maintenance dosage is adjusted to the smallest effective dose. This long-term use can contribute to steady, albeit potentially declining, revenue streams. However, the need for ongoing monitoring due to potential side effects can also increase healthcare costs and affect the overall financial trajectory[2].

Endocrine and Hematological Effects

Etrafon's endocrine and hematological effects, such as lactation, galactorrhea, and agranulocytosis, require careful monitoring. These effects can lead to additional healthcare costs and may influence patient compliance and physician prescribing habits, further impacting the drug's market dynamics[1][2].

Drug Interactions

Etrafon interacts with several other medications, including SSRIs and certain heart rhythm medications. These interactions can limit its use in certain patient populations and affect its market share. The need for careful management of these interactions adds complexity to its use and can impact its financial performance[1].

Market Size and Patient Population

Etrafon targets a specific patient population with moderate to severe anxiety and depression. The size of this market and the availability of alternative treatments influence the drug's financial trajectory. As new treatments emerge, the market share of Etrafon may decline, affecting its revenue and profitability[2].

Conclusion

The market dynamics and financial trajectory of Etrafon are influenced by a combination of factors including its indications, side effects, regulatory environment, and competition from generic products. As the pharmaceutical market continues to evolve with new innovations and regulatory changes, the financial performance of drugs like Etrafon will be shaped by these dynamics.

Key Takeaways

  • Market Exclusivity: Etrafon's financial trajectory was significantly impacted by its initial market exclusivity and subsequent generic competition.
  • Side Effects: The drug's side effect profile affects patient compliance and physician prescribing habits.
  • Regulatory Environment: Regulations play a crucial role in determining the pricing and profitability of pharmaceuticals.
  • Long-Term Use: Maintenance dosages contribute to steady revenue streams but require ongoing monitoring.
  • Drug Interactions: Interactions with other medications can limit Etrafon's use and impact its market share.

FAQs

Q: What is Etrafon used for? A: Etrafon is used to treat patients with moderate to severe anxiety and/or agitation and depressed mood, as well as for patients with depression associated with chronic physical disease.

Q: Why is Etrafon no longer available under its brand name in the U.S.? A: The brand name Etrafon is no longer available in the U.S. due to the expiration of its patent, allowing generic versions to enter the market.

Q: What are some common side effects of Etrafon? A: Common side effects include abnormal muscle contractions, neck spasms, dizziness, drowsiness, sedation, and irregular heart rate and rhythm.

Q: How do drug interactions affect the use of Etrafon? A: Etrafon interacts with several medications, including SSRIs and certain heart rhythm medications, which can limit its use in certain patient populations.

Q: What is the impact of generic competition on Etrafon's financial trajectory? A: Generic competition has significantly reduced the price and profitability of Etrafon, as generic products drive prices lower and increase market competition.

Sources

  1. MedicineNet: Side Effects of Etrafon (perphenazine/amitriptyline) - MedicineNet
  2. RxList: Etrafon (Perphenazine and Amitriptyline): Side Effects, Uses ...
  3. NBER: The Economics of Drug Development: Pricing and Innovation in a ...
  4. DrugBank: Perphenazine: Uses, Interactions, Mechanism of Action - DrugBank
  5. Drugs.com: Etrafon Side Effects: Common, Severe, Long Term - Drugs.com

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