ETRAFON 2-25 Drug Patent Profile

Which patents cover Etrafon 2-25, and when can generic versions of Etrafon 2-25 launch?

Etrafon 2-25 is a drug marketed by Schering and is included in one NDA.

The generic ingredient in ETRAFON 2-25 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.

Summary for ETRAFON 2-25

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4
DailyMed Link:	ETRAFON 2-25 at DailyMed

US Patents and Regulatory Information for ETRAFON 2-25

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	ETRAFON 2-25	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014713-004	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for ETRAFON 2-25

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	ETRAFON 2-25	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014713-004	Approved Prior to Jan 1, 1982

ETRAFON 2-25: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

ETRAFON 2-25, a fixed-dose combination of amitriptyline and perphenazine, demonstrates a mature market position characterized by established patient use and a consistent, albeit declining, revenue stream. Its primary utility lies in treating moderate to severe depression and anxiety, often where other treatments have proven insufficient. The drug's long history in the market, coupled with its generic availability, significantly influences its current financial trajectory.

What is ETRAFON 2-25's Current Market Standing?

ETRAFON 2-25 is a prescription medication approved for the treatment of moderate to severe depression and anxiety. It combines an antidepressant, amitriptyline, with an antipsychotic, perphenazine, to target a broader spectrum of symptoms associated with these conditions.

Key Market Characteristics:

• Indication: Moderate to severe depression and anxiety.
• Mechanism: Amitriptyline is a tricyclic antidepressant (TCA) that inhibits the reuptake of serotonin and norepinephrine. Perphenazine is a phenothiazine antipsychotic that blocks dopamine receptors in the brain.
• Formulation: Fixed-dose combination tablet. The "2-25" designation refers to 2 mg of perphenazine and 25 mg of amitriptyline per tablet.
• Therapeutic Use: Prescribed when symptoms are severe or when a combination of antidepressant and antipsychotic effects is deemed beneficial. It is often considered for patients who have not responded adequately to single-agent therapies.
• Market Age: ETRAFON has been available for several decades, leading to a well-established clinical profile and significant physician familiarity.
• Competitive Landscape: The market for antidepressants and antipsychotics is highly competitive, with a vast array of newer agents, including selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and atypical antipsychotics, offering different efficacy and side effect profiles.

What is the Financial Trajectory of ETRAFON 2-25?

The financial trajectory of ETRAFON 2-25 is characterized by a stable but declining revenue, primarily due to its status as a mature drug facing significant generic competition and evolving therapeutic guidelines.

Revenue and Sales Performance:

• Historical Sales: While precise, up-to-the-minute global sales figures for ETRAFON 2-25 are often aggregated within broader categories by market research firms and are not always publicly disclosed by individual manufacturers due to its generic status. However, industry reports from the early 2010s indicated annual sales in the tens of millions of dollars range in key markets like the United States.
• Current Trend: Sales are demonstrably declining. This is a direct consequence of:
  • Generic Competition: The availability of generic versions of both amitriptyline and perphenazine, and potentially generic fixed-dose combinations, significantly reduces the price point and market share of branded ETRAFON.
  • Therapeutic Evolution: Newer drug classes, such as SSRIs and SNRIs, are generally preferred as first-line treatments for depression and anxiety due to their more favorable side effect profiles and perceived safety. TCAs like amitriptyline are often relegated to second or third-line therapy.
  • Limited New Prescriptions: Physicians are less likely to initiate treatment with older drugs like ETRAFON 2-25 for new patients, favoring more contemporary options.
• Market Share: ETRAFON 2-25's market share has diminished considerably over the past two decades. Its current prescription volume is primarily driven by patients who have been on the medication for an extended period and have achieved therapeutic benefit, demonstrating stability on the regimen.

Pricing and Reimbursement:

• Pricing: The pricing of ETRAFON 2-25 is dictated by generic market dynamics. Branded ETRAFON, if still actively marketed by its original manufacturer, will be priced higher than its generic equivalents. However, the price differential is often marginal compared to newer specialty drugs. Generic versions are sold at significantly lower price points, reflecting intense competition and a focus on cost-effectiveness.
• Reimbursement: Reimbursement for ETRAFON 2-25 is generally favorable within its approved indications, as it is an established therapy. However, payers, particularly in the United States, are increasingly scrutinizing the use of older drug classes and may encourage or mandate the use of generics or preferred first-line agents through formulary management and step-therapy protocols. For patients with high-deductible health plans, the out-of-pocket cost for generic ETRAFON 2-25 is typically low.

What are the Key Factors Influencing ETRAFON 2-25's Future Market Performance?

The future market performance of ETRAFON 2-25 will be shaped by its established patient base, its niche therapeutic role, and the persistent pressure from newer pharmacotherapies.

Demand Drivers:

• Established Patient Population: The primary driver of current and near-term demand is the existing patient base that has found efficacy and tolerability with ETRAFON 2-25. These patients are unlikely to switch unless significant adverse events occur or cost becomes prohibitive.
• Treatment-Resistant Cases: In specific cases of treatment-resistant depression or anxiety, where a combination of antidepressant and antipsychotic effects is required and other options have failed, ETRAFON 2-25 may continue to be prescribed.
• Cost-Effectiveness for Certain Payers: For healthcare systems or insurance plans prioritizing cost containment, generic ETRAFON 2-25 offers a low-cost solution for patients who require its specific therapeutic profile.

Market Constraints:

• Competition from Novel Therapies: The continuous development of novel antidepressants and antipsychotics with improved efficacy, reduced side effects, and novel mechanisms of action poses the most significant threat. These newer agents are often favored for new patient initiations.
• Adverse Event Profile: TCAs like amitriptyline are associated with a higher incidence of anticholinergic side effects (dry mouth, constipation, blurred vision, urinary retention), cardiovascular effects (orthostatic hypotension, arrhythmias), and sedation compared to SSRIs. Perphenazine can cause extrapyramidal symptoms (EPS), tardive dyskinesia, and metabolic changes. These profiles limit its use in broader populations, especially those with comorbidities.
• Physician Prescribing Habits: The shift in physician training and prescribing habits toward newer drug classes means that familiarity and comfort with ETRAFON 2-25 are declining among younger practitioners.
• Regulatory Scrutiny: While not currently a primary concern for ETRAFON 2-25, older drug classes are subject to ongoing safety reviews. Any new safety signals could further impact its market viability.

Potential Future Scenarios:

• Continued Niche Use: The drug will likely maintain a stable but low-volume presence, serving a select group of patients. Revenue will be driven by generic sales, with manufacturers focusing on efficient production rather than market expansion.
• Market Exclusivity Erosion: For any remaining branded ETRAFON products, patent expiries (if not already expired) and the dominance of generic versions will continue to suppress pricing power and revenue potential.
• Product Withdrawal: Manufacturers may eventually choose to discontinue production if the declining sales volumes render it economically unviable to maintain manufacturing and distribution, particularly if dedicated production lines are required. This is a long-term possibility rather than an immediate threat.

What is the Patent Landscape for ETRAFON 2-25?

The patent landscape for ETRAFON 2-25 is largely characterized by expired patents, making it a fully genericized product in most major markets.

Key Patent Information:

• Original Patents: The original patents for the combination of amitriptyline and perphenazine, and for the individual active pharmaceutical ingredients, were filed and granted many decades ago. These patents have long since expired.
• Exclusivity Periods: Due to the age of the drug, all forms of market exclusivity based on original patent protections have concluded.
• Evergreening Attempts: While pharmaceutical companies historically pursued "evergreening" strategies (e.g., new formulations, delivery methods, combination therapies), any significant attempts related to ETRAFON 2-25 are unlikely to have extended its commercially relevant patent life in the current market. The focus for such strategies is typically on newer, more profitable drug classes.
• Current Patent Status: There are no active composition-of-matter patents covering ETRAFON 2-25 that would prevent generic manufacturers from producing and marketing it. Patents related to manufacturing processes may exist, but these are generally of limited impact in preventing generic entry once the primary composition patents have expired.
• Generic Market Entry: The absence of active patent protection has facilitated robust generic competition. Multiple manufacturers produce and market generic versions of ETRAFON 2-25, contributing to its low price point.

Conclusion:

ETRAFON 2-25 occupies a mature, declining segment of the pharmaceutical market. Its financial trajectory is a function of its established but shrinking patient base, intense generic competition, and the availability of newer, preferred therapeutic alternatives. While it will likely persist in niche applications, significant revenue growth is not anticipated. Manufacturers and investors should consider its position as a legacy product with limited future upside potential, primarily deriving revenue from cost-effective generic manufacturing.

Key Takeaways

• ETRAFON 2-25 is a long-established drug for moderate to severe depression and anxiety, combining amitriptyline and perphenazine.
• Its market is characterized by a stable but declining revenue stream, driven by generic competition and the availability of newer drug classes.
• The drug’s primary demand stems from its existing patient population and niche use in treatment-resistant cases.
• Adverse event profiles of its constituent drugs limit its broad application compared to newer therapies.
• All primary composition-of-matter patents have expired, leading to a fully genericized market.
• Future financial performance is expected to remain subdued, with revenue generated by cost-efficient generic production.

Frequently Asked Questions

1. What are the primary side effects of ETRAFON 2-25 that limit its use? The primary side effects include anticholinergic effects from amitriptyline (dry mouth, blurred vision, constipation) and potential extrapyramidal symptoms from perphenazine (tremors, muscle stiffness). Cardiovascular effects from amitriptyline are also a concern.
2. Can ETRAFON 2-25 be used for mild depression or anxiety? ETRAFON 2-25 is generally not indicated or recommended for mild cases of depression or anxiety due to its potent combination of active ingredients and potential side effects, which are often disproportionate to the severity of the condition.
3. Are there any upcoming patent expirations relevant to ETRAFON 2-25? As ETRAFON 2-25 is a combination of generic medications whose original patents expired decades ago, there are no upcoming patent expirations that would impact its generic status or market competition.
4. What are the typical alternatives to ETRAFON 2-25 for patients who cannot tolerate it? Alternatives depend on the specific symptoms and patient profile but often include SSRIs (e.g., fluoxetine, sertraline), SNRIs (e.g., venlafaxine, duloxetine), or other antipsychotics if augmentation is needed. The choice is guided by individual patient response and tolerability.
5. Is ETRAFON 2-25 still manufactured and available in major markets? Yes, ETRAFON 2-25, primarily in its generic forms, is still manufactured and available in major markets, including the United States and Europe, by multiple pharmaceutical companies.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Drug Approval Packages. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/ (Note: Specific approval dates for ETRAFON 2-25 would be found by searching the FDA's database for the drug's NDA/ANDA numbers, which are specific to the product's manufacturer.) [2] National Library of Medicine. (n.d.). DailyMed. Retrieved from https://dailymed.nlm.nih.gov/dailymed/ (Note: Drug labels and prescribing information for ETRAFON 2-25 and its generic equivalents are available via this resource.) [3] IMS Health. (various years). Market Insights Reports. (Note: Specific proprietary market data from IMS Health and similar market research firms is typically licensed and not publicly available. These reports track prescription volumes, sales, and market share for pharmaceuticals.) [4] European Medicines Agency. (n.d.). Medicines Information. Retrieved from https://www.ema.europa.eu/en/medicines (Note: Information on authorized medicines in the EU can be accessed via the EMA website.)