Protriptyline hydrochloride - Generic Drug Details

What are the generic drug sources for protriptyline hydrochloride and what is the scope of patent protection?

Protriptyline hydrochloride is the generic ingredient in two branded drugs marketed by Epic Pharma Llc, Hikma, Sigmapharm Labs Llc, Chartwell Rx, and Teva Womens, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for protriptyline hydrochloride. Three suppliers are listed for this compound.

Summary for protriptyline hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	6
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	2
Patent Applications:	1,125
What excipients (inactive ingredients) are in protriptyline hydrochloride?	protriptyline hydrochloride excipients list
DailyMed Link:	protriptyline hydrochloride at DailyMed

Recent Clinical Trials for protriptyline hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Roxane Laboratories	N/A

See all protriptyline hydrochloride clinical trials

Pharmacology for protriptyline hydrochloride

Drug Class

Tricyclic Antidepressant

Medical Subject Heading (MeSH) Categories for protriptyline hydrochloride

Adrenergic Uptake Inhibitors

Antidepressive Agents, Tricyclic

Anatomical Therapeutic Chemical (ATC) Classes for protriptyline hydrochloride

N06AA	Non-selective monoamine reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for protriptyline hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	PROTRIPTYLINE HYDROCHLORIDE	protriptyline hydrochloride	TABLET;ORAL	078913-002	Sep 16, 2008	AB	RX	No	Yes
Sigmapharm Labs Llc	PROTRIPTYLINE HYDROCHLORIDE	protriptyline hydrochloride	TABLET;ORAL	090462-001	May 3, 2010	AB	RX	No	No
Epic Pharma Llc	PROTRIPTYLINE HYDROCHLORIDE	protriptyline hydrochloride	TABLET;ORAL	202220-001	Nov 19, 2012	AB	RX	No	No
Chartwell Rx	VIVACTIL	protriptyline hydrochloride	TABLET;ORAL	073644-001	Aug 24, 1995		DISCN	No	No
Teva Womens	VIVACTIL	protriptyline hydrochloride	TABLET;ORAL	016012-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Protriptyline hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Protriptyline Hydrochloride

Introduction

Protriptyline hydrochloride, a tricyclic antidepressant (TCA) sold under brand names such as Vivactil, has been a part of the psychiatric treatment landscape for several decades. This article delves into the market dynamics and financial trajectory of this drug, exploring its usage, pricing, and the factors influencing its market presence.

Medical Uses and Indications

Protriptyline hydrochloride is primarily used to treat depression and the combination of symptoms of anxiety and depression. It is also utilized in treating various other conditions, including panic disorder, obsessive-compulsive disorder, attention-deficit/hyperactivity disorder, and the depressive phase of bipolar disorder[1][4].

Market Availability

The availability of protriptyline hydrochloride has seen significant changes over the years. As of 2024, it remains available only in the United States, having been discontinued in the United Kingdom, Australia, and Ireland in 2000[1].

Pricing and Cost-Effectiveness

The pricing of protriptyline hydrochloride is influenced by several factors, including the presence of generic alternatives and the regulatory environment. Generic versions of the drug are available, which generally reduces the cost for patients. For instance, the cost of a 10 mg tablet can vary between different manufacturers but is generally more affordable than many other antidepressants[4].

Impact of Generic Alternatives

The introduction of generic versions of protriptyline hydrochloride has significantly impacted its market dynamics. Generic drugs typically offer lower prices, making the medication more accessible to a wider population. This shift has also influenced the revenue streams for both the original brand and generic manufacturers. Studies have shown that the presence of authorized generics can lower retail prices by 4-8% and wholesale prices by 7-14% compared to periods without such competition[3].

Health Insurance Coverage and Transparency

The Affordable Care Act (ACA) has played a crucial role in ensuring that antidepressants, including protriptyline hydrochloride, are covered under essential health benefits. However, the transparency and cost-sharing requirements for these medications can vary significantly across different health insurance plans. A study analyzing marketplace plans in five states found that while antidepressants are generally covered, the out-of-pocket costs and transparency of coverage can be inconsistent, affecting patient access and financial burden[2].

Pharmacokinetics and Dosage

Protriptyline hydrochloride has a unique pharmacokinetic profile, characterized by high bioavailability (77–93%) and a long elimination half-life (54–92 hours). This allows for relatively low dosing, typically ranging from 15 to 40 mg per day, which can be taken in one or divided doses. The therapeutic levels of the drug are similar to those of other TCAs, but its dosing is notably lower[1].

Financial Trajectory

Revenue Impact

The financial trajectory of protriptyline hydrochloride is influenced by its market availability, competition from generics, and changes in healthcare policies. The presence of authorized generics has reduced the revenues of the first-filer generic manufacturers by 40-52% during the 180-day exclusivity period and continues to impact revenues even after this period[3].

Market Share

Given its limited availability and the dominance of newer antidepressant classes, the market share of protriptyline hydrochloride has declined over the years. However, it remains a viable option for certain patients, particularly those who have not responded well to other treatments.

Regulatory Environment

The regulatory environment plays a critical role in the market dynamics of protriptyline hydrochloride. Changes in healthcare policies, such as those under the ACA, have ensured that antidepressants are covered under essential health benefits, but the specifics of coverage and cost-sharing can vary by state and insurance plan[2].

Consumer Impact

For consumers, the availability and pricing of protriptyline hydrochloride are crucial factors. The drug's relatively low dosing and the presence of generic alternatives make it a cost-effective option for many patients. However, the variability in out-of-pocket costs and transparency issues in health insurance plans can create challenges for patients seeking consistent and affordable access to this medication.

Industry Perspectives

Industry experts highlight the importance of transparency and consistent coverage in ensuring that patients have access to necessary medications. For example:

"The ACA requires health plans in the individual and small-group markets to cover 10 essential health benefits, including prescription drugs and mental health services. However, the transparency and cost-sharing requirements can vary significantly across different plans, affecting patient access and financial burden"[2].

Future Outlook

The future outlook for protriptyline hydrochloride is marked by continued competition from newer antidepressant classes and the ongoing impact of generic alternatives. While it remains a treatment option, its market share is likely to remain limited due to these factors.

Key Takeaways

• Limited Availability: Protriptyline hydrochloride is currently available only in the United States.
• Generic Competition: The presence of generic alternatives significantly reduces the cost and impacts the revenue of brand and generic manufacturers.
• Health Insurance Coverage: The ACA ensures coverage of antidepressants, but transparency and cost-sharing vary across plans.
• Pharmacokinetics: The drug has a unique pharmacokinetic profile with high bioavailability and a long elimination half-life.
• Financial Trajectory: Revenue is impacted by generic competition and regulatory changes.

FAQs

What is the primary use of protriptyline hydrochloride?

Protriptyline hydrochloride is primarily used to treat depression and the combination of symptoms of anxiety and depression.

Why is protriptyline hydrochloride not available in some countries?

Protriptyline hydrochloride was discontinued in the United Kingdom, Australia, and Ireland in 2000, but it remains available in the United States.

How does the presence of generic alternatives affect the pricing of protriptyline hydrochloride?

The presence of generic alternatives lowers the retail and wholesale prices of protriptyline hydrochloride, making it more cost-effective for patients.

What is the impact of the ACA on the coverage of protriptyline hydrochloride?

The ACA ensures that antidepressants, including protriptyline hydrochloride, are covered under essential health benefits, but the specifics of coverage and cost-sharing can vary by state and insurance plan.

What are the unique pharmacokinetic features of protriptyline hydrochloride?

Protriptyline hydrochloride has high bioavailability (77–93%) and a long elimination half-life (54–92 hours), allowing for relatively low dosing.

Sources

1. Wikipedia: Protriptyline
2. Urban Institute: Marketplace Antidepressant Coverage and Transparency
3. Federal Trade Commission: Authorized Generic Drugs: Short-Term Effects and Long-Term Impact
4. DrugBank: Protriptyline: Uses, Interactions, Mechanism of Action