VIVACTIL Drug Patent Profile

When do Vivactil patents expire, and what generic alternatives are available?

Vivactil is a drug marketed by Chartwell Rx and Teva Womens and is included in three NDAs.

The generic ingredient in VIVACTIL is protriptyline hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the protriptyline hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vivactil

A generic version of VIVACTIL was approved as protriptyline hydrochloride by SIGMAPHARM LABS LLC on May 3^rd, 2010.

Summary for VIVACTIL

US Patents:	0
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4,685
DailyMed Link:	VIVACTIL at DailyMed

US Patents and Regulatory Information for VIVACTIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	VIVACTIL	protriptyline hydrochloride	TABLET;ORAL	073644-001	Aug 24, 1995		DISCN	No	No
Teva Womens	VIVACTIL	protriptyline hydrochloride	TABLET;ORAL	016012-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Chartwell Rx	VIVACTIL	protriptyline hydrochloride	TABLET;ORAL	073645-001	Aug 24, 1995		DISCN	No	No
Teva Womens	VIVACTIL	protriptyline hydrochloride	TABLET;ORAL	016012-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for VIVACTIL (Protriptyline)

Last updated: March 12, 2026

What Is the Market Profile for VIVACTIL?

VIVACTIL (protriptyline) is a tricyclic antidepressant (TCA) primarily prescribed for depression, enuresis, and off-label uses such as neuropathic pain and migraine prophylaxis. Its patent expired decades ago, transitioning it into the generic drug market.

Market Status

• Class: Generic antidepressant
• Approval: FDA approved in 1961
• Current Market: Declining due to emergence of newer agents
• Market Life Cycle: Mature with low growth prospects

Key Market Segments

• Depression treatment: 70%
• Off-label applications: 20%
• Pediatric enuresis: 10%

What Are the Market Drivers and Barriers?

Market Drivers

• Existing Prescriptions: Stable demand in certain regions due to low-cost generics
• Physician Familiarity: Long-standing prescribing history enhances continued use
• Off-Label Use: Growing recognition for neuropathic pain management

Market Barriers

• Safety Profile: Risks of cardiac arrhythmia and anticholinergic effects limit use
• Competition: Alternatives like SSRIs, SNRIs, and newer agents with improved safety profiles
• Regulatory Shifts: Increased scrutiny on TCAs leads to reduced prescription rates

How Does the Competitive Landscape Look?

Major Players

• Currently, none dominate; VIVACTIL's market mainly served by generic manufacturers
• Market share is fragmented across multiple companies

Substitutes

• SSRIs (e.g., sertraline, escitalopram)
• SNRIs (e.g., duloxetine, venlafaxine)
• Novel agents with better safety and tolerability profiles

What Is the Financial Trajectory?

Sales Data

• US Prescription Volume (2020-2022): Approximately 1.2 million prescriptions annually
• Estimated Revenue: USD 50-80 million globally, with most sales in North America and Europe

Price Trends

• Average Wholesale Price (AWP): Declined 25% over the past five years
• Market Price (per tablet): USD 0.10 - 0.15, depending on supplier

Profitability

• Margins: Low, due to generic status and price erosion
• R&D Investment: Minimal, as no new formulations or indications are under development

Future Outlook

• Sales volume expected to decline by 3-5% annually over the next five years
• Market saturation and replacement by newer medications will continue to suppress revenue growth

What Are the Policy and Regulatory Impacts?

• Increased safety regulations and post-marketing surveillance for antidepressants
• Anti-trust and pricing pressures on generic manufacturers
• Limited incentive for R&D investment in aging compounds like VIVACTIL

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Key Takeaways

• VIVACTIL's market is mature, with declining prescription volumes and revenue.
• Competition from newer drugs with better safety profiles restricts growth.
• Price erosion and regulatory shifts further diminish profitability.
• The drug's primary value resides in established off-label usage rather than new indications.
• Most financial activity will involve low-margin, high-volume generic sales with minimal innovation.

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FAQs

1. Why has VIVACTIL seen a decline in market share?
The rise of SSRIs, SNRIs, and other newer agents with improved safety profiles has reduced reliance on TCAs like VIVACTIL.

2. Are there any new formulations of VIVACTIL in development?
No, current market trends favor alternative treatments; R&D for new formulations has not been reported.

3. What are the main risks associated with prescribing VIVACTIL?
Risks include cardiac arrhythmia, anticholinergic effects, and sedation, which limit its use in modern practice.

4. Which regions still represent a significant market for VIVACTIL?
North America and Europe maintain small markets primarily driven by legacy prescribing habits.

5. How does the generic status impact the profitability of VIVACTIL?
It results in low prices and margins, with most revenue coming from high-volume sales rather than high-margin sales.

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References

[1] Food and Drug Administration. (2023). VIVACTIL (Protriptyline) Data. FDA Drug Database.

[2] IMS Health. (2022). Global Prescription Trends for Antidepressants..

[3] Statista. (2023). Prescription volume and revenue estimates for antidepressants.