AVENTYL Drug Patent Profile

Which patents cover Aventyl, and when can generic versions of Aventyl launch?

Aventyl is a drug marketed by Ranbaxy and Lilly and is included in two NDAs.

The generic ingredient in AVENTYL is nortriptyline hydrochloride. There are twelve drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the nortriptyline hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aventyl

A generic version of AVENTYL was approved as nortriptyline hydrochloride by DR REDDYS LABS SA on March 30^th, 1992.

Summary for AVENTYL

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	1
Patent Applications:	4,152
DailyMed Link:	AVENTYL at DailyMed

Recent Clinical Trials for AVENTYL

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

Sponsor	Phase
Central Michigan University	N/A
Sheppard Pratt Health System	N/A

See all AVENTYL clinical trials

US Patents and Regulatory Information for AVENTYL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ranbaxy	AVENTYL	nortriptyline hydrochloride	SOLUTION;ORAL	014685-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Lilly	AVENTYL HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	014684-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lilly	AVENTYL HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	014684-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for AVENTYL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ranbaxy	AVENTYL	nortriptyline hydrochloride	SOLUTION;ORAL	014685-001	Approved Prior to Jan 1, 1982	3,922,305

International Patents for AVENTYL

See the table below for patents covering AVENTYL around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	1468341
France	4407
Belgium	650988
Sweden	331992
Switzerland	494730	Verfahren zur Herstellung von Dibenzocyclopentenen (Dibenzo cycloheptenes)

AVENTYL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nortriptyline (Aventyl)

Introduction

Nortriptyline, marketed under the brand name Aventyl among others, is a tricyclic antidepressant (TCA) widely used in the treatment of major depression and other psychiatric disorders. This article delves into the market dynamics and financial trajectory of nortriptyline, exploring its usage, side effects, market trends, and financial projections.

Clinical Use and Indications

Nortriptyline is primarily used to treat major depression but also has off-label uses for conditions such as neuropathic pain, attention deficit hyperactivity disorder (ADHD), smoking cessation, and anxiety[1][4].

Side Effects and Safety Profile

Common side effects include dry mouth, constipation, blurry vision, sleepiness, low blood pressure with standing, and weakness. Serious side effects may include seizures, increased risk of suicide in those under 25 years old, urinary retention, glaucoma, mania, and various heart issues[1][2].

Market Presence and Prescription Trends

In 2022, nortriptyline was the 191st most commonly prescribed medication in the United States, with over 2 million prescriptions. This indicates a significant market presence despite being a second-generation TCA[1].

Brand Names and Generic Availability

Nortriptyline is marketed under several brand names, including Aventyl, Sensoval, Pamelor, Norpress, Allegron, Noritren, and Nortrilen. The availability of generic versions has impacted the market dynamics, making the drug more accessible but also affecting the revenue of branded versions[4].

Financial Trajectory

Historical Spending

Pharmaceutical expenditures in the US have seen significant growth in recent years. In 2021, overall pharmaceutical expenditures grew by 7.7% compared to 2020, reaching a total of $576.9 billion. This trend is expected to continue, with projections indicating a 4.0% to 6.0% increase in overall prescription drug spending for 2022[3].

Sector-Specific Growth

In clinics and hospitals, pharmaceutical expenditures are anticipated to rise by 7.0% to 9.0% and 3.0% to 5.0%, respectively, in 2022 compared to 2021. This growth is driven by new drug approvals, increased utilization, and the ongoing impact of the COVID-19 pandemic[3].

Impact of Generic and Specialty Drugs

The market for nortriptyline is influenced by the presence of generic versions, which reduce the cost and increase accessibility. However, the overall pharmaceutical market is also driven by specialty and cancer drugs, which tend to be more expensive and contribute significantly to expenditure growth[3].

Market Dynamics

Competition and Alternatives

Nortriptyline competes with other antidepressants, including selective serotonin reuptake inhibitors (SSRIs) like escitalopram. Studies have compared the efficacy of nortriptyline with SSRIs, showing different effects on mood, cognitive, and neurovegetative symptoms of depression[5].

Regulatory Environment

The use of nortriptyline is regulated by health authorities such as the FDA, which has approved it for the treatment of major depression. Regulatory changes and new policies can influence the market dynamics and financial trajectory of the drug[1].

Patient and Prescriber Preferences

Patient preferences and prescriber habits play a crucial role in the market dynamics of nortriptyline. The drug's side effect profile and efficacy can influence prescriber decisions, especially in light of newer antidepressants with potentially better safety profiles[2].

Economic Factors

Cost and Accessibility

The cost of nortriptyline, particularly the availability of generic versions, affects its market share. Generic drugs are generally more affordable, making nortriptyline accessible to a broader patient population[4].

Reimbursement Policies

Reimbursement policies by insurance providers can significantly impact the financial trajectory of nortriptyline. Changes in reimbursement rates or coverage can influence prescription rates and overall market performance[3].

Future Projections

Growth in Prescription Drug Spending

Given the projected increase in overall prescription drug spending, nortriptyline is likely to see continued demand. However, the growth rate may be influenced by the introduction of new antidepressants and changes in treatment guidelines[3].

Impact of New Drugs and Technologies

New drug approvals and advancements in psychiatric treatment could alter the market dynamics for nortriptyline. The evolution of the COVID-19 pandemic and its impact on mental health services will also play a role in shaping the future market[3].

Key Takeaways

• Market Presence: Nortriptyline is a widely prescribed medication, ranking 191st in the US in 2022.
• Financial Growth: Pharmaceutical expenditures, including those for nortriptyline, are expected to rise by 4.0% to 6.0% in 2022.
• Competition: Nortriptyline competes with other antidepressants, including SSRIs.
• Regulatory Environment: FDA approval and regulatory changes influence its market dynamics.
• Patient and Prescriber Preferences: Side effects and efficacy impact prescriber decisions.
• Economic Factors: Cost, accessibility, and reimbursement policies are crucial.

FAQs

What is nortriptyline used for?

Nortriptyline is primarily used to treat major depression but also has off-label uses for conditions such as neuropathic pain, ADHD, smoking cessation, and anxiety[1][4].

What are the common side effects of nortriptyline?

Common side effects include dry mouth, constipation, blurry vision, sleepiness, low blood pressure with standing, and weakness[1][2].

How does nortriptyline compare to other antidepressants?

Nortriptyline has been compared to SSRIs like escitalopram, showing different effects on mood, cognitive, and neurovegetative symptoms of depression[5].

Is nortriptyline safe during pregnancy?

Nortriptyline may cause problems if taken during pregnancy, but its use during breastfeeding appears to be relatively safe[1].

What is the projected growth in prescription drug spending for 2022?

Overall prescription drug spending is expected to rise by 4.0% to 6.0% in 2022, with higher increases anticipated in clinics and hospitals[3].

Sources

1. Wikipedia: Nortriptyline
2. Mayo Clinic: Nortriptyline (oral route)
3. PubMed: National trends in prescription drug expenditures and projections for 2022
4. Inxight Drugs: Nortriptyline Hydrochloride
5. Cambridge University Press: Differential efficacy of escitalopram and nortriptyline on dimensional measures of depression