NORPRAMIN Drug Patent Profile

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

Norpramin is a drug marketed by Validus Pharms and is included in one NDA.

The generic ingredient in NORPRAMIN is desipramine hydrochloride. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the desipramine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Norpramin

A generic version of NORPRAMIN was approved as desipramine hydrochloride by ACTAVIS TOTOWA on June 5^th, 1987.

Summary for NORPRAMIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	10
Patent Applications:	1,509
Drug Prices:	Drug price information for NORPRAMIN
What excipients (inactive ingredients) are in NORPRAMIN?	NORPRAMIN excipients list
DailyMed Link:	NORPRAMIN at DailyMed

See drug prices for NORPRAMIN

Recent Clinical Trials for NORPRAMIN

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

Sponsor	Phase
Stanford University	Phase 4
Albert Einstein College of Medicine	N/A
National Cancer Institute (NCI)	N/A

See all NORPRAMIN clinical trials

Pharmacology for NORPRAMIN

Drug Class

Tricyclic Antidepressant

US Patents and Regulatory Information for NORPRAMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-007	Feb 11, 1982	AB	RX	Yes	No
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-004	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No

Expired US Patents for NORPRAMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-005	Approved Prior to Jan 1, 1982
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-003	Approved Prior to Jan 1, 1982
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-005	Approved Prior to Jan 1, 1982

International Patents for NORPRAMIN

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

Country	Patent Number	Title	Estimated Expiration
Spain	267641
France	1445454	Nouveaux dérivés d'iminodibenzyle et leur préparation

NORPRAMIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NORPRAMIN

Introduction to NORPRAMIN

NORPRAMIN, also known as desipramine hydrochloride, is a tricyclic antidepressant (TCA) used primarily for the treatment of major depressive disorder (MDD) and other psychiatric conditions. Here, we will delve into the market dynamics and financial trajectory of NORPRAMIN, considering various factors that influence its market position.

Market Size and Growth

The US anti-depressant drugs market, within which NORPRAMIN operates, was valued at $6.9 billion in 2022 and is projected to reach $9.37 billion by 2030, growing at a compound annual growth rate (CAGR) of 3.9%[1].

Segmentation and Market Share

The anti-depressant market is segmented by drug class, indication, route of administration, end-users, and distribution channels. NORPRAMIN falls under the tricyclic antidepressants category, which, although not the largest segment, remains significant due to its established use and efficacy.

• Drug Class: Tricyclic antidepressants like NORPRAMIN are part of a broader market dominated by selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs). However, TCAs still hold a substantial market share due to their long-standing presence and specific clinical advantages[1].

Indications and Usage

NORPRAMIN is primarily indicated for the treatment of major depressive disorder (MDD). The high prevalence of MDD in the US, affecting almost 264 million people globally, drives the demand for antidepressant medications like NORPRAMIN[1].

Market Drivers

Several factors drive the market for NORPRAMIN and other antidepressants:

• Increasing Prevalence of Mental Health Disorders: The rising incidence of depression and other mental health conditions in the US fuels the demand for efficient depression management therapies, including antidepressant medications[1].
• Public Awareness and Availability of Treatments: Growing public awareness of mental health issues and the availability of effective treatments contribute to the market's expansion[1].
• Research and Development: The development of new antidepressants and the extension of pharmaceutical companies' product portfolios are key drivers. Although NORPRAMIN is an established drug, the overall innovation in the field benefits the market as a whole[1].

Market Restraints

Despite the positive trends, there are several restraints that affect the market for NORPRAMIN:

• Generic Competition: The availability of generic antidepressant medications can reduce the revenue for branded drugs like NORPRAMIN, as generics are generally less expensive[1].
• Side Effects and Compliance: Antidepressant side effects such as weight gain, nausea, and dizziness can impact patient compliance and treatment adherence, potentially affecting the market's growth[1].
• Regulatory Standards: Strict regulatory standards for antidepressant drug approval can delay the introduction of new medications and impact the market's expansion[1].

Financial Trajectory

The financial trajectory of NORPRAMIN is influenced by the broader anti-depressant market trends:

• Revenue Impact: As part of the $6.9 billion US anti-depressant market in 2022, NORPRAMIN contributes to the overall revenue. However, its specific revenue share is not isolated but is part of the tricyclic antidepressants segment[1].
• Generic Competition: The presence of generic versions of tricyclic antidepressants can reduce the pricing power and revenue for branded drugs like NORPRAMIN[1].
• Cost and Pricing: The cost of NORPRAMIN, available in various dosages (10 mg to 150 mg), is influenced by the competitive landscape and the availability of generic alternatives. This can affect its pricing strategy and overall revenue[4].

Key Players and Competition

NORPRAMIN operates in a competitive market with several key players:

• Pharmaceutical Companies: Companies like Eli Lilly and Company, Pfizer Inc., and Bristol-Myers Squibb dominate the anti-depressant market. While NORPRAMIN is not a product of these companies, it competes within the same market space[1].

Regulatory and Safety Considerations

The use of NORPRAMIN is subject to several regulatory and safety considerations:

• Suicidality Risk: Antidepressants, including NORPRAMIN, have been associated with an increased risk of suicidal thinking and behavior in children, adolescents, and young adults. This necessitates careful monitoring and risk assessment[2][4].
• Serotonin Syndrome: Concomitant use of NORPRAMIN with other serotonergic agents can increase the risk of serotonin syndrome, requiring careful management and potential discontinuation of treatment[2][4].
• Cardiovascular and Glaucoma Risks: NORPRAMIN can have cardiovascular side effects and may trigger angle-closure glaucoma in susceptible individuals, requiring cautious use and monitoring[2][4].

Conclusion

NORPRAMIN, as a tricyclic antidepressant, operates within a dynamic market driven by the increasing prevalence of mental health disorders, public awareness, and advancements in pharmaceutical research. However, it faces challenges from generic competition, side effects, and stringent regulatory standards. Understanding these market dynamics is crucial for navigating the financial trajectory of NORPRAMIN and other antidepressant medications.

Key Takeaways

• The US anti-depressant market is projected to grow from $6.9 billion in 2022 to $9.37 billion by 2030.
• NORPRAMIN is part of the tricyclic antidepressants segment, which, though smaller, remains significant.
• Increasing mental health awareness and the prevalence of depression drive the market.
• Generic competition and side effects are key restraints.
• Regulatory standards and safety considerations are critical for the use of NORPRAMIN.

FAQs

1. What is the primary indication for NORPRAMIN? NORPRAMIN is primarily indicated for the treatment of major depressive disorder (MDD)[2][4].

2. How does the presence of generic antidepressants affect NORPRAMIN's market? The availability of generic antidepressants can reduce the revenue for branded drugs like NORPRAMIN due to their lower cost[1].

3. What are the potential side effects of NORPRAMIN that could impact its market? Side effects such as weight gain, nausea, dizziness, and the risk of suicidality in certain age groups can affect patient compliance and treatment adherence[2][4].

4. How does regulatory scrutiny impact the market for NORPRAMIN? Strict regulatory standards can delay the approval and introduction of new antidepressant medications, affecting the market's expansion and potentially impacting NORPRAMIN's sales[1].

5. What is the significance of SSRIs in the anti-depressant market compared to TCAs like NORPRAMIN? SSRIs hold the largest market share due to their clinical advantages and strong pipeline of new candidates, while TCAs like NORPRAMIN maintain a significant presence due to their established use and efficacy[1].