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. Nine 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:	78
Clinical Trials:	10
Patent Applications:	1,816
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
National Cancer Institute (NCI)	N/A
Albert Einstein College of Medicine of Yeshiva University	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
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-006	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-005	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes

Expired US Patents for NORPRAMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-004	Approved Prior to Jan 1, 1982
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-006	Approved Prior to Jan 1, 1982
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-007	Feb 11, 1982
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-004	Approved Prior to Jan 1, 1982
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	014399-001	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

Market Dynamics and Financial Trajectory for NORPRAMIN (Amoxetine)

Last updated: July 30, 2025

Introduction

NORPRAMIN, primarily known as a branding for amoxetine, is an off-market or lesser-known antidepressant with a complex market trajectory. While its primary association is with ADHD treatment under various brand names, it has historically been involved in the psychiatric therapeutic landscape. In this analysis, we explore its current market dynamics, evolving demand factors, regulatory influences, and future financial outlook.

Pharmacological Profile and Therapeutic Use

Amoxetine, a selective serotonin reuptake inhibitor (SSRI), is used chiefly for treating Attention Deficit Hyperactivity Disorder (ADHD). Its pharmacodynamics include moderation of synaptic serotonin levels, addressing neurochemical imbalances linked to ADHD and certain depressive disorders (1). Despite its efficacy, NORPRAMIN's market penetration has been overshadowed by more prominent agents like methylphenidate, atomoxetine, and other SSRIs.

Market Dynamics

1. Competitive Landscape

The ADHD treatment market is highly competitive, dominated by established pharmaceuticals such as methylphenidate-based products (e.g., Ritalin) and atomoxetine (Strattera). These medications benefit from extensive clinical data, broad physician familiarity, and aggressive marketing campaigns. NORPRAMIN's relative obscurity stems from limited marketing and patent constraints, constraining its market share.

Furthermore, newer agents, including cognitive-behavioral interventions and non-stimulant drugs, are gaining prominence due to concerns about stimulant misuse and side effects associated with older therapies (2). Consequently, NORPRAMIN faces structural headwinds in capturing significant market share.

2. Regulatory Environment

Regulatory agencies, notably the U.S. Food and Drug Administration (FDA), prioritize drugs with extensive safety and efficacy data. Since NORPRAMIN is less marketed, it often lacks recent rigorous approval updates or label expansions. However, shifts towards recognizing the importance of personalized medicine dictate that older drugs can regain relevance if supported by new evidence.

Any regulatory changes facilitating off-label use or combination therapy could influence the product's market dynamics, especially in indications like depression or treatment-resistant ADHD.

3. Market Drivers

• Demand for Non-Stimulant ADHD Medications: Growing awareness around the side effects of stimulant medications increases interest in non-stimulant options, presenting potential growth avenues for NORPRAMIN if appropriately positioned.
• Off-Label and Adjunct Use: Physicians sometimes prescribe older antidepressants as adjuncts for ADHD or comorbid conditions, which could lift demand marginally.
• Pricing and Reimbursement: As generic amoxetine becomes more affordable, insurance reimbursement rates might influence prescribing behavior in favor of cheaper off-brand alternatives to newer, branded therapies.

4. Challenges and Limitations

• Limited Marketing and Awareness: Lack of active promotion hampers visibility among clinicians and consumers.
• Market Entrenchment: Established competitors’ entrenched market presence creates significant barriers to entry.
• Patent Status and Generic Competition: Patent expiry facilitates generic entry, which can erode margins and diminish the incentive to invest in marketing.

Financial Trajectory

1. Historical Context

Historically, NORPRAMIN experienced modest sales figures compared to flagship ADHD medications. Its generic status and limited marketing fundaments account for a relatively flat revenue profile.

2. Current Sales Trends

In the absence of recent blockbuster approvals, sales are primarily driven by existing prescriptions, often for off-label indications. Sales statistics from databases such as IQVIA suggest that niche market shares for amoxetine products remain minimal but stable, reflecting cautious physician-prescribing patterns.

3. Future Outlook and Revenue Forecast

• Short-term (1-3 years):
  Given the current trajectory, revenues are expected to remain stable or decline slightly primarily due to generic erosion. Without significant new indications or marketing strategies, growth prospects are limited.

• Medium to Long-term (3-10 years):
  Several factors could influence upward trajectory:

  • Potential Label Expansion: Approvals for additional indications could diversify revenue streams.
  • Generic Market Saturation: Price competition will likely dampen profit margins.
  • Emerging Therapies: Competition from novel agents (e.g., digital therapeutics) may further constrain market share.

The most probable financial scenario involves a plateau or gradual decline until a potential niche repositioning or lifecycle extension through reformulation or combination therapies.

Key Market Volatility Factors

• Regulatory Changes: Accelerated approval pathways or new indications could temporarily boost revenues.
• Market Penetration Strategies: Focused marketing or educational campaigns might expand usage.
• Emerging Competitors: Innovative treatments and biosimilars could threaten existing positions.
• Ecosystem Trends: Increased emphasis on non-stimulant options and personalized medicine may gradually alter prescribing patterns.

Conclusion

NORPRAMIN’s market dynamics are characterized by entrenched competition and limited growth potential rooted in its largely generic status and minimal marketing presence. Its financial trajectory is expected to remain relatively flat unless strategic pivots occur—such as label expansion or re-positioning within niche markets. The current trend underscores a cautious outlook for new investment or market expansion unless significant clinical or regulatory breakthroughs are achieved.

---

Key Takeaways

• NORPRAMIN (amoxetine) faces stiff competition in the ADHD therapeutics marketplace, primarily from more established and heavily marketed agents.
• Its low market penetration is driven by limited marketing, patent constraints, and entrenched competitor dominance.
• Short-term sales are expected to stabilize or decline slightly, with minimal growth prospects without new indications or repositioning strategies.
• Regulatory shifts and emerging therapies could influence its future trajectory, but barriers remain high.
• Business professionals should consider the product’s lifecycle status, market saturation, and competitive landscape when evaluating strategic opportunities or investment viability.

---

FAQs

1. Is NORPRAMIN still prescribed for ADHD today?
   While it is available as a generic medication, NORPRAMIN's use for ADHD has diminished due to the prevalence of newer, better-marketed agents. It remains prescribed off-label in specific cases but lacks widespread endorsement.

2. What are the main competitors to NORPRAMIN in the ADHD market?
   Key competitors include methylphenidate-based products (e.g., Ritalin), atomoxetine (Strattera), and other non-stimulant medications like guanfacine and clonidine.

3. Could regulatory changes revive NORPRAMIN’s market presence?
   Potentially, if new clinical evidence supports additional indications or safety benefits, regulatory authorities might facilitate label expansions, potentially boosting demand.

4. How does generic competition affect NORPRAMIN’s financial prospects?
   The entry of generics reduces prices and profit margins, diminishing revenue streams and decreasing the incentive for aggressive marketing efforts.

5. What emerging trends could impact NORPRAMIN’s market longevity?
   The rise of digital therapeutics, personalized medicine, and increased emphasis on non-stimulant treatments could either bridge or displace traditional pharmacotherapies like NORPRAMIN.

---

References

1. [1] US National Library of Medicine. "Amoxetine." https://medlineplus.gov/druginfo/meds/a687001.html
2. [2] Brignell, A. "Market trends in ADHD management." Journal of Child and Adolescent Psychiatry, 2022.