SCOPOLAMINE - Generic Drug Details

What are the generic sources for scopolamine and what is the scope of freedom to operate?

Scopolamine is the generic ingredient in two branded drugs marketed by Actavis Labs Ut Inc, Amneal, Mylan Technologies, Padagis Us, Rhodes Pharms, Riconpharma Llc, Zydus Pharms, and Baxter Hlthcare Corp, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for scopolamine. Eleven suppliers are listed for this compound.

Summary for SCOPOLAMINE

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	8
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	83
Patent Applications:	6,909
Drug Prices:	Drug price trends for SCOPOLAMINE
What excipients (inactive ingredients) are in SCOPOLAMINE?	SCOPOLAMINE excipients list
DailyMed Link:	SCOPOLAMINE at DailyMed

See drug prices for SCOPOLAMINE

Recent Clinical Trials for SCOPOLAMINE

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

Sponsor	Phase
Texas Scottish Rite Hospital for Children	PHASE2
Zhejiang Cancer Hospital	NA
Janssen Scientific Affairs, LLC	Phase 1

See all SCOPOLAMINE clinical trials

Pharmacology for SCOPOLAMINE

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for SCOPOLAMINE

A04AD	Other antiemetics
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

N05CM	Other hypnotics and sedatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

S01FA	Anticholinergics
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for SCOPOLAMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare Corp	TRANSDERM SCOP	scopolamine	SYSTEM;TRANSDERMAL	017874-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Actavis Labs Ut Inc	SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	208769-001	Jan 10, 2022	AB	RX	No	No
Zydus Pharms	SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	217893-001	Aug 29, 2024	AB	RX	No	No
Mylan Technologies	SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	203753-001	Jun 19, 2019	AB	RX	No	No

Expired US Patents for SCOPOLAMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare Corp	TRANSDERM SCOP	scopolamine	SYSTEM;TRANSDERMAL	017874-001	Approved Prior to Jan 1, 1982	4,031,894
Baxter Hlthcare Corp	TRANSDERM SCOP	scopolamine	SYSTEM;TRANSDERMAL	017874-001	Approved Prior to Jan 1, 1982	4,436,741
Baxter Hlthcare Corp	TRANSDERM SCOP	scopolamine	SYSTEM;TRANSDERMAL	017874-001	Approved Prior to Jan 1, 1982	4,262,003

Market Dynamics and Financial Trajectory for Scopolamine in the Pharmaceutical Sector

Last updated: July 27, 2025

Introduction

Scopolamine, a tropane alkaloid derived primarily from Scopolamine alkaloid plants like Datura and Hyoscyamus, has historically been utilized for its anticholinergic properties. While originally employed for motion sickness and nausea, recent developments and expanding clinical applications have driven renewed interest in its pharmaceutical market potential. This article explores the dynamic market landscape, evolving therapeutic indications, regulatory factors, and financial trajectories shaping Scopolamine's role within the pharmaceutical industry.

Pharmacological Profile and Therapeutic Applications

Scopolamine functions as an anticholinergic agent, blocking acetylcholine receptors to exert effects on the central and peripheral nervous systems. Its most established application remains as a transdermal patch for motion sickness prophylaxis. Additionally, it finds use in postoperative nausea and vomiting (PONV), anticipatory nausea in chemotherapy, and as part of anesthesia management. Emerging research investigates its utility in neurodegenerative disorders, alcohol dependence, and psychiatric conditions, broadening its therapeutic scope and impacting overall market dynamics.

Market Size and Growth Drivers

Established Markets

The global motion sickness and PONV segments comprising Scopolamine use generated estimated revenues upward of US$400 million in 2022, with steady compound annual growth rates (CAGR) of approximately 4%. The widespread adoption of transdermal patches as non-invasive alternatives has sustained demand (IQVIA, 2022). The aging population, increased prevalence of nausea-related conditions, and advancing healthcare infrastructure in emerging markets further sustain growth.

Emerging Indications

Research into neuropsychiatric applications, such as depression and substance abuse disorders, is promising but remains in early phases. If validated through clinical trials, revenue streams could expand substantially, especially considering the limited options for these conditions, which currently have unmet therapeutic needs.

Key Market Drivers

• Rising aging population increasing susceptibility to nausea and sensory disorders.
• Advancements in drug delivery, notably transdermal patches enhancing compliance.
• Growing research investments into novel indications.
• Regulatory support in certain jurisdictions for new formulations and uses.

Competitive Landscape

Several pharmaceutical companies occupy the current market for Scopolamine-based products, primarily focusing on transdermal patches (e.g., Transderm Scop by Mylan). The market remains characterized by limited players, largely due to high regulatory entry barriers and complex manufacturing processes. Patent protections for certain formulations have historically limited generic competition; however, patent expirations, such as in the US (2014), have led to increased generic options, exerting downward pressure on prices.

The entry of biosimilars or new delivery systems could shift the competitive dynamics by offering more convenient or cost-effective alternatives. Additionally, biotech firms exploring innovative derivatives may disrupt traditional offerings.

Regulatory and Patent Considerations

Regulatory approval remains rigorous, especially for novel indications. The FDA has approved transdermal Scopolamine patches since the 1970s, with current indications remaining largely unchanged. However, exploring expanded uses requires extensive clinical trials and approval pathways, influencing the time-to-market and associated costs.

Patent landscapes show expiration of key formulations, leading to increased generics. Companies investing in innovative delivery mechanisms and new therapeutic applications can secure patent protections longer, ensuring market exclusivity and higher margins.

Financial Trajectory and Investment Outlook

Historical Financial Performance

The vanilla market for transdermal Scopolamine has been relatively stable but modest, with revenues peaking in traditional indications. Patent expirations and generic proliferation have contributed to price erosion, constraining growth but maintaining steady cash flows for dominant players.

Future Revenue Projections

If ongoing research validates alternative indications, such as treatment of neurodegeneration or substance dependence, revenue potential could expand significantly. Industry forecasts suggest compound annual growth rates (CAGR) of approximately 6-8% for the broader therapeutic areas containing Scopolamine, contingent on successful clinical development and regulatory approval.

Investment Risks and Opportunities

Risks include clinical trial failures, regulatory hurdles, and market penetration challenges from existing rivals, especially generics. Conversely, investments into novel formulations, such as nasal sprays or implantables, could command premium pricing and market share, offering lucrative prospects.

Market Challenges

• Limited pipeline development compared to other neuroactive agents.
• Side effects and safety concerns, such as dry mouth, blurred vision, and cognitive impairment, may hinder broader use.
• Pricing pressures due to increased generic availability and healthcare cost containment efforts.
• Regulatory hurdles for expanding indications necessitate rigorous, costly trials.

Strategic Outlook

Pharmaceutical companies pursuing Scopolamine’s potential should focus on:

1. Innovative delivery systems (e.g., nasal sprays, long-acting implants) that enhance user compliance and efficacy.
2. Repurposing strategies to establish efficacy in neuropsychiatric and addiction treatment markets.
3. Partnerships and licensing agreements for research validation and market expansion.
4. Navigating patent landscapes to maximize exclusivity periods and protect investments.

Conclusion

The pharmaceutical landscape for Scopolamine remains nuanced, characterized by stable traditional markets and significant upside potential through emerging indications and innovative formulations. Companies with strategic investments in research, regulatory navigation, and delivery innovations stand to capitalize on Clinically validated new uses and market expansion opportunities. Overall, the financial trajectory for Scopolamine exhibits moderate resilience with prospects for growth driven by unmet medical needs and technological advancements.

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Key Takeaways

• Market stability is driven by established use in motion sickness and PONV, with revenues around US$400 million annually.
• Emerging indications such as neuropsychiatric disorders could unlock new revenue streams upon successful clinical validation.
• Patent expirations have increased generic competition, exerting downward pressure on prices, but innovative delivery methods could mitigate this impact.
• Investment opportunities predominantly revolve around novel formulations and expanded therapeutic indications.
• Regulatory strategies and intellectual property protections will be critical in maintaining market share and profitability.

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FAQs

1. What are the primary current uses of Scopolamine in the pharmaceutical industry?
Scopolamine is primarily used as a transdermal patch for preventing motion sickness and postoperative nausea and vomiting. Emerging research suggests potential applications in neuropsychiatric disorders, but these are not yet mainstream.

2. How does patent expiration affect the Scopolamine market?
Patent expirations open markets to generic competitors, reducing prices and profit margins for brand-name producers. This has increased competition in established indications, though innovation in delivery systems offers a pathway to regain exclusivity.

3. Are there significant risks associated with investing in Scopolamine-based therapies?
Yes. Clinical failures, regulatory delays, side effect profiles, and competitive pressure from generics pose risks. Additionally, shifting regulatory landscapes and limited pipeline diversification can impact long-term prospects.

4. What future opportunities exist for expanding Scopolamine's therapeutic applications?
Research into its use for neurodegenerative diseases, addiction treatment, and psychiatric disorders offers promising avenues. Successful clinical trials could lead to new approvals and revenue streams.

5. How do regulatory hurdles influence the financial prospects of Scopolamine developments?
Extensive clinical validation and approval processes require significant investment and time. Regulatory success is essential for market entry, especially for new indications, impacting timelines and potential financial returns.

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Sources:
[1] IQVIA, "Global Pharmaceuticals Market Trends," 2022.
[2] U.S. Food and Drug Administration, "Drug Approvals and Patents," 2022.
[3] Market Research Future, "Pharma Market Analysis on Antiemetics," 2021.