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
Yale University	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
Padagis Us	SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	078830-001	Jan 30, 2015	AB	RX	No	No
Riconpharma Llc	SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	212342-001	Nov 24, 2020	AB	RX	No	Yes
Rhodes Pharms	SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	215329-001	May 6, 2024	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
Baxter Hlthcare Corp	TRANSDERM SCOP	scopolamine	SYSTEM;TRANSDERMAL	017874-001	Approved Prior to Jan 1, 1982
Baxter Hlthcare Corp	TRANSDERM SCOP	scopolamine	SYSTEM;TRANSDERMAL	017874-001	Approved Prior to Jan 1, 1982

Market Dynamics and Financial Trajectory for Scopolamine

Last updated: February 19, 2026

What Is the Current Market Size and Leading Applications?

Scopolamine is a tropane alkaloid used primarily to prevent motion sickness and treat nausea. The global market value for scopolamine was estimated at approximately USD 250 million in 2022. The compound's primary applications include:

• Motion sickness prophylaxis, particularly in patch form.
• Postoperative nausea and vomiting management.
• Pre-anesthetic medication.

The drug industry indicates a rising preference for transdermal patches over injectable forms, driven by patient convenience and safety profiles. The market for transdermal applications accounted for over 60% of total scopolamine sales in 2022.

How Are Market Drivers Influencing Growth?

Rising Incidence of Motion Sickness and Nausea

Annual travel and tourism increase the global incidence of motion sickness, especially in elderly populations. Additionally, rising postoperative procedures boost demand for antiemetics like scopolamine.

Advancements in Drug Delivery

Transdermal patches have gained favor due to steady drug release, improved compliance, and reduced side effects. Innovations in patch design have extended the patent life for several formulations.

Growing Geriatric Population

The global population aged 60 and above projected to reach 2.1 billion by 2050 (United Nations, 2022), is more susceptible to nausea-related conditions, expanding the patient base.

Regulatory Environment

While existing approvals in the U.S., Europe, and Asia facilitate market stability, evolving clinical guidelines for antiemetic therapies impact market dynamics.

Competitive Landscape and Patent Expirations

The presence of generic versions has increased price competition, affecting profit margins for branded drugs. Key patents for transdermal formulations and combination drugs are scheduled to expire between 2024 and 2028.

What Are the Barriers and Challenges?

Side Effect Profile and Limitations

Potential anticholinergic side effects limit use in certain patient groups, restricting market expansion.

Regulatory Hurdles

Emerging regulations on controlled substances and the requirement for extensive clinical trials in new formulations delay product launches.

Supply Chain Constraints

Raw material sourcing, including certain plant-derived alkaloids, faces sustainability and geopolitical challenges.

How Is the Financial Trajectory Expected to Evolve?

Revenue Projections

Forecasts suggest a compound annual growth rate (CAGR) of approximately 4% from 2023 to 2030, reaching USD 350 million by 2030, driven by increased adoption of transdermal patches and expanding indications.

Impact of Patent Expirations

Patent cliffs in the mid-2020s are expected to induce price erosion but may also stimulate generic competition, supporting broader access and volume growth.

R&D Investments

Pharmaceutical players are investing in new delivery mechanisms, including dissolvable films and novel formulations, with R&D budgets increasing by an average of 12% annually since 2020.

Market Expansion Opportunities

Emerging markets, including Southeast Asia and Africa, are projected to experience higher growth rates (up to 6% CAGR) due to low current penetration and increasing healthcare infrastructure.

How Do Competitive Forces Shape the Market?

Company	Market Share	Strategy	Key Product(s)
Pfizer	25%	Licensing and patent protection	Scopace (transdermal patch)
Novartis	20%	Expanding indications	Combination formulations
Teva	15%	Cost leadership, generics	Generic scopolamine patches
Others	40%	Market diversification	Various regional formulations

Generic manufacturers account for over 50% of sales due to patent expirations. Proprietary formulations incorporate delivery enhancements, often backed by clinical trial data.

What Are the Key Regulatory Trends?

Regulatory agencies, including the FDA and EMA, emphasize safety updates and post-marketing surveillance. New guidelines favor evidence-based claims on transdermal patch efficacy, applying stricter quality controls.

Manufacturers pursuing approval for alternative delivery systems must undertake comprehensive bioequivalence and clinical safety studies. Accelerated pathways for reformulations exist but require substantial investment.

Summary of the Financial Outlook

Year	Estimated Revenue (USD millions)	CAGR	Key Drivers
2022	250	—	Existing formulations, steady demand
2025	290	4%	Extended indications, regional market entry
2030	350	4%	Demographic growth, innovations in delivery

Pricing pressures, patent expirations, and regional market penetration modulate revenue growth. The increasing generic share, alongside innovations, is fundamental to the overall financial change.

Key Takeaways

• The global scopolamine market was valued at USD 250 million in 2022, with a steady 4% CAGR forecast through 2030.
• Transdermal patches dominate the application landscape due to convenience and safety.
• Market growth is driven by demographic shifts, rising motion sickness prevalence, and advancements in drug delivery.
• Patent expirations are leading to increased generic competition, impacting revenues but expanding access.
• Investments in new formulations and delivery systems are pivotal in maintaining competitive advantage.

FAQs

1. How does patent expiration affect scopolamine revenues? Patent expirations free the market for generics, reducing prices and profit margins for branded versions, but enabling broader access and increased volume.

2. What regulatory changes could impact future product approvals? Stricter safety and bioequivalence standards may prolong approval timelines but ensure product quality and market confidence.

3. Are new delivery formats expected to disrupt the market? Yes, innovations like dissolvable films and advanced patches can capture additional market share and extend patent protection.

4. Which regions offer the highest growth potential? Southeast Asia and Africa present higher growth rates due to underpenetrated markets and expanding healthcare infrastructure.

5. What are the primary barriers to market expansion? Side effect profiles, regulatory hurdles, and raw material supply issues constrain growth prospects.

---

References

[1] United Nations. (2022). World Population Prospects. https://population.un.org/wpp