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, Mylan Technologies, Padagis Us, Rhodes Pharms, Riconpharma Llc, Zydus Pharms, and Baxter Hlthcare Corp, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for scopolamine

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	80
Patent Applications:	6,756
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
Yale University	Phase 1
Janssen Scientific Affairs, LLC	Phase 1
Dartmouth-Hitchcock Medical Center	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
Rhodes Pharms	SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	215329-001	May 6, 2024	AB	RX	No	No
Riconpharma Llc	SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	212342-001	Nov 24, 2020	AB	RX	No	No
Actavis Labs Ut Inc	SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	208769-001	Jan 10, 2022	AB	RX	No	No
Baxter Hlthcare Corp	TRANSDERM SCOP	scopolamine	SYSTEM;TRANSDERMAL	017874-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Padagis Us	SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	078830-001	Jan 30, 2015	AB	RX	No	No
Zydus Pharms	SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	217893-001	Aug 29, 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

Scopolamine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Scopolamine

Market Overview

Scopolamine, known as hyoscine or devil's breath, is a tropane alkaloid and anticholinergic medication used to treat various health conditions, including motion sickness, postoperative nausea and vomiting, and gastrointestinal issues. Here’s a detailed look at the market dynamics and financial trajectory of scopolamine.

Market Size and Growth

The global scopolamine market was valued at approximately USD 485.1 million in 2024 and is projected to reach USD 739.2 million by 2031, growing at a compound annual growth rate (CAGR) of 6.2% during the forecast period[4].

Market Dynamics

Driving Factors

Several factors are driving the growth of the scopolamine market:

• Food Habits and Lifestyles: Changes in food habits and casual lifestyles, which affect the digestive and gastrointestinal systems, contribute to the demand for scopolamine[1].
• Motion Sickness and Gastrointestinal Issues: The rising incidence of motion sickness, acute vertigo, and other gastrointestinal disorders such as irritable bowel syndrome and diverticulitis are significant drivers[1][4].
• Technological Advancements: Innovations in specialty drugs and technological advancements in delivery systems, such as transdermal patches, are boosting market growth[4].
• Easy Availability and Low Cost: The easy availability and low cost of generic medicines for motion sickness also drive the market[4].

Geographical Influence

• Asia Pacific: This region is expected to remain dominant due to the widespread use of scopolamine in countries like India and China. The growing geriatric population, expanding pharmaceutical industry, and improving healthcare access in these countries are key factors[4].
• North America: This region is anticipated to exhibit the fastest growth due to the increasing adoption of scopolamine products for treating gastrointestinal disorders[4].

Challenges and Limitations

Despite the growth drivers, the scopolamine market faces several challenges:

• Side Effects: Side effects associated with scopolamine, such as blurred vision, dry mouth, and constipation, can hamper market growth[4].
• Alternative Medications: The availability of alternative anticholinergic drugs for similar health conditions can also limit the market expansion[4].

Transdermal Scopolamine Market

The transdermal scopolamine market is a significant segment within the overall scopolamine market:

• Market Size: This market was estimated to increase from USD 330.0 million in 2015 to USD 585.3 million by 2024, highlighting its growth potential[5].
• Competition and Consolidation: The transdermal scopolamine market is experiencing high competition and consolidation due to the presence of strong players, which can impact market dynamics[2].

Regional Opportunities

• Asia Pacific: Countries like China and India are witnessing significant investments by international pharmaceutical companies, offering lucrative opportunities for market growth[4].
• Latin America: Rising generic drug manufacturing in this region can provide opportunities for market players to reduce costs and penetrate markets with affordable offerings[4].

Key Applications

Scopolamine is used in various therapeutic applications:

• Motion Sickness: It is widely used to treat motion sickness, especially through transdermal patches, which offer a convenient and effective delivery system[4][5].
• Gastrointestinal Issues: Scopolamine treats stomach or intestine issues such as spastic muscular states, diverticulitis, and irritable bowel syndrome[1].
• Postoperative Care: It is used to treat postoperative nausea and vomiting[1].

Expert Insights

Industry experts highlight the importance of technological advancements and the growing acceptance of scopolamine patches for motion sickness treatment. For instance, "The wide acceptance of scopolamine patches for the treatment of motion sickness can drive the market growth," notes a market analysis report[4].

Statistics and Trends

• CAGR: The global scopolamine market is expected to grow at a CAGR of 6.2% from 2024 to 2031[4].
• Regional Growth: Asia Pacific is expected to remain the dominant region, while North America will exhibit the fastest growth[4].
• Market Value: The transdermal scopolamine market is projected to reach USD 585.3 million by 2024, up from USD 330.0 million in 2015[5].

Key Takeaways

• The global scopolamine market is driven by factors such as changing lifestyles, rising incidence of motion sickness, and technological advancements.
• The market faces challenges including side effects and the availability of alternative medications.
• Asia Pacific and North America are key regions for market growth.
• Transdermal scopolamine patches are a significant segment with high growth potential.
• The market is expected to grow at a CAGR of 6.2% from 2024 to 2031.

FAQs

Q: What is the primary use of scopolamine? A: Scopolamine is primarily used to treat motion sickness, postoperative nausea and vomiting, and various gastrointestinal issues.

Q: What are the key drivers of the scopolamine market? A: Key drivers include changing food habits and lifestyles, the rising incidence of motion sickness, and technological advancements in drug delivery systems.

Q: Which region is expected to dominate the scopolamine market? A: Asia Pacific is expected to remain the dominant region due to widespread use in countries like India and China.

Q: What are the potential challenges for the scopolamine market? A: Challenges include side effects associated with scopolamine and the availability of alternative anticholinergic drugs.

Q: How is the transdermal scopolamine market performing? A: The transdermal scopolamine market is growing, with an estimated value of USD 585.3 million by 2024, driven by its convenience and effectiveness in treating motion sickness.

Cited Sources

1. MarketResearch.com - Global Scopolamine Market - 2022-2029
2. Biospace - Transdermal Scopolamine Market: Increase in the incidence of cancer and surgeries is major driver of the market
3. MarketResearchIntellect - Scopolamine Transdermal Patch Market Size, Scope And Forecast
4. Coherent Market Insights - Scopolamine Market - Share, Size and Industry Analysis
5. PR Newswire - Transdermal Scopolamine Market to Reach US$585.3 Million by 2024, Asia Pacific to Present Promising Growth Opportunities, Reports TMR