SONATA Drug Patent Profile

When do Sonata patents expire, and what generic alternatives are available?

Sonata is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in SONATA is zaleplon. There are twelve drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the zaleplon profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sonata

A generic version of SONATA was approved as zaleplon by AUROBINDO PHARMA on June 6^th, 2008.

Summary for SONATA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	10
Patent Applications:	3,928
Drug Prices:	Drug price information for SONATA
What excipients (inactive ingredients) are in SONATA?	SONATA excipients list
DailyMed Link:	SONATA at DailyMed

See drug prices for SONATA

Recent Clinical Trials for SONATA

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

Sponsor	Phase
Yuhan Corporation	Phase 4
Shire	Phase 3
National Aeronautics and Space Administration (NASA)	Phase 4

See all SONATA clinical trials

Paragraph IV (Patent) Challenges for SONATA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SONATA	Capsules	zaleplon	5 mg and 10 mg	020859	1	2005-06-21

US Patents and Regulatory Information for SONATA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	SONATA	zaleplon	CAPSULE;ORAL	020859-001	Aug 13, 1999	AB	RX	Yes	No
Pfizer	SONATA	zaleplon	CAPSULE;ORAL	020859-002	Aug 13, 1999	AB	RX	Yes	Yes

Expired US Patents for SONATA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	SONATA	zaleplon	CAPSULE;ORAL	020859-001	Aug 13, 1999	4,626,538
Pfizer	SONATA	zaleplon	CAPSULE;ORAL	020859-002	Aug 13, 1999	4,626,538

EU/EMA Drug Approvals for SONATA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Meda AB	Sonata	zaleplon	EMEA/H/C/000227 Sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.	Withdrawn	no	no	no	1999-03-12
Meda AB	Zerene	zaleplon	EMEA/H/C/000228 Zerene is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.	Withdrawn	no	no	no	1999-03-12

International Patents for SONATA

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

Country	Patent Number	Title	Estimated Expiration
Denmark	170534
Australia	568656
Germany	3689294
Spain	554887

Supplementary Protection Certificates for SONATA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0208846	SPC/GB99/024	United Kingdom		PRODUCT NAME: N-(3-(3-CYANOPYRAZOLO(1,5-A)PYRIMIDIN-7-YL)PHENYL)-N-ETHYLACETAMIDE (ZALEPLON); REGISTERED: UK EU/1/99/099/001 19990312; UK EU/1/99/099/002 19990312; UK EU/1/99/099/003 19990312; UK EU/1/99/099/004 19990312; UK EU/1/99/099/005 19990312; UK EU/1/99/099/006 19990312; UK EU/1/99/102/001 19990312; UK EU/1/99/102/002 19990312; UK EU/1/99/102/003 19990312; UK EU/1/99/102/004 19990312; UK EU/1/99/102/005 19990312; UK EU/1/99/102/006 19990312
0208846	C990021	Netherlands		PRODUCT NAME: ZALEPLONUM; REGISTRATION NO/DATE: EU/1/99/099/001 - EU/1/99/099/006, EU/1/99/102/001 - EU/1/99/102/006 19990312
0208846	99C0032	Belgium		PRODUCT NAME: ZANAMIVIR; NAT. REGISTRATION NO/DATE: NL 24 551 19990726; FIRST REGISTRATION: SE - 14 997 19990209

SONATA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: SONATA (Zaleplon)

Introduction to Zaleplon (SONATA)

Zaleplon, marketed under the brand name SONATA, is a nonbenzodiazepine hypnotic drug primarily used to treat insomnia. It is known for reducing the time it takes to fall asleep, improving sleep latency, and facilitating sleep induction rather than maintaining sleep.

Market Drivers

The Zaleplon market is driven by several key factors:

Increasing Prevalence of Insomnia

The rising prevalence of insomnia globally, coupled with increasing stress levels and growing awareness about treatment options, presents significant opportunities for the Zaleplon market[4].

Growing Demand for Sleep Aids

The demand for sleep aids is on the rise due to the increasing number of people suffering from sleep disorders. This trend is expected to continue, driving the growth of the Zaleplon market[4].

Expansion of Healthcare Services

Recent developments in healthcare, such as the launch of sleep disorder clinics and digital therapeutics platforms, indicate a growing focus on sleep health. This expansion is likely to boost the demand for sleep disorder treatments, including Zaleplon[1].

Market Dynamics

Growth Opportunities

• The Zaleplon market is expected to witness high growth during the forecast period, driven by the increasing prevalence of anxiety, seizures, and insomnia, as well as a rise in concerns about preventing stress-related conditions[4].

Challenges

• Despite the growth opportunities, the market faces challenges such as poor efficacy and safety profiles of the drug. Additionally, there is a rising demand for cost-effective over-the-counter (OTC) sleep aids, which could hamper the market growth[4].

Market Segmentation

By Product Type

The Zaleplon market is segmented based on product type, primarily into 5mg and 10mg doses. This segmentation helps in tailoring the treatment to the specific needs of patients[4].

By Dosage Form

Zaleplon is available in oral and intranasal dosage forms. The oral form is the most common, while the intranasal form offers an alternative for patients who prefer or require it[4].

Regional Framework

The Zaleplon market is analyzed across various regions, including North America, Europe, Asia Pacific, and others. Each region has its own market dynamics influenced by local healthcare policies, patient demographics, and economic factors.

Financial Trajectory

Market Size and Growth

The sleep disorder treatment market, which includes Zaleplon, is expected to grow significantly. For instance, the overall sleep disorder treatment market is projected to grow at a CAGR of 10.99% from $14.510 billion in 2021 to $30.102 billion in 2028[1].

Revenue and Sales

While specific financial data for Zaleplon alone is not provided, the overall sleep disorder treatment market's growth indicates a positive financial trajectory for drugs like Zaleplon. The increasing demand and expanding healthcare services are likely to contribute to higher sales and revenue for Zaleplon.

Key Developments and Strategies

Organic Growth Strategies

Companies in the Zaleplon market are focusing on organic growth strategies such as launching new product types and dosage forms, obtaining product approvals, and securing patents. These strategies help in expanding the product portfolio and enhancing market presence[4].

Inorganic Growth Strategies

Inorganic growth strategies, including acquisitions and partnerships, are also being employed. For example, collaborations with healthcare providers and technology companies can enhance the reach and effectiveness of Zaleplon treatments[4].

Industry Expert Insights

Industry experts highlight the importance of addressing the unique needs of patients suffering from insomnia and other sleep disorders. "Increasing prevalence of insomnia across the world, rising stress levels, and increasing awareness about treatment options are expected to offer significant opportunities to the Zaleplon drug market," notes a report by The Insight Partners[4].

Illustrative Statistics

• The sleep disorder treatment market is expected to reach $30.102 billion by 2028, growing at a CAGR of 10.99% from 2021 to 2028[1].
• The Zaleplon market is anticipated to witness high growth during the forecast period, driven by increasing prevalence of insomnia and related conditions[4].

Conclusion

The Zaleplon market, driven by the increasing prevalence of insomnia and other sleep disorders, is poised for significant growth. Despite challenges related to efficacy and safety profiles, the market is expected to expand due to growing demand for sleep aids and the expansion of healthcare services.

Key Takeaways

• The Zaleplon market is driven by the increasing prevalence of insomnia and related conditions.
• The market is segmented by product type and dosage form, offering flexibility in treatment options.
• Organic and inorganic growth strategies are being employed to expand market presence.
• The overall sleep disorder treatment market is expected to grow significantly, indicating a positive financial trajectory for Zaleplon.

FAQs

What is Zaleplon (SONATA) used for?

Zaleplon, marketed under the brand name SONATA, is used to treat insomnia by reducing the time it takes to fall asleep and improving sleep latency.

What are the key drivers of the Zaleplon market?

The key drivers include the increasing prevalence of insomnia, rising stress levels, and growing awareness about treatment options.

What are the challenges facing the Zaleplon market?

Challenges include poor efficacy and safety profiles of the drug and the rising demand for cost-effective OTC sleep aids.

How is the Zaleplon market segmented?

The market is segmented by product type (5mg and 10mg) and dosage form (oral and intranasal).

What is the expected growth of the sleep disorder treatment market?

The sleep disorder treatment market is expected to grow at a CAGR of 10.99% from $14.510 billion in 2021 to $30.102 billion in 2028.

Sources

1. Knowledge Sourcing: Sleep Disorder Treatment Market Size & Trends: Report, 2023-2028
2. Sonata Software: Sonata Software Limited Q4 FY'24 Earnings Conference Call
3. Sonata Software: Annual Report 2023-24 - Sonata Software
4. The Insight Partners: Zaleplon Market Dynamics 2021-2031