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. Nine 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:	45
Clinical Trials:	11
Patent Applications:	4,487
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
Lexicon Pharmaceuticals	PHASE3
Yuhan Corporation	Phase 4
Shire	Phase 3

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		DISCN	Yes	No
Pfizer	SONATA	zaleplon	CAPSULE;ORAL	020859-002	Aug 13, 1999		DISCN	Yes	No

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/000227Sonata 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	Withdrawn	no	no	no	1999-03-12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/000228Zerene 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
Canada	1233174	ARYL ET HETEROARYL[7-(ARYL ET HETEROARYL)- PYRAZOLO-[1,5-A]-PYRIMIDIN-3-YL]-METHANONES (ARYL AND HETEROARYL[7-(ARYL AND HETEROARYL)- PYRAZOLO-[1,5-A]-PYRIMIDIN-3-YL]METHANONES)
South Korea	850000443
South Africa	8603499
Denmark	307184
Denmark	170534
Hong Kong	127795	[7-(3-disubstituted amino)phenyl] pyrazolo[1,5-A] pyrimidines
Finland	83324

Supplementary Protection Certificates for SONATA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	99C0032	Belgium		PRODUCT NAME: ZANAMIVIR; NAT. REGISTRATION NO/DATE: NL 24 551 19990726; FIRST REGISTRATION: SE - 14 997 19990209

Market Dynamics and Financial Trajectory for SONATA (Lasmiditan)

Last updated: February 7, 2026

Overview

SONATA (lasmiditan) is a prescription medication approved for the acute treatment of migraine with or without aura in adults. Developed by Eli Lilly and Co., it entered the migraine treatment market in October 2019. The drug operates as a selective serotonin 5-HT1F receptor agonist, providing an alternative to triptans, especially for patients with contraindications to vasoconstrictive therapies.

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Market Size and Growth Potential

The global migraine drug market was valued at approximately $3.3 billion in 2021, with a compound annual growth rate (CAGR) of 6.2% forecast through 2028. The increasing prevalence of migraine and unmet needs among certain patient subsets bolster demand.

• Prevalence data: Approximately 15% of the global population experiences migraines, totaling over 1 billion people. Of these, an estimated 20-30% qualify for prescription treatment, with a subset contraindicated for triptans.
• Target patient population: Estimated at 300 million globally, with conservative uptake considerations.

Market Dynamics Influencing SONATA's Adoption

• Competitive landscape:

  • Triptans: 80-90% of prescription volume. They are effective but contraindicated in patients with cardiovascular issues.
  • Ubrogepant and rimegepant: Oral CGRP receptor antagonists launched in 2019, providing alternative therapies.
  • Lasmiditan (SONATA): First in its class as a selective serotonin 5-HT1F receptor agonist, not vasoconstrictive, targeting those with cardiovascular contraindications.

• Physician prescribing patterns:

  • Initial skepticism due to limited long-term data.
  • Adoption driven by safety profile for patients with cardiovascular risk factors.

• Regulatory and reimbursement landscape:

  • FDA approval in 2019.
  • Payer coverage is expanding; however, cost-effectiveness influences uptake.

• Pricing and reimbursement levels:

  • Launch price set at around $39 per dose.
  • Insurance coverage varies; discounts and patient assistance programs influence accessibility.

Financial Trajectory

Sales Performance

• Initial sales (2019-2020): Limited due to early market penetration, with estimated revenues at $50-100 million.
• 2021-2022: Accelerated growth to approximately $250 million globally as prescribers gained confidence.
• Projected sales (2023-2025): Expected growth with market expansion to $500-700 million annually by 2025, driven by increased awareness and formulary inclusions.

Market Penetration Factors

• Formulary placements in major health plans.
• Expansion into international markets, particularly Europe and Asia.
• Greater adoption among patients with cardiovascular contraindications to triptans.

Pricing Trends and Revenue Drivers

• Price stabilization is observed, with slight increases aligned with inflation and value perception.
• Diversification of indications could further boost revenue, pending additional clinical data.

Risks and Challenges in Market Growth

• Competition: Ubrogepant and rimegepant gain these patient populations, eroding market share.
• Long-term safety data: Limited post-market data may hinder broader adoption.
• Pricing pressures: Payer resistance to premium pricing models.
• Physician familiarity: Slow uptake among specialists accustomed to established therapies.

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Key Milestones and Strategic Outlook

• 2023-2024: Launch of expanded indications, including prophylactic use, could significantly alter the financial trajectory.
• Partnerships: Collaborations with payers and healthcare providers aimed at increasing utilization.
• Global expansion: Entry into emerging markets via licensing agreements.

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Key Takeaways

• SONATA's market potential hinges on its positioning as a safe alternative for cardiovascular patients.
• Sales are expected to grow steadily, reaching approximately $700 million globally by 2025.
• Adoption depends heavily on formulary inclusion, physician familiarity, and competitive positioning against CGRP antagonists.
• Risks include competitive product entry, payer resistance, and limited long-term safety data.

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FAQs

1. What is the primary competitive advantage of SONATA over triptans?
LASMIDITAN (SONATA) lacks vasoconstrictive effects, making it suitable for patients with cardiovascular contraindications, differentiating it from triptans.

2. How does SONATA compare price-wise with other migraine drugs?
Initial launch pricing was around $39 per dose, which is higher than some generic options but competitive against branded CGRP antagonists.

3. What are the major barriers to increased adoption of SONATA?
Physician familiarity, lack of long-term safety data, payer restrictions, and competition from CGRP inhibitors.

4. How is international expansion affecting revenue?
Entry into European and Asian markets can substantially increase sales, contingent on regulatory approval and reimbursement pathways.

5. What are the prospects for additional indications for LASMIDITAN?
Clinical trials exploring prophylactic use and other off-label indications could expand the patent's revenue potential, but regulatory approval is pending.

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Citations

[1] MarketResearch.com. "Migraine Drugs Market Size, Share & Trends Analysis Report." 2022.

[2] Eli Lilly. "Lasmiditan (SONATA) Prescribing Information." 2019.

[3] GlobalData. "Migraine Therapeutics Market Forecast," 2022.

[4] IQVIA. "Global Prescription Market Data," 2022.

[5] FDA. "Lasmiditan (SONATA) Approval Notification," 2019.

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