SONATA Drug Patent Profile

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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.

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Summary for SONATA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	10
Patent Applications:	4,021
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SONATA
What excipients (inactive ingredients) are in SONATA?	SONATA excipients list
DailyMed Link:	SONATA at DailyMed

Drug patent expirations by year 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

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Anatomical Therapeutic Chemical (ATC) Classes for SONATA

N05CF	Benzodiazepine related drugs
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

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

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Glossary

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

Expired US Patents for SONATA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	SONATA	zaleplon	CAPSULE;ORAL	020859-001	Aug 13, 1999	⤷ Try a Trial	⤷ Try a Trial
Pfizer	SONATA	zaleplon	CAPSULE;ORAL	020859-002	Aug 13, 1999	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for SONATA

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for SONATA

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

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Country	Patent Number	Title	Estimated Expiration
Mexico	9202928	ARIL Y HETEROARIL[7-(-ARIL Y HETEROARIL)PIRAZOLO[1,5-A]PIRIMIDIN-3-IL]METANONS.	⤷ Try a Trial
Philippines	24037	(7-(3-DISUBSTITUTED AMINO)PHENYL)PYRAZOLO(1,5-A)PYRIMIDINES	⤷ Try a Trial
European Patent Office	0208846	[7-(3-Amino disubstitué)phényl]pyrazolo[1,5-a]pyrimidines. (Ä7-(3-Disubstituted amino)phenylÜpyrazoloÄ1,5-aÜpyrimidines. ÄÄÄÄÄÜÜÜÜ)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for SONATA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0208846	99C0032	Belgium	⤷ Try a Trial	PRODUCT NAME: ZANAMIVIR; NAT. REGISTRATION NO/DATE: NL 24 551 19990726; FIRST REGISTRATION: SE - 14 997 19990209
0208846	C990021	Netherlands	⤷ Try a Trial	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	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Summary for SONATA

Recent Clinical Trials for SONATA

Anatomical Therapeutic Chemical (ATC) Classes for SONATA

Paragraph IV (Patent) Challenges for SONATA

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