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Last Updated: April 16, 2024

Zaleplon - Generic Drug Details

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What are the generic sources for zaleplon and what is the scope of patent protection?

Zaleplon is the generic ingredient in two branded drugs marketed by Pfizer, Aurobindo Pharma, Chartwell Molecular, Hikma, Hikma Pharms, Mylan, Orbion Pharms, Teva Pharms, Unichem, and Upsher Smith Labs, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for zaleplon. Ten suppliers are listed for this compound.

Summary for zaleplon

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	11
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	21
Patent Applications:	6,473
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for zaleplon
What excipients (inactive ingredients) are in zaleplon?	zaleplon excipients list
DailyMed Link:	zaleplon at DailyMed

See drug prices for zaleplon

Recent Clinical Trials for zaleplon

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

Sponsor	Phase
The University of Hong Kong	Phase 3
Saint-Joseph University	Phase 3
Taipei City Hospital	Phase 2/Phase 3

See all zaleplon clinical trials

Pharmacology for zaleplon

Drug Class	gamma-Aminobutyric Acid A Receptor Agonist
Mechanism of Action	GABA A Agonists
Physiological Effect	Central Nervous System Depression

Paragraph IV (Patent) Challenges for ZALEPLON

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 zaleplon

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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
Upsher Smith Labs	ZALEPLON	zaleplon	CAPSULE;ORAL	078095-001	Jun 6, 2008		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Orbion Pharms	ZALEPLON	zaleplon	CAPSULE;ORAL	090374-001	Sep 17, 2009	AB	RX	No	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
Aurobindo Pharma	ZALEPLON	zaleplon	CAPSULE;ORAL	078829-002	Jun 6, 2008	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma Pharms	ZALEPLON	zaleplon	CAPSULE;ORAL	078147-002	Nov 25, 2008		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Chartwell Molecular	ZALEPLON	zaleplon	CAPSULE;ORAL	077505-001	Jun 20, 2008	AB	RX	No	No	⤷ 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 zaleplon

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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 zaleplon

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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

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