SPINOSAD - Generic Drug Details

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What are the generic sources for spinosad and what is the scope of freedom to operate?

Spinosad is the generic ingredient in one branded drug marketed by Cipher and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for spinosad. Two suppliers are listed for this compound.

Summary for SPINOSAD

US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	9
Patent Applications:	7,334
Drug Prices:	Drug price trends for SPINOSAD
What excipients (inactive ingredients) are in SPINOSAD?	SPINOSAD excipients list
DailyMed Link:	SPINOSAD at DailyMed

See drug prices for SPINOSAD

Recent Clinical Trials for SPINOSAD

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

Sponsor	Phase
Medpace, Inc.	Phase 4
STATKING Clinical Services	Phase 4
Inotiv Laboratories	Phase 4

See all SPINOSAD clinical trials

Pharmacology for SPINOSAD

Drug Class	Pediculicide

US Patents and Regulatory Information for SPINOSAD

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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
Cipher	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cipher	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 SPINOSAD

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cipher	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011	⤷ Sign Up	⤷ Sign Up
Cipher	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011	⤷ Sign Up	⤷ Sign Up
Cipher	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for SPINOSAD

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Elanco GmbH	Comfortis	spinosad	EMEA/V/C/002233 Treatment and prevention of flea infestations (Ctenocephalides felis).The preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of the product.The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).	Withdrawn	no	no	no	2011-02-11
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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