Spinosad - Generic Drug Details

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

Spinosad is the generic ingredient in one branded drug marketed by Parapro Llc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Spinosad has thirty-seven patent family members in twenty-eight countries.

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

Summary for spinosad

International Patents:	37
US Patents:	2
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:	7,749
Formulation / Manufacturing:	see details
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
Inotiv Laboratories	Phase 4
MicroConstants, Inc.	Phase 4
Concentrics Research	Phase 4

See all spinosad clinical trials

Pharmacology for spinosad

Drug Class

Pediculicide

US Patents and Regulatory Information for spinosad

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Parapro Llc	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011		RX	Yes	Yes			Y
Parapro Llc	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011		RX	Yes	Yes
Parapro Llc	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011		RX	Yes	Yes

Expired US Patents for spinosad

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Parapro Llc	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011
Parapro Llc	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011
Parapro Llc	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011

EU/EMA Drug Approvals for spinosad

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).	Authorised	no	no	no	2011-02-11

International Patents for spinosad

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1040622
European Patent Office	0968706	Compositions contenant de la spinosyne pour controller les poux humains (Formulations for controlling human lice containing spynosin)
Slovakia	20062000	Prostriedok proti ľudským všiam (FORMULATIONS FOR CONTROLLING HUMAN LICE)

Supplementary Protection Certificates for spinosad

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0375316	SPC/GB02/028	United Kingdom		PRODUCT NAME: SPINOSAD; REGISTERED: CH W 6020 20010313; UK 0714 20020227
0375316	06C0047	France		PRODUCT NAME: SPINOSAD; REGISTRATION NO/DATE IN FRANCE: 2060098 DU 20060628; REGISTRATION NO/DATE AT EEC: 9275/B DU 20011023
0375316	C350009	Netherlands		PRODUCT NAME: SPINOSAD, DESGEWENST IN DE VORM VAN EEN ZOUT; NATL. REGISTRATION NO/DATE: 12363 N 20020913; FIRST REGISTRATION: SE 4511 20020204