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NATROBA Drug Patent Profile

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When do Natroba patents expire, and what generic alternatives are available?

Natroba is a drug marketed by Cipher and is included in one NDA. There is one patent protecting this drug.

The generic ingredient in NATROBA is spinosad. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the spinosad profile page.

DrugPatentWatch^® Generic Entry Outlook for Natroba

Natroba was eligible for patent challenges on January 18, 2015.

Indicators of Generic Entry

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Summary for NATROBA

US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Patent Applications:	3,493
Drug Prices:	Drug price information for NATROBA
Drug Sales Revenues:	Drug sales revenues for NATROBA
What excipients (inactive ingredients) are in NATROBA?	NATROBA excipients list
DailyMed Link:	NATROBA at DailyMed

Drug patent expirations by year for NATROBA

Recent Clinical Trials for NATROBA

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

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

See all NATROBA clinical trials

Pharmacology for NATROBA

Drug Class	Pediculicide

US Patents and Regulatory Information for NATROBA

NATROBA is protected by one US patents and one FDA Regulatory Exclusivity.

Patents protecting NATROBA

Methods and compositions useful for controlling cutaneous mites
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: THE PRODUCT COMPOSITION (NATROBA) IS FOR THE TOPICAL TREATMENT OF HUMAN SCABIES MITE INFESTATIONS BY MELTING AND DELIVERING THE ACTIVE INGREDIENT, SPINOSAD, TO THE STRATUM CORNEUM WHERE SCABIES MITES LIVE AND BREED

FDA Regulatory Exclusivity protecting NATROBA

FOR THE TOPICAL TREATMENT OF SCABIES INFESTATIONS IN ADULT AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Sign Up

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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 NATROBA

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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
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 NATROBA

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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

International Patents for NATROBA

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

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Country	Patent Number	Title	Estimated Expiration
New Zealand	509118	Formulations for controlling human lice containing spinosyn	⤷ Sign Up
Finland	950946		⤷ Sign Up
Romania	106065	COMPUSI MACROLIDICI CU ACTIVITATE INSECTICIDA SI MITICIDA SI PROCEDEU DE PREPARARE A LOR (MACROLIQUIDIC COMPOUNDS WITH INSECTICIDE AND MITICIDE ACTIVITY AND PREPARATION PROCESS THEREFOR)	⤷ Sign Up
Morocco	21697		⤷ Sign Up
Canada	2337789	FORMULATIONS ANTI-POUX POUR L'HOMME (FORMULATIONS FOR CONTROLLING HUMAN LICE)	⤷ Sign Up
Ireland	894068		⤷ Sign Up
Turkey	200003818		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for NATROBA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0375316	350009	Netherlands	⤷ Sign Up
0375316	C350009	Netherlands	⤷ Sign Up	PRODUCT NAME: SPINOSAD, DESGEWENST IN DE VORM VAN EEN ZOUT; NATL. REGISTRATION NO/DATE: 12363 N 20020913; FIRST REGISTRATION: SE 4511 20020204
0375316	06C0047	France	⤷ Sign Up	PRODUCT NAME: SPINOSAD; REGISTRATION NO/DATE IN FRANCE: 2060098 DU 20060628; REGISTRATION NO/DATE AT EEC: 9275/B DU 20011023
0375316	SPC/GB02/028	United Kingdom	⤷ Sign Up	PRODUCT NAME: SPINOSAD; REGISTERED: CH W 6020 20010313; UK 0714 20020227
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description