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Last Updated: March 28, 2024

Spinosad - Generic Drug Details


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

Spinosad is the generic ingredient in one branded drug marketed by Parapro Llc 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.

Drug Prices for spinosad

See drug prices for spinosad

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for spinosad
Generic Entry Date for spinosad*:
Constraining patent/regulatory exclusivity:
FOR THE TOPICAL TREATMENT OF SCABIES INFESTATIONS IN ADULT AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER
Dosage:
SUSPENSION;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for spinosad

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

SponsorPhase
MicroConstants, Inc.Phase 4
Concentrics ResearchPhase 4
Medpace, Inc.Phase 4

See all spinosad clinical trials

Pharmacology for spinosad
Drug ClassPediculicide

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Parapro Llc NATROBA spinosad SUSPENSION;TOPICAL 022408-001 Jan 18, 2011 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 spinosad

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

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).
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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