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Last Updated: February 22, 2024

Spinosad - Generic Drug Details


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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
Drug Prices for spinosad

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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
Medpace, Inc.Phase 4
STATKING Clinical ServicesPhase 4
Inotiv LaboratoriesPhase 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 Y ⤷  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
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

International Patents for spinosad

Country Patent Number Title Estimated Expiration
Malaysia 121392 FORMULATIONS FOR CONTROLLING HUMAN LICE ⤷  Try a Trial
Taiwan I228994 ⤷  Try a Trial
Brazil 9911795 Formulação de xampu pediculicida para controle de pediculus humanus humanus, pediculus humanus capitas ou pthius pubis em um ser humano, formulação condicionadora pediculicida capilar, formulação de loção antipiolho e uso de uma espinosina ou sal da mesma ⤷  Try a Trial
Norway 329238 ⤷  Try a Trial
Indonesia 29130 ⤷  Try a Trial
Austria 326212 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for spinosad

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.