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Last Updated: May 29, 2020

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NATROBA Drug Profile


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

Natroba is a drug marketed by Parapro Llc and is included in one NDA. There are two patents protecting this drug.

This drug has forty-eight patent family members in thirty countries.

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.

US ANDA Litigation and Generic Entry Outlook for Natroba

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 2, 2021. This may change due to patent challenges or generic licensing.

Annual sales in 2017 were $2mm indicating the motivation for generic entry.

Indicators of Generic Entry

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Drug patent expirations by year for NATROBA
Drug Prices for NATROBA

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Drug Sales Revenue Trends for NATROBA

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Generic Entry Opportunity Date for NATROBA
Generic Entry Date for NATROBA*:
Constraining patent/regulatory exclusivity:
NDA:
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 NATROBA

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

SponsorPhase
AccelovancePhase 3
ParaPRO LLCPhase 3
ParaPRO LLCPhase 4

See all NATROBA clinical trials

Pharmacology for NATROBA
Drug ClassPediculicide
Synonyms for NATROBA
Comfortis
EC 434-300-1
NaturaLyte
Spinosad [USAN]
UNII-XPA88EAP6V
XDE 105
XPA88EAP6V

US Patents and Regulatory Information for NATROBA

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

Supplementary Protection Certificates for NATROBA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0375316 C350009 Netherlands   Start Trial PRODUCT NAME: SPINOSAD, DESGEWENST IN DE VORM VAN EEN ZOUT; NATL. REGISTRATION NO/DATE: 12363 N 20020913; FIRST REGISTRATION: SE 4511 20020204
0375316 350009 Netherlands   Start Trial
0375316 06C0047 France   Start Trial 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   Start Trial PRODUCT NAME: SPINOSAD; REGISTERED: CH W 6020 20010313; UK 0714 20020227
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Baxter
Express Scripts
Mallinckrodt
Johnson and Johnson
McKinsey

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.