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Last Updated: January 17, 2021

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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.

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
ParaPRO LLCPhase 3
AccelovancePhase 3
ParaPRO LLCPhase 4

See all NATROBA clinical trials

Pharmacology for NATROBA
Drug ClassPediculicide

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 350009 Netherlands   Start Trial
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 SPC/GB02/028 United Kingdom   Start Trial PRODUCT NAME: SPINOSAD; REGISTERED: CH W 6020 20010313; UK 0714 20020227
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
>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

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