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Spinosad - Generic Drug Details

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Spinosad is the generic ingredient in one branded drug marketed by Parapro Llc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-six patent family members in thirty countries.

There is one drug master file entry for spinosad. Three suppliers are listed for this compound.

Summary for Generic Name: spinosad

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list1
Suppliers / Packaging: see list3
Formulation / Manufacturing:see details

Pharmacology for Ingredient: spinosad

Drug ClassPediculicide

Clinical Trials for: spinosad

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parapro Llc
NATROBA
spinosad
SUSPENSION;TOPICAL022408-001Jan 18, 2011RXYes6,342,482<disabled>Y <disabled>
Parapro Llc
NATROBA
spinosad
SUSPENSION;TOPICAL022408-001Jan 18, 2011RXYes<disabled><disabled>
Parapro Llc
NATROBA
spinosad
SUSPENSION;TOPICAL022408-001Jan 18, 2011RXYes6,063,771<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: spinosad

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Parapro Llc
NATROBA
spinosad
SUSPENSION;TOPICAL022408-001Jan 18, 20115,496,931<disabled>
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Non-Orange Book Patents for Generic Ingredient: spinosad

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,727,228 Pediculicidal and ovacidal treatment compositions and methods for killing head lice and their eggs<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: spinosad

Country Document Number Estimated Expiration
Japan2010229147<disabled in preview>
Austria320713<disabled in preview>
South Korea20020083144<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: SPINOSAD

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/028United Kingdom<disabled>PRODUCT NAME: SPINOSAD; REGISTERED: CH W 6020 20010313; UK 0714 20020227
50009Netherlands<disabled>PRODUCT NAME: SPINOSAD, DESGEWENST IN DE VORM VAN EEN ZOUT; NATL. REGISTRATION NO/DATE: 12363 N 20020913; FIRST REGISTRATION: SE 4511 20020204
C0047France<disabled>PRODUCT NAME: SPINOSAD; REGISTRATION NO/DATE IN FRANCE: 2060098 DU 20060628; REGISTRATION NO/DATE AT EEC: 9275/B DU 20011023
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