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Details for Generic Name: spinosad

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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

A Pilot Dose Ranging Study of Spinosad Creme Rinse
Status: Completed Condition: Pediculosis Capitis; Head Lice

Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies
Status: Recruiting Condition: Scabies

Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies
Status: Recruiting Condition: Scabies

Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation
Status: Completed Condition: Pediculosis

A Dose Ranging Study of Different Strengths of Spinosad Topical Creme in Subjects With Pediculosis Capitis
Status: Completed Condition: Pediculosis Capitis (Head Lice)

Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice
Status: Completed Condition: Pediculosis

Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice
Status: Completed Condition: Pediculus Capitis Infestation

NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers
Status: Completed Condition: Head Lice

Phototoxicity Potential of NatrOVA Creme Rinse - 1%
Status: Completed Condition: Head Lice

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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, 2011RXYes6,063,771<disabled>Y<disabled>
Parapro Llc
NATROBA
spinosad
SUSPENSION;TOPICAL022408-001Jan 18, 2011RXYes<disabled><disabled>
Parapro Llc
NATROBA
spinosad
SUSPENSION;TOPICAL022408-001Jan 18, 2011RXYes<disabled><disabled>
Parapro Llc
NATROBA
spinosad
SUSPENSION;TOPICAL022408-001Jan 18, 2011RXYes7,030,095<disabled>Y<disabled>
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International Patent Family for Ingredient: spinosad

Country Document Number Publication Date
Japan2002519365Jul 02, 2002
Turkey200003818Jun 21, 2001
Germany69931309Apr 26, 2007
Israel140072Feb 10, 2002
China1382375Dec 04, 2002
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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