.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Drug patents in 130+ countries

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Merck
Cantor Fitzgerald
US Army
McKesson
Farmers Insurance
Citi
Fuji
Federal Trade Commission
Cerilliant
Mallinckrodt

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022408

« Back to Dashboard

NDA 022408 describes NATROBA, which is a drug marketed by Parapro Llc and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the NATROBA profile page.

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.

Summary for 022408

Tradename:1
Applicant:1
Ingredient:1
Patents:3
Formulation / Manufacturing:see details

Pharmacology for NDA: 022408

Suppliers and Packaging for NDA: 022408

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NATROBA spinosad SUSPENSION;TOPICAL 022408 NDA Allegis Pharmaceuticals, LLC 28595-570 28595-570-04 1 BOTTLE, PLASTIC in 1 CARTON (28595-570-04) > 120 mL in 1 BOTTLE, PLASTIC
NATROBA spinosad SUSPENSION;TOPICAL 022408 NDA ParaPRO LLC 52246-929 52246-929-04 1 BOTTLE, PLASTIC in 1 CARTON (52246-929-04) > 120 mL in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;TOPICALStrength0.9%
Approval Date:Jan 18, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 30, 2017
Regulatory Exclusivity Use:INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION OF THE LABELING REGARDING A SAFETY STUDY IN PEDIATRIC SUBJECTS AGES 6 MONTHS TO 4 YEARS OF AGE WITH AN ACTIVE HEAD LICE INFESTATION
Patent:► SubscribePatent Expiration:Jul 25, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:NATROBA TOPICAL SUSPENSION IS A PEDICULICIDE INDICATED FOR THE TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS SIX (6) MONTHS OF AGE AND OLDER.
Patent:► SubscribePatent Expiration:Jun 22, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS FOUR (4) YEARS OF AGE AND OLDER

Expired Orange Book Patents for NDA: 022408

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Parapro LlcNATROBAspinosadSUSPENSION;TOPICAL022408-001Jan 18, 2011► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Fuji
Chubb
QuintilesIMS
AstraZeneca
Healthtrust
US Army
Boehringer Ingelheim
Covington
Cantor Fitzgerald

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 verifification 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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot