Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022059

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NDA 022059 describes TYKERB, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TYKERB profile page.

The generic ingredient in TYKERB is lapatinib ditosylate. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lapatinib ditosylate profile page.
Summary for 022059
Tradename:TYKERB
Applicant:Novartis
Ingredient:lapatinib ditosylate
Patents:5
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022059
Generic Entry Date for 022059*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*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.

Pharmacology for NDA: 022059
Mechanism of ActionProtein Kinase Inhibitors
Suppliers and Packaging for NDA: 022059
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TYKERB lapatinib ditosylate TABLET;ORAL 022059 NDA Novartis Pharmaceuticals Corporation 0078-0671 0078-0671-19 150 TABLET in 1 BOTTLE (0078-0671-19)
Paragraph IV (Patent) Challenges for 022059
Tradename Dosage Ingredient NDA Submissiondate
TYKERB TABLET;ORAL lapatinib ditosylate 022059 2011-03-14

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Mar 13, 2007TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 6, 2021
Regulatory Exclusivity Use:INFORMATION ADDED TO SECTION 14 OF THE LABELING TO DESCRIBE STUDY LAP016A2307 TO FULFILL POSTMARKETING STUDY REQUIREMENT 1586-1
Patent:  Start TrialPatent Expiration:Sep 29, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATIENTS WITH ADVANCED OR METASTATIC BREAST CANCER WHOSE TUMORS OVEREXPRESS HER2 AND WHO HAVE RECEIVED PRIOR THERAPY INCLUDING ANTHRACYCLINE, A TAXANE AND TRASTUZUMAB
Patent:  Start TrialPatent Expiration:Sep 29, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATIENTS WITH BREAST CANCER WHOSE TUMORS OVEREXPRESS THE HER2 RECEPTOR

Expired US Patents for NDA 022059

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007   Start Trial   Start Trial
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007   Start Trial   Start Trial
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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