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: December 8, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 013217

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NDA 013217 describes SKELAXIN, which is a drug marketed by King Pharms and is included in one NDA. It is available from six suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SKELAXIN profile page.

The generic ingredient in SKELAXIN is metaxalone. There are twenty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the metaxalone profile page.
Summary for 013217
Tradename:SKELAXIN
Applicant:King Pharms
Ingredient:metaxalone
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 013217
Suppliers and Packaging for NDA: 013217
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SKELAXIN metaxalone TABLET;ORAL 013217 NDA Amneal Pharmaceuticals of New York LLC 0115-1748 0115-1748-01 100 TABLET in 1 BOTTLE (0115-1748-01)
SKELAXIN metaxalone TABLET;ORAL 013217 NDA Amneal Pharmaceuticals of New York LLC 0115-1748 0115-1748-02 500 TABLET in 1 BOTTLE (0115-1748-02)
Paragraph IV (Patent) Challenges for 013217
Tradename Dosage Ingredient NDA Submissiondate
SKELAXIN TABLET;ORAL metaxalone 013217 2004-11-04

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Aug 30, 2002TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Feb 6, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MUSCULOSKELETAL CONDITIONS
Patent:  Start TrialPatent Expiration:Dec 3, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF METAXALONE FOR TREATMENT OF MUSCULOSKELETAL CONDITIONS

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Serving leading biopharmaceutical companies globally:

Colorcon
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Merck
Harvard Business School
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Boehringer Ingelheim

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