.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

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

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 013217

« Back to Dashboard
NDA 013217 describes SKELAXIN, which is a drug marketed by King Pharms and is included in one NDA. It is available from twenty 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 nineteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the metaxalone profile page.

Summary for NDA: 013217

Tradename:
SKELAXIN
Applicant:
King Pharms
Ingredient:
metaxalone
Patents:2
Therapeutic Class:Skeletal Muscle Relaxants
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 Blenheim Pharmacal, Inc. 10544-002 10544-002-20 20 TABLET in 1 BOTTLE (10544-002-20)
SKELAXIN
metaxalone
TABLET;ORAL 013217 NDA Blenheim Pharmacal, Inc. 10544-524 10544-524-20 20 TABLET in 1 BOTTLE (10544-524-20)

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Aug 30, 2002TE:ABRLD:Yes
Patent:7,122,566Patent Expiration:Feb 6, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MUSCULOSKELETAL CONDITIONS
Patent:7,714,006Patent Expiration:Dec 3, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF METAXALONE FOR TREATMENT OF MUSCULSKELETAL CONDITIONS


Complete Access Available with Subscription
« Back to Dashboard

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

How are People Using DrugPatentWatch?

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.

`abc