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Serving 500+ biopharmaceutical companies globally:

Covington
Colorcon
Fish and Richardson
Argus Health
Medtronic
Federal Trade Commission
Cantor Fitzgerald
Chinese Patent Office
Dow
Johnson and Johnson

Generated: August 17, 2017

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 nineteen 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-eight suppliers are listed for this compound. Additional details are available on the metaxalone profile page.

Summary for NDA: 013217

Tradename:
1
Applicant:
1
Ingredient:
1
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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:Yes

Summary for product number 003

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


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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
UBS
Mallinckrodt
Healthtrust
Covington
Boehringer Ingelheim
Medtronic
Fuji
McKesson
Cerilliant

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.

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