.

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): 207958

« Back to Dashboard
NDA 207958 describes SPRITAM, which is a drug marketed by Aprecia Pharms Co and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the SPRITAM profile page.

The generic ingredient in SPRITAM is levetiracetam. There are thirty-four drug master file entries for this compound. Ninety suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the levetiracetam profile page.

Summary for NDA: 207958

Tradename:
SPRITAM
Applicant:
Aprecia Pharms Co
Ingredient:
levetiracetam
Patents:3
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 207958

Suppliers and Packaging for NDA: 207958

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPRITAM
levetiracetam
TABLET, FOR SUSPENSION;ORAL 207958 NDA Aprecia Pharmaceuticals Company 43485-101 43485-101-60 60 BLISTER PACK in 1 CARTON (43485-101-60) > 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-101-01)
SPRITAM
levetiracetam
TABLET, FOR SUSPENSION;ORAL 207958 NDA Aprecia Pharmaceuticals Company 43485-102 43485-102-60 60 BLISTER PACK in 1 CARTON (43485-102-60) > 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-102-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrength250MG
Approval Date:Jul 31, 2015TE:RLD:No
Patent:6,471,992Patent Expiration:Feb 20, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:9,463,160Patent Expiration:Feb 20, 2018Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrength500MG
Approval Date:Jul 31, 2015TE:RLD:No
Patent:6,471,992Patent Expiration:Feb 20, 2018Product Flag?YSubstance Flag?Delist Request?


Complete Access Available with Subscription
« Back to Dashboard

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

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