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Generated: July 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020717

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NDA 020717 describes PROVIGIL, which is a drug marketed by Cephalon and is included in one NDA. It is available from twelve suppliers. There is one patent protecting this drug. Additional details are available on the PROVIGIL profile page.

The generic ingredient in PROVIGIL is modafinil. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the modafinil profile page.

Summary for NDA: 020717

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020717

Suppliers and Packaging for NDA: 020717

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROVIGIL
modafinil
TABLET;ORAL 020717 NDA Rebel Distributors Corp 21695-234 21695-234-15 15 TABLET in 1 BOTTLE (21695-234-15)
PROVIGIL
modafinil
TABLET;ORAL 020717 NDA Rebel Distributors Corp 21695-234 21695-234-30 30 TABLET in 1 BOTTLE (21695-234-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 24, 1998TE:ABRLD:Yes
Patent:7,297,346*PEDPatent Expiration:May 29, 2024Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Dec 24, 1998TE:ABRLD:Yes
Patent:7,297,346*PEDPatent Expiration:May 29, 2024Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020717

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon
PROVIGIL
modafinil
TABLET;ORAL020717-002Dec 24, 19984,177,290► Subscribe
Cephalon
PROVIGIL
modafinil
TABLET;ORAL020717-002Dec 24, 19984,927,855*PED► Subscribe
Cephalon
PROVIGIL
modafinil
TABLET;ORAL020717-001Dec 24, 19984,177,290► Subscribe
Cephalon
PROVIGIL
modafinil
TABLET;ORAL020717-002Dec 24, 19985,618,845► Subscribe
Cephalon
PROVIGIL
modafinil
TABLET;ORAL020717-001Dec 24, 19985,618,845► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Moodys
AstraZeneca
Accenture
Julphar
Fuji
McKesson
Queensland Health
US Department of Justice
Cipla

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