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Generated: May 24, 2017

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Modafinil - Generic Drug Details

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What are the generic sources for modafinil and what is the scope of modafinil patent protection?

is the generic ingredient in two branded drugs marketed by Alembic Ltd, Watson Labs Inc, Cephalon, Hikma Pharms, Orchid Hlthcare, Aurobindo Pharma Ltd, Apotex Inc, and Mylan Pharms Inc, and is included in eight NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for modafinil. Twenty-nine suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: modafinil

Drug Master File Entries: see list26
Suppliers / Packagers: see list29
Bulk Api Vendors: see list61
Clinical Trials: see list40
Patent Applications: see list3,676
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:modafinil at DailyMed

Pharmacology for Ingredient: modafinil

Tentative approvals for MODAFINIL

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe100MGTABLET; ORAL
► Subscribe► Subscribe200MGTABLET; ORAL
► Subscribe► Subscribe200MGTablet; Oral
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma Pharms
TABLET;ORAL090543-002Sep 26, 2012ABRXNoNo► Subscribe► Subscribe
TABLET;ORAL020717-002Dec 24, 1998ABRXYesYes7,297,346*PED► SubscribeY► Subscribe
Aurobindo Pharma Ltd
TABLET;ORAL202566-001Sep 27, 2012ABRXNoNo► Subscribe► Subscribe
Apotex Inc
TABLET;ORAL077667-002Feb 3, 2014ABRXNoNo► Subscribe► Subscribe
Hikma Pharms
TABLET;ORAL090543-001Sep 26, 2012ABRXNoNo► Subscribe► Subscribe
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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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