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Serving leading biopharmaceutical companies globally:

Farmers Insurance
McKinsey
Cantor Fitzgerald
Federal Trade Commission
AstraZeneca
Julphar
Baxter
Chubb
Daiichi Sankyo
QuintilesIMS

Generated: December 12, 2017

DrugPatentWatch Database Preview

Modafinil - Generic Drug Details

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

Modafinil
is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Apotex Inc, Appco Pharma Llc, Aurobindo Pharma Ltd, Hikma Pharms, Mylan Pharms Inc, Orchid Hlthcare, Watson Labs Inc, Zydus Pharms Usa Inc, and Cephalon, and is included in ten NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Tentative approvals for MODAFINIL

Applicant Application No. Strength Dosage Form
u► Subscribe100MGTABLET; ORAL
u► Subscribe200MGTABLET; ORAL
u► Subscribe200MGTablet; Oral
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Appco Pharma LlcMODAFINILmodafinilTABLET;ORAL207196-002Aug 16, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Alembic Pharms LtdMODAFINILmodafinilTABLET;ORAL202700-002Oct 18, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Hikma PharmsMODAFINILmodafinilTABLET;ORAL090543-001Sep 26, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Apotex IncMODAFINILmodafinilTABLET;ORAL077667-001Feb 3, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Orchid HlthcareMODAFINILmodafinilTABLET;ORAL078963-001Sep 26, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncMODAFINILmodafinilTABLET;ORAL076594-002Jul 16, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Watson Labs IncMODAFINILmodafinilTABLET;ORAL076715-002Nov 1, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Alembic Pharms LtdMODAFINILmodafinilTABLET;ORAL202700-001Oct 18, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Orchid HlthcareMODAFINILmodafinilTABLET;ORAL078963-002Sep 26, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa IncMODAFINILmodafinilTABLET;ORAL209966-002Sep 14, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: modafinil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
CephalonPROVIGILmodafinilTABLET;ORAL020717-002Dec 24, 1998► Subscribe► Subscribe
CephalonPROVIGILmodafinilTABLET;ORAL020717-001Dec 24, 1998► Subscribe► Subscribe
CephalonPROVIGILmodafinilTABLET;ORAL020717-002Dec 24, 1998► Subscribe► Subscribe
CephalonPROVIGILmodafinilTABLET;ORAL020717-002Dec 24, 1998► Subscribe► Subscribe
CephalonPROVIGILmodafinilTABLET;ORAL020717-001Dec 24, 1998► Subscribe► Subscribe
CephalonPROVIGILmodafinilTABLET;ORAL020717-002Dec 24, 1998► Subscribe► Subscribe
CephalonPROVIGILmodafinilTABLET;ORAL020717-001Dec 24, 1998► Subscribe► Subscribe
CephalonPROVIGILmodafinilTABLET;ORAL020717-001Dec 24, 1998► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Colorcon
Daiichi Sankyo
McKinsey
McKesson
Accenture
Baxter
UBS
Julphar
Chubb
Medtronic

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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