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Serving leading biopharmaceutical companies globally:

Medtronic
Fish and Richardson
Boehringer Ingelheim
Julphar
Federal Trade Commission
Mallinckrodt
Healthtrust
McKinsey
Cantor Fitzgerald
UBS

Generated: February 19, 2018

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-two suppliers are listed for this compound. There are four tentative approvals for this compound.
Tentative approvals for MODAFINIL
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up100MGTABLET; ORAL
➤ Sign Up➤ Sign Up200MGTABLET; ORAL
➤ Sign Up➤ Sign Up200MGTablet; Oral

US Patents and Regulatory Information for modafinil

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd MODAFINIL modafinil TABLET;ORAL 202566-002 Sep 27, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-001 Dec 24, 1998 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Hikma Pharms MODAFINIL modafinil TABLET;ORAL 090543-001 Sep 26, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc MODAFINIL modafinil TABLET;ORAL 076594-002 Jul 16, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc MODAFINIL modafinil TABLET;ORAL 077667-001 Feb 3, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Watson Labs Inc MODAFINIL modafinil TABLET;ORAL 076715-002 Nov 1, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hikma Pharms MODAFINIL modafinil TABLET;ORAL 090543-002 Sep 26, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Alembic Pharms Ltd MODAFINIL modafinil TABLET;ORAL 202700-001 Oct 18, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc MODAFINIL modafinil TABLET;ORAL 076594-001 Jul 16, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Orchid Hlthcare MODAFINIL modafinil TABLET;ORAL 078963-002 Sep 26, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for modafinil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-001 Dec 24, 1998 ➤ Sign Up ➤ Sign Up
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-001 Dec 24, 1998 ➤ Sign Up ➤ Sign Up
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-002 Dec 24, 1998 ➤ Sign Up ➤ Sign Up
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-002 Dec 24, 1998 ➤ Sign Up ➤ Sign Up
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-002 Dec 24, 1998 ➤ Sign Up ➤ Sign Up
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-002 Dec 24, 1998 ➤ Sign Up ➤ Sign Up
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-001 Dec 24, 1998 ➤ Sign Up ➤ Sign Up
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-001 Dec 24, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Baxter
Fuji
UBS
Merck
Dow
AstraZeneca
Queensland Health
Cipla

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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