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Last Updated: December 12, 2019

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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 patent protection?

Modafinil is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cadila, Heritage Pharms Inc, Hikma Pharms, Mylan Pharms Inc, Orchid Hlthcare, Watson Labs 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.

Modafinil has sixty-one patent family members in twenty-eight countries.

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.

Drug Prices for modafinil

See drug prices for modafinil

Drug Sales Revenue Trends for modafinil

See drug sales revenues for modafinil

Recent Clinical Trials for modafinil

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
United States Army Aeromedical Research LaboratoryPhase 2
Emory UniversityPhase 2
American Academy of Sleep MedicinePhase 2

See all modafinil clinical trials

Recent Litigation for modafinil

Identify potential future generic entrants

District Court Litigation
Case NameDate
Cephalon Inc. v. Unimark Remedies Ltd.2015-02-02
Cephalon, Inc. v. Apotex Corp2010-12-14
In Re: Armodafinil Patent Litigation2010-12-08

See all modafinil litigation

Generic filers with tentative approvals for MODAFINIL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial200MGTABLET; ORAL
  Start Trial  Start Trial100MGTABLET; ORAL
  Start Trial  Start Trial200MGTablet; Oral

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Synonyms for modafinil
(-)benzhydrylsulphinylacetamide
(+-)-Modafinil
112111-49-6
152JRG3T0U
2-((Diphenylmethyl)sulfinyl)acetamide
2-(Benzhydrylsulfinyl)acetamide
2-(Diphenyl-methanesulfinyl)-acetamide
2-(diphenylmethane)sulfinylacetamide
2-(diphenylmethyl)sulfinylacetamide
2-(diphenylmethyl)sulfinylethanamide
2-[(diphenylmethyl)sulfinyl]acetamide
2-[di(phenyl)methylsulfinyl]acetamide
2-benzhydrylsulfinylacetamide
2-diphenylmethanesulfinylacetamide
68693-11-8
693M118
A836219
AB0021223
AB00639993_03
AB00639993_04
AC-1382
AC1L1HPP
ACE069
Acetamide, 2-((diphenylmethyl)sulfinyl)-
Acetamide, 2-((S)-(diphenylmethyl)sulfinyl)-
Acetamide, 2-[(diphenylmethyl)sulfinyl]-
AFT-801
AKOS004118314
Alertec
AM20060710
AN-38078
AOB87710
API0003414
AS-17039
Attenace
BC208846
BCP28422
BDBM50156055
BIDD:GT0714
BR-49128
BRD-A16332958-001-02-4
BRD-A16332958-001-04-0
BSPBio_002270
C-45684
C15H15NO2S
CAS-68693-11-8
CCG-39511
CEP 1538
CEP-1538
CHEBI:77585
CHEMBL1373
CN-801
CPD000058957
CRL 40476
CRL 40476; GRL 40476; CN 801
CRL 40983
CRL-40476
CRL-40983
CS-2191
D01832
DB00745
DEA No. 1680
DSSTox_CID_3329
DSSTox_GSID_23329
DSSTox_RID_76980
DTXSID0023329
F2173-0797
FT-0602599
GTPL7555
HMS1922F12
HMS2051P17
HMS2093D15
HMS3264I03
HMS3393P17
HMS3713C12
HSDB 7585
HY-15201A
I06-0190
KB-226631
L001269
LS-176682
MCULE-6678415272
MFCD00868082
MLS000759427
MLS001424049
Modafinil (JAN/USAN/INN)
Modafinil [USAN:INN]
Modafinil [USAN:USP:INN:BAN]
Modafinil 1.0 mg/ml in Acetonitrile
Modafinil D5
Modafinil for system suitability, European Pharmacopoeia (EP) Reference Standard
Modafinil solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material
Modafinil, (+)-
Modafinil, >=98% (HPLC)
Modafinil, European Pharmacopoeia (EP) Reference Standard
Modafinilo
Modafinilo [Spanish]
Modafinilum
Modafinilum [Latin]
Modalert
Modasomil
Modavigil
Moderateafinil
Modiodal
NC00224
NCGC00095176-01
NCGC00095176-02
NCGC00095176-03
NCGC00095176-04
NCGC00095176-05
NCGC00095176-06
NCGC00095176-08
NH 02D
NH-02D
NSC-751178
NSC-751850
NSC-758711
NSC-759110
NSC751178
NSC751850
NSC758711
NSC759110
Pharmakon1600-01504283
Pharmakon1600-01505361
Provigil
Provigil (TN)
S-3878
SAM001246587
SBI-0206841.P001
SC-74637
SCHEMBL34488
SMR000058957
Sparlon
SPBio_001724
SPECTRUM1505361
Spectrum2_001712
SR-01000759419
SR-01000759419-3
SR-01000759419-4
ST45021999
TL8004816
Tox21_111470
Tox21_111470_1
UNII-152JRG3T0U
YFGHCGITMMYXAQ-UHFFFAOYSA-N
Paragraph IV (Patent) Challenges for MODAFINIL
Tradename Dosage Ingredient NDA Submissiondate
PROVIGIL TABLET;ORAL modafinil 020717

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   Start Trial   Start Trial   Start Trial
Alembic Pharms Ltd MODAFINIL modafinil TABLET;ORAL 202700-002 Oct 18, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Heritage Pharms Inc MODAFINIL modafinil TABLET;ORAL 207196-001 Aug 16, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc MODAFINIL modafinil TABLET;ORAL 077667-001 Feb 3, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for modafinil

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

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Serving leading biopharmaceutical companies globally:

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Express Scripts
Mallinckrodt
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Johnson and Johnson
Dow

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