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Last Updated: December 14, 2019

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SERAX Drug Profile

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Which patents cover Serax, and when can generic versions of Serax launch?

Serax is a drug marketed by Alpharma Us Pharms and is included in one NDA.

The generic ingredient in SERAX is oxazepam. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the oxazepam profile page.

US ANDA Litigation and Generic Entry Outlook for Serax

A generic version of SERAX was launched as oxazepam by ACTAVIS ELIZABETH on December 14th, 2019.

Summary for SERAX
Drug patent expirations by year for SERAX
Synonyms for SERAX
(.+/-.)-Oxazepam
(+-)-7-Chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one
(+-)-Oxazepam
(RS)-Oxazepam
(Z)-7-chloro-3-hydroxy-5-phenyl-1H-benzo[e][1,4]diazepin-2(3H)-one
1,3-Dihydro-7-chloro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one
2H-1, 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-
2H-1,4-Benzodiazepin-2-one, 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-
2H-1,4-Benzodiazepin-2-one, 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-, (+-)-
2H-1,4-Benzodiazepin-2-one,7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-
3-hydroxy-1,3-dihydro-7-chloro-5-phenyl-2H-1,4-benzodiazepin-2-one
3-hydroxy-5-phenyl-7-chloro-2,3-dihydro-1H-1,4-benzodiazepin-2-one
3-Hydroxynordiazepam
35295-88-6
604-75-1
604O751
61036-43-9
7-Chloro-1,3-dihydro-3-hydroxy-5-phenyl-1,4 [2H]-benzodiazepin-2-one
7-Chloro-1,3-dihydro-3-hydroxy-5-phenyl-1,4 [2Hl-benzodiazepin-2-one
7-Chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one
7-Chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepine-2-one
7-Chloro-1,4-benzodiazepine-2-one
7-chloro-3-hydroxy-5-phenyl-1,3-dihydro-1,4-benzodiazepin-2-one
7-Chloro-3-hydroxy-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one
7-CHLORO-3-HYDROXY-5-PHENYL-1,3-DIHYDRO-2H-BENZO[E][1,4]DIAZEPIN-2-ONE
7-Chloro-3-hydroxy-5-phenyl-1,3-dihydro-benzo[e][1,4]diazepin-2-one
7-Chloro-3-hydroxy-5-phenyl-1,4-benzodiazepin-2-one
7-chloro-3-hydroxy-5-phenyl-2,3-dihydro-1H-1,4-benzodiazepin-2-one
7-chloro-5-phenyl-3H-1,4-benzodiazepine-2,3-diol
Abboxampam
Abboxapam
AC1L1IKD
ADIMAYPTOBDMTL-UHFFFAOYSA-
ADIMAYPTOBDMTL-UHFFFAOYSA-N
Adumbran
Alepam
AN-16712
Ansioxacepam
Anxiolit
Anxiolit retard
API0003709
Aplakil
Apo-astress
Astress
Azutranguil
Azutranquil
BDBM85031
Bonare
C07359
CAS_604-75-1
CAS-604-75-1
CB 8092
CCRIS 488
CHEBI:7823
CHEMBL568
D00464
DB00842
DEA No. 2835
DivK1c_000986
Drimuel
Droxacepam
DSSTox_CID_1087
DSSTox_GSID_21087
DSSTox_RID_75934
DTXSID1021087
Durazepam
EINECS 210-076-9
FT-0673333
GTPL7253
Hi-Long
Hilong
HMS503E13
HSDB 3140
IDI1_000986
InChI=1/C15H11ClN2O2/c16-10-6-7-12-11(8-10)13(9-4-2-1-3-5-9)18-15(20)14(19)17-12/h1-8,15,20H,(H,17,19)
Isodin
KBio1_000986
Lederpam
Limbial
LS-34236
LS-44
MFCD00057903
Murelax
N-Desmethyltemazepam
NCGC00159323-02
NCGC00159323-03
NCGC00159323-04
NCGC00257352-01
NCGC00258254-01
Nesontil
NINDS_000986
Noctazepam
Nortemazepam
Nozepam
NSC 169448
NSC_4616
NSC-169448
NSC169448
Oprea1_501459
Ossazepam
Ossazepam [DCIT]
Oxa-puren
Oxanid
oxazepam
Oxazepam (JAN/USP/INN)
Oxazepam [USAN:INN:BAN:JAN]
Oxazepam [USAN:USP:INN:BAN:JAN]
Oxazepam 0.1 mg/ml in Methanol
Oxazepam 1.0 mg/ml in Methanol
Oxazepam for peak identification, European Pharmacopoeia (EP) Reference Standard
Oxazepam solution, 1 mg/mL in methanol, ampule of 1 mL, certified reference material
Oxazepam solution, drug standard, 1.0 mg/mL in methanol
Oxazepam, European Pharmacopoeia (EP) Reference Standard
Oxazepamum
Oxazepamum [INN-Latin]
Oxazipam
Oxozepam
p acienx
Pacienx
Praxiten
Propax
Psicopax
Psiquiwas
QUEN
Quilibrex
Ro 5-6789
Rondar
SCHEMBL27435
Sedigoa
Serax (TN)
Serenal
Serenid
Serenid-D
Serepax
Seresta
Serpax
Sigacalm
Sobril
SR-01000942251
SR-01000942251-1
Tacepam
Tarchomin
Tazepam
Tox21_111572
Tox21_112819
Tox21_200700
Tox21_303501
tranquo-buscopan- wirkstoff
Tranquo-buscopan-wirkstoff
Uskan
Vaben
WLN: T67 GMV JN IHJ CG IQ KR
Wy 3498
WY-3498
Wy-3498 stic
Z 10 tr
Z10-Tr
Zaxopam
Paragraph IV (Patent) Challenges for SERAX
Tradename Dosage Ingredient NDA Submissiondate
SERAX TABLET;ORAL oxazepam 015539
SERAX CAPSULE;ORAL oxazepam 015539

US Patents and Regulatory Information for SERAX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alpharma Us Pharms SERAX oxazepam CAPSULE;ORAL 015539-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Alpharma Us Pharms SERAX oxazepam TABLET;ORAL 015539-008 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Alpharma Us Pharms SERAX oxazepam CAPSULE;ORAL 015539-004 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Alpharma Us Pharms SERAX oxazepam CAPSULE;ORAL 015539-006 Approved Prior to Jan 1, 1982 DISCN 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 SERAX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alpharma Us Pharms SERAX oxazepam CAPSULE;ORAL 015539-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Alpharma Us Pharms SERAX oxazepam CAPSULE;ORAL 015539-006 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Alpharma Us Pharms SERAX oxazepam CAPSULE;ORAL 015539-004 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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