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Last Updated: November 12, 2019

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OMEPRAZOLE - Generic Drug Details

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What are the generic drug sources for omeprazole and what is the scope of freedom to operate?

Omeprazole is the generic ingredient in seven branded drugs marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Breckenridge, Dr Reddys Labs Ltd, Glenmark Generics, Impax Labs, Lannett Co Inc, Lupin Ltd, Mylan, Sandoz, Teva Pharms Usa, Zydus Pharms Usa Inc, Astrazeneca Pharms, Apotex Inc, Dexcel Pharma, Dr Reddys, Sun Pharm, Spil, Covis Pharma Bv, Perrigo R And D, Actavis Elizabeth, Ajanta Pharma Ltd, Aurolife Pharma Llc, Par Pharm, Sciegen Pharms Inc, Zydus Pharms, Santarus Inc, Bayer Healthcare Llc, and Salix, and is included in forty-five NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Omeprazole has eighty-eight patent family members in thirty-seven countries.

There are one hundred and thirty-one drug master file entries for omeprazole. Ninety-six suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for OMEPRAZOLE

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Drug Sales Revenue Trends for OMEPRAZOLE

See drug sales revenues for OMEPRAZOLE

Recent Clinical Trials for OMEPRAZOLE

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

SponsorPhase
Hospital Universitário Oswaldo CruzPhase 2/Phase 3
Infan Industria Quimica Farmaceutica NacionalPhase 2/Phase 3
Oregon Health and Science UniversityPhase 2

See all OMEPRAZOLE clinical trials

Recent Litigation for OMEPRAZOLE

Identify potential future generic entrants

District Court Litigation
Case NameDate
DEXCEL PHARMA TECHNOLOGIES LTD. v. DR. REDDY'S LABORATORIES, LTD.2015-11-12
DEXCEL PHARMA TECHNOLOGIES LTD. v. SUN PHARMA GLOBAL FZE2015-11-11
Astrazeneca AB v. Apotex Corp.2014-01-09

See all OMEPRAZOLE litigation

Generic filers with tentative approvals for OMEPRAZOLE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial40MGCAPSULE, DELAYED REL PELLETS;ORAL
  Start Trial  Start Trial20MGCAPSULE, DELAYED REL PELLETS;ORAL
  Start Trial  Start Trial10MGCAPSULE, DELAYED REL PELLETS;ORAL

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

Pharmacology for OMEPRAZOLE
Medical Subject Heading (MeSH) Categories for OMEPRAZOLE
Synonyms for OMEPRAZOLE
( -)-Omeprazole
(-)-5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]-sulfinyl]-1h-benzimidazole
(.+/-.)-Omeprazole
(+-)-Omeprazole
(+)-5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]-sulfinyl]-1h-benzimidazole
(+)-omeprazole
(omeprazole)5-Methoxy-2-(4-methoxy-3,5-dimethyl-pyridin-2-ylmethanesulfinyl)-1H-benzoimidazole
(R)-Esomeprazole
(RS)-5-Methoxy-2-(4-methoxy-3,5-dimethyl-2-pyridylmethylsulphinyl)benzimidazole
(RS)-6-methoxy-2-((4-methoxy-3,5-dimethylpyridin-2-yl) methylsulfinyl)-1H-benzo[d]imidazole
(s)-omeprazole sodium
(S)-Omeprazole sodium salt hydrate
119141-88-7 (base)
131959-78-9
141O887
161796-78-7
172964-80-6
177541-02-5
1H-Benzimidazole, 5-methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl)-
1H-Benzimidazole, 6-methoxy-2-((R)-((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl)-
2-(((3,5-Dimethyl-4-methoxy-2-pyridyl)methyl)sulfinyl)-5-methoxy-1H-benzimidazole
2-({[3,5-dimethyl-4-(methyloxy)pyridin-2-yl]methyl}sulfinyl)-5-(methyloxy)-1H-benzimidazole
2-(3-methoxy-2,4-dimethylbenzylsulfinyl)-6-methoxy-1H-benzo[d]imidazole
2,3,5-Trimethylpyridine/Omeprazole
5-methoxy 2-[[(4-methoxy-3,5-dimethyl-2-pyrdinyl)-methyl]sulfinyl]-1H-benzimidazole
5-methoxy 2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1 H-benzimidazole
5-methoxy 2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1H-benzimidazole
5-Methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridyl)methyl)sulfinyl)benzimidazole
5-methoxy-2-(((4-methoxy-3,5-dimethylpyridin-2-yl)methyl)sulfinyl)-1H-benzo[d]imidazole
5-methoxy-2-((4-methoxy-3,5-dimethylpyridin-2-yl)
5-methoxy-2-((4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl)-1H-benzo[d]imidazole
5-Methoxy-2-((S)-((4-methoxy-3,5-dimethyl-2- pyridinyl)methyl)sulfinyl)-
5-methoxy-2-(2-(4-methoxy-3,5-dimethylpyridin-2-yl)ethylsulfinyl)-1H-benzo[d]imidazole
5-Methoxy-2-(4-methoxy-3,5-dimethyl-pyridin-2-ylmethanesulfinyl)-1H-benzoimidazole
5-Methoxy-2-(4-methoxy-3,5-dimethyl-pyridin-2-ylmethanesulfinyl)-1H-benzoimidazole (omeprazole)
5-Methoxy-2-(4-methoxy-3,5-dimethyl-pyridin-2-ylmethanesulfinyl)-1H-benzoimidazole(Omeprazole)
5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]sulfinyl- 1H-benzimidazole
5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridyl)methylsulfinyl]-1H-benzimidazole
5-methoxy-2-[(4-methoxy-3,5-dimethyl-pyridin-2-yl)methylsulfinyl]-3H-benzoimidazole
5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methanesulfinyl]-1H-1,3-benzodiazole
5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methanesulfinyl]-3H-1,3-benzodiazole
5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1H-benzimidazole
5-Methoxy-2-[(RS)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl]-1H-benzimidazole
5-methoxy-2-[[(3,5-dimethyl-4-methoxy-2-pyridyl)methyl]sulfinyl]-1H-benzimidazole
5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole
5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole; Antra; Losec
5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulphinyl]-1H-benzimidazole
5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]sulfinyl]-benzimidazole
5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]sulfinyl]benzimidazole
5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]sulfonyl]benzimidazole
5-methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]1H-benzimidazole
5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methane]sulfinyl}-1H-1,3-benzodiazole
5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole
5-Methoxy-2[(4-methoxy-3,5-dimethyl-2-pyridyl)methylsulfinyl]-1H-benzimidazole
6-methoxy-2-(((4-methoxy-3,5-dimethylpyridin-2-yl)methyl)sulfinyl)-1H-benzo[d]imidazole
6-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methylsulfinyl]-1H-benzimidazole
6-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridyl)methylsulfinyl]-1H-benzimidazole
6-methoxy-2-[(4-methoxy-3,5-dimethyl-pyridin-2-yl)methylsulfinyl]-1H-benzimidazole
6-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1H-benzimidazole
6-Methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole sodium salt
6-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1h-benzimidazole
6-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1h-benzimidazole
6-methoxy-2-[[(4-methoxy-3,5dimethyl-2-pyridinyl)-methyl]sulfinyl]-1h-benzimidazole
6-methoxy-2-[[(4-methoxy3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1h-benzimidazole
6-methoxy-2-[[(4methoxy-3,5-dimethyl2-pyridinyl)methyl]sulfinyl]-1h-benzimidazole
6-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methane]sulfinyl}-1H-1,3-benzodiazole
668985-31-7 (Mg)
73590-58-6
A19447
A837865
AB0014122
AB1009257
AC-401
AC-4676
AC1L1IIJ
ACMC-20p1du
AGI-010
AK162396
AKOS005066653
AKOS015895343
AN-11759
AN-15878
Antra
Antra MUPS
Audazol
AULCER
BBL028172
BC203197
BC226373
BCP05852
BCP13592
BCP21299
BDBM50103597
BDBM50241343
Belmazol
BIDD:GT0189
BPBio1_000425
BRD-A55962179-001-04-9
BRD-A55962179-001-08-0
BRD-A55962179-001-20-5
BRD-A88691025-001-07-4
BSPBio_000385
C07324
C17H19N3O3S
CAS-73590-58-6
CCG-101130
CCG-213517
CCRIS 7099
Ceprandal
CHEBI:77260
CHEBI:91766
CHEMBL1503
cid_4594
CO0037
CPD000058847
CS-1868
CTK8I2124
CTK9A5793
D00455
Danlox
DB00338
Demeprazol
Desec
Dizprazol
DL-462
DM-3458
DSSTox_CID_1080
DSSTox_GSID_21080
DSSTox_RID_75929
DTXSID6021080
Dudencer
Elgam
Emeproton
Emilok
Epirazole
Erbolin
Esomeprazole
Esomeprazole Sodium
Esomeprazole sodium salt
Esomeprazole sodium salt hydrate
Esomperazole
Exter
F0001-2386
FT-0601585
FT-0652860
FT-0653294
Gasec
Gastrimut
Gastrogard
Gastroloc
Gibancer
GTPL4279
H 168-68
H 168/68
H 199
H-168/68
H168/68
HMS1528I05
HMS1569D07
HMS2052G17
HMS2090E16
HMS2090F11
HMS2096D07
HMS2232B21
HMS3269D17
HMS3394G17
HMS3651A11
HMS3713D07
HS-0055
HSDB 3575
HY-B0113
I06-0705
I14-40975
IDI1_032523
Indurgan
Inhibitron
Inhipump
J10125
K253
KB-63582
KS-000001KH
Lensor
Logastric
Lomac
Losec
LS-7629
Maybridge4_002645
MCULE-3224208952
Mepral
MFCD00083192
MFCD00083192 (98%)
Miol
Miracid
MLS000069373
MLS001076112
MLS001424148
MLS006010400
MLS006011759
MolPort-003-666-741
MolPort-003-849-702
Mopral
Morecon
NC00380
NCGC00016925-01
NCGC00016925-02
NCGC00016925-03
NCGC00016925-04
NCGC00016925-05
NCGC00016925-06
NCGC00016925-07
NCGC00016925-08
NCGC00016925-10
NCGC00016925-11
NCGC00021522-03
NCGC00021522-04
NCGC00021522-05
NCGC00258063-01
NE55490
Nexiam
Nexium
Nexium IV
Nilsec
Nopramin
NSC-751450
NSC-759192
NSC751450
NSC759192
Nuclosina
O0359
Ocid
Olexin
Omapren
Omebeta 20
Omed
Omegast
OMEP
Omepradex
Omepral
Omeprazen
Omeprazol
Omeprazol [INN-Spanish]
Omeprazole (JP17/USP/INN)
Omeprazole (Prilosec)
Omeprazole [USAN:INN:BAN:JAN]
Omeprazole [USAN:USP:INN:BAN:JAN]
Omeprazole delayed-release
Omeprazole for peak identification, European Pharmacopoeia (EP) Reference Standard
Omeprazole magnesium
Omeprazole Pellets
Omeprazole solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Omeprazole, (R)-
Omeprazole, 98+%
Omeprazole, analytical reference material
Omeprazole, British Pharmacopoeia (BP) Reference Standard
Omeprazole, European Pharmacopoeia (EP) Reference Standard
Omeprazole, Pharmaceutical Secondary Standard; Certified Reference Material
Omeprazole, solid
Omeprazole, United States Pharmacopeia (USP) Reference Standard
Omeprazole,(S)
Omeprazolum
Omeprazolum [INN-Latin]
Omeprazon
Omeprazone
Omeprol
Omerprazole
Omesec
Omesek
Omez
Omezol
Omezolan
Omid
Omisec
Omizac
Ompanyt
Omperazole
OMZ
Opera_ID_1863
Ortanol
Osiren
Ozoken
Paprazol
Parizac
Pepticum
Pepticus
Peptilcer
Pharmakon1600-01505693
Prazentol
Prazidec
Prazolit
Prestwick_808
Prestwick0_000493
Prestwick1_000493
Prestwick2_000493
Prestwick3_000493
Prilosec
Prilosec (TN)
Prilosec OTC
Procelac
Proclor
Prysma
r-omeprazole
R-Omeprazole [USP-RS]
Ramezol
Regulacid
Result
s1389
S51HU491WJ
SAM001246900
SAN-15
Sanamidol
SBI-0206896.P001
SC-15162
SCHEMBL1191
SCHEMBL11995456
Secrepina
SMR000058847
SPBio_002306
SR-01000003003
SR-01000003003-4
SR-01000003003-7
SR-01000003003-8
ST24048844
STK623746
SUBDBMMJDZJVOS-UHFFFAOYSA-N
SW196942-4
SY077145
Tedec Ulceral
TL8005099
Tox21_110686
Tox21_110686_1
Tox21_200509
Ulceral
Ulcesep
Ulcometion
Ulcozol
Ulcsep
Ulsen
Ultop
Ulzol
UNII-S51HU491WJ
UPCMLD-DP075
UPCMLD-DP075:001
Victrix
Z1672902589
Zefxon
Zegerid
Zepral
Zimor
Zoltum
Paragraph IV (Patent) Challenges for OMEPRAZOLE
Tradename Dosage Ingredient NDA Submissiondate
OMEPRAZOLE TABLET, DELAYED RELEASE;ORAL omeprazole 022032
PRILOSEC CAPSULE, DELAYED REL PELLETS;ORAL omeprazole 019810

US Patents and Regulatory Information for OMEPRAZOLE

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 OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 203270-003 Aug 19, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995 DISCN Yes No   Start Trial   Start Trial   Start Trial
Sciegen Pharms Inc OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 207476-001 Dec 6, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Breckenridge OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 203481-002 Jul 3, 2017 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 OMEPRAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995   Start Trial   Start Trial
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-001 Sep 14, 1989   Start Trial   Start Trial
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-002 Jan 15, 1998   Start Trial   Start Trial
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-001 Sep 14, 1989   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for OMEPRAZOLE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 SPC/GB11/015 United Kingdom   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957 2012/048 Ireland   Start Trial PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
1411900 2011/016 Ireland   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
0984957 SPC/GB11/013 United Kingdom   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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