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PRILOSEC OTC Drug Profile

Which patents cover Prilosec Otc, and what generic alternatives are available?

Prilosec Otc is a drug marketed by Astrazeneca Pharms and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has forty-eight patent family members in nineteen countries.

The generic ingredient in PRILOSEC OTC is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

US ANDA Litigation and Generic Entry Outlook for Prilosec Otc

A generic version of PRILOSEC OTC was approved as omeprazole magnesium by DR REDDYS LABS LTD on January 28^th, 2020.

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Summary for PRILOSEC OTC

International Patents:	48
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	148
Clinical Trials:	22
Patent Applications:	4,159
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PRILOSEC OTC
Drug Sales Revenues:	Drug sales revenues for PRILOSEC OTC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PRILOSEC OTC
DailyMed Link:	PRILOSEC OTC at DailyMed

Drug patent expirations by year for PRILOSEC OTC

Recent Clinical Trials for PRILOSEC OTC

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

Sponsor	Phase
Corcept Therapeutics	Phase 1
The University of Texas Health Science Center at San Antonio	Phase 0
AstraZeneca	Phase 1

See all PRILOSEC OTC clinical trials

Recent Litigation for PRILOSEC OTC

Identify potential future generic entrants

District Court Litigation

Case Name	Date
DR. REDDY'S LABORATORIES, INC. v. ASTRAZENECA AB	2018-11-12
AUROBINDO PHARMA LIMITED v. ASTRAZENECA AB	2016-08-18
ASTRAZENECA AB v. PERRIGO COMPANY PLC	2015-02-04

See all PRILOSEC OTC litigation

Synonyms for PRILOSEC OTC

( -)-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
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)
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 PRILOSEC OTC

Tradename	Dosage	Ingredient	NDA	Submissiondate
PRILOSEC OTC	TABLET, DELAYED RELEASE;ORAL	omeprazole magnesium	021229	2012-03-30
PRILOSEC OTC	TABLET, DELAYED RELEASE;ORAL	omeprazole magnesium	021229	2007-03-19

US Patents and Regulatory Information for PRILOSEC OTC

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Pharms	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003		OTC	Yes	Yes	Start Trial	Start Trial				Start Trial
Astrazeneca Pharms	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003		OTC	Yes	Yes	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 PRILOSEC OTC

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Pharms	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003	Start Trial	Start Trial
Astrazeneca Pharms	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003	Start Trial	Start Trial
Astrazeneca Pharms	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003	Start Trial	Start Trial
Astrazeneca Pharms	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003	Start Trial	Start Trial
Astrazeneca Pharms	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003	Start Trial	Start Trial
Astrazeneca Pharms	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for PRILOSEC OTC

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Country	Patent Number	Estimated Expiration
Japan	4610086	Start Trial
Canada	2347981	Start Trial
Japan	2002529397	Start Trial
Norway	20012222	Start Trial
Brazil	9915087	Start Trial
Spain	2201837	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for PRILOSEC OTC

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	SPC/GB11/015	United Kingdom	Start Trial	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
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
0124495	SPC/GB01/006	United Kingdom	Start Trial	PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
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