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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
UBS
Queensland Health
Accenture
Colorcon
AstraZeneca
Covington
Cipla
Fish and Richardson

Generated: October 17, 2018

DrugPatentWatch Database Preview

PRILOSEC OTC Drug Profile

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When do Prilosec Otc patents expire, 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.

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

Drug patent expirations by year for PRILOSEC OTC
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
161973-10-0
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)-
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
217087-09-7
3B1-000638
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-1H-1,3-benzimidazol-2-yl (4-methoxy-3,5-dimethyl-2-pyridinyl)methyl sulfoxide
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, magnesium salt (2:1)
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)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-[ methylsulfinyl]-3H-benzoimidazole
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]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)methanesulfinyl]-1H-1,3-benzodiazole
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
95382-33-5
A19447
A810316
A837865
AB0014122
AB1009257
AB2000267
AC-401
AC-4676
AC1L1IIJ
AC1L2XM7
AC1NSJYQ
ACMC-20p1du
AGI-010
AK162396
AKOS005066653
AKOS015895343
AKOS015896379
AKOS025402081
AN-11759
AN-11885
AN-15878
AN-34918
Antra
Antra MUPS
Audazol
AULCER
azol-1-ide
BBL028172
BC203197
BC226373
BDBM50103597
BDBM50241343
Belmazol
BIDD:GT0189
Bio-0888
BPBio1_000425
BRD-A55962179-001-04-9
BSPBio_000385
C07324
C17H19N3O3S
CAS-73590-58-6
CCG-101130
CCG-213517
CCRIS 7099
CE0112
Ceprandal
CHEBI:77260
CHEBI:91766
CHEBI:94401
CHEMBL1503
CHEMBL1567328
cid_4594
CO0037
CPD000058847
CS-1868
CTK8E8954
CTK8I2124
CTK9A5793
D00455
D01XNB
D05259
Danlox
DB00338
Demeprazol
Desec
Dizprazol
DL-462
DM-3458
DR001724
DSSTox_CID_1080
DSSTox_GSID_21080
DSSTox_RID_75929
DTXSID6021080
Dudencer
Elgam
Emeproton
Emilok
Epirazole
Erbolin
Esomeprazole
Esomeprazole magnesium
Esomeprazole magnesium trihydrate
ESOMEPRAZOLE Mg
Esomeprazole Sodium
Esomeprazole sodium salt
Esomeprazole sodium salt hydrate
Esomeprazole(magnesium)
Esomperazole
Exter
F0001-2386
FT-0601585
FT-0652860
FT-0653294
FT-0657297
Gasec
Gastrimut
Gastrogard
Gastroloc
Gibancer
GTPL4279
H 168-68
H 168/68
H 168/68 magnesium
H-168/68
H168/68
HE073137
HE226602
HE316079
HE340315
HE417571
HMS1528I05
HMS1569D07
HMS2052G17
HMS2090E16
HMS2090F11
HMS2096D07
HMS2232B21
HMS2878H13
HMS3269D17
HMS3394G17
HMS3651A11
HS-0055
HSDB 3575
HY-B0113
I06-0705
I06-1976
I14-40975
IDI1_032523
Indurgan
Inhibitron
Inhipump
J-014249
J10125
K253
KB-63582
KS-000001KH
KWORUUGOSLYAGD-UHFFFAOYSA-N
Lensor
Logastric
Lomac
Losec
Losec (TN)
Losec, Omesec, Prilosec, Zegerid, Omeprazole
LS-7629
magnesium 5-methoxy-2-(((4-methoxy-3,5-dimethylpyridin-2-yl)methyl)sulfinyl)benzo[d]imidazol-1-ide 6-methoxy-2-(((4-methoxy-3,5-dimethylpyridin-2-yl)methyl)sulfinyl)benzo[d]imid
magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methylsulfinyl]benzimidazol-1-ide
magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridyl)methylsulfinyl]benzimidazol-1-ide
magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethyl-pyridin-2-yl)methylsulfinyl]benzimidazol-1-ide
magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide
magnesium(2+) bis(5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methanesulfinyl]-1H-1,3-benzodiazol-1-ide)
MAGNESIUM(2+) ION 5-METHOXY-2-[(4-METHOXY-3,5-DIMETHYLPYRIDIN-2-YL)METHANESULFINYL]-1H-1,3-BENZODIAZOL-1-IDE 6-METHOXY-2-[(4-METHOXY-3,5-DIMETHYLPYRIDIN-2-YL)METHANESULFINYL]-1H-1,3-BENZODIAZOL-1-IDE
Maybridge4_002645
MCULE-3224208952
Mepral
MFCD00083192
MFCD06798050
Miol
Miracid
MLS000069373
MLS001076112
MLS001165732
MLS001424148
MLS006010400
MLS006011759
MolPort-003-666-741
MolPort-003-849-702
MolPort-016-633-260
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
Olit
Omapren
Omebeta
Omebeta 20
Omed
Omegast
OMEP
Omepradex
Omepral
Omeprazen
Omeprazol
Omeprazol [INN-Spanish]
omeprazole
Omeprazole (JAN/USP/INN)
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 magnesium (10 mg)
Omeprazole magnesium (USAN)
Omeprazole magnesium [USAN:USP]
Omeprazole magnesium [USAN]
omeprazole magnesium, ep
omeprazole mg
Omeprazole Pellets
OMEPRAZOLE SODIUM
omeprazole sodium bicarbonate
Omeprazole solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Omeprazole, (R)-
Omeprazole, 98% 1g
Omeprazole, analytical reference material
Omeprazole, European Pharmacopoeia (EP) Reference Standard
Omeprazole, pharmaceutical secondary standard; traceable to USP, PhEur and BP
Omeprazole, solid
Omeprazole, United States Pharmacopeia (USP) Reference Standard
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 (TN)
Procelac
Proclor
Prysma
Q-100195
r-omeprazole
R-Omeprazole [USP-RS]
Ramezol
Regulacid
Result
RT-012496
s1389
S51HU491WJ
SAM001246900
SAN-15
Sanamidol
SBI-0206896.P001
SC-15162
SC-72064
SCHEMBL1191
SCHEMBL11995456
SCHEMBL722792
Secrepina
SMR000058847
SMR000550477
SPBio_002306
ST24048844
ST51053319
STK623746
SUBDBMMJDZJVOS-UHFFFAOYSA-N
Tedec Ulceral
TL8005099
Tox21_110686
Tox21_110686_1
Tox21_200509
Ulceral
Ulcesep
Ulcometion
Ulcozol
Ulcsep
Ulsen
Ultop
Ulzol
UNII-426QFE7XLK
UNII-S51HU491WJ
UPCMLD-DP075
UPCMLD-DP075:001
Victrix
Z1672902589
Zefxon
Zegerid
Zepral
Zimor
Zoltum

US Patents and Regulatory Information for PRILOSEC OTC

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 OTC Yes Yes ➤ 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 PRILOSEC OTC

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

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Paragraph IV (Patent) Challenges for PRILOSEC OTC
Drugname Dosage Strength RLD Date
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Delayed-release Capsules 20 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for PRILOSEC OTC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB11/015 United Kingdom ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
11/016 Ireland ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
C/GB01/006 United Kingdom ➤ Sign Up PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
12/048 Ireland ➤ Sign Up 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
C/GB11/013 United Kingdom ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
UBS
Queensland Health
Accenture
Colorcon
AstraZeneca
Covington
Cipla
Fish and Richardson

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