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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
UBS
QuintilesIMS
Mallinckrodt
McKesson
Moodys
US Army
Daiichi Sankyo

Generated: May 24, 2018

DrugPatentWatch Database Preview

PRILOSEC Drug Profile

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When do Prilosec patents expire, and when can generic versions of Prilosec launch?

Prilosec is a drug marketed by Astrazeneca Pharms and Covis Pharma Bv and is included in three NDAs. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred patent family members in thirty-eight countries.

The generic ingredient in PRILOSEC is omeprazole magnesium. There are one hundred and twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Drug patent expirations by year for PRILOSEC
Pharmacology for PRILOSEC
Synonyms for PRILOSEC
( -)-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)-
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
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-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)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
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
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
Ceprandal
CHEBI:77260
CHEBI:91766
CHEMBL1503
cid_4594
CO0037
CPD000058847
CS-1868
CTK8I2124
CTK9A5793
D00455
D01XNB
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 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-168/68
H168/68
HE226602
HE340315
HE417571
HMS1528I05
HMS1569D07
HMS2052G17
HMS2090E16
HMS2090F11
HMS2096D07
HMS2232B21
HMS3269D17
HMS3394G17
HMS3651A11
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
Losec (TN)
Losec, Omesec, Prilosec, Zegerid, Omeprazole
LS-7629
Maybridge4_002645
MCULE-3224208952
Mepral
MFCD00083192
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
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 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 (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
ST24048844
STK623746
SUBDBMMJDZJVOS-UHFFFAOYSA-N
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

US Patents and Regulatory Information for PRILOSEC

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 omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-001 Sep 14, 1989 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-002 Jan 15, 1998 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-001 Sep 14, 1989 ➤ Sign Up ➤ Sign Up
Covis Pharma Bv PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056-002 Mar 20, 2008 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-002 Jan 15, 1998 ➤ 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
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2012-03-30
➤ Subscribe Delayed-release Capsules 20 mg ➤ Subscribe 2007-03-19

Non-Orange Book US Patents for PRILOSEC

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,384,059 Crystalline form of omeprazole ➤ Sign Up
7,514,560 Crystalline form of omeprazole ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for PRILOSEC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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/GB11/013 United Kingdom ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
C/GB11/015 United Kingdom ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Dow
Moodys
Merck
Colorcon
Baxter
Express Scripts
Cantor Fitzgerald
Cipla

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.