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PRILOSEC OTC Drug Profile

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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 suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

Summary for PRILOSEC OTC

International Patents:	48
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	138
Clinical Trials:	22
Patent Applications:	4,110
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

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

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

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

Paragraph IV (Patent) Challenges for PRILOSEC OTC

Drugname	Dosage	Strength	RLD	Date
	Delayed-release Tablets	20 mg
	Delayed-release Capsules	20 mg

International Patents for PRILOSEC OTC

Country	Patent Number	Estimated Expiration
Sweden	9803772
New Zealand	510993
Norway	321275

Supplementary Protection Certificates for PRILOSEC OTC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	2012/048	Ireland		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