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Last Updated: October 23, 2019

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PROTONIX Drug Profile

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Which patents cover Protonix, and what generic alternatives are available?

Protonix is a drug marketed by Wyeth Pharms and is included in three NDAs. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-four patent family members in twenty-seven countries.

The generic ingredient in PROTONIX is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.

Drug patent expirations by year for PROTONIX
Drug Prices for PROTONIX

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Drug Sales Revenue Trends for PROTONIX

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Recent Clinical Trials for PROTONIX

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SponsorPhase
Assiut UniversityPhase 1
Assiut UniversityPhase 2
University of Southern CaliforniaPhase 4

See all PROTONIX clinical trials

Recent Litigation for PROTONIX

Identify potential future generic entrants

District Court Litigation
Case NameDate
Nycomed GmbH v. Apotex Inc.2009-08-14
ALTANA PHARMA AG v. SUN PHARMACEUTICAL INDUSTRIES, LTD.2005-04-13
ALTANA PHARMA AG v. TEVA PHARMACEUTICALS USA INC

See all PROTONIX litigation

Pharmacology for PROTONIX
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
Synonyms for PROTONIX
(-)-Pantoprazole
102625-70-7
142678-35-1
1H-Benzimidazole, 5-(difluoromethoxy)-2-(((3,4-dimethoxy-2-pyridinyl)methyl)sulfinyl)-
1H-Benzimidazole, 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-
1H-Benzimidazole, 6-(difluoromethoxy)-2-((S)-((3,4-dimethoxy-2-pyridinyl)methyl)sulfinyl)-
2-(((3,4-Dimethoxy-2-pyridinyl)methyl)-sulfinyl)-5-methyl-1H-1,3-benzimidazole
5-(Difluoromethoxy)-2-(((3,4-dimethoxy-2-pyridyl)methyl)sulfinyl)benzimidazole
5-(difluoromethoxy)-2-(((3,4-dimethoxypyridin-2-yl)methyl)sulfinyl)-1H-benzo[d]imidazole
5-(difluoromethoxy)-2-((3,4-dimethoxypyridin-2-yl)
5-(difluoromethoxy)-2-((3,4-dimethoxypyridin-2-yl)methylsulfinyl)-1H-benzo[d]imidazole
5-(difluoromethoxy)-2-[(3,4-dimethoxy-2-pyridyl)methylsulfinyl]-1H-benzimidazole
5-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methanesulfinyl]-3H-1,3-benzodiazole
5-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methylsulfinyl]-1H-benzimidazole
5-(DIFLUOROMETHOXY)-2-[[(3,4-DIMETHOXY-2-PYRIDINYL)METHYL]SULFINYL]-1H-BENZIMIDAZOLE(Sodium salt form)
5-(difluoromethoxy)-2-{[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole
5-Difluoromethoxy-2-(3,4-dimethoxy-pyridin-2-ylmethanesulfinyl)-1H-benzoimidazole
5-DifluoroMethoxy-2-[(3,4-diMethoxy-2-pyridinyl)Methyl-sulfinyl]-1H-benziMidazole
5-Difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)methylsulfinyl]-1H-benzimidazole
6-(difluoromethoxy)-2-((3,4-dimethoxypyridin-2-yl)methylsulfinyl)-1H-benzo[d]imidazole
6-(difluoromethoxy)-2-[(3,4-dimethoxy-2-pyridinyl)methylsulfinyl]-1H-benzimidazole
6-(difluoromethoxy)-2-[(3,4-dimethoxy-2-pyridyl)methylsulfinyl]-1H-benzimidazole
6-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methanesulfinyl]-1H-1,3-benzodiazole
6-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methylsulfinyl]-1H-benzimidazole
6-(difluoromethoxy)-2-{[(3,4-dimethoxypyridin-2-yl)methane]sulfinyl}-1H-1,3-benzodiazole
6-[bis(fluoranyl)methoxy]-2-[(3,4-dimethoxypyridin-2-yl)methylsulfinyl]-1H-benzimidazole
625P707
A800593
AB0012612
AB01275513_02
AB01275513-01
AB2000509
AC-679
AC1L1IPJ
AKOS015894910
AKOS034831879
AN-15599
apo-Pantoprazole
Astropan
B4720
BC203892
BCP21400
BDBM50241342
BIDD:GT0003
BRD-A22380646-001-01-5
BRD-A22380646-001-02-3
BSPBio_002320
BY 1023
BY-1023
C11806
C16H15F2N3O4S
CAS-102625-70-7
CCG-213558
CHEBI:7915
CHEMBL1502
Controloc Control
CS-3161
CTK8E8734
D05353
DB00213
DSSTox_CID_3416
DSSTox_GSID_23416
DSSTox_RID_77019
DTXSID4023416
EC 600-331-6
FT-0602547
GTPL7260
HMS1922H20
HMS2090H03
HMS2093F14
HSDB 7292
HY-17507
I06-0068
IQPSEEYGBUAQFF-UHFFFAOYSA-N
J-000744
L-Pantoprazole
LS-32883
MCULE-8988409059
MFCD00870182
MLS003882559
MolPort-003-666-752
MolPort-005-933-577
NCGC00095188-01
NCGC00095188-02
NCGC00095188-03
NCGC00095188-04
NCGC00095188-05
NSC-759257
NSC759257
Pantecta Control
Pantoloc
Pantoloc Control
Pantoprazol
Pantoprazol [INN-Spanish]
pantoprazole
Pantoprazole (Protonix)
Pantoprazole (USAN/INN)
Pantoprazole [USAN:BAN:INN]
Pantoprazole [USAN:INN:BAN]
Pantoprazole Na
Pantoprazole sodium hydrate
Pantoprazole-d6 (Rac)
Pantoprazole, S-
Pantoprazolum
Pantoprazolum [INN-Latin]
Pantoprozole
Pantor
Pantozol
Pantozol Control
Panyocid
Pharmakon1600-01505818
Protium
Protonix I.V.
Protonix IV
RT-014935
S-(-)-Pantoprazole
s2105
SB17368
SBI-0206873.P001
SCHEMBL29465
SK-96022
SK&F 96022
SK&F-96022
SKF-96022
SMR002533625
Somac Control
SPECTRUM1505818
SR-01000763715
SR-01000763715-3
STL451032
SX78SGO2TV
TL8000127
Tox21_111477
Tox21_111477_1
UNII-SX78SGO2TV
W-1227
Zosecta

US Patents and Regulatory Information for PROTONIX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Pharms PROTONIX pantoprazole sodium FOR SUSPENSION, DELAYED RELEASE;ORAL 022020-001 Nov 14, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Wyeth Pharms PROTONIX IV pantoprazole sodium INJECTABLE;IV (INFUSION) 020988-001 Mar 22, 2001 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Wyeth Pharms PROTONIX pantoprazole sodium FOR SUSPENSION, DELAYED RELEASE;ORAL 022020-001 Nov 14, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Wyeth Pharms PROTONIX IV pantoprazole sodium INJECTABLE;IV (INFUSION) 020988-001 Mar 22, 2001 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Wyeth Pharms PROTONIX pantoprazole sodium FOR SUSPENSION, DELAYED RELEASE;ORAL 022020-001 Nov 14, 2007 RX Yes Yes   Start Trial   Start Trial Y   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 PROTONIX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms PROTONIX pantoprazole sodium FOR SUSPENSION, DELAYED RELEASE;ORAL 022020-001 Nov 14, 2007   Start Trial   Start Trial
Wyeth Pharms PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-001 Feb 2, 2000   Start Trial   Start Trial
Wyeth Pharms PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-002 Jun 12, 2001   Start Trial   Start Trial
Wyeth Pharms PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-002 Jun 12, 2001   Start Trial   Start Trial
Wyeth Pharms PROTONIX pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 020987-001 Feb 2, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for PROTONIX
Drugname Dosage Strength RLD Date
➤ Subscribe Delayed-release Tablets 20 mg and 40 mg ➤ Subscribe   Start Trial

Supplementary Protection Certificates for PROTONIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0166287 96C0032 Belgium   Start Trial PRODUCT NAME: PANTOPRAZOL. NATR. SESQUIHYDRAS PANTOPRAZOLE; NAT. REGISTRATION NO/DATE: 127 IS 98 F 3 19960222; FIRST REGISTRATION: SE 12131 19940506
0166287 SPC/GB96/056 United Kingdom   Start Trial PRODUCT NAME: PANTOPRAZOLE AND ITS SALTS, HYDRATES AND HYDRATES OF ITS SALTS; REGISTERED: SE SE12131 19940506; UK 04889/0010 19960604
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Merck
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Boehringer Ingelheim
Mallinckrodt
Colorcon
Baxter

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