You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Moodys
Dow
Baxter
Harvard Business School

Last Updated: April 8, 2020

DrugPatentWatch Database Preview

PROTONIX IV Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

When do Protonix Iv patents expire, and what generic alternatives are available?

Protonix Iv is a drug marketed by Wyeth Pharms and is included in one NDA. There are three patents protecting this drug.

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

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

US ANDA Litigation and Generic Entry Outlook for Protonix Iv

A generic version of PROTONIX IV was approved as pantoprazole sodium by TEVA on August 2nd, 2007.

  Start Trial

Drug patent expirations by year for PROTONIX IV
Drug Prices for PROTONIX IV

See drug prices for PROTONIX IV

Recent Clinical Trials for PROTONIX IV

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

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

See all PROTONIX IV clinical trials

Recent Litigation for PROTONIX IV

Identify potential future generic entrants

District Court Litigation
Case NameDate
Nycomed GmbH v. Apotex Inc.2009-08-14
Nycomed GmbH v. Sandoz Inc.2008-05-16
ALTANA PHARMA AG v. SUN PHARMACEUTICAL INDUSTRIES, LTD.2005-04-13

See all PROTONIX IV litigation

Pharmacology for PROTONIX IV
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
Synonyms for PROTONIX IV
138786-67-1
164579-32-2
1H-Benzimidazole, 5-(difluoromethoxy)-2-(((3,4-dimethoxy-2-pyridinyl)methyl)sulfinyl)-, sodiums salt
1H-Benzimidazole, 5-(difluoromethoxy)-2-(((3,4-dimethoxy-2-pyridinyl)methyl)sulfinyl)-,sodium salt
5-(Difluoromethoxy)-2-(((3,4-dimethoxy-2-pyridinyl)methyl)sulfinyl)-1H-benzimidazole sodium
5-(Difluoromethoxy)-2-(((3,4-dimethoxypyridin-2-yl)methyl)sulfinyl)-1h-benzo[d]imidazole, sodium salt
AB0000909
ACT02633
AK326135
AKOS015852182
AKOS015960812
AKOS015994677
Anagastra
API0003746
Apton
B-8510-29
B-8610-23/SK&F-96022-Z
BCP07444
BY-1023 sodium
By-1023/SK&F-96022
C16H14F2N3NaO4S
C16H16F2N3O4S.Na
CAS-138786-67-1
CCG-100980
CHEBI:50270
CHEMBL1200408
Citrel
Controloc
CPD000469592
CS-3494
DSSTox_CID_24215
DSSTox_GSID_44215
DSSTox_RID_80123
DTXSID7044215
DZ-2352a
FT-0602602
HMS2051L19
HMS3393L19
HMS3715D12
HY-17507A
Inipomp
J-007177
J-516336
J10399
KS-00000GVT
KS-1093
LS-32884
MLS001424073
NC00230
NCGC00255835-01
Pantecta
Pantoloc
Pantoprazole (sodium)
Pantoprazole Sodium
Pantoprazole Sodium [USAN]
Pantoprazole sodium hydrate
PANTOPRAZOLE SODIUM SALT
Pantoprazole sodium sesquihydrate
Pantoprazole sodium,(S)
Pantoprazole sodium;
pantoprazole-sodium
Pantorc
Pantozol Control
Peptazol
Protium
Protonix delayed-release
Protonix DR
Protonix I.V
Protonix I.V.
Q27122012
Rifun
s4538
S86P671
SAM001246591
SB17369
SC-19214
SCHEMBL3543
SKF96022 sodium
SKF96022 sodium hydrate
SMR000469592
sodium 5-(Difluoromethoxy)-2-(((3,4-dimethoxy-2-pyridinyl)methyl)sulfinyl)-1H-benzimidazole
sodium 5-(difluoromethoxy)-2-((3,4-dimethoxypyridin-2-yl)methylsulfinyl)benzo[d]imidazol-1-ide
sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole sesquihydrate
sodium 5-(difluoromethoxy)-2-{[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl}benzimidazol-1-ide
Sodium-[5(difluoromethoxy)-2-[[3,4-dimethoxy-2-pyridyl)-methyl]sulfinyl]-1H-benzimidazole sesquihydrate
sodium;5-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methylsulfinyl]benzimidazol-1-ide
sodium;5-(difluoromethoxy)-2-[(S)-(3,4-dimethoxypyridin-2-yl)methylsulfinyl]benzimidazol-3-ide
Somac
Tox21_112996
Tox21_302362
Ulcotenal
YNWDKZIIWCEDEE-UHFFFAOYSA-N
Zurcal
Paragraph IV (Patent) Challenges for PROTONIX IV
Tradename Dosage Ingredient NDA Submissiondate
PROTONIX IV INJECTABLE;IV (INFUSION) pantoprazole sodium 020988

US Patents and Regulatory Information for PROTONIX IV

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 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 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 IV pantoprazole sodium INJECTABLE;IV (INFUSION) 020988-001 Mar 22, 2001 AP 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

Supplementary Protection Certificates for PROTONIX IV

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
0166287 96C0033 Belgium   Start Trial PRODUCT NAME: EPTACOG ALFA (ACTIVATED); REGISTRATION NO/DATE: EU/1/96/006/002 19960223
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Moodys
Dow
Baxter
Harvard Business School

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 verification 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.