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Last Updated: October 20, 2019

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Pantoprazole sodium - Generic Drug Details

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What are the generic drug sources for pantoprazole sodium and what is the scope of freedom to operate?

Pantoprazole sodium is the generic ingredient in three branded drugs marketed by Wyeth Pharms, Akorn Inc, Aurobindo Pharma Ltd, Mylan Labs Ltd, Sandoz Inc, Sun Pharm, Hikma, Actavis Totowa, Amneal Pharms, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Ingenus Pharms Llc, Jubilant Generics, L Perrigo Co, Lannett Co Inc, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Rubicon, Sun Pharm Inds Ltd, Teva, Torrent Pharms, and Wockhardt, and is included in twenty-seven NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pantoprazole sodium has ninety-two patent family members in forty-five countries.

There are forty-eight drug master file entries for pantoprazole sodium. Fifty-three suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for pantoprazole sodium

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Drug Sales Revenue Trends for pantoprazole sodium

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Recent Clinical Trials for pantoprazole sodium

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

SponsorPhase
Mansoura UniversityN/A
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all pantoprazole sodium clinical trials

Recent Litigation for pantoprazole sodium

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 pantoprazole sodium litigation

Generic filers with tentative approvals for PANTOPRAZOLE SODIUM
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial40MGINJECTABLE; INJECTION
  Start Trial  Start TrialEQ 40MG BASE/VIALINJECTABLE; IV (INFUSION)

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for pantoprazole sodium
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
Synonyms for pantoprazole sodium
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
5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Sodium Salt
6-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Sodium Salt
AB0000909
ACT02633
AK326135
AKOS015994677
Anagastra
API0003746
Apton
B-8510-29
B-8610-23/SK&F-96022-Z
BC215353
BY-1023 sodium
By-1023/SK&F-96022
C16H14F2N3NaO4S
C16H16F2N3O4S.Na
CAS-138786-67-1
CCG-100980
CHEBI:50270
CHEMBL1200408
Citrel
Controloc
CPD000469592
DSSTox_CID_24215
DSSTox_GSID_44215
DSSTox_RID_80123
DTXSID7044215
DZ-2352a
FT-0602602
HMS2051L19
HMS3393L19
HMS3715D12
Inipomp
J-516336
J10399
KB-303064
KS-00000GVT
KS-1093
LS-32884
MLS001424073
MolPort-006-069-204
MolPort-006-823-953
NC00230
NCGC00255835-01
Nolpaza
Pantecta
Pantoloc
Pantoprazole Sodium [USAN]
Pantoprazole sodium hydrate
Pantoprazole Sodium Monohydrate
PANTOPRAZOLE SODIUM SALT
Pantoprazole sodium,(S)
Pantoprazole sodium;
Pantorc
Pantozol Control
Peptazol
Protium
Protonix I.V
Protonix IV
Rifun
s4538
S86P671
SAM001246591
SB17369
SC-19214
SCHEMBL3543
SKF96022 sodium
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
Tox21_112996
Tox21_302362
Ulcotenal
YNWDKZIIWCEDEE-UHFFFAOYSA-N
Zurcal

US Patents and Regulatory Information for pantoprazole sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Totowa PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 090797-002 Feb 7, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 200794-001 May 2, 2012 DISCN No No   Start Trial   Start Trial   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
Mylan Labs Ltd PANTOPRAZOLE SODIUM pantoprazole sodium INJECTABLE;IV (INFUSION) 208580-001 May 4, 2018 AP RX No No   Start Trial   Start Trial   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 pantoprazole sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms PROTONIX IV pantoprazole sodium INJECTABLE;IV (INFUSION) 020988-001 Mar 22, 2001   Start Trial   Start Trial
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 020987-002 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for pantoprazole sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Colorcon
Harvard Business School
Mallinckrodt
Dow

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.