PANTOPRAZOLE SODIUM - Generic Drug Details

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What are the generic drug sources for pantoprazole sodium and what is the scope of patent protection?

Pantoprazole sodium is the generic ingredient in four branded drugs marketed by Ajanta Pharma Ltd, Annora Pharma, Dexcel, Sun Pharm, Wyeth Pharms, Aspiro, Be Pharms, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Hangzhou Zhongmei, Knack, Meitheal, Norvium Bioscience, Sandoz, Fresenius Kabi Usa, Hikma, Baxter Hlthcare Corp, Actavis Totowa, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Granules, Hetero Labs Ltd V, Ingenus Pharms Llc, Jubilant Generics, L Perrigo Co, Lannett Co Inc, Macleods Pharms Ltd, Mankind Pharma, Mylan Pharms Inc, Orbion Pharms, Rubicon, Sun Pharm Inds Ltd, Teva, Torrent Pharms, and Wockhardt Bio Ag, and is included in forty-one NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pantoprazole sodium has thirty-five patent family members in twenty-eight countries.

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

Summary for PANTOPRAZOLE SODIUM

International Patents:	35
US Patents:	4
Tradenames:	4
Applicants:	37
NDAs:	41
Drug Master File Entries:	48
Finished Product Suppliers / Packagers:	70
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	23
Patent Applications:	7,225
Drug Prices:	Drug price trends for PANTOPRAZOLE SODIUM
Drug Sales Revenues:	Drug sales revenues for PANTOPRAZOLE SODIUM
What excipients (inactive ingredients) are in PANTOPRAZOLE SODIUM?	PANTOPRAZOLE SODIUM excipients list
DailyMed Link:	PANTOPRAZOLE SODIUM at DailyMed

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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

Sponsor	Phase
Alexandria University	Phase 3
Mansoura University	Phase 1/Phase 2
Federal University of São Paulo	Phase 4

See all PANTOPRAZOLE SODIUM clinical trials

Generic filers with tentative approvals for PANTOPRAZOLE SODIUM

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	40MG	INJECTABLE; INJECTION
⤷ Sign Up	⤷ Sign Up	EQ 40MG BASE/VIAL	POWDER;INTRAVENOUS

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 Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PANTOPRAZOLE SODIUM

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for PANTOPRAZOLE SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PROTONIX	for Delayed-release Oral Suspension	pantoprazole sodium	40 mg	022020	1	2019-09-13
PROTONIX IV	For Injection	pantoprazole sodium	40 mg/vial	020988	1	2005-04-07
PROTONIX	Delayed-release Tablets	pantoprazole sodium	20 mg and 40 mg	020987		2004-02-02

US Patents and Regulatory Information for PANTOPRAZOLE SODIUM

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hangzhou Zhongmei	PANTOPRAZOLE SODIUM	pantoprazole sodium	INJECTABLE;INTRAVENOUS	209524-001	Aug 30, 2021	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Meitheal	PANTOPRAZOLE SODIUM	pantoprazole sodium	INJECTABLE;INTRAVENOUS	215860-001	Aug 29, 2022	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Ltd	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	077619-002	Jan 19, 2011	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd V	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	202882-002	Sep 10, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	PROTONIX	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	020987-001	Feb 2, 2000	⤷ Sign Up	⤷ Sign Up
Wyeth Pharms	PROTONIX	pantoprazole sodium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022020-001	Nov 14, 2007	⤷ Sign Up	⤷ Sign Up
Wyeth Pharms	PROTONIX	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	020987-001	Feb 2, 2000	⤷ Sign Up	⤷ Sign Up
Wyeth Pharms	PROTONIX IV	pantoprazole sodium	INJECTABLE;INTRAVENOUS	020988-001	Mar 22, 2001	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for PANTOPRAZOLE SODIUM

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Country	Patent Number	Title	Estimated Expiration
Guatemala	200400194	FORMULACIONES DE MULTIPARTICULAS DE PANTOPRAZOL.	⤷ Sign Up
Russian Federation	2006114690	СОСТАВЫ ПАНТОПРАЗОЛА, СОСТОЯЩИЕ ИЗ МНОЖЕСТВА ЧАСТИЦ	⤷ Sign Up
Taiwan	I372066		⤷ Sign Up
Mexico	266708	FORMULACIONES DE MICROPARTICULAS DE PANTOPRAZOL.	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PANTOPRAZOLE SODIUM

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0166287	96C0032	Belgium	⤷ Sign Up	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	⤷ Sign Up	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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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.