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 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-one 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:	71
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

See drug prices for pantoprazole sodium

Drug Sales Revenue Trends for pantoprazole sodium

See drug sales revenues for pantoprazole sodium

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
Fundação de Amparo à Pesquisa do Estado de 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
Epic Pharma Llc	PANTOPRAZOLE SODIUM	pantoprazole sodium	INJECTABLE;INTRAVENOUS	079197-001	Nov 8, 2012	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mankind Pharma	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	215880-002	Apr 25, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ingenus Pharms Llc	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	211368-001	Mar 1, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mankind Pharma	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	215880-001	Jul 26, 2022	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 IV	pantoprazole sodium	INJECTABLE;INTRAVENOUS	020988-001	Mar 22, 2001	⤷ 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
Costa Rica	8318	FORMULACIONES DE MULTIPLES PARTICULAS DE PANTOPRAZOL	⤷ Sign Up
Ukraine	83255	СОСТАВ ПАНТОПРАЗОЛА, КОТОРЫЙ СОСТОИТ ИЗ МНОЖЕСТВА ЧАСТИЧЕК;СКЛАД ПАНТОПРАЗОЛУ, ЩО СКЛАДАЄТЬСЯ З МНОЖИНИ ЧАСТИНОК (PANTOPRAZOLE MULTIPARTICULATE FORMULATIONS)	⤷ Sign Up
Peru	20050960	FORMULACIONES DE MULTIPARTICULAS DE PANTOPRAZOL	⤷ Sign Up
New Zealand	581267	Pantoprazole multiparticulate formulations	⤷ 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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