PANTOPRAZOLE SODIUM - Generic Drug Details

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, Acic Pharms, Aspiro, Be Pharms, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Knack, Meitheal, Mylan Labs Ltd, Sandoz, 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 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. Sixty-nine 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:	36
NDAs:	40
Drug Master File Entries:	48
Finished Product Suppliers / Packagers:	69
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	23
Patent Applications:	6,382
Formulation / Manufacturing:	see details
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

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
		40MG	INJECTABLE; INJECTION
		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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	202038-002	Sep 28, 2012	AB	RX	No	No
Wyeth Pharms	PROTONIX IV	pantoprazole sodium	INJECTABLE;INTRAVENOUS	020988-001	Mar 22, 2001	AP	RX	Yes	Yes
Aspiro	PANTOPRAZOLE SODIUM	pantoprazole sodium	INJECTABLE;INTRAVENOUS	213778-001	May 18, 2022	AP	RX	No	No
Hetero Labs Ltd V	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	202882-002	Sep 10, 2014	AB	RX	No	No
Granules	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	217282-001	Dec 11, 2023	AB	RX	No	No
Gland Pharma Ltd	PANTOPRAZOLE SODIUM	pantoprazole sodium	INJECTABLE;INTRAVENOUS	204400-001	May 18, 2022	AP	RX	No	No
Wyeth Pharms	PROTONIX	pantoprazole sodium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022020-001	Nov 14, 2007	AB	RX	Yes	Yes					Y

Expired US Patents for PANTOPRAZOLE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	PROTONIX	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	020987-002	Jun 12, 2001
Wyeth Pharms	PROTONIX IV	pantoprazole sodium	INJECTABLE;INTRAVENOUS	020988-001	Mar 22, 2001
Wyeth Pharms	PROTONIX	pantoprazole sodium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022020-001	Nov 14, 2007
Wyeth Pharms	PROTONIX IV	pantoprazole sodium	INJECTABLE;INTRAVENOUS	020988-001	Mar 22, 2001
Wyeth Pharms	PROTONIX IV	pantoprazole sodium	INJECTABLE;INTRAVENOUS	020988-001	Mar 22, 2001
Wyeth Pharms	PROTONIX	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	020987-001	Feb 2, 2000
Wyeth Pharms	PROTONIX	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	020987-002	Jun 12, 2001

International Patents for PANTOPRAZOLE SODIUM

Country	Patent Number	Title	Estimated Expiration
Poland	1667660
Japan	4789806
Colombia	5690538	FORMULACIONES DE MULTIPLES PARTICULAS DE PANTOPRAZOL
Taiwan	200524643	Pantoprazole multiparticulate formulations
Russian Federation	2006114690	СОСТАВЫ ПАНТОПРАЗОЛА, СОСТОЯЩИЕ ИЗ МНОЖЕСТВА ЧАСТИЦ
China	1886119	Pantoprazole multiparticulate formulations
European Patent Office	1667660	PREPARATIONS MULTIPARTICULAIRES DE PANTOPRAZOLE (PANTOPRAZOLE MULTIPARTICULATE FORMULATIONS)

Supplementary Protection Certificates for PANTOPRAZOLE SODIUM

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