PROTONIX IV Drug Patent Profile

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 and one Paragraph IV challenge.

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. Sixty-two suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Protonix Iv

A generic version of PROTONIX IV was approved as pantoprazole sodium by DR REDDYS LABS LTD on January 19^th, 2011.

Summary for PROTONIX IV

International Patents:	58
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	32
Patent Applications:	792
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PROTONIX IV
DailyMed Link:	PROTONIX IV at DailyMed

See drug prices for PROTONIX IV

Recent Clinical Trials for PROTONIX IV

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

Sponsor	Phase
Pfizer	Phase 2
Mirati Therapeutics Inc.	Phase 1
Assiut University	Phase 2

See all PROTONIX IV clinical trials

Pharmacology for PROTONIX IV

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PROTONIX IV

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 PROTONIX IV

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PROTONIX IV	For Injection	pantoprazole sodium	40 mg/vial	020988	1	2005-04-07

US Patents and Regulatory Information for PROTONIX IV

PROTONIX IV is protected by two US patents.

Patents protecting 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;INTRAVENOUS	020988-001	Mar 22, 2001	AP	RX	Yes	Yes
Wyeth Pharms	PROTONIX IV	pantoprazole sodium	INJECTABLE;INTRAVENOUS	020988-001	Mar 22, 2001	AP	RX	Yes	Yes
Wyeth Pharms	PROTONIX IV	pantoprazole sodium	INJECTABLE;INTRAVENOUS	020988-001	Mar 22, 2001	AP	RX	Yes	Yes

Expired US Patents for PROTONIX IV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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 IV	pantoprazole sodium	INJECTABLE;INTRAVENOUS	020988-001	Mar 22, 2001
Wyeth Pharms	PROTONIX IV	pantoprazole sodium	INJECTABLE;INTRAVENOUS	020988-001	Mar 22, 2001

International Patents for PROTONIX IV

See the table below for patents covering PROTONIX IV around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	201188
Canada	1254215	DIALKOXYPIRIDINES, ET LEUR PREPARATION (DIALKOXYPYRIDINES AND PROCESS FOR THEIR PREPARATION)
New Zealand	212415	2-BENZIMIDAZOLYL 2-PYRIDYLMETHYLSULPHIDE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS
South Korea	20080003010
Czech Republic	304348	Způsob výroby lyofilizovaného prostředku (Process for preparing lyophilized preparation)
Israel	75400	DIALKOXYPYRIDINE METHYL(SULFINYL OR SULFONYL)BENZIMIDAZOLES,PROCESSES FOR THE PREPARATION THEREOF AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME

Supplementary Protection Certificates for PROTONIX IV

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	96C0033	Belgium		PRODUCT NAME: EPTACOG ALFA (ACTIVATED); REGISTRATION NO/DATE: EU/1/96/006/002 19960223
0166287	96C0032	Belgium		PRODUCT NAME: PANTOPRAZOL. NATR. SESQUIHYDRAS PANTOPRAZOLE; NAT. REGISTRATION NO/DATE: 127 IS 98 F 3 19960222; FIRST REGISTRATION: SE 12131 19940506