SODIUM NITRITE Drug Patent Profile

Which patents cover Sodium Nitrite, and when can generic versions of Sodium Nitrite launch?

Sodium Nitrite is a drug marketed by Hope Pharms and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-eight patent family members in fourteen countries.

The generic ingredient in SODIUM NITRITE is sodium nitrite. There are one thousand four hundred and seventy-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium nitrite profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sodium Nitrite

A generic version of SODIUM NITRITE was approved as sodium nitrite by HOPE PHARMS on February 14^th, 2012.

Summary for SODIUM NITRITE

International Patents:	28
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	58
Patent Applications:	1,397
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in SODIUM NITRITE?	SODIUM NITRITE excipients list
DailyMed Link:	SODIUM NITRITE at DailyMed

Recent Clinical Trials for SODIUM NITRITE

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

Sponsor	Phase
University of Alabama at Birmingham	Early Phase 1
University of Alabama at Birmingham	Phase 1
National Institutes of Health (NIH)	Phase 1

See all SODIUM NITRITE clinical trials

Medical Subject Heading (MeSH) Categories for SODIUM NITRITE

Food Preservatives

Indicators and Reagents

Anatomical Therapeutic Chemical (ATC) Classes for SODIUM NITRITE

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for SODIUM NITRITE

SODIUM NITRITE is protected by three US patents.

Patents protecting SODIUM NITRITE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hope Pharms	SODIUM NITRITE	sodium nitrite	SOLUTION;INTRAVENOUS	203922-001	Feb 14, 2012		RX	Yes	Yes			Y
Hope Pharms	SODIUM NITRITE	sodium nitrite	SOLUTION;INTRAVENOUS	203922-001	Feb 14, 2012		RX	Yes	Yes			Y	Y

International Patents for SODIUM NITRITE

See the table below for patents covering SODIUM NITRITE around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	2395834
Hungary	E044781
Cyprus	1121939
Spain	2743303
Denmark	3569237
Cyprus	1124426

Supplementary Protection Certificates for SODIUM NITRITE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203431	2015/009	Ireland		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
2666774	CR 2020 00037	Denmark		PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217
1856135	CR 2020 00018	Denmark		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
1259550	08C0052	France		PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
2822954	18C1035	France		PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
0290047	SPC/GB97/078	United Kingdom		PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522