NITHIODOTE Drug Patent Profile

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

Nithiodote is a drug marketed by Hope Pharms and is included in one NDA. There are six patents protecting this drug.

This drug has fifty-two patent family members in fourteen countries.

The generic ingredient in NITHIODOTE is sodium nitrite; sodium thiosulfate. 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; sodium thiosulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Nithiodote

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 24, 2031. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for NITHIODOTE

International Patents:	52
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NITHIODOTE
What excipients (inactive ingredients) are in NITHIODOTE?	NITHIODOTE excipients list
DailyMed Link:	NITHIODOTE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NITHIODOTE

NDA:

201444

Dosage:

SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Anatomical Therapeutic Chemical (ATC) Classes for NITHIODOTE

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

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

US Patents and Regulatory Information for NITHIODOTE

NITHIODOTE is protected by seven US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting NITHIODOTE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y

International Patents for NITHIODOTE

When does loss-of-exclusivity occur for NITHIODOTE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Croatia

Denmark

European Patent Office

Hungary

Japan

Lithuania

Poland

Portugal

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering NITHIODOTE around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2752129	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Spain	2655883
Japan	5905387
Japan	2017165758	チオ硫酸ナトリウムを含有する薬学的組成物 (SODIUM THIOSULFATE CONTAINING PHARMACEUTICAL COMPOSITIONS)
Japan	7166377
Spain	2743303

Supplementary Protection Certificates for NITHIODOTE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822954	1890030-8	Sweden		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625
1948158	93075	Luxembourg		PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN, C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3'-METHYL-2-(PENTANYOL(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE) DE TRISODIUM HEMIPENTAHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
0806968	SPC/GB07/011	United Kingdom		PRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003
0579826	02C0041	France		PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
0480717	SPC/GB98/025	United Kingdom		PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
2666774	CA 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