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Last Updated: December 12, 2019

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Sodium nitrite; sodium thiosulfate - Generic Drug Details

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What are the generic sources for sodium nitrite; sodium thiosulfate and what is the scope of freedom to operate?

Sodium nitrite; sodium thiosulfate is the generic ingredient in one branded drug marketed by Hope Pharms and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sodium nitrite; sodium thiosulfate has twenty-nine patent family members in eleven countries.

There are one thousand four hundred and seventy-two drug master file entries for sodium nitrite; sodium thiosulfate. One supplier is listed for this compound.

Summary for sodium nitrite; sodium thiosulfate
International Patents:29
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1472
Suppliers / Packagers: 1
Bulk Api Vendors: 1
DailyMed Link:sodium nitrite; sodium thiosulfate at DailyMed

US Patents and Regulatory Information for sodium nitrite; sodium thiosulfate

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

Supplementary Protection Certificates for sodium nitrite; sodium thiosulfate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0290047 SPC/GB97/078 United Kingdom   Start Trial 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
0579826 02C0041 France   Start Trial PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
1666481 17C1031 France   Start Trial PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324
0788511 SPC/GB08/036 United Kingdom   Start Trial PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
1912999 2014/058 Ireland   Start Trial PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Boehringer Ingelheim
Colorcon
Moodys
Johnson and Johnson
Express Scripts

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