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Last Updated: March 20, 2023

Cyanocobalamin - Generic Drug Details


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What are the generic sources for cyanocobalamin and what is the scope of patent protection?

Cyanocobalamin is the generic ingredient in fifteen branded drugs marketed by Par Pharm, Pharmacia And Upjohn, Lilly, Watson Labs, Abraxis Pharm, Akorn, Am Regent, Dell Labs, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Luitpold, Lyphomed, Mylan Institutional, Mylan Labs Ltd, Sagent Pharms Inc, Sandoz Inc, Sanofi Aventis Us, Sola Pharms, Solopak, Somerset Theraps Llc, Vitruvias Therap, Warner Chilcott, West-ward Pharms Int, Wyeth Ayerst, Xiromed, Zydus Pharms, Accord Hlthcare, Merck, Bel Mar, Bristol Myers Squibb, Savage Labs, Bayer Hlthcare, Padagis Israel, Endo Pharms Inc, West Ward, Ge Healthcare, and Armour Pharm, and is included in forty-three NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for cyanocobalamin. Twenty-three suppliers are listed for this compound.

Drug Prices for cyanocobalamin

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Drug Sales Revenue Trends for cyanocobalamin

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Recent Clinical Trials for cyanocobalamin

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SponsorPhase
Fundação Educacional Serra dos ÓrgãosPhase 4
University of Kansas Medical CenterPhase 2
Tanta UniversityPhase 3

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Pharmacology for cyanocobalamin
Drug ClassVitamin B12
Paragraph IV (Patent) Challenges for CYANOCOBALAMIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NASCOBAL Nasal Spray cyanocobalamin 500 mcg/spray 021642 1 2017-04-28

US Patents and Regulatory Information for cyanocobalamin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ge Healthcare DICOPAC KIT cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58 N/A;N/A 017406-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Accord Hlthcare DODEX cyanocobalamin INJECTABLE;INJECTION 083022-001 Approved Prior to Jan 1, 1982 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Solopak CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 087551-001 Feb 29, 1984 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb RUBRAMIN PC cyanocobalamin INJECTABLE;INJECTION 006799-004 Approved Prior to Jan 1, 1982 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Akorn CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 087969-001 Nov 10, 1983 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abraxis Pharm CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 080510-002 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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