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Last Updated: November 30, 2021

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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, Sandoz Inc, Sanofi Aventis Us, Solopak, Somerset Theraps Llc, Vitruvias Therap, Warner Chilcott, West-ward Pharms Int, Wyeth Ayerst, Xiromed, 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 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. Fourteen 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
University of Kansas Medical CenterPhase 2
Tanta UniversityPhase 3
The University of Texas Health Science Center, HoustonPhase 4

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Pharmacology for cyanocobalamin
Drug ClassVitamin B12
Paragraph IV (Patent) Challenges for CYANOCOBALAMIN
Tradename Dosage Ingredient NDA Submissiondate
NASCOBAL SPRAY, METERED;NASAL cyanocobalamin 021642 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
Dell Labs CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 080689-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Bayer Hlthcare VI-TWEL cyanocobalamin INJECTABLE;INJECTION 007012-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
West Ward CYANOCOBALAMIN cyanocobalamin TABLET;ORAL 084264-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Solopak CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 087551-001 Feb 29, 1984 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Dr Reddys CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 080573-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Watson Labs COBAVITE cyanocobalamin INJECTABLE;INJECTION 083064-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>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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