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Last Updated: October 20, 2020

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Cyanocobalamin - Generic Drug Details

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What are the generic drug 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, Fresenius Kabi Usa, Luitpold, Lyphomed, Mylan Institutional, Mylan Labs Ltd, Sanofi Aventis Us, Solopak, Somerset Theraps Llc, Vitruvias Therap, Warner Chilcott, West-ward Pharms Int, Wyeth Ayerst, Accord Hlthcare, Merck, Bel Mar, Bristol Myers Squibb, Savage Labs, Bayer Hlthcare, Perrigo Uk Finco, Endo Pharms Inc, West Ward, Ge Healthcare, and Armour Pharm, and is included in thirty-six 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. Twelve 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

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

The University of Texas Health Science Center, HoustonPhase 4
Tanta UniversityPhase 3
IMSS Hospital General de Zona 11, Piedras NegrasPhase 3

See all cyanocobalamin clinical trials

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
Lilly BETALIN 12 cyanocobalamin INJECTABLE;INJECTION 080855-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa VIBISONE cyanocobalamin INJECTABLE;INJECTION 080557-003 Approved Prior to Jan 1, 1982 AP RX No Yes   Start Trial   Start Trial   Start Trial
Pharmacia And Upjohn BERUBIGEN cyanocobalamin INJECTABLE;INJECTION 006798-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Somerset Theraps Llc CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 209429-001 Dec 18, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 080557-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start 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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