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Last Updated: October 26, 2021

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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, Aurobindo Pharma Ltd, Dell Labs, Dr Reddys, 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

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

SponsorPhase
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
Watson Labs CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 083120-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Luitpold CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 080668-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Accord Hlthcare DODEX cyanocobalamin INJECTABLE;INJECTION 083022-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Armour Pharm DEPINAR cyanocobalamin; tannic acid; zinc acetate INJECTABLE;INJECTION 011208-001 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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Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
Boehringer Ingelheim
Johnson and Johnson
Merck
Colorcon

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