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Last Updated: May 19, 2024

CYANOCOBALAMIN - Generic Drug Details


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What are the generic sources for cyanocobalamin and what is the scope of freedom to operate?

Cyanocobalamin is the generic ingredient in fifteen branded drugs marketed by Par Pharm, Pharmacia And Upjohn, Lilly, Watson Labs, Abraxis Pharm, Am Regent, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Luitpold, Lyphomed, Mylan Institutional, Mylan Labs Ltd, Sagent Pharms Inc, Sandoz, 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, Lupin, Padagis Israel, Endo Pharms Inc, West Ward, Ge Healthcare, and Armour Pharm, and is included in forty-four 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

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

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

See all CYANOCOBALAMIN clinical trials

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
Abraxis Pharm CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 080510-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 083120-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bel Mar RUBIVITE cyanocobalamin INJECTABLE;INJECTION 010791-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
West-ward Pharms Int CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 080515-002 Approved Prior to Jan 1, 1982 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 080573-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CYANOCOBALAMIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 ⤷  Try a Trial ⤷  Try a Trial
Par Pharm NASCOBAL cyanocobalamin GEL, METERED;NASAL 019722-001 Nov 5, 1996 ⤷  Try a Trial ⤷  Try a Trial
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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