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Last Updated: March 28, 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-four 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
Somerset Theraps Llc CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 209429-001 Dec 18, 2018 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 080564-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa VIBISONE cyanocobalamin INJECTABLE;INJECTION 080557-003 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Solopak CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 087551-001 Feb 29, 1984 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Luitpold CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 080668-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  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
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
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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