Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 9, 2019

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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 eighteen 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, Endo Pharms Inc, West Ward, Bracco, Ge Healthcare, Mallinckrodt, and Armour Pharm, and is included in thirty-eight 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. Thirteen suppliers are listed for this compound.

Drug Prices for cyanocobalamin

See drug prices for cyanocobalamin

Drug Sales Revenue Trends for cyanocobalamin

See drug sales revenues for cyanocobalamin

Recent Clinical Trials for cyanocobalamin

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

SponsorPhase
University of Southern CaliforniaEarly Phase 1
The University of Hong KongN/A
Bambino Gesù Hospital and Research InstitutePhase 2

See all cyanocobalamin clinical trials

Recent Litigation for cyanocobalamin

Identify potential future generic entrants

District Court Litigation
Case NameDate
ENDO PHARMACEUTICALS INC. v. LUPIN ATLANTIS HOLDINGS SA2018-06-22
Endo Pharmaceuticals Inc. v. Lupin Atlantis Holdings SA2017-07-28
Endo Pharmaceuticals Inc. v. Perrigo UK FINCO Limited Partnership

See all cyanocobalamin litigation

Pharmacology for cyanocobalamin
Drug ClassVitamin B12
Synonyms for cyanocobalamin
0.1% Cobalamin Concentrate Trituration w/Mannitol
18534-66-2
1H-Benzimidazole,6-dimethyl-1-(3-O-phosphono-.alpha.-D-ribofuranosyl)-, monoester with cobinamide cyanide hydroxide, inner salt
3-[tris(2-amino-2-oxo-ethyl)-bis(3-amino-3-oxo-propyl)-cyano-dihydroxy-(hydroxymethyl)-undecamethyl-dioxo-[?]yl]propanamide
5,6-Dimethylbenzimidazolyl cyanocobamide
5,6-Dimethylbenzimidazolyl-CO-cyanocobamide
68-19-9
AB01568252_01
AB2000361
AKOS015894306
alpha-(5,6-Dimethylbenzimidazolyl)cyanocobamide
Anacobin
AS-13159
B-Twelve
B-Twelve ora
BDBM83973
Bedoz
BEROCCA PN
Berubigen
Betalin 12, crystalline
Betaline-12
Betolvex
Bevidox concentrate
Biocobalamine
Byladoce
C02823
C63H88CoN14O14P
Cabadon M
CAS-68-19-9
CCG-220433
CHEBI:15982
CHEBI:17439
cid_25102581
CN-Cbl
Coalpha-[alpha-(5,6-dimethylbenzimidazolyl)]-Cobeta-cyanocobamide
cob(I)alamin
Cobadoce forte
cobalamin
Cobalamin;vitamin B-12;Cyanocobalamin
COBALAMINE CONCENTRATE
Cobamide,6-dimethyl-1H-benzimidazole-
Cobamide,6-dimethyl-1H-benzimidazolyl-, cyanide
Cobavite
Cobinamide, dihydrogen phosphate
Cobinamide, dihydrogen phosphate (ester), inner salt, 3'-ester with 5,6-dimethyl-1-.alpha.-D-ribofuranosylbenzimidazole
Cobinamide,6-dimethyl-1-.alpha.-D-ribofuranosylbenzimidazole, inner salt
Cobinamide,dihydrogenphosphate(ester),inner salt,3'-ester with(5,6-Dimethyl-1-a-d-ribofuranosyl-1H-benzimidazole-kn3),ion(1+)(9ci)
Cobolin-M
component of Endoglobin
component of Vitron-C-Plus
Copharvit 5000
Covit
Crystamine
Crysti-12
Crystimin
Crystwel
Cyano-B12
Cyanobalamin concentrate
Cyanocob(III)alamin
Cyanocobalamin (B12)
Cyanocobalamin (B12), analytical standard
Cyanocobalamin (JP15/USP)
Cyanocobalamin (JP17/USP/INN)
Cyanocobalamin (Vitamin B12)
Cyanocobalamin (Vitamin B12) 1.0 mg/ml in Methanol
Cyanocobalamin (Vitamin B12) solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
CYANOCOBALAMIN 0.1% IN MANNITOL
Cyanocobalamin, European Pharmacopoeia (EP) Reference Standard
Cyanocobalamin, meets USP testing specifications
Cyanocobalamin, pharmaceutical secondary standard; traceable to PhEur and BP
Cyanocobalamin, SAJ special grade, >=95.0%
Cyanocobalamin, tested according to Ph.Eur.
Cyanocobalamin;Cyanocob(III)alamin
Cyanocobalamine
Cyanocobalmin
cyanoject
Cycobemin
Cycolamin
Cykobemin
Cykobeminet
Cyomin
Cyomin (TN)
Cyredin
Cytacon
Cytamen
Cytobion
D00166
DB00115
Depinar
Dicopac
Dimethylbenzimidazoylcobamide
Distivit
Dobetin
Docemine
Docibin
Docivit
Dodecabee
Dodecavite
Dodex
DSSTox_CID_24346
DSSTox_GSID_44346
DSSTox_RID_80159
DTXSID7044346
Ducobee
Duodecibin
Embiol
Emociclina
Eritrone
Erycytol
Erythrotin
Euhaemon
Extrinsic factor
FDJOLVPMNUYSCM-WZHZPDAFSA-L
Fermin
Fresmin
H486
Hemomin
Hepagon
Hepcovite
HMS1569G08
HMS2096G08
HMS2232I12
HMS3713G08
Hydrido-Cobalamin
Hydridocobalamin
hydrobexan
Hylugel plus
Macrabin
Mecobalamin
Megalovel
MFCD00151092 (98%)
Milbedoce
Millevit
MLS002153809
MolPort-016-633-264
MolPort-035-395-693
Nagravon
Nascobal
Nascobal (TN)
NCGC00016302-01
NCGC00249888-01
Neuroforte-R
Normocytin
Novidroxin
NSC-80365
NSC80365
P6YC3EG204
Pernaemon
Pernaevit
Pernipuron
Plecyamin
Poyamin
Prestwick_564
Primabalt
Rebramin
Redamina
Redisol
Rhodacryst
RL04605
Rubesol
RUBIVITE
Rubramin PC
Rubramin PC (TN)
RUBRATOPE-60 KIT
Rubripca
Rubrocitol
RUVITE
s1902
Shovite
SMR001233181
SRI 2215
SY010769
Sytobex
Tox21_110358
Tox21_113664
UNII-P6YC3EG204
V0344
Vi-Twel
Vibal
Vibalt
Vibisone
Virubra
Vita-rubra
Vitabee 12
vitamin B-12
vitamin B-12s
vitamin B12
Vitamin B12 complex
Vitamin B12 NOS
Vitamin B12 preparation
Vitamin B12, >=98%
Vitamin B12, BioReagent, suitable for cell culture, suitable for insect cell culture, suitable for plant cell culture, >=98%
Vitamin B12, p.a., 96.0-102.0%
Vitamin B12, Vetec(TM) reagent grade, >=98%
Vitamin B12b
vitamin B12s
Vitamine B12
Vitarubin
Vitral
WLN: D C5656 B-5 B6 B5 S5 J&5 B-19- Q&6 N&5/B-N/DU/J&-M& J&- O& 9ABBBBCSTT V& AN-CO-&& B-N CN TN C&
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
Ge Healthcare DICOPAC KIT cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58 N/A;N/A 017406-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 RX Yes Yes   Start Trial   Start Trial   Start Trial
Wyeth Ayerst CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 080554-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Bel Mar RUBIVITE cyanocobalamin INJECTABLE;INJECTION 010791-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb RUBRAMIN PC cyanocobalamin INJECTABLE;INJECTION 006799-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare DODEX cyanocobalamin INJECTABLE;INJECTION 083022-001 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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