HYDROXOCOBALAMIN - Generic Drug Details

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What are the generic drug sources for hydroxocobalamin and what is the scope of patent protection?

Hydroxocobalamin is the generic ingredient in four branded drugs marketed by Merck, Btg Intl, Abraxis Pharm, Actavis, Watson Labs, and Bel Mar, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for hydroxocobalamin. Two suppliers are listed for this compound.

Summary for HYDROXOCOBALAMIN

US Patents:	0
Tradenames:	4
Applicants:	6
NDAs:	6
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	11
Patent Applications:	870
Drug Prices:	Drug price trends for HYDROXOCOBALAMIN
What excipients (inactive ingredients) are in HYDROXOCOBALAMIN?	HYDROXOCOBALAMIN excipients list
DailyMed Link:	HYDROXOCOBALAMIN at DailyMed

See drug prices for HYDROXOCOBALAMIN

Recent Clinical Trials for HYDROXOCOBALAMIN

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

Sponsor	Phase
Mayo Clinic	Phase 4
General Oncology, Inc.	Phase 1
Joshua Korzenik	Phase 2

See all HYDROXOCOBALAMIN clinical trials

Pharmacology for HYDROXOCOBALAMIN

Drug Class	Antidote

Medical Subject Heading (MeSH) Categories for HYDROXOCOBALAMIN

Hematinics
Vitamin B Complex

Anatomical Therapeutic Chemical (ATC) Classes for HYDROXOCOBALAMIN

B03BA	Vitamin B12 (cyanocobalamin and analogues)
B03B	VITAMIN B12 AND FOLIC ACID
B03	ANTIANEMIC PREPARATIONS
B	Blood and blood forming organs

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for HYDROXOCOBALAMIN

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abraxis Pharm	HYDROXOCOBALAMIN	hydroxocobalamin	INJECTABLE;INJECTION	084921-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	HYDROXOCOBALAMIN	hydroxocobalamin	INJECTABLE;INJECTION	085528-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Btg Intl	CYANOKIT	hydroxocobalamin	INJECTABLE;INJECTION	022041-002	Dec 15, 2006		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Btg Intl	CYANOKIT	hydroxocobalamin	INJECTABLE;INJECTION	022041-001	Apr 8, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 HYDROXOCOBALAMIN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Btg Intl	CYANOKIT	hydroxocobalamin	INJECTABLE;INJECTION	022041-002	Dec 15, 2006	⤷ Sign Up	⤷ Sign Up
Btg Intl	CYANOKIT	hydroxocobalamin	INJECTABLE;INJECTION	022041-001	Apr 8, 2011	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for HYDROXOCOBALAMIN

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
SERB SA	Cyanokit	hydroxocobalamin	EMEA/H/C/000806 Treatment of known or suspected cyanide poisoning.Cyanokit is to be administered together with appropriate decontamination and supportive measures.	Authorised	no	no	no	2007-11-23
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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