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 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in hydroxocobalamin? | hydroxocobalamin excipients list |
DailyMed Link: | hydroxocobalamin at DailyMed |
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 |
Pharmacology for hydroxocobalamin
Drug Class | Antidote |
Medical Subject Heading (MeSH) Categories for hydroxocobalamin
Anatomical Therapeutic Chemical (ATC) Classes for hydroxocobalamin
US Patents and Regulatory Information for hydroxocobalamin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Actavis | HYDROXOCOBALAMIN | hydroxocobalamin | INJECTABLE;INJECTION | 085998-001 | Approved Prior to Jan 1, 1982 | RX | No | Yes | ⤷ 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 | ||||
Bel Mar | HYDROXOMIN | hydroxocobalamin | INJECTABLE;INJECTION | 084629-001 | 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 | ||||
>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
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
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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