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 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bel Mar | HYDROXOMIN | hydroxocobalamin | INJECTABLE;INJECTION | 084629-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Merck | ALPHAREDISOL | hydroxocobalamin | INJECTABLE;INJECTION | 080778-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Actavis | HYDROXOCOBALAMIN | hydroxocobalamin | INJECTABLE;INJECTION | 085998-001 | Approved Prior to Jan 1, 1982 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abraxis Pharm | HYDROXOCOBALAMIN | hydroxocobalamin | INJECTABLE;INJECTION | 084921-001 | Approved Prior to Jan 1, 1982 | 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 | ||||
| Btg Intl | CYANOKIT | hydroxocobalamin | INJECTABLE;INJECTION | 022041-002 | Dec 15, 2006 | 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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