PYRIDOXINE HYDROCHLORIDE Drug Patent Profile
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When do Pyridoxine Hydrochloride patents expire, and when can generic versions of Pyridoxine Hydrochloride launch?
Pyridoxine Hydrochloride is a drug marketed by Bel Mar, Dell Labs, Dr Reddys, Elkins Sinn, Epic Pharma Llc, Fresenius Kabi Usa, Luitpold, Mylan Institutional, and Watson Labs. and is included in ten NDAs.
The generic ingredient in PYRIDOXINE HYDROCHLORIDE is pyridoxine hydrochloride. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pyridoxine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Pyridoxine Hydrochloride
A generic version of PYRIDOXINE HYDROCHLORIDE was approved as pyridoxine hydrochloride by FRESENIUS KABI USA on December 31st, 1969.
Summary for PYRIDOXINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 10 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 146 |
| Clinical Trials: | 80 |
| Patent Applications: | 2,177 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | PYRIDOXINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for PYRIDOXINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Anahuac University | N/A |
| Valenta Pharm JSC | N/A |
| All India Institute of Medical Sciences, New Delhi | Phase 2/Phase 3 |
Pharmacology for PYRIDOXINE HYDROCHLORIDE
| Ingredient-type | Analogs/Derivatives Vitamin B 6 |
| Drug Class | Vitamin B6 Analog |
Medical Subject Heading (MeSH) Categories for PYRIDOXINE HYDROCHLORIDE
US Patents and Regulatory Information for PYRIDOXINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bel Mar | PYRIDOXINE HYDROCHLORIDE | pyridoxine hydrochloride | INJECTABLE;INJECTION | 080761-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Fresenius Kabi Usa | PYRIDOXINE HYDROCHLORIDE | pyridoxine hydrochloride | INJECTABLE;INJECTION | 080618-001 | Approved Prior to Jan 1, 1982 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Dr Reddys | PYRIDOXINE HYDROCHLORIDE | pyridoxine hydrochloride | INJECTABLE;INJECTION | 080572-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Luitpold | PYRIDOXINE HYDROCHLORIDE | pyridoxine hydrochloride | INJECTABLE;INJECTION | 080669-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Dell Labs | PYRIDOXINE HYDROCHLORIDE | pyridoxine hydrochloride | INJECTABLE;INJECTION | 083771-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Dell Labs | PYRIDOXINE HYDROCHLORIDE | pyridoxine hydrochloride | INJECTABLE;INJECTION | 083772-001 | 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 |
