THIAMINE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for thiamine hydrochloride and what is the scope of freedom to operate?
Thiamine hydrochloride
is the generic ingredient in two branded drugs marketed by Lilly, Abraxis Pharm, Bel Mar, Caplin, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hospira, Luitpold, Mylan Institutional, Parke Davis, Sagent Pharms Inc, Watson Labs, West-ward Pharms Int, and Wyeth Ayerst, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.There are five drug master file entries for thiamine hydrochloride. Twelve suppliers are listed for this compound.
Summary for THIAMINE HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 17 |
NDAs: | 18 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 12 |
Raw Ingredient (Bulk) Api Vendors: | 140 |
Clinical Trials: | 83 |
Patent Applications: | 6,460 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in THIAMINE HYDROCHLORIDE? | THIAMINE HYDROCHLORIDE excipients list |
DailyMed Link: | THIAMINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for THIAMINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Canadian Institutes of Health Research (CIHR) | Phase 3 |
Hamilton Health Sciences Corporation | Phase 3 |
Population Health Research Institute | Phase 3 |
Medical Subject Heading (MeSH) Categories for THIAMINE HYDROCHLORIDE
US Patents and Regulatory Information for THIAMINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Parke Davis | THIAMINE HYDROCHLORIDE | thiamine hydrochloride | INJECTABLE;INJECTION | 080770-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Caplin | THIAMINE HYDROCHLORIDE | thiamine hydrochloride | INJECTABLE;INJECTION | 215692-001 | Mar 6, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Abraxis Pharm | THIAMINE HYDROCHLORIDE | thiamine hydrochloride | INJECTABLE;INJECTION | 080509-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Watson Labs | THIAMINE HYDROCHLORIDE | thiamine hydrochloride | INJECTABLE;INJECTION | 083534-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Eugia Pharma | THIAMINE HYDROCHLORIDE | thiamine hydrochloride | INJECTABLE;INJECTION | 208703-001 | Apr 20, 2022 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Bel Mar | THIAMINE HYDROCHLORIDE | thiamine hydrochloride | INJECTABLE;INJECTION | 080718-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Dr Reddys | THIAMINE HYDROCHLORIDE | thiamine hydrochloride | INJECTABLE;INJECTION | 080571-001 | Approved Prior to Jan 1, 1982 | AP | RX | 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 |