THIAMINE HYDROCHLORIDE - Generic Drug Details
✉ Email this page to a colleague
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: | 82 |
| Patent Applications: | 6,257 |
| 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 |
|---|---|
| Population Health Research Institute | Phase 3 |
| Canadian Institutes of Health Research (CIHR) | Phase 3 |
| Hamilton Health Sciences Corporation | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lilly | BETALIN S | thiamine hydrochloride | INJECTABLE;INJECTION | 080853-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hospira | THIAMINE HYDROCHLORIDE | thiamine hydrochloride | INJECTABLE;INJECTION | 040079-001 | May 3, 1996 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Wyeth Ayerst | THIAMINE HYDROCHLORIDE | thiamine hydrochloride | INJECTABLE;INJECTION | 080553-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan Institutional | THIAMINE HYDROCHLORIDE | thiamine hydrochloride | INJECTABLE;INJECTION | 091623-001 | Jun 25, 2012 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Parke Davis | THIAMINE HYDROCHLORIDE | thiamine hydrochloride | INJECTABLE;INJECTION | 080770-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Watson Labs | THIAMINE HYDROCHLORIDE | thiamine hydrochloride | INJECTABLE;INJECTION | 083534-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Dell Labs | THIAMINE HYDROCHLORIDE | thiamine hydrochloride | INJECTABLE;INJECTION | 083775-001 | 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 |
