Chlordiazepoxide - Generic Drug Details
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What are the generic sources for chlordiazepoxide and what is the scope of freedom to operate?
Chlordiazepoxide
is the generic ingredient in twelve branded drugs marketed by Valeant Pharm Intl, Abbott, Rachelle, Ascot, Barr, Chartwell Rx, Ferrante, Halsey, Impax Labs, Ivax Sub Teva Pharms, Lederle, Mast Mm, Mylan, Parke Davis, Pioneer Pharms, Purepac Pharm, Roxane, Superpharm, Teva, Upsher Smith Labs, Usl Pharma, Vangard, Watson Labs, West Ward, Bausch, Alra, Alembic, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Corepharma, Dr Reddys, Micro Labs, Misemer, Nuvo Pharms Inc, Teva Pharms Usa, Torrent, and Roche, and is included in ninety-seven NDAs. Additional information is available in the individual branded drug profile pages.There are nine drug master file entries for chlordiazepoxide.
Summary for chlordiazepoxide
| US Patents: | 0 |
| Tradenames: | 12 |
| Applicants: | 38 |
| NDAs: | 97 |
| Drug Master File Entries: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 48 |
| Clinical Trials: | 8 |
| Patent Applications: | 6,859 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for chlordiazepoxide |
| What excipients (inactive ingredients) are in chlordiazepoxide? | chlordiazepoxide excipients list |
| DailyMed Link: | chlordiazepoxide at DailyMed |
Recent Clinical Trials for chlordiazepoxide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mayo Clinic | Phase 4 |
| Oregon Health and Science University | Phase 2 |
| Chang Gung Memorial Hospital | Phase 2/Phase 3 |
Medical Subject Heading (MeSH) Categories for chlordiazepoxide
US Patents and Regulatory Information for chlordiazepoxide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbott | A-POXIDE | chlordiazepoxide hydrochloride | CAPSULE;ORAL | 085518-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Lederle | CHLORDIAZEPOXIDE HYDROCHLORIDE | chlordiazepoxide hydrochloride | CAPSULE;ORAL | 086893-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Usl Pharma | CHLORDIAZEPOXIDE HYDROCHLORIDE | chlordiazepoxide hydrochloride | CAPSULE;ORAL | 084644-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mast Mm | CHLORDIAZEPOXIDE HYDROCHLORIDE | chlordiazepoxide hydrochloride | CAPSULE;ORAL | 086217-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Teva Pharms Usa | CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE | chlordiazepoxide hydrochloride; clidinium bromide | CAPSULE;ORAL | 211476-001 | Nov 2, 2021 | 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 |
Expired US Patents for chlordiazepoxide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Valeant Pharm Intl | LIBRELEASE | chlordiazepoxide | CAPSULE, EXTENDED RELEASE;ORAL | 017813-001 | Sep 12, 1983 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
