Oxytetracycline hydrochloride - Generic Drug Details
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What are the generic drug sources for oxytetracycline hydrochloride and what is the scope of patent protection?
Oxytetracycline hydrochloride
is the generic ingredient in six branded drugs marketed by Ferrante, Hikma, Impax Labs, Proter, Purepac Pharm, Pfizer, and Casper Pharma Llc, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.There are thirteen drug master file entries for oxytetracycline hydrochloride.
Summary for oxytetracycline hydrochloride
| US Patents: | 0 |
| Tradenames: | 6 |
| Applicants: | 7 |
| NDAs: | 10 |
| Drug Master File Entries: | 13 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 5 |
| Patent Applications: | 2,754 |
| DailyMed Link: | oxytetracycline hydrochloride at DailyMed |
Recent Clinical Trials for oxytetracycline hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Oslo | N/A |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
| Federal University of São Paulo | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for oxytetracycline hydrochloride
US Patents and Regulatory Information for oxytetracycline hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | TERRAMYCIN W/ POLYMYXIN | oxytetracycline hydrochloride; polymyxin b sulfate | OINTMENT;OTIC | 061841-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Proter | OXYTETRACYCLINE HYDROCHLORIDE | oxytetracycline hydrochloride | CAPSULE;ORAL | 060869-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pfizer | TERRAMYCIN | oxytetracycline hydrochloride | INJECTABLE;INJECTION | 060586-002 | 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 |
