Oxytetracycline - Generic Drug Details
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What are the generic sources for oxytetracycline and what is the scope of freedom to operate?
Oxytetracycline
is the generic ingredient in six branded drugs marketed by Pfizer, Ferrante, Hikma, Impax Labs, Proter, Purepac Pharm, and Casper Pharma Llc, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.There are thirty-six drug master file entries for oxytetracycline.
Summary for oxytetracycline
US Patents: | 0 |
Tradenames: | 6 |
Applicants: | 7 |
NDAs: | 12 |
Drug Master File Entries: | 36 |
Raw Ingredient (Bulk) Api Vendors: | 83 |
Clinical Trials: | 5 |
Patent Applications: | 5,948 |
Formulation / Manufacturing: | see details |
DailyMed Link: | oxytetracycline at DailyMed |
Recent Clinical Trials for oxytetracycline
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Oslo | N/A |
Federal University of São Paulo | Phase 4 |
Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
Medical Subject Heading (MeSH) Categories for oxytetracycline
Anatomical Therapeutic Chemical (ATC) Classes for oxytetracycline
US Patents and Regulatory Information for oxytetracycline
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer | TERRAMYCIN-POLYMYXIN | oxytetracycline hydrochloride; polymyxin b sulfate | TABLET;VAGINAL | 061009-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Pfizer | TERRAMYCIN | oxytetracycline hydrochloride | INJECTABLE;INJECTION | 060586-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Pfizer | TERRAMYCIN | oxytetracycline hydrochloride | CAPSULE;ORAL | 050286-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Pfizer | TERRAMYCIN | oxytetracycline | TABLET;ORAL | 050287-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Pfizer | TERRAMYCIN | oxytetracycline hydrochloride | CAPSULE;ORAL | 050286-001 | 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 |