Prilocaine hydrochloride - Generic Drug Details
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What are the generic drug sources for prilocaine hydrochloride and what is the scope of freedom to operate?
Prilocaine hydrochloride
is the generic ingredient in four branded drugs marketed by Astrazeneca, Dentsply Pharm, and Septodont Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for prilocaine hydrochloride. One supplier is listed for this compound.
Summary for prilocaine hydrochloride
US Patents: | 0 |
Tradenames: | 4 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 123 |
Clinical Trials: | 108 |
Patent Applications: | 350 |
What excipients (inactive ingredients) are in prilocaine hydrochloride? | prilocaine hydrochloride excipients list |
DailyMed Link: | prilocaine hydrochloride at DailyMed |
Recent Clinical Trials for prilocaine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Assiut University | N/A |
Universitas Sebelas Maret | Phase 4 |
Indonesia Endowment Fund for Education | Phase 4 |
Pharmacology for prilocaine hydrochloride
Drug Class | Amide Local Anesthetic |
Physiological Effect | Local Anesthesia |
Medical Subject Heading (MeSH) Categories for prilocaine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for prilocaine hydrochloride
US Patents and Regulatory Information for prilocaine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca | CITANEST PLAIN | prilocaine hydrochloride | INJECTABLE;INJECTION | 014763-007 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Septodont Inc | PRILOCAINE HYDROCHLORIDE | prilocaine hydrochloride | INJECTABLE;INJECTION | 079235-001 | Sep 29, 2010 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Astrazeneca | CITANEST | prilocaine hydrochloride | INJECTABLE;INJECTION | 014763-005 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Astrazeneca | CITANEST | prilocaine hydrochloride | INJECTABLE;INJECTION | 014763-003 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Astrazeneca | CITANEST | prilocaine hydrochloride | INJECTABLE;INJECTION | 014763-004 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Dentsply Pharm | CITANEST PLAIN DENTAL | prilocaine hydrochloride | INJECTABLE;INJECTION | 021382-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | 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 |
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