XYLOCAINE Drug Patent Profile
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Which patents cover Xylocaine, and when can generic versions of Xylocaine launch?
Xylocaine is a drug marketed by Astrazeneca, Fresenius Kabi Usa, Epic Pharma Llc, and Dentsply Pharm. and is included in fourteen NDAs.
The generic ingredient in XYLOCAINE is epinephrine; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.
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Summary for XYLOCAINE
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 14 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 131 |
| Clinical Trials: | 159 |
| Patent Applications: | 4,993 |
| Drug Prices: | Drug price information for XYLOCAINE |
| What excipients (inactive ingredients) are in XYLOCAINE? | XYLOCAINE excipients list |
| DailyMed Link: | XYLOCAINE at DailyMed |
Recent Clinical Trials for XYLOCAINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| CHU de Reims | N/A |
| Vrije Universiteit Brussel | Phase 4 |
| Centre hospitalier de l'Université de Montréal (CHUM) | Phase 4 |
Pharmacology for XYLOCAINE
| Drug Class | Amide Local Anesthetic Antiarrhythmic Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist |
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
| Physiological Effect | Local Anesthesia |
US Patents and Regulatory Information for XYLOCAINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | XYLOCAINE W/ EPINEPHRINE | epinephrine; lidocaine hydrochloride | INJECTABLE;INJECTION | 006488-019 | Nov 13, 1986 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Astrazeneca | XYLOCAINE W/ EPINEPHRINE | epinephrine; lidocaine hydrochloride | INJECTABLE;INJECTION | 010418-008 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Fresenius Kabi Usa | XYLOCAINE W/ EPINEPHRINE | epinephrine; lidocaine hydrochloride | INJECTABLE;INJECTION | 006488-004 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Fresenius Kabi Usa | XYLOCAINE W/ EPINEPHRINE | epinephrine; lidocaine hydrochloride | INJECTABLE;INJECTION | 006488-012 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Astrazeneca | XYLOCAINE | lidocaine | AEROSOL;ORAL | 014394-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dentsply Pharm | XYLOCAINE DENTAL WITH EPINEPHRINE | epinephrine; lidocaine hydrochloride | INJECTABLE;INJECTION | 021381-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Fresenius Kabi Usa | XYLOCAINE PRESERVATIVE FREE | lidocaine hydrochloride | INJECTABLE;INJECTION | 016801-004 | 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 |
