LIDOCAINE; PRILOCAINE - Generic Drug Details
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What are the generic drug sources for lidocaine; prilocaine and what is the scope of patent protection?
Lidocaine; prilocaine
is the generic ingredient in three branded drugs marketed by Teva Branded Pharm, Alembic, Encube, Fougera Pharms, Hikma, Padagis Us, Pai Holdings Pharm, Rhodes Pharms, Astrazeneca, and Dentsply Pharm, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.Ten suppliers are listed for this compound.
Summary for LIDOCAINE; PRILOCAINE
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 10 |
NDAs: | 10 |
Finished Product Suppliers / Packagers: | 10 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 75 |
DailyMed Link: | LIDOCAINE; PRILOCAINE at DailyMed |
Recent Clinical Trials for LIDOCAINE; PRILOCAINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Universitas Sebelas Maret | Phase 4 |
Indonesia Endowment Fund for Education | Phase 4 |
Cairo University | N/A |
Pharmacology for LIDOCAINE; PRILOCAINE
Drug Class | Amide Local Anesthetic Antiarrhythmic |
Physiological Effect | Local Anesthesia |
Anatomical Therapeutic Chemical (ATC) Classes for LIDOCAINE; PRILOCAINE
US Patents and Regulatory Information for LIDOCAINE; PRILOCAINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dentsply Pharm | ORAQIX | lidocaine; prilocaine | GEL;PERIODONTAL | 021451-001 | Dec 19, 2003 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Astrazeneca | EMLA | lidocaine; prilocaine | DISC;TOPICAL | 020962-001 | Feb 4, 1998 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Padagis Us | LIDOCAINE AND PRILOCAINE | lidocaine; prilocaine | CREAM;TOPICAL | 212482-001 | Jul 27, 2021 | AB | RX | 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 |
Expired US Patents for LIDOCAINE; PRILOCAINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Teva Branded Pharm | EMLA | lidocaine; prilocaine | CREAM;TOPICAL | 019941-001 | Dec 30, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Dentsply Pharm | ORAQIX | lidocaine; prilocaine | GEL;PERIODONTAL | 021451-001 | Dec 19, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Teva Branded Pharm | EMLA | lidocaine; prilocaine | CREAM;TOPICAL | 019941-001 | Dec 30, 1992 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for LIDOCAINE; PRILOCAINE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Recordati Ireland Ltd. | Fortacin | lidocaine, prilocaine | EMEA/H/C/002693 Treatment of primary premature ejaculation in adult men. |
Authorised | no | no | no | 2013-11-15 | |
Plethora Pharma Solutions Limited | Senstend | lidocaine, prilocaine | EMEA/H/C/005298 Senstend is indicated for the treatment of primary premature ejaculation in adult men. |
Withdrawn | no | no | no | 2019-11-14 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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