Lidocaine; prilocaine - Generic Drug Details
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What are the generic sources for lidocaine; prilocaine and what is the scope of freedom to operate?
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | EMLA | lidocaine; prilocaine | DISC;TOPICAL | 020962-001 | Feb 4, 1998 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rhodes Pharms | LIDOCAINE AND PRILOCAINE | lidocaine; prilocaine | CREAM;TOPICAL | 213253-001 | Sep 21, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alembic | LIDOCAINE AND PRILOCAINE | lidocaine; prilocaine | CREAM;TOPICAL | 213923-001 | Apr 8, 2022 | AB | RX | 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 | |||
| Pai Holdings Pharm | LIDOCAINE AND PRILOCAINE | lidocaine; prilocaine | CREAM;TOPICAL | 205887-001 | Jun 29, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Encube | LIDOCAINE AND PRILOCAINE | lidocaine; prilocaine | CREAM;TOPICAL | 076320-001 | Aug 27, 2003 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Branded Pharm | EMLA | lidocaine; prilocaine | CREAM;TOPICAL | 019941-001 | Dec 30, 1992 | 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 |
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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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