LIDOCAINE AND PRILOCAINE Drug Patent Profile
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When do Lidocaine And Prilocaine patents expire, and when can generic versions of Lidocaine And Prilocaine launch?
Lidocaine And Prilocaine is a drug marketed by Alembic, Encube, Fougera Pharms, Hikma, Padagis Us, Pai Holdings Pharm, and Rhodes Pharms. and is included in seven NDAs.
The generic ingredient in LIDOCAINE AND PRILOCAINE is lidocaine; prilocaine. There are twenty-nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the lidocaine; prilocaine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lidocaine And Prilocaine
A generic version of LIDOCAINE AND PRILOCAINE was approved as lidocaine; prilocaine by FOUGERA PHARMS on August 18th, 2003.
Summary for LIDOCAINE AND PRILOCAINE
| US Patents: | 0 |
| Applicants: | 7 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 5 |
| Clinical Trials: | 74 |
| Patent Applications: | 100 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in LIDOCAINE AND PRILOCAINE? | LIDOCAINE AND PRILOCAINE excipients list |
| DailyMed Link: | LIDOCAINE AND PRILOCAINE at DailyMed |
Recent Clinical Trials for LIDOCAINE AND 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 AND PRILOCAINE
| Drug Class | Amide Local Anesthetic Antiarrhythmic |
| Physiological Effect | Local Anesthesia |
Anatomical Therapeutic Chemical (ATC) Classes for LIDOCAINE AND PRILOCAINE
US Patents and Regulatory Information for LIDOCAINE AND PRILOCAINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic | LIDOCAINE AND PRILOCAINE | lidocaine; prilocaine | CREAM;TOPICAL | 213923-001 | Apr 8, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Rhodes Pharms | LIDOCAINE AND PRILOCAINE | lidocaine; prilocaine | CREAM;TOPICAL | 213253-001 | Sep 21, 2020 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hikma | LIDOCAINE AND PRILOCAINE | lidocaine; prilocaine | CREAM;TOPICAL | 076290-001 | Sep 25, 2003 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Encube | LIDOCAINE AND PRILOCAINE | lidocaine; prilocaine | CREAM;TOPICAL | 076320-001 | Aug 27, 2003 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Fougera Pharms | LIDOCAINE AND PRILOCAINE | lidocaine; prilocaine | CREAM;TOPICAL | 076453-001 | Aug 18, 2003 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Pai Holdings Pharm | LIDOCAINE AND PRILOCAINE | lidocaine; prilocaine | CREAM;TOPICAL | 205887-001 | Jun 29, 2018 | 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 |
EU/EMA Drug Approvals for LIDOCAINE AND 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 |
