EMLA Drug Patent Profile
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Which patents cover Emla, and what generic alternatives are available?
Emla is a drug marketed by Teva Branded Pharm and Astrazeneca and is included in two NDAs.
The generic ingredient in EMLA 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 Emla
A generic version of EMLA was approved as lidocaine; prilocaine by FOUGERA PHARMS on August 18th, 2003.
Summary for EMLA
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 5 |
Patent Applications: | 100 |
Formulation / Manufacturing: | see details |
DailyMed Link: | EMLA at DailyMed |
Anatomical Therapeutic Chemical (ATC) Classes for EMLA
US Patents and Regulatory Information for EMLA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Branded Pharm | EMLA | lidocaine; prilocaine | CREAM;TOPICAL | 019941-001 | Dec 30, 1992 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Astrazeneca | EMLA | lidocaine; prilocaine | DISC;TOPICAL | 020962-001 | Feb 4, 1998 | 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 |
Expired US Patents for EMLA
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Teva Branded Pharm | EMLA | lidocaine; prilocaine | CREAM;TOPICAL | 019941-001 | Dec 30, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for EMLA
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 |
International Patents for EMLA
See the table below for patents covering EMLA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 149913 | ⤷ Try a Trial | |
Ireland | 782350 | ⤷ Try a Trial | |
Japan | S54101414 | LOCAL ANAESTHETICS MIXTURE | ⤷ Try a Trial |
Finland | 68173 | ⤷ Try a Trial | |
Finland | 783642 | ⤷ Try a Trial | |
New Zealand | 189026 | TOPICAL LOCAL ANAESTHETIC COMPOSITIONS | ⤷ Try a Trial |
United Kingdom | 2008946 | EMULSION CREAM COMPOSITION PROCESS FOR ITS PREPARATION ANDMETHOD OF OBTAINING LOCAL ANESTHESIA | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |