ORAQIX Drug Patent Profile
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Which patents cover Oraqix, and when can generic versions of Oraqix launch?
Oraqix is a drug marketed by Dentsply Pharm and is included in one NDA.
The generic ingredient in ORAQIX is lidocaine; prilocaine. There are twenty-nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the lidocaine; prilocaine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Oraqix
A generic version of ORAQIX was approved as lidocaine; prilocaine by FOUGERA PHARMS on August 18th, 2003.
Summary for ORAQIX
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 5 |
Clinical Trials: | 2 |
Patent Applications: | 140 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ORAQIX |
What excipients (inactive ingredients) are in ORAQIX? | ORAQIX excipients list |
DailyMed Link: | ORAQIX at DailyMed |
Recent Clinical Trials for ORAQIX
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Joanneum Research Forschungsgesellschaft mbH | N/A |
Dentsply International | Phase 4 |
Pharmacology for ORAQIX
Drug Class | Amide Local Anesthetic Antiarrhythmic |
Physiological Effect | Local Anesthesia |
Anatomical Therapeutic Chemical (ATC) Classes for ORAQIX
US Patents and Regulatory Information for ORAQIX
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 | ⤷ 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 ORAQIX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Dentsply Pharm | ORAQIX | lidocaine; prilocaine | GEL;PERIODONTAL | 021451-001 | Dec 19, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ORAQIX
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 ORAQIX
See the table below for patents covering ORAQIX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Sweden | 9601421 | ⤷ Try a Trial | |
Czech Republic | 9703711 | ⤷ Try a Trial | |
Australia | 2416897 | ⤷ Try a Trial | |
Japan | 2004149544 | NEW MEDICINAL PREPARATION HAVING ANESTHETIC ACTION | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |