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. Ten 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.
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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: | 100 |
| 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 |
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 | ⤷ 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 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 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Estonia | 9700363 | ⤷ Sign Up | |
| Russian Federation | 2185153 | NOVEL PHARMACEUTICAL COMPOSITION WITH ANALGETIC EFFECT | ⤷ Sign Up |
| Taiwan | 473386 | ⤷ Sign Up | |
| China | 1188407 | ⤷ Sign Up | |
| Japan | H11501678 | ⤷ Sign Up | |
| Norway | 975831 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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