QDOLO Drug Patent Profile
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Which patents cover Qdolo, and when can generic versions of Qdolo launch?
Qdolo is a drug marketed by Rosemont and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has one patent family member in one country.
The generic ingredient in QDOLO is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Qdolo
A generic version of QDOLO was approved as tramadol hydrochloride by SUN PHARM INDS INC on June 19th, 2002.
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Summary for QDOLO
| International Patents: | 1 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for QDOLO |
Paragraph IV (Patent) Challenges for QDOLO
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| QDOLO | Oral Solution | tramadol hydrochloride | 5 mg/mL | 214044 | 1 | 2024-09-16 |
US Patents and Regulatory Information for QDOLO
QDOLO is protected by two US patents.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rosemont | QDOLO | tramadol hydrochloride | SOLUTION;ORAL | 214044-001 | Sep 1, 2020 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Rosemont | QDOLO | tramadol hydrochloride | SOLUTION;ORAL | 214044-001 | Sep 1, 2020 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for QDOLO
See the table below for patents covering QDOLO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2021092406 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for QDOLO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0566709 | SPC/GB04/012 | United Kingdom | ⤷ Start Trial | PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925 |
| 2488169 | C202330042 | Spain | ⤷ Start Trial | PRODUCT NAME: COCRISTAL DE TRAMADOL, OPCIONALMENTE EN FORMA DE UNA SAL FISIOLOGICAMENTE ACEPTABLE, Y CELECOXIB; NATIONAL AUTHORISATION NUMBER: 89051; DATE OF AUTHORISATION: 20230925; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 89051; DATE OF FIRST AUTHORISATION IN EEA: 20230925 |
| 0566709 | C300152 | Netherlands | ⤷ Start Trial | PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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