QDOLO Drug Patent Profile
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When do Qdolo patents expire, and when can generic versions of Qdolo launch?
Qdolo is a drug marketed by Athena and is included in one NDA. There are two patents protecting this drug.
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-eight 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 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 94 |
| Patent Applications: | 2,368 |
| What excipients (inactive ingredients) are in QDOLO? | QDOLO excipients list |
| DailyMed Link: | QDOLO at DailyMed |
Pharmacology for QDOLO
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
US Patents and Regulatory Information for QDOLO
QDOLO is protected by two US patents.
Patents protecting QDOLO
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Athena | QDOLO | tramadol hydrochloride | SOLUTION;ORAL | 214044-001 | Sep 1, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Athena | QDOLO | tramadol hydrochloride | SOLUTION;ORAL | 214044-001 | Sep 1, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for QDOLO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0566709 | C300152 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405 |
| 0566709 | SPC/GB04/012 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925 |
| >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. 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.
ISSN: 2162-2639
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