QUIXIN Drug Patent Profile
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Which patents cover Quixin, and when can generic versions of Quixin launch?
Quixin is a drug marketed by Santen and is included in one NDA.
The generic ingredient in QUIXIN is levofloxacin. There is one drug master file entry for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Quixin
A generic version of QUIXIN was approved as levofloxacin by RISING on December 20th, 2010.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for QUIXIN?
- What are the global sales for QUIXIN?
- What is Average Wholesale Price for QUIXIN?
Summary for QUIXIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 83 |
| Clinical Trials: | 2 |
| Patent Applications: | 3,559 |
| DailyMed Link: | QUIXIN at DailyMed |
Recent Clinical Trials for QUIXIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Roswell Park Cancer Institute | Phase 4 |
| National Cancer Institute (NCI) | Phase 4 |
| Children's Oncology Group | Phase 3 |
US Patents and Regulatory Information for QUIXIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Santen | QUIXIN | levofloxacin | SOLUTION/DROPS;OPHTHALMIC | 021199-001 | Aug 18, 2000 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 QUIXIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Santen | QUIXIN | levofloxacin | SOLUTION/DROPS;OPHTHALMIC | 021199-001 | Aug 18, 2000 | 4,382,892 | ⤷ Start Trial |
| Santen | QUIXIN | levofloxacin | SOLUTION/DROPS;OPHTHALMIC | 021199-001 | Aug 18, 2000 | 5,503,407 | ⤷ Start Trial |
| Santen | QUIXIN | levofloxacin | SOLUTION/DROPS;OPHTHALMIC | 021199-001 | Aug 18, 2000 | 5,053,407 | ⤷ Start Trial |
| Santen | QUIXIN | levofloxacin | SOLUTION/DROPS;OPHTHALMIC | 021199-001 | Aug 18, 2000 | 4,551,456 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for QUIXIN
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Chiesi Farmaceutici S.p.A | Quinsair | levofloxacin | EMEA/H/C/002789Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis.Consideration should be given to official guidance on the appropriate use of antibacterial agents. | Authorised | no | no | no | 2015-03-25 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for QUIXIN
See the table below for patents covering QUIXIN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 10282 | ⤷ Start Trial | |
| Australia | 529263 | ⤷ Start Trial | |
| Australia | 7487881 | ⤷ Start Trial | |
| Bosnia and Herzegovina | 97190 | ⤷ Start Trial | |
| Canada | 1167840 | DERIVES DE BENZOXAZINE (BENZOXAZINE DERIVATIVES) | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for QUIXIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0206283 | SPC/GB97/085 | United Kingdom | ⤷ Start Trial | PRODUCT NAME: LEVOFLOXACIN, OPTIONALLY IN THE FORM OF A HEMIHYDRATE; REGISTERED: UK 13402/0011 19970606; UK 13402/0012 19970606; UK 13402/0013 19970606 |
| 0206283 | C980016 | Netherlands | ⤷ Start Trial | PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606 |
| 0206283 | 98C0041 | Belgium | ⤷ Start Trial | PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |

