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AVELOX Drug Profile
» See Plans and Pricing
When do Avelox patents expire, and when can generic versions of Avelox launch?
Avelox is a drug marketed by Bayer Hlthcare and is included in two NDAs. There is one patent protecting this drug and one Paragraph IV challenge.
The generic ingredient in AVELOX is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Avelox
A generic version of AVELOX was approved as moxifloxacin hydrochloride by TEVA PHARMS USA on February 18th, 2014.
Summary for AVELOX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 94 |
| Clinical Trials: | 45 |
| Patent Applications: | 1,009 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AVELOX |
| DailyMed Link: | AVELOX at DailyMed |
Recent Clinical Trials for AVELOX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Spero Therapeutics | Phase 1 |
| Ministry of Health, Republic of Uzbekistan | Phase 2/Phase 3 |
| Clinical HIV Reserach Unit, Wits Health Consortium | Phase 2/Phase 3 |
Paragraph IV (Patent) Challenges for AVELOX
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| AVELOX | TABLET;ORAL | moxifloxacin hydrochloride | 021085 |
US Patents and Regulatory Information for AVELOX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | AVELOX | moxifloxacin hydrochloride | TABLET;ORAL | 021085-001 | Dec 10, 1999 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Bayer Hlthcare | AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER | moxifloxacin hydrochloride | SOLUTION;INTRAVENOUS | 021277-001 | Nov 30, 2001 | 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 |
Expired US Patents for AVELOX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | AVELOX | moxifloxacin hydrochloride | TABLET;ORAL | 021085-001 | Dec 10, 1999 | Start Trial | Start Trial |
| Bayer Hlthcare | AVELOX | moxifloxacin hydrochloride | TABLET;ORAL | 021085-001 | Dec 10, 1999 | Start Trial | Start Trial |
| Bayer Hlthcare | AVELOX | moxifloxacin hydrochloride | TABLET;ORAL | 021085-001 | Dec 10, 1999 | Start Trial | Start Trial |
| Bayer Hlthcare | AVELOX | moxifloxacin hydrochloride | TABLET;ORAL | 021085-001 | Dec 10, 1999 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AVELOX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 1340114 | Start Trial |
| Argentina | 021074 | Start Trial |
| Japan | H09169757 | Start Trial |
| Australia | 1267400 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AVELOX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0780390 | PA2004012 | Lithuania | Start Trial | PRODUCT NAME: MOXIFLOXACINI HYDROCHLORIDUM (1-CIKLOPROPIL-6-FLUOR-__ 1,4-DIHIDRO-8-METOKSI-7-[(4AS, 7AS)-OKTAHIDRO-6H-PIROLO[3,4-B]PIRIDIN_-6-IL]-4-OKSO-3-CHINOLINKARBOKSIRûGðTIES HIDROCHLORIDAS) |
| 0350733 | 300111 | Netherlands | Start Trial | |
| 0350733 | 11/2000 | Austria | Start Trial | PRODUCT NAME: MOXIFLOXACIN, DESSEN PHARMAZEUTISCH VERWENDBARE HYDRATE UND SAEUREADDITIONSSALZE, DESSEN ALKALI-ERDALKALI-SILBER- UND GUANIDINIUMSALZE, SOWIE DESSEN C1 - C4 ALKYL- ODER; NAT. REGISTRATION NO/DATE: 1-23494, 1-23495, 1-23496 20000215; FIRST REGISTRATION: DE 45263.00.00 19990621 |
| 0350733 | C300111 | Netherlands | Start Trial | PRODUCT NAME: MOXIFLOXACINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER MOXIFLOXACINEHYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 28118 RVG 28119 20021017; FIRST REGISTRATION: DE 45263.00.00 19990621 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
