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Generated: October 18, 2017
What is the patent landscape for Avelox, and when can generic versions of Avelox launch?
Avelox is a drug marketed by Bayer Hlthcare and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge.| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 11 |
| Bulk Api Vendors: see list | 105 |
| Clinical Trials: see list | 38 |
| Patent Applications: see list | 717 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | AVELOX at DailyMed |
| Ingredient-type | Quinolones |
| Drug Class | Quinolone Antimicrobial |
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bayer Hlthcare | AVELOX | moxifloxacin hydrochloride | TABLET;ORAL | 021085-001 | Dec 10, 1999 | ► Subscribe | ► Subscribe | ||||||||
Bayer Hlthcare | AVELOX | moxifloxacin hydrochloride | TABLET;ORAL | 021085-001 | Dec 10, 1999 | ► Subscribe | ► Subscribe | ||||||||
Bayer Hlthcare | AVELOX | moxifloxacin hydrochloride | TABLET;ORAL | 021085-001 | Dec 10, 1999 | ► Subscribe | ► Subscribe | ||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| moxifloxacin hydrochloride | Injection | 1.6 mg/mL | Avelox in Sodium Chloride 0.8% in plastic container | 2/7/2014 |
| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Yugoslavia | 65096 | ► Subscribe | |||||||||||||
| Malaysia | 117492 | ► Subscribe | |||||||||||||
| Argentina | 021074 | ► Subscribe | |||||||||||||
| China | 1061348 | ► Subscribe | |||||||||||||
| Canada | 2192418 | ► Subscribe | |||||||||||||
| Indonesia | 29089 | ► Subscribe | |||||||||||||
| Cuba | 23260 | ► Subscribe | |||||||||||||
| Slovenia | 780390 | ► Subscribe | |||||||||||||
| Uruguay | 25792 | ► Subscribe | |||||||||||||
| Ukraine | 72483 | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 01C/030 | Belgium | ► Subscribe | PRODUCT NAME: MOXIFLOXACINE CHLORHYDRATE (CORRESPONDANT A MOXIFLOXACINE); NATL. REGISTRATION NO/DATE: 187 IS 328 F 3 20010507; FIRST REGISTRATION: DE 45263.00.00 19990621 | ||||||||||||
| 2004012 | Lithuania | ► Subscribe | 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) | ||||||||||||
| /2000 | Austria | ► Subscribe | 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 | ||||||||||||
| 00111 | Netherlands | ► Subscribe | 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 | ||||||||||||
| C/GB03/034 | United Kingdom | ► Subscribe | PRODUCT NAME: MOXIFLOXACIN AND PHARMACEUTICALLY USABLE HYDRATES AND ACID ADDITION SALTS THEREOF AND THE ALKALI METAL, ALKALINE EARTH METAL, SILVER AND GUANIDINIUM SALTS OF THE UNDERLYING CARBOXYLIC ACIDS AND THE RACEMATES THEREOF; REGISTERED: DE 45263.00.00 19990621; UK PL 000 10/0291 20030313 | ||||||||||||
| 2004012,C0780390 | Lithuania | ► Subscribe | 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-CHINOLINKARBOKSIRUGSTIES HIDROCHLORIDAS); REGISTRATION NO/DATE: 04/8383/3 20040309 | ||||||||||||
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Serving leading biopharmaceutical companies globally:
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 verifification 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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