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Serving leading biopharmaceutical companies globally:

Baxter
UBS
Teva
US Department of Justice
QuintilesIMS
Novartis
Merck
Mallinckrodt
Deloitte
Medtronic

Generated: December 13, 2017

DrugPatentWatch Database Preview

AVELOX Drug Profile

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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 are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred patent family members in forty-five countries and six supplementary protection certificates in five countries.

The generic ingredient in AVELOX is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Bayer HlthcareAVELOXmoxifloxacin hydrochlorideTABLET;ORAL021085-001Dec 10, 1999ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Bayer HlthcareAVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINERmoxifloxacin hydrochlorideSOLUTION;IV (INFUSION)021277-001Nov 30, 2001APRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Bayer HlthcareAVELOXmoxifloxacin hydrochlorideTABLET;ORAL021085-001Dec 10, 1999ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Bayer HlthcareAVELOXmoxifloxacin hydrochlorideTABLET;ORAL021085-001Dec 10, 1999ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Bayer HlthcareAVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINERmoxifloxacin hydrochlorideSOLUTION;IV (INFUSION)021277-001Nov 30, 2001APRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Bayer HlthcareAVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINERmoxifloxacin hydrochlorideSOLUTION;IV (INFUSION)021277-001Nov 30, 2001APRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: AVELOX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer HlthcareAVELOXmoxifloxacin hydrochlorideTABLET;ORAL021085-001Dec 10, 1999► Subscribe► Subscribe
Bayer HlthcareAVELOXmoxifloxacin hydrochlorideTABLET;ORAL021085-001Dec 10, 1999► Subscribe► Subscribe
Bayer HlthcareAVELOXmoxifloxacin hydrochlorideTABLET;ORAL021085-001Dec 10, 1999► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for AVELOX

Drugname Dosage Strength RLD Submissiondate
moxifloxacin hydrochlorideInjection1.6 mg/mLAvelox in Sodium Chloride 0.8% in plastic container2/7/2014

International Patent Family for Tradename: AVELOX

Country Document Number Estimated Expiration
Canada2192418► Subscribe
El Salvador1996000109► Subscribe
New Zealand511554► Subscribe
Norway306725► Subscribe
Romania119782► Subscribe
Poland184885► Subscribe
Austria221531► Subscribe
Slovakia283936► Subscribe
Spain2179910► Subscribe
Argentina005009► 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 Certificates for Tradename: AVELOX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2004012,C0780390Lithuania► SubscribePRODUCT 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
2004012Lithuania► SubscribePRODUCT 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)
01C/030Belgium► SubscribePRODUCT NAME: MOXIFLOXACINE CHLORHYDRATE (CORRESPONDANT A MOXIFLOXACINE); NATL. REGISTRATION NO/DATE: 187 IS 328 F 3 20010507; FIRST REGISTRATION: DE 45263.00.00 19990621
00111Netherlands► SubscribePRODUCT 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
/2000Austria► SubscribePRODUCT 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
C/GB03/034United Kingdom► SubscribePRODUCT 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
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Serving leading biopharmaceutical companies globally:

AstraZeneca
Deloitte
Healthtrust
Merck
Johnson and Johnson
Argus Health
Medtronic
Accenture
UBS
US Army

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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