Moxifloxacin hydrochloride - Generic Drug Details
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What are the generic drug sources for moxifloxacin hydrochloride and what is the scope of freedom to operate?
Moxifloxacin hydrochloride
is the generic ingredient in six branded drugs marketed by Harrow Eye, Adaptis, Alembic, Apotex, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Lupin Ltd, Mylan, Upsher Smith Labs, Bayer Hlthcare, Fresenius Kabi Usa, Mylan Labs Ltd, Aurobindo Pharma Ltd, Chartwell Rx, Crossmedika Sa, Dr Reddys, Hetero Labs Ltd V, MSN, Natco, Sunshine, Teva Pharms Usa, and Torrent, and is included in twenty-six NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Moxifloxacin hydrochloride has twenty-three patent family members in fifteen countries.
There are seventeen drug master file entries for moxifloxacin hydrochloride. Thirty-six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for moxifloxacin hydrochloride
International Patents: | 23 |
US Patents: | 2 |
Tradenames: | 6 |
Applicants: | 23 |
NDAs: | 26 |
Drug Master File Entries: | 17 |
Finished Product Suppliers / Packagers: | 36 |
Raw Ingredient (Bulk) Api Vendors: | 111 |
Clinical Trials: | 486 |
Patent Applications: | 2,409 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for moxifloxacin hydrochloride |
What excipients (inactive ingredients) are in moxifloxacin hydrochloride? | moxifloxacin hydrochloride excipients list |
DailyMed Link: | moxifloxacin hydrochloride at DailyMed |
Recent Clinical Trials for moxifloxacin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
North Eastern Indira Gandhi Regional Institute of Health ans Medical Sciences | Phase 3 |
Christian Medical College, Vellore, India | Phase 3 |
Indian Council of Medical Research | Phase 3 |
Generic filers with tentative approvals for MOXIFLOXACIN HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 0.5% | SOLUTION; OPHTHALMIC |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for moxifloxacin hydrochloride
Drug Class | Fluoroquinolone Antibacterial Quinolone Antimicrobial |
Anatomical Therapeutic Chemical (ATC) Classes for moxifloxacin hydrochloride
Paragraph IV (Patent) Challenges for MOXIFLOXACIN HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
MOXEZA | Ophthalmic Solution | moxifloxacin hydrochloride | 0.5% | 022428 | 1 | 2012-02-29 |
VIGAMOX | Ophthalmic Solution/Drops | moxifloxacin hydrochloride | 0.5% | 021598 | 1 | 2005-12-22 |
US Patents and Regulatory Information for moxifloxacin hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sunshine | MOXIFLOXACIN HYDROCHLORIDE | moxifloxacin hydrochloride | TABLET;ORAL | 206295-001 | Sep 28, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Alembic | MOXIFLOXACIN HYDROCHLORIDE | moxifloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 209469-001 | Feb 13, 2019 | AT1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Fresenius Kabi Usa | MOXIFLOXACIN HYDROCHLORIDE | moxifloxacin hydrochloride | SOLUTION;INTRAVENOUS | 205572-001 | Apr 3, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Adaptis | MOXIFLOXACIN HYDROCHLORIDE | moxifloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 202525-001 | Mar 6, 2015 | AT1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 moxifloxacin hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Hlthcare | AVELOX | moxifloxacin hydrochloride | TABLET;ORAL | 021085-001 | Dec 10, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER | moxifloxacin hydrochloride | SOLUTION;INTRAVENOUS | 021277-001 | Nov 30, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Harrow Eye | MOXEZA | moxifloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 022428-001 | Nov 19, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Harrow Eye | VIGAMOX | moxifloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021598-001 | Apr 15, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for moxifloxacin hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | PI0914971 | composições farmacêuticas que contêm fármaco antibiótico de fluoroquinolonas | ⤷ Sign Up |
Mexico | 2010012933 | COMPOSICIONES FARMACEUTICAS QUE CONTIENEN UNA DROGA ANTIBIOTICA DE FLUOROQUINOLONA. (PHARMACEUTICAL COMPOSITIONS CONTAINING A FLUOROQUINOLONE ANTIBIOTIC DRUG.) | ⤷ Sign Up |
Canada | 2726616 | COMPOSITIONS PHARMACEUTIQUES CONTENANT UN MEDICAMENT ANTIBIOTIQUE DE FLUOROQUINOLONE (PHARMACEUTICAL COMPOSITIONS CONTAINING A FLUOROQUINOLONE ANTIBIOTIC DRUG) | ⤷ Sign Up |
Uruguay | 31880 | COMPOSICIONES FARMACÉUTICAS MEJORADAS QUE CONTIENEN UN MEDICAMENTO ANTIBIÓTICO DE FLUOROQUINOLONA | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for moxifloxacin hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0350733 | C300111 | Netherlands | ⤷ Sign Up | 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 |
0350733 | 11/2000 | Austria | ⤷ Sign Up | 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 |
0780390 | PA2004012,C0780390 | Lithuania | ⤷ Sign Up | 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 |
0350733 | 2001C/030 | Belgium | ⤷ Sign Up | PRODUCT NAME: MOXIFLOXACINE CHLORHYDRATE (CORRESPONDANT A MOXIFLOXACINE); NATL. REGISTRATION NO/DATE: 187 IS 328 F 3 20010507; FIRST REGISTRATION: DE 45263.00.00 19990621 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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