Moxifloxacin hydrochloride - Generic Drug Details
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What are the generic sources for moxifloxacin hydrochloride and what is the scope of patent protection?
Moxifloxacin hydrochloride
is the generic ingredient in six branded drugs marketed by Harrow Eye, Alembic, Apotex, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Indoco, 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, 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-five 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: | 22 |
NDAs: | 26 |
Drug Master File Entries: | 17 |
Finished Product Suppliers / Packagers: | 35 |
Raw Ingredient (Bulk) Api Vendors: | 111 |
Clinical Trials: | 474 |
Patent Applications: | 2,409 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Ministry of Health, France | Phase 3 |
Assistance Publique Hopitaux De Marseille | Phase 3 |
Hôpital Necker-Enfants Malades | Phase 3 |
Generic filers with tentative approvals for MOXIFLOXACIN HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 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 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hetero Labs Ltd V | MOXIFLOXACIN HYDROCHLORIDE | moxifloxacin hydrochloride | TABLET;ORAL | 204836-001 | Mar 2, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Aurobindo Pharma Ltd | MOXIFLOXACIN HYDROCHLORIDE | moxifloxacin hydrochloride | TABLET;ORAL | 202632-001 | Mar 4, 2014 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Harrow Eye | VIGAMOX | moxifloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021598-001 | Apr 15, 2003 | AT1 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 moxifloxacin hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Harrow Eye | VIGAMOX | moxifloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021598-001 | Apr 15, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Harrow Eye | MOXEZA | moxifloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 022428-001 | Nov 19, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Hlthcare | AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER | moxifloxacin hydrochloride | SOLUTION;INTRAVENOUS | 021277-001 | Nov 30, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for moxifloxacin hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Uruguay | 31880 | COMPOSICIONES FARMACÉUTICAS MEJORADAS QUE CONTIENEN UN MEDICAMENTO ANTIBIÓTICO DE FLUOROQUINOLONA | ⤷ Try a Trial |
Taiwan | 201000102 | Improved pharmaceutical compositions containing a fluoroquinolone antibiotic drug | ⤷ Try a Trial |
South Korea | 101587056 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for moxifloxacin hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0780390 | PA2004012,C0780390 | Lithuania | ⤷ Try a 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-CHINOLINKARBOKSIRUGSTIES HIDROCHLORIDAS); REGISTRATION NO/DATE: 04/8383/3 20040309 |
0350733 | C300111 | Netherlands | ⤷ Try a 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 |
0780390 | PA2004012 | Lithuania | ⤷ Try a 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) |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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