Vancomycin - Generic Drug Details
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What are the generic drug sources for vancomycin and what is the scope of freedom to operate?
Vancomycin
is the generic ingredient in seven branded drugs marketed by Xellia Pharms Aps, Ani Pharms, Fresenius Kabi Usa, Lupin Ltd, Orient Pharma Co Ltd, Pai Holdings Pharm, Strides Pharma, Watson Labs, Azurity, Lederle, Alkem Labs Ltd, Amneal, Steriscience, Hikma, Aspiro, Avet Lifesciences, Eugia Pharma, Gland Pharma Ltd, Hainan Poly, Hainan Poly Pharm, Hikma Pharms, Hospira, Hospira Inc, Knack, Meitheal, Mylan Labs Ltd, Pharm Assoc, Sagent Pharms, Sandoz, Sandoz Inc, Teva Pharms Usa, Pharmacia And Upjohn, Samson Medcl, Zhejiang Novus Pharm, and Baxter Hlthcare, and is included in sixty-four NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Vancomycin has forty-seven patent family members in twenty-nine countries.
There are twenty-two drug master file entries for vancomycin.
Summary for vancomycin
International Patents: | 47 |
US Patents: | 13 |
Tradenames: | 7 |
Applicants: | 35 |
NDAs: | 64 |
Drug Master File Entries: | 22 |
Raw Ingredient (Bulk) Api Vendors: | 37 |
Clinical Trials: | 423 |
Patent Applications: | 5,720 |
Drug Prices: | Drug price trends for vancomycin |
What excipients (inactive ingredients) are in vancomycin? | vancomycin excipients list |
DailyMed Link: | vancomycin at DailyMed |
Recent Clinical Trials for vancomycin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Cologne | Phase 2 |
Heidelberg University | Phase 2 |
Universitätsmedizin Mannheim | Phase 2 |
Pharmacology for vancomycin
Drug Class | Glycopeptide Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes for vancomycin
US Patents and Regulatory Information for vancomycin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alkem Labs Ltd | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | FOR SOLUTION;ORAL | 214913-002 | Nov 14, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Azurity | FIRVANQ KIT | vancomycin hydrochloride | FOR SOLUTION;ORAL | 208910-001 | Jan 26, 2018 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Watson Labs | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | CAPSULE;ORAL | 065510-001 | Apr 9, 2012 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Xellia Pharms Aps | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | SOLUTION;INTRAVENOUS | 211962-004 | Feb 15, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Hikma | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 062879-001 | Aug 2, 1988 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Orient Pharma Co Ltd | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | CAPSULE;ORAL | 210729-002 | Apr 29, 2019 | AB | RX | No | No | ⤷ 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 |
International Patents for vancomycin
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Serbia | 59851 | KOMPOZICIJE GLIKOPEPTIDA (GLYCOPEPTIDE COMPOSITIONS) | ⤷ Try a Trial |
European Patent Office | 4147710 | COMPOSITIONS GLYCOPEPTIDIQUES EN SOLUTION (GLYCOPEPTIDE COMPOSITIONS IN SOLUTION) | ⤷ Try a Trial |
Denmark | 3542812 | ⤷ Try a Trial | |
Mexico | 2017005749 | COMPOSICIONES ANTIBIÓTICAS. (GLYCOPEPTIDE COMPOSITIONS.) | ⤷ Try a Trial |
Chile | 2017001139 | Composiciones de antibiótico | ⤷ Try a Trial |
Japan | 2020183424 | グリコペプチド組成物 (GLYCOPEPTIDE COMPOSITIONS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
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