VANCOMYCIN HYDROCHLORIDE Drug Patent Profile
When do Vancomycin Hydrochloride patents expire, and what generic alternatives are available?
Vancomycin Hydrochloride is a drug marketed by Fresenius Kabi Usa, Lupin, Orient Pharma Co Ltd, Pai Holdings, Strides Pharma, Watson Labs, Alkem Labs Ltd, Amneal, Aurobindo Pharma, Aspiro, Avet Lifesciences, Eugia Pharma, Eurofarma, Gland, Hainan Poly, Hikma, Hikma Pharms, Hospira, Hospira Inc, Knack, Meitheal, Mylan Labs Ltd, Plano Pharms, Sagent Pharms, Teva Pharms Usa, Xellia Pharms Aps, Samson Medcl, Steriscience, Zhejiang Novus Pharm, and Baxter Hlthcare. and is included in fifty-five NDAs.
The generic ingredient in VANCOMYCIN HYDROCHLORIDE is vancomycin hydrochloride. There is one drug master file entry for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Vancomycin Hydrochloride
A generic version of VANCOMYCIN HYDROCHLORIDE was approved as vancomycin hydrochloride by FRESENIUS KABI USA on March 17th, 1987.
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Summary for VANCOMYCIN HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 30 |
| NDAs: | 55 |
| Finished Product Suppliers / Packagers: | 32 |
| Raw Ingredient (Bulk) Api Vendors: | 80 |
| Clinical Trials: | 481 |
| Patent Applications: | 898 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VANCOMYCIN HYDROCHLORIDE |
| What excipients (inactive ingredients) are in VANCOMYCIN HYDROCHLORIDE? | VANCOMYCIN HYDROCHLORIDE excipients list |
| DailyMed Link: | VANCOMYCIN HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for VANCOMYCIN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| McGill University Health Centre/Research Institute of the McGill University Health Centre | PHASE3 |
| The Methodist Hospital Research Institute | NA |
| Nantes University Hospital | PHASE2 |
Pharmacology for VANCOMYCIN HYDROCHLORIDE
| Drug Class | Glycopeptide Antibacterial |
Medical Subject Heading (MeSH) Categories for VANCOMYCIN HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for VANCOMYCIN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for VANCOMYCIN HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| FIRVANQ KIT | For Oral Solution | vancomycin hydrochloride | 25 mg/mL and 50 mg/mL | 208910 | 1 | 2020-05-18 |
US Patents and Regulatory Information for VANCOMYCIN HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Labs Ltd | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 091469-001 | Jul 1, 2011 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Mylan Labs Ltd | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | POWDER;INTRAVENOUS | 209481-006 | Jun 26, 2024 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hainan Poly | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 215821-002 | Nov 18, 2021 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Fresenius Kabi Usa | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 062663-004 | Nov 28, 1997 | AP | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Xellia Pharms Aps | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 204125-001 | Dec 28, 2015 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Zhejiang Novus Pharm | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | POWDER;INTRAVENOUS, ORAL | 210274-005 | Aug 1, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hikma | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 203300-001 | Aug 11, 2020 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
