Vancomycin hydrochloride - Generic Drug Details
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What are the generic sources for vancomycin hydrochloride and what is the scope of freedom to operate?
Vancomycin hydrochloride
is the generic ingredient in six branded drugs marketed by 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 Speclts, Hikma, Aspiro, Avet Lifesciences, Eugia Pharma, Gland Pharma Ltd, Hikma Pharms, Hospira, Hospira Inc, Knack, Medimetriks Pharms, Meitheal, Mylan Labs Ltd, Sagent Pharms, Sandoz, Sandoz Inc, Slate Run Pharma, Teva Pharms Usa, Xellia Pharms Aps, Pharmacia And Upjohn, Samson Medcl, Zhejiang Novus Pharm, and Baxter Hlthcare, and is included in sixty-three NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.Vancomycin hydrochloride has fifty-six patent family members in twenty-nine countries.
There are twenty drug master file entries for vancomycin hydrochloride. Thirty suppliers are listed for this compound.
Summary for vancomycin hydrochloride
International Patents: | 56 |
US Patents: | 12 |
Tradenames: | 6 |
Applicants: | 34 |
NDAs: | 63 |
Drug Master File Entries: | 20 |
Finished Product Suppliers / Packagers: | 30 |
Raw Ingredient (Bulk) Api Vendors: | 104 |
Clinical Trials: | 429 |
Patent Applications: | 1,997 |
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 |
---|---|
Chang Gung Memorial Hospital | N/A |
Hospital Universitario Evangelico de Curitiba | Phase 3 |
University of Duhok | N/A |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Xellia Pharms Aps | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 091377-001 | Sep 9, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Xellia Pharms Aps | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | SOLUTION;INTRAVENOUS | 211962-006 | May 13, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Xellia Pharms Aps | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | SOLUTION;INTRAVENOUS | 211962-005 | May 13, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Pai Holdings Pharm | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | CAPSULE;ORAL | 065478-002 | Apr 9, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hikma | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 203300-002 | Aug 11, 2020 | AP | 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 |
International Patents for vancomycin hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2017508807 | ⤷ Sign Up | |
Costa Rica | 20170234 | COMPOSICIONES DE ANTIBIÓTICO | ⤷ Sign Up |
Poland | 3542812 | ⤷ Sign Up | |
Poland | 3215173 | ⤷ Sign Up | |
South Africa | 201702767 | GLYCOPEPTIDE COMPOSITIONS | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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