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 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, 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: | 34 |
| NDAs: | 64 |
| Drug Master File Entries: | 22 |
| Raw Ingredient (Bulk) Api Vendors: | 37 |
| Clinical Trials: | 429 |
| Patent Applications: | 7,211 |
| 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 |
|---|---|
| Chang Gung Memorial Hospital | N/A |
| Hospital Universitario Evangelico de Curitiba | Phase 3 |
| University of Duhok | N/A |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 204360-002 | Oct 15, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma Pharms | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 206616-001 | Oct 3, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gland Pharma Ltd | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 205694-003 | Jun 6, 2023 | 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 |
