VANCOMYCIN HYDROCHLORIDE Drug Patent Profile
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When do Vancomycin Hydrochloride patents expire, and what generic alternatives are available?
Vancomycin Hydrochloride is a drug marketed by Fresenius Kabi Usa, Lupin Ltd, Orient Pharma Co Ltd, Pai Holdings Pharm, Strides Pharma, Watson Labs, Alkem Labs Ltd, Amneal, Aspiro, Avet Lifesciences, Eugia Pharma, Gland Pharma Ltd, Hainan Poly, Hainan Poly Pharm, Hikma, Hikma Pharms, Hospira, Hospira Inc, Knack, Meitheal, Mylan Labs Ltd, Pharm Assoc, Sagent Pharms, Sandoz, Sandoz Inc, Teva Pharms Usa, Xellia Pharms Aps, Zhejiang Novus Pharm, Samson Medcl, and Baxter Hlthcare. and is included in fifty-three NDAs. There are five patents protecting this drug.
This drug has forty-seven patent family members in twenty-nine countries.
The generic ingredient in VANCOMYCIN HYDROCHLORIDE is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Thirty-one 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.
Summary for VANCOMYCIN HYDROCHLORIDE
| International Patents: | 47 |
| US Patents: | 5 |
| Applicants: | 30 |
| NDAs: | 53 |
| Finished Product Suppliers / Packagers: | 25 |
| Raw Ingredient (Bulk) Api Vendors: | 104 |
| Clinical Trials: | 423 |
| Patent Applications: | 1,332 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Heidelberg University | Phase 2 |
| Universitätsmedizin Mannheim | Phase 2 |
| German Cancer Research Center | Phase 2 |
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
VANCOMYCIN HYDROCHLORIDE is protected by five US patents and two FDA Regulatory Exclusivities.
Patents protecting VANCOMYCIN HYDROCHLORIDE
Glycopeptide compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING BACTERIAL INFECTIONS
Glycopeptide compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING BACTERIAL INFECTIONS
Glycopeptide compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Glycopeptide compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING BACTERIAL INFECTIONS
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting VANCOMYCIN HYDROCHLORIDE
PATENT CHALLENGE
Exclusivity Expiration: ⤷ Try a Trial
COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sagent Pharms | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 200837-002 | Sep 2, 2014 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Xellia Pharms Aps | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | SOLUTION;INTRAVENOUS | 211962-002 | Feb 15, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hikma | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 204360-001 | Oct 15, 2018 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Gland Pharma Ltd | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 205694-003 | Jun 6, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Xellia Pharms Aps | VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 206243-002 | Dec 23, 2015 | DISCN | 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 HYDROCHLORIDE
See the table below for patents covering VANCOMYCIN HYDROCHLORIDE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Colombia | 2017005391 | Composiciones de antibiótico | ⤷ Try a Trial |
| New Zealand | 731955 | Glycopeptide compositions | ⤷ Try a Trial |
| Poland | 3215173 | ⤷ Try a Trial | |
| Saudi Arabia | 517381446 | تركيبات مضاد حيوي (ANTIBIOTIC COMPOSITIONS) | ⤷ Try a Trial |
| Croatia | P20200101 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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