FIRVANQ KIT Drug Patent Profile
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Which patents cover Firvanq Kit, and what generic alternatives are available?
Firvanq Kit is a drug marketed by Azurity and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has nine patent family members in seven countries.
The generic ingredient in FIRVANQ KIT 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 Firvanq Kit
A generic version of FIRVANQ KIT was approved as vancomycin hydrochloride by FRESENIUS KABI USA on March 17th, 1987.
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Summary for FIRVANQ KIT
| International Patents: | 9 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Clinical Trials: | 1 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FIRVANQ KIT |
| DailyMed Link: | FIRVANQ KIT at DailyMed |
Recent Clinical Trials for FIRVANQ KIT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Sydney | Phase 4 |
| Flinders University | Phase 4 |
| Telethon Kids Institute | Phase 4 |
Paragraph IV (Patent) Challenges for FIRVANQ KIT
| 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 FIRVANQ KIT
FIRVANQ KIT is protected by ten US patents.
Patents protecting FIRVANQ KIT
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Composition and method for vancomycin oral liquid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Composition and method for vancomycin oral liquid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Composition and method for vancomycin oral liquid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF STAPHYLOCOCCAL ENTEROCOLITIS
Composition and method for vancomycin oral liquid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA
Composition and method for vancomycin oral liquid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF STAPHYLOCOCCAL ENTEROCOLITIS
Composition and method for vancomycin oral liquid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA
Composition and method for vancomycin oral liquid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA
Composition and method for vancomycin oral liquid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF STAPHYLOCOCCAL ENTEROCOLITIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Azurity | FIRVANQ KIT | vancomycin hydrochloride | FOR SOLUTION;ORAL | 208910-001 | Jan 26, 2018 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Azurity | FIRVANQ KIT | vancomycin hydrochloride | FOR SOLUTION;ORAL | 208910-002 | Jan 26, 2018 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Azurity | FIRVANQ KIT | vancomycin hydrochloride | FOR SOLUTION;ORAL | 208910-001 | Jan 26, 2018 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Azurity | FIRVANQ KIT | vancomycin hydrochloride | FOR SOLUTION;ORAL | 208910-002 | Jan 26, 2018 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Azurity | FIRVANQ KIT | vancomycin hydrochloride | FOR SOLUTION;ORAL | 208910-001 | Jan 26, 2018 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 FIRVANQ KIT
See the table below for patents covering FIRVANQ KIT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2015138983 | ⤷ Sign Up | |
| Spain | 2903419 | ⤷ Sign Up | |
| Japan | 6552528 | ⤷ Sign Up | |
| Australia | 2015229069 | Composition and method for vancomycin oral liquid | ⤷ Sign Up |
| China | 106573037 | 用于万古霉素口服液的组合物和方法 (Composition and method for vancomycin oral liquid) | ⤷ Sign Up |
| >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.
ISSN: 2162-2639
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