PYLERA Drug Patent Profile
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Which patents cover Pylera, and what generic alternatives are available?
Pylera is a drug marketed by Labs Juvise and is included in one NDA.
The generic ingredient in PYLERA is bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride profile page.
Summary for PYLERA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Clinical Trials: | 7 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for PYLERA |
What excipients (inactive ingredients) are in PYLERA? | PYLERA excipients list |
DailyMed Link: | PYLERA at DailyMed |
Recent Clinical Trials for PYLERA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Coimbra | N/A |
Centro Hospitalar e Universitário de Coimbra, E.P.E. | N/A |
Hospital da Senhora da Oliveira | Early Phase 1 |
Pharmacology for PYLERA
Anatomical Therapeutic Chemical (ATC) Classes for PYLERA
Paragraph IV (Patent) Challenges for PYLERA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
PYLERA | Capsules | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | 140 mg/125 mg/ 125 mg | 050786 | 1 | 2014-08-12 |
US Patents and Regulatory Information for PYLERA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Labs Juvise | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | AB | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for PYLERA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Labs Juvise | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Labs Juvise | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Labs Juvise | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PYLERA
See the table below for patents covering PYLERA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Indonesia | 26340 | ⤷ Sign Up | |
European Patent Office | 1037614 | DOUBLE CAPSULE POUR ADMINISTRER DES PRINCIPES ACTIFS SELON UNE POLYTHERAPIE (A DOUBLE CAPSULE FOR THE ADMINISTRATION OF ACTIVE PRINCIPLES IN MULTIPLE THERAPIES) | ⤷ Sign Up |
Spain | 2212391 | ⤷ Sign Up | |
Australia | 743090 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |