PYLERA Drug Patent Profile

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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. Three suppliers are listed for this compound. Additional details are available on the bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride profile page.

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	7
Drug Prices:	Drug price information for PYLERA
What excipients (inactive ingredients) are in PYLERA?	PYLERA excipients list
DailyMed Link:	PYLERA at DailyMed

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

Drug Class	Bismuth Nitroimidazole Antimicrobial Tetracycline-class Antimicrobial

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

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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

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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

See the table below for patents covering PYLERA around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	2733849		⤷ Sign Up
Spain	2212391		⤷ Sign Up
Norway	20003159		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration