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Serving leading biopharmaceutical companies globally:

Moodys
Julphar
Fuji
QuintilesIMS
Healthtrust
Farmers Insurance
Boehringer Ingelheim
Harvard Business School
Federal Trade Commission
Cerilliant

Generated: December 12, 2017

DrugPatentWatch Database Preview

PYLERA Drug Profile

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When do Pylera patents expire, and what generic alternatives are available?

Pylera is a drug marketed by Forest Labs Llc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in twenty-four countries.

The generic ingredient in PYLERA is bismuth subcitrate potassium; metronidazole; tetracycline. There are twenty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bismuth subcitrate potassium; metronidazole; tetracycline profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Forest Labs LlcPYLERAbismuth subcitrate potassium; metronidazole; tetracyclineCAPSULE;ORAL050786-001Sep 28, 2006RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: PYLERA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs LlcPYLERAbismuth subcitrate potassium; metronidazole; tetracyclineCAPSULE;ORAL050786-001Sep 28, 2006► Subscribe► Subscribe
Forest Labs LlcPYLERAbismuth subcitrate potassium; metronidazole; tetracyclineCAPSULE;ORAL050786-001Sep 28, 2006► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for PYLERA

Drugname Dosage Strength RLD Submissiondate
bismuth subcitrate potassium, metronidazole, and tetracycline hydrochlorideCapsules140 mg/125 mg/ 125 mgPylera8/12/2014

International Patent Family for Tradename: PYLERA

Country Document Number Estimated Expiration
Norway329126► Subscribe
Germany69820108► Subscribe
Austria254910► Subscribe
Poland341737► Subscribe
China1285741► Subscribe
Malaysia121713► Subscribe
China1147292► Subscribe
Poland192541► Subscribe
Canada2315408► Subscribe
Australia743090► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

UBS
Farmers Insurance
McKinsey
Argus Health
Harvard Business School
Medtronic
Johnson and Johnson
Chubb
Dow
Express Scripts

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 verifification 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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