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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Covington
Johnson and Johnson
Express Scripts
Fish and Richardson
Merck
UBS
Federal Trade Commission
Dow

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050786

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NDA 050786 describes PYLERA, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the PYLERA profile page.

The generic ingredient in PYLERA is bismuth subcitrate potassium; metronidazole; tetracycline. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bismuth subcitrate potassium; metronidazole; tetracycline profile page.
Summary for 050786
Tradename:PYLERA
Applicant:Allergan Sales Llc
Ingredient:bismuth subcitrate potassium; metronidazole; tetracycline
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 050786
Suppliers and Packaging for NDA: 050786
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PYLERA bismuth subcitrate potassium; metronidazole; tetracycline CAPSULE;ORAL 050786 NDA Allergan, Inc. 58914-601 N 58914-601-20
PYLERA bismuth subcitrate potassium; metronidazole; tetracycline CAPSULE;ORAL 050786 NDA Allergan, Inc. 58914-601 N 58914-601-21

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength140MG;125MG;125MG
Approval Date:Sep 28, 2006TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Dec 14, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:PYLERA CAPSULES, IN COMBINATION WITH OMEPRAZOLE ARE INDICATED FOR THE TREATMENT OF PATIENTS WITH HELICOBACTER PYLORI INFECTION AND DUODENAL ULCER DISEASE TO ERADICATE H. PYLORI
Patent:➤ Sign UpPatent Expiration:Dec 14, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH H. PYLORI INFECTION AND DUODENAL ULCER DISEASE

Expired US Patents for NDA 050786

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc PYLERA bismuth subcitrate potassium; metronidazole; tetracycline CAPSULE;ORAL 050786-001 Sep 28, 2006 ➤ Sign Up ➤ Sign Up
Allergan Sales Llc PYLERA bismuth subcitrate potassium; metronidazole; tetracycline CAPSULE;ORAL 050786-001 Sep 28, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Harvard Business School
UBS
Deloitte
Express Scripts
Johnson and Johnson
Colorcon
Fuji
AstraZeneca

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