TALICIA Drug Patent Profile

Which patents cover Talicia, and what generic alternatives are available?

Talicia is a drug marketed by Redhill and is included in one NDA. There are five patents protecting this drug.

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

The generic ingredient in TALICIA is amoxicillin; omeprazole magnesium; rifabutin. There are forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amoxicillin; omeprazole magnesium; rifabutin profile page.

DrugPatentWatch^® Generic Entry Outlook for Talicia

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 12, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TALICIA

International Patents:	29
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TALICIA
What excipients (inactive ingredients) are in TALICIA?	TALICIA excipients list
DailyMed Link:	TALICIA at DailyMed

See drug prices for TALICIA

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for TALICIA

NDA:

213004

Dosage:

CAPSULE, DELAYED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for TALICIA

Drug Class	Penicillin-class Antibacterial Proton Pump Inhibitor Rifamycin Antimycobacterial
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TALICIA

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

J01CA	Penicillins with extended spectrum
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J04AB	Antibiotics
J04A	DRUGS FOR TREATMENT OF TUBERCULOSIS
J04	ANTIMYCOBACTERIALS
J	Antiinfectives for systemic use

US Patents and Regulatory Information for TALICIA

TALICIA is protected by five US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TALICIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes			Y
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes			Y
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes			Y
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes			Y
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes			Y

International Patents for TALICIA

When does loss-of-exclusivity occur for TALICIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Croatia

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Philippines

Poland

Portugal

Russian Federation

Singapore

Slovenia

South Korea

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TALICIA around the world.

Country	Patent Number	Title	Estimated Expiration
Croatia	P20191559
Mexico	2015010490	COMPOSICION FARMACEUTICA PARA EL TRATAMIENTO DE HELICOBACTER PYLORI. (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF HELICOBACTER PYLORI.)
Brazil	112015019264	composições farmacêuticas para o tratamento de helicobacter pylori
South Korea	20150118176	헬리코박터 파일로리 치료용 약제학적 조성물 (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF HELICOBACTER PYLORI)
Russian Federation	2671400	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ОТ HELICOBACTER PYLORI (PHARMACEUTICAL COMPOSITIONS FOR TREATMENT OF HELICOBACTER PYLORI)