TALICIA Drug Patent Profile

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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

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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

Drug patent expirations by year for TALICIA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TALICIA

Generic Entry Date for TALICIA^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

US Patents and Regulatory Information for TALICIA

TALICIA is protected by five US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TALICIA is ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
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

Pharmaceutical compositions for the treatment of Helicobacter pylori
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Rifabutin-based compositions and methods for treating Helicobacter pylori infection
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF H. PYLORI INFECTION IN ADULTS

Pharmaceutical compositions for the treatment of Helicobacter pylori
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF H. PYLORI INFECTION IN ADULTS

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Glossary

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

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

Patent: 14216373
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 2015019264
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 00763
Estimated Expiration: ⤷ Try a Trial

Chile

Patent: 15002253
Estimated Expiration: ⤷ Try a Trial

China

Patent: 5163743
Estimated Expiration: ⤷ Try a Trial

Patent: 9893516
Estimated Expiration: ⤷ Try a Trial

Croatia

Patent: 0191559
Estimated Expiration: ⤷ Try a Trial

Denmark

Patent: 56149
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 56149
Estimated Expiration: ⤷ Try a Trial

Hong Kong

Patent: 17645
Estimated Expiration: ⤷ Try a Trial

Hungary

Patent: 52411
Estimated Expiration: ⤷ Try a Trial

Israel

Patent: 0387
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 94529
Estimated Expiration: ⤷ Try a Trial

Patent: 16508516
Estimated Expiration: ⤷ Try a Trial

Mexico

Patent: 8536
Estimated Expiration: ⤷ Try a Trial

Patent: 15010490
Estimated Expiration: ⤷ Try a Trial

New Zealand

Patent: 1754
Estimated Expiration: ⤷ Try a Trial

Philippines

Patent: 015501783
Estimated Expiration: ⤷ Try a Trial

Poland

Patent: 56149
Estimated Expiration: ⤷ Try a Trial

Portugal

Patent: 56149
Estimated Expiration: ⤷ Try a Trial

Russian Federation

Patent: 71400
Estimated Expiration: ⤷ Try a Trial

Patent: 15138708
Estimated Expiration: ⤷ Try a Trial

Singapore

Patent: 201506318Q
Estimated Expiration: ⤷ Try a Trial

Slovenia

Patent: 56149
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 2062357
Estimated Expiration: ⤷ Try a Trial

Patent: 150118176
Estimated Expiration: ⤷ Try a Trial

Spain

Patent: 44406
Estimated Expiration: ⤷ Try a Trial

Ukraine

Patent: 0249
Estimated Expiration: ⤷ Try a Trial

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.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2956149	COMPOSITIONS PHARMACEUTIQUES DESTINÉES AU TRAITEMENT D'HELICOBACTER PYLORI (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF HELICOBACTER PYLORI)	⤷ Try a Trial
Hong Kong	1217645	用於治療幽門螺桿菌的藥物組合物 (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF HELICOBACTER PYLORI)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2014127025		⤷ Try a Trial
Canada	2900763	COMPOSITIONS PHARMACEUTIQUES DESTINEES AU TRAITEMENT D'HELICOBACTER PYLORI (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF HELICOBACTER PYLORI)	⤷ Try a Trial
South Korea	102062357		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration