TALICIA Drug Patent Profile
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When do Talicia patents expire, and what generic alternatives are available?
Talicia is a drug marketed by Redhill and is included in one NDA. There are seven patents protecting this drug.
This drug has thirty patent family members in twenty-five 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 November 1, 2027. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for TALICIA
| International Patents: | 30 |
| US Patents: | 7 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TALICIA
*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
US Patents and Regulatory Information for TALICIA
TALICIA is protected by seven US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TALICIA is ⤷ Sign Up.
This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Rifabutin-based compositions and methods for treating Helicobacter pylori infection
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF H. PYLORI INFECTION IN ADULTS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HELICOBACTER PYLORI INFECTION USING THE ADMINISTERED DOSAGE FORMS IN ADULTS WITH DIFFERENT BODY MASS INDEX DETERMINATIONS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HELICOBACTER PYLORI INFECTION IN ADULTS USING SPECIFIED DOSAGE FORM
Pharmaceutical compositions for the treatment of Helicobacter pylori
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF H. PYLORI INFECTION IN ADULTS
Pharmaceutical compositions for the treatment of Helicobacter pylori
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF H. PYLORI INFECTION IN ADULTS
Pharmaceutical compositions for the treatment of Helicobacter pylori
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF H. PYLORI INFECTION IN ADULTS
FDA Regulatory Exclusivity protecting TALICIA
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Redhill | TALICIA | amoxicillin; omeprazole magnesium; rifabutin | CAPSULE, DELAYED RELEASE;ORAL | 213004-001 | Nov 1, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Redhill | TALICIA | amoxicillin; omeprazole magnesium; rifabutin | CAPSULE, DELAYED RELEASE;ORAL | 213004-001 | Nov 1, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Redhill | TALICIA | amoxicillin; omeprazole magnesium; rifabutin | CAPSULE, DELAYED RELEASE;ORAL | 213004-001 | Nov 1, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Redhill | TALICIA | amoxicillin; omeprazole magnesium; rifabutin | CAPSULE, DELAYED RELEASE;ORAL | 213004-001 | Nov 1, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Redhill | TALICIA | amoxicillin; omeprazole magnesium; rifabutin | CAPSULE, DELAYED RELEASE;ORAL | 213004-001 | Nov 1, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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: ⤷ Sign Up
Brazil
Patent: 2015019264
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 00763
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 15002253
Estimated Expiration: ⤷ Sign Up
China
Patent: 5163743
Estimated Expiration: ⤷ Sign Up
Patent: 9893516
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0191559
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 56149
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 56149
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 17645
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 52411
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 0387
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 94529
Estimated Expiration: ⤷ Sign Up
Patent: 16508516
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 8536
Estimated Expiration: ⤷ Sign Up
Patent: 15010490
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 1754
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 015501783
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 56149
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 56149
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 71400
Estimated Expiration: ⤷ Sign Up
Patent: 15138708
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201506318Q
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 56149
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2062357
Estimated Expiration: ⤷ Sign Up
Patent: 150118176
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 44406
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 0249
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Hungary | E052411 | ⤷ Sign Up | |
| Chile | 2015002253 | Composiciones farmacéuticas para el tratamiento de la helicobacter pylori. | ⤷ Sign Up |
| Israel | 240387 | תכשירי רוקחות לטיפול בהליקובקטר פילורי (Pharmaceutical compositions for the treatment of helicobacter pylori) | ⤷ Sign Up |
| Russian Federation | 2671400 | ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ОТ HELICOBACTER PYLORI (PHARMACEUTICAL COMPOSITIONS FOR TREATMENT OF HELICOBACTER PYLORI) | ⤷ Sign Up |
| Japan | 6494529 | ⤷ Sign Up | |
| Singapore | 11201506318Q | PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF HELICOBACTER PYLORI | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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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