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TALICIA Drug Profile
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» See Plans and PricingWhich patents cover Talicia, and what generic alternatives are available?
Talicia is a drug marketed by Redhill and is included in one NDA. There are four patents protecting this drug.
This drug has twenty-seven patent family members in twenty-two 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.
US ANDA Litigation and 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: | 27 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TALICIA |
| DailyMed Link: | TALICIA at DailyMed |
Generic Entry Opportunity Date for TALICIA
Generic Entry Date for TALICIA*:
Constraining patent/regulatory exclusivity:
NDA:
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 | Proton Pump Inhibitor Penicillin-class Antibacterial Rifamycin Antimycobacterial |
| Mechanism of Action | Proton Pump Inhibitors Cytochrome P450 2C19 Inhibitors |
US Patents and Regulatory Information for 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Redhill | TALICIA | amoxicillin; omeprazole magnesium; rifabutin | CAPSULE, DELAYED RELEASE;ORAL | 213004-001 | Nov 1, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Redhill | TALICIA | amoxicillin; omeprazole magnesium; rifabutin | CAPSULE, DELAYED RELEASE;ORAL | 213004-001 | Nov 1, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Redhill | TALICIA | amoxicillin; omeprazole magnesium; rifabutin | CAPSULE, DELAYED RELEASE;ORAL | 213004-001 | Nov 1, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1217645 | Start Trial |
| Japan | 2016508516 | Start Trial |
| Mexico | 2015010490 | Start Trial |
| Philippines | 12015501783 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
