Talicia® is the first and only FDA approved rifabutin-based pylori therapy and is designed to address the high and growing bacterial resistance and diminished efficacy of clarithromycin-based standard-of-care therapy
Active Ingredients: Omeprazole magnesium (10.3 mg), Amoxicillin trihydrate (286.9 mg) and Rifabutin (12.5 mg)
Dosage form: Delayed release capsules
Approval date: 1 Nov. 2019
Innovator: Redhill biopharma
Indication: treatment of Helicobacter pylori infection in adults
Excipients: crospovidone, FD&C Red 3, FD&C Yellow 6, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, mannitol-starch, methacrylic acid copolymer, meglumine, pregelatinized starch, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate.
Exclusivity status: Based on Press release by Redhill biopharma, Talicia® is eligible for 8 years of U.S. market exclusivity under QIDP designation.
Launch plan: RedHill plans to launch Talicia® in the U.S. in Q1/2020.
Source: Prescribing Information; Press release
If you need information on patents/patent applications covering Redhill’s Talicia®, then write us at pharmacaption@gmail.com
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