Source: FDA, National Drug Code (US) Revision Year: 2026
HOVILPRI (pritelivir), a helicase-primase inhibitor, is developed as a mesylate monohydrate salt. It is chemically described as Benzeneacetamide, N-[5-(aminosulfonyl)-4-methyl-2-thiazolyl]-N-methyl-4-(2-pyridinyl)-, methanesulfonate, hydrate (1:1:1). Its molecular formula C19H22N4O6S3 x H2O corresponds to a molecular weight of 516.62 g/mole. Pritelivir mesylate monohydrate salt has the following structural formula:
Each tablet contains 100 mg of pritelivir (equivalent to 123.9 mg of pritelivir mesylate) and is available as immediate release tablets for oral administration.
The tablet core contains standard excipients: colloidal silica dioxide, croscarmellose sodium, magnesium stearate, mannitol, and microcrystalline cellulose, as well as the film-coat (hydroxy propyl methyl cellulose and polyethylene glycol) and the colorant/opacifier calcium diphosphate.
| Dosage Forms and Strengths |
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HOVILPRI film-coated tablets are white to off-white, round, biconvex and contain 100 mg pritelivir. The tablets are embossed with 'AIC' on one side and with '1' on the other side. |
| How Supplied |
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HOVILPRI 100 mg tablets are white to off-white film-coated tablets. The tablets are round and biconvex with a diameter of about 11 mm, debossed with "1" on one side and "AIC" on the other side and with weight of 513 mg. HOVILPRI is available in cartons of 16 or 32 film-coated tablets. NDC 68992-100-32 - Each carton contains two blister wallets. Each blister wallet contains 16 film-coated tablets, for a total of 32 film-coated tablets per carton. NDC 68992-100-16 - Each carton contains one blister wallet containing 16 film-coated tablets. Distributed by: Asahi Kasei Therapeutics, Inc., Cary, North Carolina 27518 |
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