721 Generic Drugs on Japan's NHI List

31 July 1994

A total of 721 generic pharmaceutical products manufactured by 131 companies are now included on Japan's National Health Insurance Price list, the Ministry of Health and Welfare has announced. The 0.9-fold rule was used in calculations of NHI prices for 352 of the 721 products.

Since generics were first included on the NHI list, their numbers have moved from 990 in October 1987, 426 in July 1988, 985 in July 1990, and 863 in July 1992 to 721 in July 1994.

Pricing hearings conducted before the listing by the Ministry's Pharmaceutical Affairs Bureau revealed that New Drug Applications for 123 generics have been withdrawn. Of these, NDAs for six active ingredients in 19 presentations were withdrawn because of the likelihood of a patent dispute developing, in the event of their being included on the NHI listing.

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