Japan Pharma Regulatory Brief

Japan · re-examination periods · patent term extensions · generic NHI listing

Japan Generic Entry Calendar

When can a generic of each new drug be listed in Japan? Re-examination end from MHLW notices, patent term extensions from J-PlatPat, and the February/August approval → June/December listing rule. Re-examination periods from MHLW notices. Patent column shows only public patent term extension (PTE) registration facts from the JPO / J-PlatPat. We make no legal judgement on which patents are valid, cover the product, or would actually block a generic. Not investment advice.

Data as of 2026-09-28 · sources: MHLW, PMDA (PDL1.0), J-PlatPat; edited and analysed

200new active ingredients whose re-examination period ends in the next 5 years
2028-06earliest possible generic NHI listing in the table (last: 2033-06)
137with 2 or fewer Japan Drug Master File registrants (118 with none yet)
31with later indication periods that will be carved out of generic labels

Next generic entries (first 10 of 200)

Sorted by earliest possible generic NHI listing month. The patent column is shown for the first 3 rows; the full table with patent numbers, carve-outs, MF registrants by country (India / China / Korea) and sources is for subscribers. Patent term extensions have not been searched yet for this build.

IngredientBrand / originatorRe-exam endsPatent term extension (latest)BindingEarliest generic listingTypical listingMF registrants
Apremilast
アプレミラスト		Otezla
Celgene K.K.		2026-12-18not checkedre-exam2028-062030-061
thin MF
Dimethyl fumarate
フマル酸ジメチル orphan		Tecfidera
Biogen Japan Ltd.		2026-12-18not checkedre-exam2028-062030-060
thin MF
Plerixafor
プレリキサホル orphan		Mozobil
Sanofi K.K.		2026-12-18not checkedre-exam2028-062030-060
thin MF
Ceftolozane sulfate/Tazobactam sodium
セフトロザン硫酸塩/タゾバクタムナトリウム		Zerbaxa
MSD K.K.		2027-01-072028-062030-060
thin MF
Dacomitinib hydrate
ダコミチニブ水和物		Vizimpro
Pfizer Japan Inc.		2027-01-072028-062030-060
thin MF
Esaxerenone
エサキセレノン		Minnebro
Daiichi Sankyo Company, Limited		2027-01-072028-062030-060
thin MF
Mirogabalin besilate
ミロガバリンベシル酸塩		Tarlige
Daiichi Sankyo Company, Limited		2027-01-072028-062030-060
thin MF
Nalmefene hydrochloride hydrate
ナルメフェン塩酸塩水和物		Selincro
Otsuka Pharmaceutical Co., Ltd.		2027-01-072028-062030-062
thin MF
Relugolix
レルゴリクス		Relumina
Takeda Pharmaceutical Company Limited		2027-01-072028-062030-060
thin MF
Romosozumab
ロモソズマブ(遺伝子組換え)		Evenity
Amgen Astellas BioPharma K.K.		2027-01-072028-062030-060
biologic

Binding = whichever ends later: the re-examination period or the latest registered patent term extension. MF registrants = companies with an API / intermediate master file at PMDA (registration is optional, so this is a lower bound).

Earliest generic listing (year)Ingredients
202827
202939
203042
203139
203237
203316

What the subscriber edition adds

  • All 200 ingredients (plus later years), refreshed when MHLW publishes new re-exam notices and extensions.
  • Patent term extension facts from J-PlatPat: patent numbers, number of extensions, latest extended expiry.
  • Carve-out dates for later indications, and MF registrants by country (India, China, Korea, Japan).
  • CSV export and an email when a date changes. Sample: subscriber preview.

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How a generic reaches the Japanese market

  1. Re-examination period ends. A new active ingredient gets an 8-year re-examination period (orphan drugs up to 10, some extended for paediatric work). A generic cannot be filed until it ends.
  2. Filing round. Generic applications run in two rounds: filed 1 March–31 August → approved the next August; filed 1 September–end of February → approved the following February (standard review 12 months).
  3. NHI price listing. Generics are listed in June and December: February approvals in June, August approvals in December. Sales start after listing.
  4. Patent linkage. MHLW does not approve a generic while a substance or use patent remains. The application can be filed during the patent term, so when a patent term extension (PTE) runs past the re-exam end, the earliest listing is the round right after the extended expiry (first 15 Feb / 15 Aug on or after expiry → June / December).
  5. Carve-outs. Re-examination periods granted later for new indications do not block the generic, but those indications stay out of the generic label until they end.

Example: re-exam ends 18 Dec 2026 → file from 19 Dec (second round) → approval Feb 2028 → earliest listing June 2028. In 2016–2026 the first generic was listed at the earliest possible round for about a third of ingredients; the median was 4 rounds (about 2 years) later, which is the “typical listing” column.

Sources & attribution

出典：厚生労働省ホームページ（事務連絡「新医薬品として承認された医薬品について」、課長通知「新医薬品の再審査期間の延長について」、後発医薬品の承認・薬価収載の取扱い）、独立行政法人医薬品医療機器総合機構（PMDA）ウェブサイト「新医薬品の承認品目一覧」「原薬等登録原簿（MF）の公示」、特許情報プラットフォーム（J-PlatPat）を加工して Japan Pharma Regulatory Brief が作成

MHLW and PMDA content is used under the Public Data License 1.0 (compatible with CC BY 4.0); see the MHLW terms of use and PMDA's site policy. Created by editing, translating and analysing this material. Listing months are our estimates from the published rules, not official dates. This page is not made by, affiliated with or endorsed by MHLW, PMDA or the JPO. The Japanese originals prevail.

Last built: · data as of 2026-09-28.