Osaka, Japan – August 17, 2026 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Toshiomi Nakate) received approvals by the Ministry of Health, Labour and Welfare for seven generic drugs with 12 strengths. The four compounds marked with an asterisk below are approved for the first time as generics.
The list of approved products
1. LINAGLIPTIN Tablets*
| Generic name |
Linagliptin |
| Strengths |
Tablets: 5mg |
| Brand products |
Trazenta®Tablets 5mg |
2. TENELIGLIPTIN Tablets*
| Generic name |
Teneligliptin Hydrobromide Hydrate |
| Strengths |
Tablets: 20mg, 40mg |
| Brand products |
TENELIA® TABLETS 20mg, 40mg |
3. GUANFACINE Sustained-release Tablets*
| Generic name |
Guanfacine Hydrochloride |
| Strengths |
Sustained-release Tablets: 1mg, 2mg, 3mg |
| Brand products |
intuniv® Tablets 1mg, 3mg |
4. PERAMPANEL Tablets, Fine Granules
| Generic name |
Perampanel |
| Strengths |
Tablets: 2mg, 4mg
Fine Granules: 1% |
| Brand products |
Fycompa® tablets 2mg, 4mg, Fycompa® fine granules 1% |
5. ATOVAQUONE Oral Suspension
| Generic name |
Atovaquone |
| Strengths |
Oral Suspension: 15% |
| Brand products |
SAMTIREL Oral Suspension 15% |
6. ISTRADEFYLLINE OD Tablets*
| Generic name |
Istradefylline |
| Strengths |
OD Tablets: 20mg |
| Brand products |
NOURIAST® Tablets 20mg |
7. TOLVAPTAN OD Tablets
| Generic name |
Tolvaptan |
| Strengths |
OD Tablets: 30mg |
| Brand products |
Samsca® OD tablets 30mg |
The products announced in this press release are not approved by the Food & Drug Administration for sale and distribution in the United States.
