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Table 5 Remaining validity of the patent corresponding to P3 certification (month)

From: Characteristics and outcomes of the drug patent linkage system in China

 

2021

(Second half)

2022

2023

(First half)

Total

Total number of P3 (N)

90

184

116

390

 Median (IQR)[range], month

19.5(15–32)[5–92]

18(9–29)[-1-95]

14(8-26.25)[-2-204]

17(10-30.75)[-2-204]

Only P3 (N)

65

129

86

280

 Median (IQR)[range], month

17(15–31)[5–92]

15(9–27)[-1-95]

14(8–27)[-2-204]

16(9.75–29.25)[-2-204]

P3 and P2 (N)

6

15

8

29

 Median (IQR)[range], month

60.5(59–62)[14–62]

21(12-48.5)[7–58]

44.5(12-45.25)[-1-46]

45(12–49)[-1-62]

P3 and P4 (N)

19

24

14

57

 Median (IQR)[range], month

22(19–29)[10–75]

14(4.5–64)[1–67]

2(1.25–13.75)[0–23]

15(5–27)[0–75]

P3 and P2 and P4 (N)

0

16

8

24

 Median (IQR)[range], month

NA

23(19.5-25.25)[18–34]

19(17–22) [13,14,15,16,17,18,19,20,21,22]

21(18–25)[13–34]

  1. Note: when an ANDA submitted more than one P3 certifications, the remaining patent validity was measured according to the latest expired patent
  2. NA: not applicable