Trend of China Pesticide Registration on the Off-Patent Active Ingredients

From a proprietary rights perspective, pesticides can be classified into three categories: patent pesticide, off-patent pesticide and non-patent pesticide/generic pesticide. Patent pesticides refers to pesticides containing active ingredient which are legally protected by both domestic and global patent infringement laws, off-patent refers to patents which have expired, however certain formulations, processing technology, usage of the active ingredient or other aspects may still be under protection. Generic pesticides refer to the product that can be produced, commercialized by any entity without causing patent disputes.

In 2010, the global pesticide market was valued at 44.19 billion USD and the percentages of patent pesticide; off-patent pesticide and the generics were 30%, 42.5% and 27.5% respectively. The leading MNCs have strong R&D capacities and develop novel pesticides; however innovation is increasingly difficult due to rising costs and regulatory uncertainty. When the patent on a pesticide expires it becomes an off-patent pesticide a market which according to forecasters will grow significantly over the coming years. Mr. Wu houbin, Division Director from ICAMA combined the outcome of Agrow’s report-“agrochemicals Coming Off-Patent 2012-2016” and a research report from another UK company and pointed out the trend towards increased numbers of off-patent registrations here in China.

Totally 58 active ingredient have been or will be out of patent in the coming several years:

Insecticide

Fungicide

Herbicide

Safener

bifenazate(联苯肼酯)

bistrifluron(双三氟虫脲)

chromafenozide(环虫酰肼)

flutenzine(氟螨嗪)

dinotefuran(呋虫胺)

etoxazole(乙螨唑)

flonicamid(氟啶虫酰胺)

indoxacarb(茚虫威)

metaflumizone(氰氟虫)腙

methoxyfenozide(甲氧虫酰肼)

pyridalyl(三氟甲吡醚)

spirodiclofen(螺螨酯)

Spiromesifen(螺甲螨酯)

spirotetramat(螺虫乙酯)

thiamethoxam(噻虫嗪)

flubendiamide氟苯虫酰胺)

metofluthrin(甲氧苄氟菊酯)

Pyrifluquinazon(新喹唑啉)

benthiavalicarb-isopropyl(苯噻菌胺)

boscalid(啶酰菌胺

cyflufenamid(环氟菌胺)

Dimoxystrobin(醚菌胺)

ethaboxam(噻唑菌胺)

fluoxastrobin(氟嘧菌酯)

orysastrobin(肟醚菌胺)

penthiopyrad(吡噻菌胺)

proquinazid(丙氧喹啉)

prothioconazole(丙硫菌唑)

pyraclostrobin(吡唑醚菌酯)

silthiopham(硅噻菌胺)

simeconazole(硅氟唑)

zoxamide(苯酰菌胺)

amisulbrom(吲唑磺菌胺)

fenpyrazamine(胺苯吡菌酮)

fluopicolide(氟吡菌胺)

metalaxyl-M(精甲霜灵)

metrafenone(苯菌酮)

valifenalate(缬菌胺)

benzobicyclon(双环磺草酮)

dimethenamid-p(二甲吩草胺)

fentrazamide(四唑酰草胺)

foramsulfuron(甲酰氨基嘧磺隆)

iodosulfuron-methyl-sodium(甲基碘磺隆钠盐)

isoxaflutole(异噁唑草酮)

mesosulfuron-methyl(甲基二磺隆)

Oxasulfuron(环氧嘧磺隆)

oxaziclomefone(噁嗪草酮)

pyribenzoxim(嘧啶肟草醚)

trifloxysulfuron sodium(三氟啶磺隆)

flucetosulfuron(氟吡磺隆)

metamifop(噁唑酰草胺)

orthosulfamuron(嘧苯胺磺隆)

penoxsulam(五氟磺草胺)

pinoxaden(唑啉草酯)

tembotrione(环磺酮)

thiencarbazone-methyl(噻酮磺隆)

topramezone(苯唑草酮)

Cyprosulfamid(对异丙基甲苯磺酰胺)

From 1 January 2013 to 20 April 2015, China ICAMA received almost 15,000 applications for field trial, which is an essential part of obtaining pesticide registration in China, of which 10,234 were based on the off-patent or the sub-new active ingredients. The name, category, number of application for single formulation, total number of application and the sales in 2012 were summarized below:

Number of Field Trial Application of Pesticide Based on the Off-Patent Active Ingredient

No.

Active Ingredient

Chinese Name

Category

 single formulation

Total Number

of Application

Sales in 2012

(00 million USD)

notes

1

pyraclostrobin

吡唑醚菌酯

fungicide

298

746

8

 

2

thiamethoxam

噻虫嗪

insecticide

324

644

11.4

 

3

imidacloprid

吡虫啉

insecticide

343

549

10.3

 

4

azoxystrobin

嘧菌酯

fungicide

161

509

12.6

 

5

dinotefuran

呋虫胺

insecticide

232

405

1.1

Sales in 2011

6

tebuconazole

戊唑醇

fungicide

123

389

5

 

7

Glyphosate ammonium

草甘膦铵盐

herbicide

80

373

45.75

All glyphosate salts

8

difenoconazole

苯醚甲环唑

fungicide

140

312

2.6

 

9

pymetrozine

吡蚜酮

insecticide

129

303

  

10

abamectin

阿维菌素

insecticide

179

299

3.6

 

11

penoxsulam

五氟磺草胺

herbicide

194

273

2.2

Sales in 2011

12

chlorpyrifos

毒死蜱

insecticide

117

257

6.25

 

13

lambda-cyhalothrin

高效氯氟氰菊酯

insecticide

169

244

5.3

 

14

glufosinate-ammonium

草铵膦

herbicide

195

238

4.2

 

15

thifluzamide

噻呋酰胺

fungicide

113

234

0.45

 

16

indoxacarb

茚虫威

insecticide

86

220

1.65

 

17

prochloraz

咪鲜胺

fungicide

61

210

 

Sales in 2011

18

fludioxonil

咯菌腈

fungicide

62

203

2.8

Sales in 2011

19

Emamectin benzoate

甲氨基阿维菌素苯甲酸盐

insecticide

94

197

  

20

mesotrione

硝磺草酮

herbicide

90

197

5.35

Sales in 2011

21

epoxiconazole

氟环唑

fungicide

69

195

4.95

 

22

cyhalofop-butyl

氰氟草酯

herbicide

113

192

  

23

fipronil

氟虫腈

insecticide

87

181

6.45

 

24

paraquat

百草枯

herbicide

131

162

6.85

 

25

hexaconazole

己唑醇

fungicide

44

150

  

26

spirodiclofen

螺螨酯

insecticide

57

139

1.1

Sales in 2011

27

brassinolide

芸苔素内酯

PGR

97

137

  

28

florasulam

双氟磺草胺

herbicide

59

131

1.95

Sales in 2011

29

kresoxim-methyl

醚菌酯

fungicide

43

131

  

30

acetamiprid

啶虫脒

insecticide

101

130

2.05

Sales in 2011

31

boscalid

啶酰菌胺

fungicide

48

127

3.55

 

32

fosthiazate

噻唑膦

fungicide

76

125

  

33

propiconazol

丙环唑

fungicide

64

124

3.5

 

34

oxadiazon

噁草酮

herbicide

42

123

  

35

carbendazim

多菌灵

fungicide

42

121

  

36

thiophanate-methyl

甲基硫菌灵

fungicide

53

119

  

37

pendimethalin

二甲戊灵

herbicide

86

106

3.45

 

38

nitenpyram

烯啶虫胺

insecticide

50

101

  

39

clodinafop-propargyl

炔草酯

herbicide

71

95

  

40

beta-cypermethrin

高效氯氰菊酯

insecticide

78

91

2.9

 

41

diquat

敌草快

herbicide

76

89

  

42

spinosad

多杀霉素

insecticide

58

89

2.6

 

43

mesosulfuron-methyl

甲基二磺隆

herbicide

59

87

2.9

Sales in 2011

44

oligosaccharins

氨基寡糖素

PGR

62

83

  

45

bentazone

灭草松

herbicide

45

81

  

46

flonicamid

氟啶虫酰胺

insecticide

59

70

0.35

Sales in 2011

47

bacillussubtilis

枯草芽孢杆菌

insecticide

55

64

  

48

bacillusthuringiensis

苏云金杆菌

insecticide

43

64

  

49

matrine

苦参碱

insecticide

45

63

  

50

picoxystrobin

啶氧菌酯

fungicide

41

62

  

The number the application filed by over-seas applicants was relatively small, reflecting the Chinese producers are inflating expectation on the off-patent market:

Number of Application Filed by Overseas Applicant

Active Ingredient

Chinese name

Number of Application

azoxystrobin

嘧菌酯

33

tebuconazole

戊唑醇

32

trifloxystrobin

肟菌酯

22

pyraclostrobin

吡唑醚菌酯

16

mancozeb

代森锰锌

16

chlorantraniliprole

氯虫苯甲酰胺

14

picoxystrobin

啶氧菌酯

13

fluopyram

氟吡菌酰胺

12

sulfoxaflor

氟啶虫胺腈

11

propiconazol

丙环唑

11

pendimethalin

二甲戊灵

11

thiophanate-methyl

甲基硫菌灵

11

In term of crop and pesticide usage, both the overseas and Chinese applicant filed most application on paddy, wheat, maize. But potato became the ninth most applied crop, which happened to coincide with China’s recent national policy to promote potato as food staple:

Top applied Crops/Application Area by Overseas and Chinese Applicant

Overseas Applicant

Chinese Applicant

No.

Crop/Usage

Number of Application

No.

Crop/ Usage

Number of Application

1

paddy

65

1

paddy

3332

2

wheat

34

2

wheat

1595

3

maize

31

3

maize

1213

4

citrus

31

4

cucumber

837

5

cucumber

25

5

non-arable land

740

6

apple

21

6

citrus

588

7

tomato

21

7

Brassica oleracea

562

8

grape

19

8

apple

490

9

potato

14

9

hygiene

404

10

peanut

13

10

Cotton

376

11

cotton

12

11

tomato

340

12

pepper

10

12

peanut

329

-

-

-

13

grape

311

 

For more information on the pesticide registration status of each active ingredient and the crop, target and dosage of each formulated product in China, click here to explore our CPAD database (China Pesticide Approval Directory).

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