API Commercial

APIs with NCE-1 Exclusivity

Sr. No.

Product Name

Therapeutic Category

US filing date (NCE-1)

EU filing date (DE-2)

Approved/Filed

Under Filing

DMF

US DMF

PMDA

CADIFA

CEP/ASMF

WC

NMPA

MFDS

COFEPRIS

1

Bempedoic Acid

Lipid lowering agent

Expired

April 01, 2028

Y

Y

Y

CEP, MFDS, COFEPRIS

2

Daprodustat

Anemia with CKD

February 01, 2027

Not approved

Y

Y

PMDA, NMPA

3

Finerenone

Prevention of kidney disease

July 09, 2025

February 16, 2030

Y

Y

PMDA, NMPA

4

Mirogabalin Besylate

Neuropathic pain

Not approved

Not approved

Y

Y

Y

PMDA, NMPA

5

Pemafibrate

Lipid Lowering Agent

Not approved

Not approved

Y

PMDA, NMPA

6

Roxadustat

Anemia with CKD

Not approved

August 18, 2029

Y

PMDA

7

Tegoprazan Amorphous

Anti-ulcer

Not approved

Not approved

Y

Y

NMPA

8

Tegoprazan Benzoate

Anti-ulcer

Not approved

Not approved

Y

9

Tegoprazan Crystalline

Anti-ulcer

Not approved

Not approved

Y

Y

10

Tegoprazan Salicylate

Anti-ulcer

Not approved

Not approved

Y

Y

11

Trelagliptin Succinate

Anti-diabetic

Not approved

Not approved

Y

MFDS

12

Vadadustat

Anemia with CKD

March 28, 2028

April 24, 2031

Y

Y

13

Vibegron

Overactive bladder

Expired

July 2032

Y

Y

14

Vonoprazan Fumarate

Anti-ulcer

May 03, 2031 (NCE*GAIN-1)

Not approved

Y

Y

Y

Y

Y

Y

ASMF, PMDA

Sr. No.

Product Name

Therapeutic Category

Approved/Filed

Under Filing

DMF

US DMF

PMDA

CADIFA

CEP/ASMF

WC

NMPA

MFDS

COFEPRIS

15

Acebrophylline

Anti-asthmatic/Bronchodilator

Y

Y

Y

Y

Y

PMDA

16

Alpha Lipoic Acid

Anti-oxidant

Y

CEP

Y

CADIFA

17

Ambroxol Hydrochloride

Mucolytic expectorant

Y

Y

CEP

Y

Y

Y

Y

CADIFA

18

Azilsartan Medoxomil Potassium Salt

Anti-hypertensive

Y

Y

CEP, USDMF, NMPA

19

Benfotiamine

Vitamin supplement

Y

Y

Y

20

Benzonatate

Anti-tussive

Y

Y

Y

21

Betahistine Dihydrochloride

Anti-vertigo

Y

Y

CEP

Y

Y

Y

22

Bilastine

Anti-histaminic

Y

ASMF

NMPA, PMDA, CEP, CADIFA, COFEPRIS

23

Bisbentiamine

Vitamin supplement

Y

Y

24

Brivaracetam

Anti-epileptic

Y

Y

ASMF

Y

Y

CEP, CADIFA, COFEPRIS, NMPA

25

Colesevelam Hydrochloride

Lipid lowering agent

Y

26

Choline Fenofibrate

Lipid lowering agent

Y

Y

Y

Y

27

Dapagliflozin Amorphous

Anti-diabetic

Y

Y

PMDA, NMPA

28

Dapagliflozin Propandiol Solvate

Anti-diabetic

Y

Y

Y

PMDA, COFEPRIS, MFDS

29

Dapoxetine Hydrochloride

Premature ejaculation

Y

Y

Y

Y

CADIFA, MFDS

30

Desvenlafaxine Succinate

Anti-depressant

Y

Y

Y

Y

Y

Y

CEP

31

Diacerein

Anti-rheumatic

Y

Y

CEP

Y

Y

Y

Y

32

Dicyclomine Hydrochloride

Anti-spasmodic

Y

Y

CEP

33

Doxofylline

Anti-asthmatic/Bronchodilator

Y

ASMF

Y

Y

Y

Y

34

Edoxaban Tosylate

Anti-coagulant

Y

Y

Y

ASMF, COFEPRIS, NMPA

35

Empagliflozin Crystalline

Anti-diabetic

Y

Y

COFEPRIS

36

Eslicarbazepine Acetate

Anti-epileptic

Y

Y

ASMF

Y

Y

NMPA

37

Febuxostat

Anti-gout

Y

Y

Y

Y

Y

CADIFA, PMDA, NMPA

38

Fenofibrate

Lipid lowering agent

Y

39

Fexofenadine Hydrochloride

Anti-histaminic

Y

40

Fimasartan Potassium

Anti-hypertensive

Y

Y

Y

COFEPRIS

41

Flavoxate Hydrochloride

Anti-muscarinic

Y

ASMF

Y

Y

MFDS, PMDA

42

Fursultiamine Hydrochloride

Vitamin supplement

Y

Y

PMDA

43

Gliclazide

Anti-diabetic

Y

CEP

CADIFA, COFEPRIS, NMPA

44

Itopride Hydrochloride

Non-ulcer dyspepsia

Y

ASMF

Y

Y

Y

Y

PMDA

45

Levocloperastine Fendizoate

Anti-tussive

Y

Y

CADIFA, MFDS

46

Mirabegron

Urinary infrequency

Y

Y

CEP

Y

CADIFA

47

Oxcarbazepine

Anti-epileptic

Y

Y

CEP

Y

COFEPRIS, CADIFA

48

Pamabrom

Diuretic

Y

Y

Y

49

R-thioctic Acid Tromethamine

Anti-oxidant

Y

50

Rivaroxaban

Anti-coagulant

Y

Y

CEP

Y

CADIFA, COFEPRIS

51

Sacubitril Calcium

Anti-hypertensive/Heart failure

MFDS

52

Sacubitril Sodium

Anti-hypertensive/Heart failure

Y

Y

COFEPRIS

53

Sacubitril Valsartan Trisodium Pentahemihydrate

Anti-hypertensive/Heart failure

Y

Y

Y

Y

CEP, CADIFA, PMDA, COFEPRIS

54

Salcaprozate Sodium

Intestinal Permeability Enhancer

Y

Y

USDMF, MFDS

55

Sevelamer Carbonate

Anti-hyperphosphatemic

Y

Y

Y

Y

Y

56

Sevelamer Hydrochloride

Anti-hyperphosphatemic

Y

Y

Y

CADIFA, COFEPRIS

57

Sitagliptin Hydrochloride

Anti-diabetic

Y

Y

58

Sitagliptin Phosphate Anhydrous

Anti-diabetic

Y

59

Sitagliptin Phosphate Monohydrate

Anti-diabetic

Y

Y

CEP

NMPA, PMDA CADIFA, COFEPRIS

60

Tadalafil

Erectile dysfunction

Y

Y

Y

CEP

Y

Y

Y

Y

61

Tapentadol Hydrochloride

Analgesic

Y

CEP

Y

Y

CADIFA, NMPA

62

Tapentadol Phosphate

Analgesic

Y

CEP

63

Teneligliptin Hydrobromide Hydrate

Anti-diabetic

Y

Y

Y

Y

64

Tolvaptan

Hyponatremia

Y

Y

MFDS

65

Tranexamic Acid

Anti-fibrinolytic

Y

Y

Y

CEP

Y

Y

Y

Y

PMDA

66

Vildagliptin

Anti-diabetic

Y

Y

Y

Y

Y

Y

COFEPRIS

* Patents infringement is the responsibilty of buyers. Products currently covered by valid patents are offered for R & D purposes only.