DoP Shortlists Patented, Unlaunched Drugs for Global Tender Exemption, See Full List

s.

No

Pharmaceutical formulation and strength

Status- Patented or

Proprietary (based on submission from industry)

1.

Pancreatin Minimicrospheres 10000, 25000, 40000

Patented

2.

Venetoclax 1Omg, 50 mg and 100mg

Patented

3.

Botulinum Toxin Type A 200U

Powder for solution for Injection

Patented

4.

Evolocumab

Solution for Injection l40mg/ml (r-DNA origin)

Patented

5.

Enfortumab Vedotin —

20 mg and 30 mg powder concentrate for solution for infusion

Patented

6.

Gilteritinib - 40 mg film-coated tablets

Patented

7.

Eculizumab Concentrate for solution for infusion 300 mg

(10mg/ml)

Proprietary

8.

Tremelimumab Concentrate for Solution for infusion 20 mg/ml

(25 mg/ 1.25 ml and 300 ing/ 15 ml presentations)

Proprietary

9.

Budesonide 1 60mcg + Glycopyrronium 7.2mcg + Formoterol

Fumarate Dihydrate 5 mcg inhalation preparations

Patented

10.

Darolutamide 300 mg Film-coated Tablets

Patented

11.

Dienogest + Estradiol vale rate Film-coated tablet, 3 mg + 3 mg

Proprietary

12.

Peg interferon Beta-lA 125mcg/0.5 ml PFS

Patented

13.

Alteplase 20mg and 50mg

Proprietary

14.

Lemborexant 5mg and 10 mg Tablet

Patented

15.

• Tirzepatide 2.5 mg/0.5ml,

b) Tirzepatide 5 mg/0.5ml,

c) Tirzepatide 7.5 mg/0.5ml

d) Tirzepatide 10 mg/0.5m1

• Tirzepatide 1 2.5 mg/0.5m1

Patented

f) Tirzepatide 15 mg/0.5ml

All solution for injection in a singte dose vial/ PFS

16.

Teclistamab Solution for Injection 50mg and l53 mg

Patented

17.

Gusclkumab Solution for Injection 100 mg

Patented

18.

Methylphenidate Hydrochloride Extended-Release Tablets l8mg,

36mg and 54mg

Proprietary

l9.

Follitropin Alfa 450IUf0.75ml (33mcg/0.75 ml)

20.

Ceritinib Hard Gelatin Capsule 150 Mg

21.

Ofatumumab 20 mg/0.4 mL solution for injection in pre-filled

syringe

Proprietary

22.

Erenumab solution for injection 70 mgfml in pre-filled syringe

Patented

23.

Turoctocog Alfa Pegol (Glyoopegylated r-DNA origin Factor

Vf11\ 500 IU/1000 IU/l 500 fU/2000 lU

Patented

24.

Dcgludec 100 IU/ml in 3 ml Pre-filled syringes (PFS)/Pcnfill

Patented

25.

Insulin fkgludec 70% + Insulin Aspart 30 % 100 IU/ml in 3rn1

PFSfPenfill

Patented

26.

Etonogestrcl Implant 68mg’(Radiopaque}

27.

• Recombinant Follitropin 8eta 600lU (Follicle Stimulatin8

Hormone Injection l.P.)

• Recombinant Follittopin Beta 3001 U (Follicle Stimulating Hormone Injection I.P.)

Proprietary

28.

Romosozumab (r-DNA origin) Injection

Patented

29.

.a) 100 u/ml Iniulin glargine with 50 mcg/ml Lixisenatide

b) 100 u/ml Insulin glargine with 33 mcg/ml Lixisenatide

Paiented

30.

a) Pegylated Liposomal lrinotecan 4.3 mg/ml concentrate for

dispersion for infusion

Patented

31.

• Bisoprolol Fumante 5mg + Perindopril Argininr 5mg

tablets

• Bisoprolol Fumante 5mg + Perindopril arginine 10 mg

tablets

Proprietari

32.

Sulbutiamine 200 mg

Proprietary

33.

Piribedil S0m8

34.

Perindopril Erbumine 8mg + Indapamide 2.5mg

Proprietary

35.

• Perindoptil Erbumine 4 mg + Amlodipine Besilate Tablets

• Perindoptil Erbumine 8 mg + Amlodipine Besilate Tablets 10 mg

c) Perindopril Erbumine 8mg + Amlodipine Besilate Tablets 5

Proprietary

36.

• Indapamide lP as sustained release (1.5 mg) Amlodipine

Besilate IP Tablets (2.5 mg)

• Indapamide 1 P sustained release (1.5 mg) + Amlodipine Besilate IP Tablets (5 mg)
• Indapamide IP sustained release (1.5 mg) + Amlodipine Besilate IP Tablets (10 mg)

Proprietary

37.

Brentuximab Vedotin 50 mg

Proprietary

38.

Vedolizumab 300 mg

Patented

39.

Velaglucerase Alfa (r-DNA Origin) 400 Units

Proprietary

40.

Agalsidase alfa (r-DNA origin) - I mg/ml

Proprietary

41.

Coagulation Factor IX (Recombinant)

Proprietary

42.

Rurioctocog Alfa Pegol (PEGy lated Recombinant Human FVII I)

Proprietary

43.

Toripalimab inj

Patented

44.

Entrectinib (100mg & 200 mg)

Patented

45.

Sodium Zirconium Cyclosilicate

Powder for Oral Suspension *s & 10 g

Patent (applied for)

46.

Belumosudil Tablet 200mg

Patented

47.

Palivizumab solution for injection 50 mg/0.5 mL

Proprietary

48.

Plazomicin

Patented

49.

Aminoven Infant 10% 100 ml Each 100 ml contains:

active constituents:

L-leucine 1.30 g, L-isoleucine 0.80 g, L -lysine acetate 1.20 g, L- lysine 0.851 g. L-methionine 0.312 g, L-pheny lalanine 0.375 g, L-

threonine 0.440 g, L-tryptophan 0.201 g, L-valine 0.900 g. L-arginine

Proprietary

0.750 g, L-histidine 0.476 g, Glycine 0.415 g, Taurine 0.040 g, L-

serine 0.767 g, L-alanine 0.930 g, L-proline 0.971 g, N-acety 1-L- tyrosine 0.5176 g, L-tyrosine 0.420 g, N-acetyl-L-cysteine 0.070 g, L-cysteine 0,052 g. L-malic acid 0.262 g, Water for injections q.s.Total amino acids 100 g/l, Total nitrogen content 14.9 g/l, Theor.osmolarity 885 mosm/1

50.

SmofLipid 20% (100 ml, 250 ml, 500inl) Parenteral lipid

emulsion with a combination of 4 different oils in concentrations : 30oz’»Soyabean oil, 30% MCT, 23% Olive Oil and I 5% Fish oil with a Omega 6: Omega 3 ratio of 2.5:1.

Proprietary

5 1.

Omegaven 10% 50 ml Injection Intravenous Fat Emulsion with

Omega 3 Fatty Acids, Highly refined fish oil 10 g , Eicosapentaenoic acid (EPA)1.25-2.82g. Docosahexaenoic acid (DHA) 1.44-3.09 g, alpha tocopherol as antioxidant., Glycerol, Purified egg phosphate, sodium oleate, sodium hydroxide.

Proprietary

52.

SMOFKabiven Central 1477 ml New Generation 3 Chambered

Bag for parenteral nutrition (IV injection for central line) 1477 ml containing combination of SMOFlipid 20%; refined soyabean oil 16.9 g, Medium Chain triglycerides 16.9 g, Refinded Olive Oil 14.1 g and Fish oil rich in Omega-3-acids 8.4 g as source of calories with 75 g Amino acids,taurine, zinc, electolytes and 42% Glucose solution with enviornment friendly bag material having tamper evident arrows flaps providing 1600 total calories in 1477 ml - 1300 non protein energy

Proprietary

53.

SMOFKabiven Central 1970 ml New Generation 3 Chambered

Bag for parenteral nutrition (1 V injection for central line) 1970 ml containing combination of SMOFlipid 20%; refined soyabean oil 22.5 g, Medium Chain triglycerides 22.5 g, Refinded Olive Oil 18.8 gm and Fish oil rich in Omega-3-acids 11.3 g with 100 gm Amino acids,taurine, zinc, electolytes and 42% Glucose solution with enviornment friendly bag material having tamper evident arrows flaps providing 2100 total calories in 1970 ml -1700 non protein energy

Proprietary

54.

SMOFKabiven Central 986 ml New Generation 3 Chambered Bag

for parenteral nutrition (I V injection for central line) 986 ml containing combination of SMOFlipid 20%; refined soyabean oil I 1.3 g, Medium Chain triglycerides 1 1.3 g, Refinded Olive Oil 9.4 gm and Fish oil rich in Omega-3-acids 5.6 g with 50 g Amino acids,taurine, zinc, electolytes and 42% Glucose solution with enviornment friendly bag material having tamper evident arrows fiaps providing 1 100 total calories in 986 ml - 900 non protein energy

Proprietary

55.

SMOFKabiven Peripheral 1206 ml New Generation 3 Chambered Bag for patenteral nutrition (IV injection for peripheral line) 1206 ml containing combination of SMOFlipid 20°Z»; refined soyabean oil 10.2 g, Medium Chain triglycerides 10.2 g, Refinded Olive Oil 8.5 gm and Fish oil rich in Omega-3-acids 5.1 g with 38 g Amino acids,taurine, zinc, electolytes and l3k» Glucose solution with enviornment friendly bag material having tamper evident artows flaps providing 800 total calories in 1206 ml -700 non protein energy

Proprienuy

56.

SMOFKabiven Peripheral 1448 ml New Genemtion 3 Chambered

Bag for parenteral nutrition (lV injection for peripheral line) 1448 ml containing combination of SMOFlipid 20°Z»; refined soyabean oil I 2.3 g, Medium Chain triglycerides 12.3 g, Refinded Olive Oil 10.1 g and Fish oil rich in Omega-3-acids 6.1 g with 46 g Amino acids,taurine, zinc, electolytes and 13% Glucose solution with enviornment friendly bag material having tamper evident arrows flaps providing 1000 total calories in 1448 ml -800 non protein energy

Proprietary

57.

SMOFKabiven Peripheral 1904 ml New Generation 3 Chambered Bag for parenteral nutrition (lV injection for peripheral line) 1904 ml containing combination of SMOFlipid 20°/»; refined soyabean oil 16.1 g, Medium Chain triglycerides 16.1 g, Refinded Olive Oil 13.4 g and Fish oil rich in Omega-3-acids 8 g with 60 g Amino acids,taurine, zinc, electolytes and 13% Glucose solution with enviornment friendly bag material having tamper evident arrows flaps providing 1300 total calories in 1904 ml -1100 non protein energy

Proprietary

58.

Nirsevinub solution 50mg and l0Omg (r-DNA origin}

Patented

S9.

Cross linked Sodium Hyaluronate 1-2.9 mDA, 22mg/ml (88mg/4mI) with Triamcinolone Hexacetonide l8mg (4mI Prefilled Syringe)

Proprietary

60.

Semaglutide 0.25 mg/0.5 mg/ 1 mg/1.7 mg/2.4 mg solution for Injection (r-DNA origin) in PFS

Patented

61.

Pneumococcal polysaccharide conjugate vaccine (adsorbed) I.P., 20- valent

Patented

62.

Niraparib Tablets 100 mg

Patented

63.

Dostarlimab concentrate for solution for infusion 500 mg/10 mL

Patented

64.

tablets- 30 mg/90 mg/180 mg

Proprietary

6S.

Concizumab Injection l5mgf1.5 mL, 60rng/l.5 md, 150mg/1.5 mL,

300mg/3 mL

Patented

66.

Aztreonam 1.5g + Avibactam 0.5g powder for concentrate for

solution for Infusion

Proprietary

S. no

Details

Information

1

Name, serial number and parts of

formulation from Annex-A against which objection is raised

Name of the local manufacturing entity'

3

Address of the registered office and

manufacturing location (complete postal address)

Contact details, email id and phone

numbers (mobi le and office)

5

Generic name of locally manufactured

drug and its strength

6

Brand name of drus Mentioned against

S. no. 5

7

Local content percentage of the drug as

per the DP1IT OM dated 19.7.2024

8

Manufacturing capacity per annum

9

Manufacturing license (mandatory)

10

Patent certificate, if any.