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1. 202189-78-4
2. Bilaxten
3. Ilaxten
4. Bilastine [inn]
5. 2-[4-[2-[4-[1-(2-ethoxyethyl)benzimidazol-2-yl]piperidin-1-yl]ethyl]phenyl]-2-methylpropanoic Acid
6. 2-(4-(2-(4-(1-(2-ethoxyethyl)-1h-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoic Acid
7. Pa1123n395
8. Bilastinum
9. Bilatex
10. Unii-pa1123n395
11. 2-[4-[2-[4-[1-(2-ethoxyethyl)-1h-benzo[d]imidazol-2-yl]piperidin-1-yl]ethyl]phenyl]-2-methylpropanoic Acid
12. Bilanoa (tn)
13. Bilastine (jan/inn)
14. Bilastine [jan]
15. Bilastine [mi]
16. Bilastine [who-dd]
17. Dsstox_cid_31467
18. Dsstox_rid_97352
19. Dsstox_gsid_57678
20. Benzeneacetic Acid,4-[2-[4-[1-(2-ethoxyethyl)-1h-benzimidazol-2-yl]-1-piperidinyl]ethyl]-a,a-dimethyl-
21. Schembl991810
22. Chembl1742423
23. Dtxsid5057678
24. Gtpl11579
25. Chebi:135954
26. Hms3887o17
27. Amy16470
28. Bcp02576
29. Ex-a2962
30. Zinc3822702
31. Tox21_113905
32. Mfcd09837814
33. S3721
34. Akos030241723
35. Bcp9000412
36. Ccg-269384
37. Db11591
38. F-96221-bm
39. Sb17508
40. Ncgc00262907-01
41. Ac-29231
42. Bs-15792
43. Hy-14447
44. B5392
45. Cas-202189-78-4
46. Ft-0700542
47. D09570
48. 189b784
49. A856214
50. Q2902977
51. P-(2-(4-(1-(2-ethoxyethyl)-2-benzimidazolyl)piperidino)ethyl)-alpha-methylhydratropic Acid
52. 2-[4-(2-{4-[1-(2-ethoxy-ethyl)-1h-benzoimidazol-2-yl]-piperidin-1-yl}-ethyl)-phenyl]-2-methyl-propionic Acid
53. 2-[4-(2-{4-[1-(2-ethoxy-ethyl)-1h-benzoimidazol-2-yl]-piperidin-1-yl}ethyl)-phenyl]-2-methyl-propionic Acid
54. 2-[4-[2-[4-[1-(2-ethoxyethyl)-1h-benzoimidazole-2-yl]piperidine-1-yl]ethyl]phenyl]-2-methylpropanoic Acid
55. 2-[4-[2-[4-[1-(2-ethoxyethyl)benzoimidazol-2-yl]-1-piperidyl]ethyl]phenyl]-2-methyl-propanoic Acid
56. Benzeneacetic Acid, 4-(2-(4-(1-(2-ethoxyethyl)-1h-benzimidazol-2-yl)-1-piperidinyl)ethyl-alpha, Alpha-dimethyl-
57. Benzeneacetic Acid, 4-[2-[4-[1-(2-ethoxyethyl)-1h-benzimidazol-2-yl]-1-piperidinyl]ethyl]-alpha,alpha-dimethyl-
58. Benzeneaceticacid,4-(2-(4-(1-(2-ethoxyethyl)-1h-benzimidazol-2-yl)-1-piperidinyl)ethyl-alpha,alpha-dimethyl-
59. Bilastine; 2-(4-(2-(4-(1-(2-ethoxyethyl)-1h-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoic Acid
60. P-(2-(4-(1-(2-ethoxyethyl)-2-benzimidazolyl)piperidino)ethyl)-.alpha.-methylhydratropic Acid
| Molecular Weight | 463.6 g/mol |
|---|---|
| Molecular Formula | C28H37N3O3 |
| XLogP3 | 2.3 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 10 |
| Exact Mass | 463.28349205 g/mol |
| Monoisotopic Mass | 463.28349205 g/mol |
| Topological Polar Surface Area | 67.6 Ų |
| Heavy Atom Count | 34 |
| Formal Charge | 0 |
| Complexity | 641 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
For symptomatic relief of nasal and non-nasal symptoms of seasonal rhinitis in patients 12 years of age and older and for symptomatic relief in chronic spontaneous urticaria in patients 18 years of age and older.
FDA Label
Treatment of allergic rhinoconjunctivitis, Treatment of urticaria
Treatment of urticaria, Treatment of allergic rhinoconjunctivitis
Treatment of acute type I hypersensitivity reactions
Treatment of allergic conjunctivitis
Bilastine is an antiallergenic and acts to reduce allergic symptoms such as nasal congestion and urticaria.
R06AX29
S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355
R - Respiratory system
R06 - Antihistamines for systemic use
R06A - Antihistamines for systemic use
R06AX - Other antihistamines for systemic use
R06AX29 - Bilastine
S - Sensory organs
S01 - Ophthalmologicals
S01G - Decongestants and antiallergics
S01GX - Other antiallergics
S01GX13 - Bilastine
Absorption
Bilastine has a Tmax of 1.13 h. The absolute bioavailability is 61%. No accumulation observed with daily dosing of 20-100 mg after 14 days. Cmax decreased by 25 % and 33% when taken with a low fat and high fat meal compared to fasted state. Administration with grapefruit juice decreased Cmax by 30%.
Route of Elimination
Bilastine is mainly excreted in the feces (66.5%) with some excreted in the urine (28.3%). Nearly all is excreted as the parent compound.
Clearance
Bilastine has a total clearance is 9.20 L/h and a renal clearance of 8.7 L/h.
Bilastine does not interact with the cytochrome P450 system and does not undergo significant metabolism in humans.
The mean half life of elimination is 14.5h.
Bilastine is a selective histamine H1 receptor antagonist (Ki = 64nM). During allergic response mast cells undergo degranulation which releases histamine and other subastances. By binding to and preventing activation of the H1 receptor, bilastine reduces the development of allergic symptoms due to the release of histamine from mast cells.
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DMF Number : 39332
Submission : 2023-12-29
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Submission : 2022-04-30
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NDC Package Code : 42765-045
Start Marketing Date : 2022-05-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
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Submission : 2024-02-14
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Drugs in Development
Details:
Bilastine Tiefenbacher (Bilastine) is a histamine H1 receptor inverse agonist, small molecule drug candidate which is indicated for the treatment of allergic rhino-conjunctivitis & urticaria.
Lead Product(s): Bilastine
Therapeutic Area: Immunology Brand Name: Bilastine Tiefenbacher
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 14, 2023
Lead Product(s) : Bilastine
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Bilastine Tiefenbacher (Bilastine) is a histamine H1 receptor inverse agonist, small molecule drug candidate which is indicated for the treatment of allergic rhino-conjunctivitis & urticaria.
Brand Name : Bilastine Tiefenbacher
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 14, 2023
Details:
Bilastine is an innovative anti-allergy medicine improving the life of patients suffering from allergic symptoms also a second-generation antihistamine product helps to relieve nasal and non-nasal symptoms of seasonal rhinitis as well as urticaria caused symptoms.
Lead Product(s): Bilastine
Therapeutic Area: Immunology Brand Name: Bilastine-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 20, 2021
Lead Product(s) : Bilastine
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Bilastine is an innovative anti-allergy medicine improving the life of patients suffering from allergic symptoms also a second-generation antihistamine product helps to relieve nasal and non-nasal symptoms of seasonal rhinitis as well as urticaria caused...
Brand Name : Bilastine-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 20, 2021
Details:
Blexten (bilastine) is a second-generation antihistamine drug, exerts its effect through its highly selective inhibition of peripheral histamine H1 receptors for the symptomatic relief of allergic rhinitis and chronic spontaneous urticaria.
Lead Product(s): Bilastine
Therapeutic Area: Immunology Brand Name: Blexten
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Miravo Healthcare
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2022
Lead Product(s) : Bilastine
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Miravo Healthcare
Deal Size : Not Applicable
Deal Type : Not Applicable
Miravo Healthcare™ Announces the Canadian Commercial Launch of Blexten® for Patients 4 Years of...
Details : Blexten (bilastine) is a second-generation antihistamine drug, exerts its effect through its highly selective inhibition of peripheral histamine H1 receptors for the symptomatic relief of allergic rhinitis and chronic spontaneous urticaria.
Brand Name : Blexten
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 01, 2022
Details:
Under the terms of the agreement, Hikma will be responsible for obtaining regulatory approval of Bilastine by the US Food and Drug Administration (FDA) and for the commercialisation of the product in the US following approval.
Lead Product(s): Bilastine
Therapeutic Area: Immunology Brand Name: Bilaxten
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Hikma Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement September 20, 2021
Lead Product(s) : Bilastine
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Hikma Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Under the terms of the agreement, Hikma will be responsible for obtaining regulatory approval of Bilastine by the US Food and Drug Administration (FDA) and for the commercialisation of the product in the US following approval.
Brand Name : Bilaxten
Molecule Type : Small molecule
Upfront Cash : Undisclosed
September 20, 2021
Details:
The company has received approval for Bilastin tablets, which are used for the treatment of allergic Rhino conjunctivitis and Urticaria, the Hyderabad-based company said in a regulatory filing.
Lead Product(s): Bilastine
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 08, 2021
Lead Product(s) : Bilastine
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Vivimed Labs Gets Approval from Uzbekistan Govt for Two Products
Details : The company has received approval for Bilastin tablets, which are used for the treatment of allergic Rhino conjunctivitis and Urticaria, the Hyderabad-based company said in a regulatory filing.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 08, 2021
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
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Brand Name : Bilastin Zentiva
Dosage Form : Tablet
Dosage Strength : 20mg
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Brand Name : Bilastin Zentiva
Dosage Form : Tablet
Dosage Strength : 20mg
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Brand Name : Bilastin Zentiva
Dosage Form : Tablet
Dosage Strength : 20mg
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Brand Name : Bilastin Zentiva
Dosage Form : Tablet
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Brand Name : Bilastin Zentiva
Dosage Form : Tabl
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We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
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Dosage Strength : 10mg
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Brand Name : Bilastin axapharm
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Brand Name : BLEXTEN
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Dosage Strength : 2.5MG/ML
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Application Number : 2519011
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : BLEXTEN
Dosage Form : TABLET (ORALLY DISINTEGRATING)
Dosage Strength : 10MG
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Application Number : 2519038
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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : BLEXTEN
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Dosage Strength : 20MG
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Application Number : 2454130
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Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
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Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
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We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Annual Reports
Main Therapeutic Indication : Immunology
Currency : USD
2020 Revenue in Millions : 95
2019 Revenue in Millions : 116
Growth (%) : -18
Main Therapeutic Indication : Immunology
Currency : USD
2021 Revenue in Millions : 96
2020 Revenue in Millions : 91
Growth (%) : 14
Main Therapeutic Indication : Immunology
Currency : USD
2022 Revenue in Millions : 100
2021 Revenue in Millions : 96
Growth (%) : 4
Main Therapeutic Indication : Immunology
Currency : USD
2023 Revenue in Millions : 92
2022 Revenue in Millions : 100
Growth (%) : 5
Main Therapeutic Indication : Anti-allergic
Currency : USD
2017 Revenue in Millions : 19
2016 Revenue in Millions : 21
Growth (%) : -9
Main Therapeutic Indication : Anti-allergic
Currency : USD
2018 Revenue in Millions : 59
2017 Revenue in Millions : 18
Growth (%) : 230%
Main Therapeutic Indication : Immunology
Currency : USD
2019 Revenue in Millions : 113
2018 Revenue in Millions : 61
Growth (%) : 85
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