Bepotastine Besylate
Bepotastine besylate was first approved by Pharmaceuticals and Medical Devices Agency of Japan (PMDA) on July 3, 2000, then approved by the U.S. Food and Drug Administration (FDA) on September 8, 2009. It was co-developed by UBE, Mitsubishi Tanabe and Bausch & Lomb, and marketed as Talion® by UBE in JP, 坦亮® by Mitsubishi Tanabe in CN and Bepreve® by Bausch & Lomb in the US .
Bepotastine is a topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from mast cells. It is indicated for the treatment of allergic rhinitis, hives and itching associated with skin disease.
Talion® is available as tablet for oral use, containing 5 or 10 mg of Bepotastine besylate. The recommended dose is 10 mg twice daily for adults.
Update Date：2016-05-16
- Drug Name：
- Bepotastine Besylate
- Research Code：
- TAU-284
- Trade Name：
- Talion® / Bepreve®
- MOA：
- Histamine H1 receptor antagonist
- Indication：
- Skin infectious; Allergic rhinitis (AR); Allergic conjunctivitis; Hives
- Status：
- Approved
- Company：
- UBE (Originator) , Mitsubishi Tanabe,Bausch & Lomb
- Sales：
-
$148.1 Million (Y2015);
$151 Million (Y2014);
$144.3 Million (Y2013);
$184 Million (Y2012);
$175.8 Million (Y2011); - ATC Code：
- R06AX
Update Date：2015-07-29
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2009-09-08 | Marketing approval | Bepreve | Allergic conjunctivitis | Suspension/ Drops | 1.5% | Bausch & Lomb |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2007-03-14 | New dosage form | Talion | Allergic rhinitis (AR),Hives | Tablet, Orally disintegrating | 5 mg/10 mg | UBE | |
| 2000-07-03 | Marketing approval | Talion | Allergic rhinitis (AR),Skin infectious | Tablet | 5 mg/10 mg | UBE |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2011-05-24 | Marketing approval | 坦亮/Talion | Allergic rhinitis (AR),Skin infectious | Tablet | 10 mg | Mitsubishi Tanabe | |
| 2011-05-24 | Marketing approval | 坦亮/Talion | Allergic rhinitis (AR),Skin infectious | Tablet | 10 mg | Mitsubishi Tanabe | |
| 2010-08-24 | Marketing approval | 坦亮/Talion | Allergic rhinitis (AR),Skin infectious | Tablet | 10 mg | Mitsubishi Tanabe |
Update Date：2015-08-27
|
Molecular Weight | 547.06 | ||||||||||||
| Formula | C21H25ClN2O3 • C6H6O3S | |||||||||||||
| CAS No. |
125602-71-3 (Bepotastine ); 190786-44-8 (Bepotastine Besylate); |
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| Chemical Name | (+)-(S )-4-[4-[(4-Chlorophenyl)(2-pyridyl)methoxy]piperidino] butyric acid monobenzenesulfonate | |||||||||||||
| Bepotastine （Free Acid/Base）Parameters： | ||||||||||||||
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| *：Calculated by ACD/Labs software V11.02. | ||||||||||||||
Update Date：2016-01-28
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