Olmesartan Medoxomil

Olmesartan Medoxomil is an angiotensin II receptor antagonist with actions similar to those of losartan (Losartan Potassium). It is used in the management of high blood pressure. This angiotensin II receptor antagonist's originator is Daiichi Sankyo, and it is marketed worldwide by the company under brand names of Benicar and Benicar HCTZ . It may be used alone or in combination with other antihypertensive agents. Olmesartan Medoxomil is a prodrug that hydrolyzed to Olmesartan during absorption from the gastrointestinal tract. It is rapidly and completely bioactivated by ester hydrolysis during absorption from the gastrointestinal tract to Olmesartan, a selective AT 1 subtype angiotensin II receptor antagonist.  BENICAR® is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of Olmesartan Medoxomil or in combination tablets with hydrochlorothiazide (20 mg or 40 mg combined with 12.5 mg of hydrochlorothiazide, or 40 mg of combined with 25 mg of hydrochlorothiazide ) administrated once daily. Recently additional fixed dose combination with Amlodipine Mesylate  was introduced to the market( amlodipine 5 mg/olmesartan 20 mg ).

This Active pharmaceutical ingredient is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol.

Olmesartan Medoxomil plain and the combination with HCTZ tablets are on the market since 2003.

General data on Olmesartan Medoxomil Active Pharmaceutical Ingredient

Molecular Formula: C29H30N6O6
Molecular Weight:558.6
CAS Registry: 144689-24-7 (olmesartan);144689-63-4 (olmesartan medoxomil)
ATC:C09CA08

Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder. It is practically insoluble in water and sparingly soluble in methanol.

TAPI's Olmesartan Medoxomil  Pharmaceutical Ingredient

TAPI's Olmesartsan Medoxomil Active Pharmaceutical Ingredient is produced in Assia Industries Limited –Teva Tech site in Beer Sheva, Israel.

It is produced by TAPI by organic synthesis and considered to be medium volume Active Pharmaceutical Ingredient.

 TAPI's product has unique features that might be advantage for final dosage development. TAPI has filed several patent applications for this product.  Please, see table below for issued patents and pending applications.

TAPI's Olmesartan Medoxomil has unique features that might be advantage for final dosage development. TAPI has filed several patent applications for This product.  Please, see table below for issued patents and pending applications.

TAPI's Active Patent Applications

Patent type	Description	App./publication/patent #	Status (date)
Process	A process for preparing Olmesartan Medoxomil at pH 2.5-7	WO 2006073518	Published 13/07/2006
		US 20060148870	Published 06/07/2006
Process	A Novel Process for Olmesartan Medoxomil	WO 2006029056	Published 16/03/2006
		US 20060069141	Published 30/03/2006
Impurity	Pure olmesartan medoxomil	WO 2006029057	Published 16/03/2006
		US 20060074117	Published 06/04/2006
		US20070054948	Published 08/03/2007
Impurity	Olmesartan medoxomil free of impurities A, B and C	WO 2006073519	Published 13/07/2006
		US 20060149078	Published 06/07/2006
Impurity	Olmesartan medoxomil with reduced levels of impurities	US20060258727	Published 16/11/2006

TAPI plans to submit  DMFs for major pharmaceutical markets.

TAPI provide full service on this product and other APIs in our portfolio. Our local sales offices provide full information on our product, regulatory compliance and documentation on Olmesartan Medoxomil. Contact us today for further inquiries and samples and kilograms availability information for TAPI's Olmesartan Medoxomil.

Other products, in the group of Angiotensin II Antagonists, available on TAPI's portfolio are: Losartan Potasium, Valsartan, Irbesartan, Telmisartan  and Candesartan Cilexetil.  Contact us today for information on these products.

Legal Note

Product exploitation, including development, sales and offer for sale are performed where permissible by patent law. This presentation is not and should not constitute an offer for sale in territories where it is not permitted by law. In USA Products  that  Currently on Patent are available for R&D Use in Accordance with 35 USC §271 (e) (1).

*TAPI stands for Teva's Active Pharmaceutical Ingredients