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Serving leading biopharmaceutical companies globally:

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Express Scripts
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Generated: December 18, 2017

DrugPatentWatch Database Preview

Amlodipine besylate; olmesartan medoxomil - Generic Drug Details

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What are the generic drug sources for amlodipine besylate; olmesartan medoxomil and what is the scope of amlodipine besylate; olmesartan medoxomil freedom to operate?

Amlodipine besylate; olmesartan medoxomil
is the generic ingredient in two branded drugs marketed by Ajanta Pharma Ltd, Alembic Pharms Ltd, Alkem Labs Ltd, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Jubilant Generics, Macleods Pharms Ltd, Micro Labs, Teva Pharms Usa, Torrent Pharms Ltd, Zydus Pharms Usa Inc, and Daiichi Sankyo, and is included in twelve NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Amlodipine besylate; olmesartan medoxomil has one hundred and one patent family members in twenty-seven countries and thirty-two supplementary protection certificates in nine countries.

There are fifty drug master file entries for amlodipine besylate; olmesartan medoxomil. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for amlodipine besylate; olmesartan medoxomil

Pharmacology for amlodipine besylate; olmesartan medoxomil

Tentative approvals for AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Applicant Application No. Strength Dosage Form
u► Subscribe5MG/20MGTABLET; ORAL
u► Subscribe10MG/40MGTABLET; ORAL
u► Subscribe10MG/20MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms Usa IncAMLODIPINE AND OLMESARTAN MEDOXOMILamlodipine besylate; olmesartan medoxomilTABLET;ORAL207771-001Sep 22, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms UsaAMLODIPINE AND OLMESARTAN MEDOXOMILamlodipine besylate; olmesartan medoxomilTABLET;ORAL091154-004Oct 26, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Glenmark Pharms LtdAMLODIPINE AND OLMESARTAN MEDOXOMILamlodipine besylate; olmesartan medoxomilTABLET;ORAL207807-002Jul 5, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Glenmark Pharms LtdAMLODIPINE AND OLMESARTAN MEDOXOMILamlodipine besylate; olmesartan medoxomilTABLET;ORAL207807-004Jul 5, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Daiichi SankyoAZORamlodipine besylate; olmesartan medoxomilTABLET;ORAL022100-002Sep 26, 2007ABRXYesNo► Subscribe► Subscribe► Subscribe
Micro LabsAMLODIPINE AND OLMESARTAN MEDOXOMILamlodipine besylate; olmesartan medoxomilTABLET;ORAL207435-002Nov 2, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Alkem Labs LtdAMLODIPINE AND OLMESARTAN MEDOXOMILamlodipine besylate; olmesartan medoxomilTABLET;ORAL209042-002Aug 14, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms UsaAMLODIPINE AND OLMESARTAN MEDOXOMILamlodipine besylate; olmesartan medoxomilTABLET;ORAL091154-002Oct 26, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa IncAMLODIPINE AND OLMESARTAN MEDOXOMILamlodipine besylate; olmesartan medoxomilTABLET;ORAL207771-002Sep 22, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Ajanta Pharma LtdAMLODIPINE AND OLMESARTAN MEDOXOMILamlodipine besylate; olmesartan medoxomilTABLET;ORAL207216-003Oct 28, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: amlodipine besylate; olmesartan medoxomil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi SankyoAZORamlodipine besylate; olmesartan medoxomilTABLET;ORAL022100-001Sep 26, 2007► Subscribe► Subscribe
Daiichi SankyoAZORamlodipine besylate; olmesartan medoxomilTABLET;ORAL022100-004Sep 26, 2007► Subscribe► Subscribe
Daiichi SankyoAZORamlodipine besylate; olmesartan medoxomilTABLET;ORAL022100-003Sep 26, 2007► Subscribe► Subscribe
Daiichi SankyoAZORamlodipine besylate; olmesartan medoxomilTABLET;ORAL022100-002Sep 26, 2007► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: amlodipine besylate; olmesartan medoxomil

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,646,171 Angiotensin II antagonist 1-biphenylmethylimidazole compounds and their therapeutic use► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: amlodipine besylate; olmesartan medoxomil

Country Document Number Estimated Expiration
Russian Federation2092481► Subscribe
Finland112476► Subscribe
Germany122011000011► Subscribe
Norway931980► Subscribe
Denmark0545912► Subscribe
Australia661153► Subscribe
Norway2006012► Subscribe
Hungary9301600► Subscribe
Norway2011013► Subscribe
Greece3035624► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
847Luxembourg► Subscribe91847, EXPIRES: 20170221
2011 00026Denmark► SubscribePRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
/2009Austria► SubscribePRODUCT NAME: KOMBINATION VON OLMESARTAN MEDOXOMIL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, MIT AMLODIPINBESILAT; NAT. REGISTRATION NO/DATE: 1-27894, 1-27895, 1-27896 20081217; FIRST REGISTRATION: NL 100989, 100990, 100991 20080819
2006 00012Denmark► Subscribe
07C/043Belgium► SubscribePRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
00478Netherlands► SubscribePRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
2009 00015Denmark► SubscribePRODUCT NAME: EN KOMBINATION AF OLMESARTANMEDOXOMIL, EVT. I FORM AF ET FARMACEUTISK ACCEPTABELT SALT OG AMLODIPIN-BESILAT; NAT. REG. NO/DATE: MT 42061, 42062, 42063 20081120; FIRST REG. NO/DATE: NL RVG 100984 20080819
0503785/03Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
00499Netherlands► SubscribePRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
330Luxembourg► SubscribeCERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS)
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Serving leading biopharmaceutical companies globally:

McKesson
Healthtrust
Fish and Richardson
Accenture
Federal Trade Commission
Johnson and Johnson
Chubb
AstraZeneca
Baxter
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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