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Last Updated: June 1, 2020

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Adhera Company Profile


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Summary for Adhera
International Patents:69
US Patents:2
Tradenames:1
Ingredients:1
NDAs:1

Drugs and US Patents for Adhera

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Adhera PRESTALIA amlodipine besylate; perindopril arginine TABLET;ORAL 205003-002 Jan 21, 2015 RX Yes No 7,846,961   Start Trial Y Y   Start Trial
Adhera PRESTALIA amlodipine besylate; perindopril arginine TABLET;ORAL 205003-001 Jan 21, 2015 RX Yes No 7,846,961   Start Trial Y Y   Start Trial
Adhera PRESTALIA amlodipine besylate; perindopril arginine TABLET;ORAL 205003-003 Jan 21, 2015 RX Yes Yes 7,846,961   Start Trial Y Y   Start Trial
Adhera PRESTALIA amlodipine besylate; perindopril arginine TABLET;ORAL 205003-002 Jan 21, 2015 RX Yes No 6,696,481   Start Trial Y Y   Start Trial
Adhera PRESTALIA amlodipine besylate; perindopril arginine TABLET;ORAL 205003-003 Jan 21, 2015 RX Yes Yes 6,696,481   Start Trial Y Y   Start Trial
Adhera PRESTALIA amlodipine besylate; perindopril arginine TABLET;ORAL 205003-001 Jan 21, 2015 RX Yes No 6,696,481   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for ADHERA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 3.5 mg/2.5 mg, 7 mg/5 mg and 14 mg/10 mg ➤ Subscribe 2016-11-04

Supplementary Protection Certificates for Adhera Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0503785 CA 2011 00026 Denmark   Start Trial PRODUCT 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
0443983 2007C/043 Belgium   Start Trial PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
0443983 C300445 Netherlands   Start Trial PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
1915993 92315 Luxembourg   Start Trial PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
0678503 C300499 Netherlands   Start Trial PRODUCT 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
1507558 C300528 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
0503785 C300486 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Harvard Business School
Mallinckrodt
McKinsey
Colorcon

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