Adhera Company Profile

What is the competitive landscape for ADHERA, and when can generic versions of ADHERA drugs launch?

ADHERA has one approved drug.

There is one US patent protecting ADHERA drugs.

There are twenty-seven patent family members on ADHERA drugs in twenty-seven countries and sixteen supplementary protection certificates in eight countries.

Summary for Adhera

International Patents:	27
US Patents:	1
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	205003-001	Jan 21, 2015		DISCN	Yes	No	7,846,961		Y	Y
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-003	Jan 21, 2015		DISCN	Yes	No	7,846,961		Y	Y
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-002	Jan 21, 2015		DISCN	Yes	No	7,846,961		Y	Y

Expired US Patents for Adhera

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-001	Jan 21, 2015	6,696,481
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-003	Jan 21, 2015	6,696,481
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-002	Jan 21, 2015	6,696,481

Paragraph IV (Patent) Challenges for ADHERA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	3.5 mg/2.5 mg, 7 mg/5 mg and 14 mg/10 mg		2016-11-04

International Patents for Adhera Drugs

Country	Patent Number	Estimated Expiration
Poland	1989182
Croatia	P20160644
European Patent Office	1989182
Australia	2007220435
Morocco	30276

Supplementary Protection Certificates for Adhera Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1507558	2012/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
0503785	C300375	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
1915993	C300625	Netherlands		PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
0503785	CA 2011 00026	Denmark		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

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Adhera