Viewing data from:

PRESTALIA

NDA

AMLODIPINE BESYLATE; PERINDOPRIL ARGININE | N205003 | ADHERA THERAPEUTICS INC

3 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

Today

Oct. 5, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Apotex Inc. et al v. Symplmed Pharmaceuticals, LLC et al 1:2017cv00276 2 patentsANDA 209749perindopril arginine and amlodipine besylate	D. Del.	2017-03-15	Terminated 2019-03-07	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 2.5MG BASE;3.5MG

RLD

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Jan 21, 2015

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7846961	Oct 5, 2029	—	Yes	Yes		—

#002 — EQ 5MG BASE;7MG

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Jan 21, 2015

#003 — EQ 10MG BASE;14MG

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Jan 21, 2015