Viewing data from:

ACTIVELLA

NDA

ESTRADIOL; NORETHINDRONE ACETATE | N020907 | AMNEAL PHARMACEUTICALS LLC

2 strengths0 unique patents0 unique exclusivities

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Activella (2023)

Total Spending

$125K

Total Claims

234

Beneficiaries

Avg Cost/Unit

$9.98

Spending Trend

$124K(2019)→$135K(2020)→$135K(2021)→$142K(2022)→$125K(2023)

YoY Change:+2.4%

5yr CAGR:+0.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

9 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1MG;0.5MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 18, 1998

No patent or exclusivity listings for this strength.

#002 — 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 28, 2006