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YAZ

NDA

DROSPIRENONE; ETHINYL ESTRADIOL | N021676 | BAYER HEALTHCARE PHARMACEUTICALS INC

1 strength0 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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Bayer Schering Pharma AG et al v. Mylan Pharmaceuticals Inc. et al 2:2011cv00604 ANDA 202594drospirenone and ethinylestradiol (micronized drospirenone and micronized 17-ethinylestradiol)	NVD	2011-04-19	Terminated 2014-01-02	—
Bayer Schering Pharma AG et al v. Teva Pharmaceuticals USA, Inc. et al 1:2010cv03697 1 patentdrospirenone and 17α-ethinylestradiol (stabilized by β-cyclodextrin)	N.D. Ill.	2010-06-15	Terminated 2010-06-29	—

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

Medicare Part D Spending

CMS annual spending data for Yaz (2023)

Total Spending

$114K

Total Claims

273

Beneficiaries

Avg Cost/Unit

$6.47

Spending Trend

$101K(2019)→$102K(2020)→$117K(2021)→$112K(2022)→$114K(2023)

YoY Change:+5.4%

5yr CAGR:+5.8%

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 (1)

#001 — 3MG;0.02MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 16, 2006

No patent or exclusivity listings for this strength.