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NATAZIA

NDA

DIENOGEST; ESTRADIOL VALERATE | N022252 | BAYER HEALTHCARE PHARMACEUTICALS INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expired (1)Active (1)Today

2027

2028

Today

8071577

May. 13, 2026

8153616

Jan. 30, 2028

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 Pharma AG et al v. Watson Laboratories Inc. 1:2012cv01726 1 patentANDA 202349estradiol valerate and dienogest	D. Del.	2012-12-18	Terminated 2016-12-28	—
Bayer Pharma AG et al v. Lupin Ltd. et al 1:2012cv01592 1 patentANDA 203307estradiol valerate and dienogest	D. Del.	2012-11-28	Terminated 2014-03-18	—

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 Natazia (2023)

Total Spending

$121K

Total Claims

236

Beneficiaries

Avg Cost/Unit

$9.20

Spending Trend

$86K(2019)→$107K(2020)→$108K(2021)→$124K(2022)→$121K(2023)

YoY Change:+4.3%

5yr CAGR:+5.0%

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jun 27, 2024	SUPPL -9	View Letter (PDF)
May 3, 2022	SUPPL -7	View Letter (PDF)
Aug 24, 2015	SUPPL -4	View Letter (PDF)
Aug 23, 2013	SUPPL -3	View Letter (PDF)
Mar 16, 2012	ORIG -2	View Letter (PDF)
Feb 15, 2012	SUPPL -1	View Letter (PDF)
May 12, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A

RLD

2 patents0 exclusivities▴

TABLET;ORAL | Approved: May 6, 2010

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8071577	May 13, 2026	—	—	Yes		—
8153616	Jan 30, 2028	—	—	—		—