Viewing data from:

PREMPRO

NDA

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE | N020527 | WYETH PHARMACEUTICALS LLC

5 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 Prempro (2023)

Total Spending

$39.7M

Total Claims

89,537

Beneficiaries

19,244

Avg Cost/Unit

$8.70

Spending Trend

$37.9M(2019)→$38.7M(2020)→$40.1M(2021)→$39.7M(2022)→$39.7M(2023)

YoY Change:+5.9%

5yr CAGR:+6.3%

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

Approval Letters

22 letters from Drugs@FDA

Date	Submission	Document
Feb 16, 2024	SUPPL -68	View Letter (PDF)
Nov 6, 2017	SUPPL -65	View Letter (PDF)
Sep 4, 2015	SUPPL -62	View Letter (PDF)
Feb 7, 2012	SUPPL -52	View Letter (PDF)
Feb 7, 2012	SUPPL -51	View Letter (PDF)
Feb 7, 2012	SUPPL -56	View Letter (PDF)
Feb 7, 2012	SUPPL -54	View Letter (PDF)
Jan 6, 2010	SUPPL -45	View Letter (PDF)
May 26, 2009	SUPPL -46	View Letter (PDF)
Mar 5, 2008	SUPPL -43	View Letter (PDF)
Aug 4, 2006	SUPPL -37	View Letter (PDF)
Jul 8, 2005	SUPPL -36	View Letter (PDF)
Apr 29, 2004	SUPPL -34	View Letter (PDF)
Apr 29, 2004	SUPPL -35	View Letter (PDF)
Jun 8, 2003	SUPPL -26	View Letter (PDF)
Jun 8, 2003	SUPPL -24	View Letter (PDF)
Jun 8, 2003	SUPPL -31	View Letter (PDF)
Mar 18, 2003	SUPPL -17	View Letter (PDF)
Jan 7, 2003	SUPPL -30	View Letter (PDF)
Nov 27, 2002	SUPPL -29	View Letter (PDF)
Feb 11, 2002	SUPPL -18	View Letter (PDF)
Jan 9, 1998	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#002 — 0.625MG,0.625MG;N/A,5MG

RLD

0 patents0 exclusivities▾

TABLET;ORAL-28 | Approved: Nov 17, 1995

#001 — 0.625MG;2.5MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL-28 | Approved: Nov 17, 1995

No patent or exclusivity listings for this strength.

#003 — 0.625MG;5MG

RLD

0 patents0 exclusivities▾

TABLET;ORAL-28 | Approved: Jan 9, 1998

#004 — 0.45MG;1.5MG

RLD

0 patents0 exclusivities▾

TABLET;ORAL-28 | Approved: Mar 12, 2003

#005 — 0.3MG;1.5MG

RLD

0 patents0 exclusivities▾

TABLET;ORAL-28 | Approved: Jun 4, 2003