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

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis NCT00808132	Phase 3	Completed	Pfizer	1,886	2009-01 → 2011-02

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 5 NDCs

Highest NADAC/Unit

$8.69

per ea

Lowest NADAC/Unit

$8.67

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00046110811PREMPRO 0.625-5 MG TABLET	$8.69	EA	Brand	—	2026-06-17
00046257512PREMPHASE 0.625-5 MG TABLET	$8.68	EA	Brand	—	2026-01-01
00046110611PREMPRO 0.45-1.5 MG TABLET	$8.68	EA	Brand	—	2026-06-17
00046110511PREMPRO 0.3 MG-1.5 MG TABLET	$8.68	EA	Brand	—	2026-06-17
00046110711PREMPRO 0.625-2.5 MG TABLET	$8.67	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 10 NDCs (5 FSS, 5 Big4)

Lowest Price

$184.44

Highest Price

$253.02

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00046-1106-11PREMPRO 0.45MG/1.5MG TAB,28 BLISTER CARD	$253.02	FSS	Pfizer Inc.	06/30/2029
00046-1106-11PREMPRO 0.45MG/1.5MG TAB,28 BLISTER CARD	$184.46	Big4	Pfizer Inc.	06/30/2029
00046-2575-12PREMPHASE COMBO PAK 0.625MG/5MG,14+14	$253.02	FSS	Pfizer Inc.	06/30/2029
00046-2575-12PREMPHASE COMBO PAK 0.625MG/5MG,14+14	$184.60	Big4	Pfizer Inc.	06/30/2029
00046-1107-11PREMPRO 0.625MG/2.5MG TAB,28 PACK	$253.02	FSS	Pfizer Inc.	06/30/2029
00046-1107-11PREMPRO 0.625MG/2.5MG TAB,28 PACK	$184.44	Big4	Pfizer Inc.	06/30/2029

Showing 6 of 10 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Prempro (2024)

Total Spending

$37.8M

Total Claims

88,870

Beneficiaries

19,265

Avg Cost/Unit

$8.25

Spending Trend

$37.9M(2019)→$38.7M(2020)→$40.1M(2021)→$39.7M(2022)→$39.7M(2023)→$37.8M(2024)

YoY Change:-5.2%

5yr CAGR:+3.6%

Source: CMS Medicare Part D Spending by Drug (2024). 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