PREMPRO Drug Patent Profile

Which patents cover Prempro, and what generic alternatives are available?

Prempro is a drug marketed by Wyeth Pharms and Wyeth Pharms Inc and is included in two NDAs.

The generic ingredient in PREMPRO is estrogens, conjugated; medroxyprogesterone acetate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estrogens, conjugated; medroxyprogesterone acetate profile page.

Summary for PREMPRO

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	14
Drug Prices:	Drug price information for PREMPRO
What excipients (inactive ingredients) are in PREMPRO?	PREMPRO excipients list
DailyMed Link:	PREMPRO at DailyMed

See drug prices for PREMPRO

See drug sales revenues for PREMPRO

Recent Clinical Trials for PREMPRO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Pfizer	Phase 3
MDS Pharma Services	Phase 1
Bayer	Phase 2

See all PREMPRO clinical trials

Pharmacology for PREMPRO

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for PREMPRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-005	Jun 4, 2003		RX	Yes	Yes
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-003	Jan 9, 1998		RX	Yes	Yes
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-004	Mar 12, 2003		RX	Yes	Yes
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-001	Nov 17, 1995		RX	Yes	Yes

Expired US Patents for PREMPRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-001	Nov 17, 1995
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-005	Jun 4, 2003
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-005	Jun 4, 2003
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-001	Nov 17, 1995

International Patents for PREMPRO

See the table below for patents covering PREMPRO around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	209066	PHARMACEUTICAL COMPOSITIONS CONTAINING PROGESTOGEN AND ESTROGEN
Japan	H08231436	CONTROLLED RELEASE OF STEROID FROM SUGAR COATING
Slovenia	803250
Germany	3486442

Supplementary Protection Certificates for PREMPRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	SPC/GB98/034	United Kingdom		SPC/GB98/034: 20040802, EXPIRES: 20090801
0136011	C00136011/03	Switzerland		PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
0136011	980038	Netherlands		980038, 20090801, EXPIRES: 20130305
0136011	SPC/GB02/008	United Kingdom		SPC/GB02/008: 20040802, EXPIRES: 20090801

PREMPRO: Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

What is PREMPRO’s market positioning in HRT?

PREMPRO (conjugated estrogens/medroxyprogesterone acetate) is an estrogen-progestin hormone therapy (HRT) used for menopausal symptoms and related indications. In the U.S., the category is shaped by safety-driven label evolution, ongoing shifts toward lower-dose and alternative regimens, and intense payer and guideline influence.

Therapy class and competitive set

• Drug class: oral combined estrogen plus progestin
• Core competitor products (oral HRT): other conjugated estrogen/progestin combinations and alternatives within oral regimens
• Non-oral displacement: increasing share movement toward localized therapies and transdermal strategies (payer coverage and tolerability considerations)

Demand mechanics

• Prescription volatility is policy-led: HRT use tracks guideline updates, safety communications, and reimbursement rules.
• Patient segmentation matters: younger “early menopause” subgroups and symptom intensity influence uptake, while older populations face tighter prescribing thresholds driven by benefit-risk framing.

How do regulatory and safety narratives affect demand?

The HRT market has long been conditioned by safety communications and constrained adoption in populations where benefits are narrower. Over time, prescribers shifted toward more conservative patterns:

• Lower persistence: combined HRT regimens often show higher discontinuation compared with single-agent or localized options, driven by tolerability and perceived risk.
• Shorter treatment horizons: prescribers frequently favor time-limited use aligned with symptom control.
• Trial and switching behavior: intolerance or risk perceptions drive switching across progestin types or routes.

These dynamics are material for PREMPRO because it is a combined systemic regimen where benefit-risk framing is a central prescribing gate.

What market dynamics determine PREMPRO’s competitive trajectory?

PREMPRO’s performance is typically governed by four overlapping forces:

1. Guideline alignment

   • Recommendations increasingly emphasize the lowest effective dose, shortest duration, and individualized risk assessment.
   • Combined systemic therapy is generally reserved for patients with a uterus who require endometrial protection.

2. Formulary and payer controls

   • Formularies trend toward preferred products, step therapy, and tighter coverage criteria for systemic HRT where plan liability is a concern.
   • Medicare Part D and commercial formularies influence net retention through preferred-tier placement and prior authorization in selected segments.

3. Generic and multiple-source pressure

   • Oral estrogen-progestin combinations face ongoing price compression as alternatives become available through generic pathways and authorized generics.
   • Net sales are therefore less dependent on “unit growth” and more on persistence, conversion, and channel mix.

4. Route substitution

   • Transdermal and localized therapies can displace oral systemic combined regimens when patients and prescribers target side-effect profiles or risk stratification.
   • This displacement is not uniform, but it reduces addressable demand over time for oral combination leaders.

What is the financial trajectory for PREMPRO?

Across mature HRT, financial trajectories typically follow a pattern: early growth from brand penetration, plateauing after label and guideline normalization, then gradual erosion under generic competition and payer pressure, with occasional stabilization from persistence and life-cycle contracting.

Life-cycle reality for PREMPRO

• PREMPRO is a long-established brand, so growth is typically limited to incremental gains from:
  • persistence and switching within combined oral HRT,
  • formulary position within the relevant classes,
  • channel coverage for specific dosing strengths.

Channel-level implications

• Gross-to-net contraction: HRT brands often experience net compression from rebates, wholesaler/contracting dynamics, and competition.
• Mix shift: as preferred status moves, higher-volume strengths can become less profitable even if volume holds.

Net effect

• The financial path is usually characterized by:
  • volume stabilization with mature brand use,
  • margin pressure from price competition and contractual concessions,
  • declining net sales over longer horizons absent protected exclusivity.

How has patent and exclusivity status shaped pricing power?

PREMPRO’s longer-term financial path is tightly linked to the end of exclusivity and the entrance of competition through generic/authorized-generic pathways. For established HRT products, once exclusivity ends:

• price erosion accelerates
• rebates intensify
• net sales become driven by retention rather than new-user growth

Market outcomes: what should investors and R&D teams expect?

For a mature HRT brand like PREMPRO, expectations center on incremental, not step-change, value creation:

• Sales are retention-led: performance depends more on whether patients continue therapy than on new initiation.
• Net sales are contract-driven: payer and plan behavior can shift profitability without large volume movements.
• Regimen substitution is structural: route and regimen shifts typically create headwinds that no single lifecycle intervention reverses quickly.

Competitive landscape and scenario logic (what drives winners and losers)?

In oral combined HRT, relative winners tend to have:

• stronger formulary access
• fewer coverage barriers
• dosing profiles that map to common guideline-aligned practice

Relative laggards face:

• higher contracting friction
• substitution to non-oral or lower-combination intensity regimens
• faster net erosion due to competitive breadth

PREMPRO’s historical position means its trajectory is most sensitive to formulary placement and generic pricing pressure rather than clinical breakthrough cycles.

What are the practical business levers for sustaining PREMPRO performance?

Given the mature state, the dominant levers are commercial and lifecycle, not development:

• Formulary strategy: maintain preferred positions in key plan lists
• Dosing and brand architecture: keep access to widely used strengths and minimize step therapy barriers
• Channel management: optimize rebates and contracting to protect net pricing
• Patient persistence programs: support adherence and switching management to reduce discontinuation

Key takeaways on PREMPRO’s market and financial path

• PREMPRO sits in a mature oral combined systemic HRT category where demand is policy- and guideline-shaped.
• Safety narratives and individualized risk assessment constrain net new initiation.
• Payer contracting, generic/authorized-generic competition, and route substitution are the main drivers of declining net sales over time.
• Financial performance depends largely on persistence, formulary access, and net-price management rather than growth from clinical differentiation.

FAQs

1) Is PREMPRO still a growth product in HRT?

No. As a mature, long-established oral combined HRT product, PREMPRO’s performance is typically retention-led with volume stabilization and net-price pressure.

2) What most impacts PREMPRO’s net sales in the U.S.?

Formulary placement and payer contracting, which drive net price, rebates, and coverage friction, plus generic competition and oral-to-alternative regimen substitution.

3) Why does combined HRT face different demand than single-agent or localized therapy?

Combined therapy requires uterine endometrial protection and therefore fits a narrower patient subset, while perceived risk and tolerability can increase discontinuation rates.

4) What is the biggest structural headwind for PREMPRO?

Oral combination displacement by alternative routes (transdermal) and regimen strategies aligned to individualized risk assessment.

5) What levers can realistically improve PREMPRO outcomes?

Commercial levers that protect net price and access: formulary strategy, minimizing step therapy, channel contracting discipline, and persistence-focused adherence support.

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References

[1] U.S. Food and Drug Administration. Drug Label Information for PREMPRO (conjugated estrogens/medroxyprogesterone acetate). FDA accessdata databases. https://www.accessdata.fda.gov
[2] Centers for Medicare & Medicaid Services. Medicare Part D formularies and coverage policy documentation. https://www.cms.gov
[3] IMS Health / IQVIA and related industry reporting on hormone therapy market dynamics (established HRT category reporting). https://www.iqvia.com