DROSPIRENONE; ESTRADIOL - Generic Drug Details

What are the generic sources for drospirenone; estradiol and what is the scope of freedom to operate?

Drospirenone; estradiol is the generic ingredient in two branded drugs marketed by Bayer Hlthcare and Novast Labs, and is included in two NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Drospirenone; estradiol has twenty-one patent family members in sixteen countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for DROSPIRENONE; ESTRADIOL

International Patents:	21
US Patents:	1
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	62
DailyMed Link:	DROSPIRENONE; ESTRADIOL at DailyMed

Recent Clinical Trials for DROSPIRENONE; ESTRADIOL

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

Sponsor	Phase
Novartis Pharmaceuticals	PHASE1
Institut de Recherches Internationales Servier (I.R.I.S.)	PHASE1
Vertex Pharmaceuticals Incorporated	PHASE1

See all DROSPIRENONE; ESTRADIOL clinical trials

Generic filers with tentative approvals for DROSPIRENONE; ESTRADIOL

Applicant	Application No.	Strength	Dosage Form
		0.5MG;1MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for DROSPIRENONE; ESTRADIOL

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for DROSPIRENONE; ESTRADIOL

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for DROSPIRENONE; ESTRADIOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ANGELIQ	Tablets	drospirenone; estradiol	0.25 mg/0.5 mg	021355	1	2015-01-08
ANGELIQ	Tablets	drospirenone; estradiol	0.5 mg/1 mg	021355	1	2007-12-26

US Patents and Regulatory Information for DROSPIRENONE; ESTRADIOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-001	Feb 29, 2012		RX	Yes	No			Y
Novast Labs	DROSPIRENONE AND ESTRADIOL	drospirenone; estradiol	TABLET;ORAL	218031-001	Oct 28, 2025	AB	RX	No	No
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-002	Sep 28, 2005	AB	RX	Yes	Yes

Expired US Patents for DROSPIRENONE; ESTRADIOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-002	Sep 28, 2005

International Patents for DROSPIRENONE; ESTRADIOL

Country	Patent Number	Title	Estimated Expiration
Uruguay	33343	FORMAS DE DOSIFICACIÓN SÓLIDAS ORALES CON DOSIS MUY BAJAS PARA LA HRT
Brazil	112012026115	formas de dosagem sólidas orais muito baixas para hrt
South Korea	20180018827	초저-용량의 ＨＲＴ용 고체 경구 투여 형태 (- VERY LOW-DOSED SOLID ORAL DOSAGE FORMS FOR HRT)
Colombia	6630107	Formas de dosificación sólidas orales con dosis muy bajas para hrt
World Intellectual Property Organization (WIPO)	2011128336
Guatemala	201200281	FORMAS DE DOSIFICACIÓN SÓLIDAS ORALES CON DOSIS MUY BAJAS PARA LA HRT
Eurasian Patent Organization	201201403	ОЧЕНЬ НИЗКОДОЗИРОВАННЫЕ ТВЕРДЫЕ ПЕРОРАЛЬНЫЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ ДЛЯ ГЗТ (VERY LOW-DOSED SOLID ORAL DOSAGE FORMS FOR HORMONE REPLACEMENT THERAPY (HRT))

Supplementary Protection Certificates for DROSPIRENONE; ESTRADIOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3632448	22C1031	France		PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016
3632448	LUC00266	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
0398460	SPC/GB04/032	United Kingdom		PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
3632448	202240023	Slovenia		PRODUCT NAME: DROSPIRENONE; NATIONAL AUTHORISATION NUMBER: H/21/02860/001-004; DATE OF NATIONAL AUTHORISATION: 20211217; AUTHORITY FOR NATIONAL AUTHORISATION: SI; FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: 61678; DATE OF FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: 20191016; AUTHORITY OF FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: DK
2588114	LUC00227	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
0398460	04C0022	France		PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211

Market Dynamics and Financial Trajectory for Drospirenone; Estradiol

Last updated: April 24, 2026

What is the commercial and regulatory footprint for drospirenone; estradiol?

Drospirenone; estradiol is a combined oral hormone therapy using:

• Drospirenone (a progestin component)
• Estradiol (an estrogen component)

Commercially, the most established branded market reference is Angeliq (drospirenone/estradiol 0.25 mg/0.5 mg), sold in multiple jurisdictions for hormone replacement therapy. The drug class sits at the intersection of postmenopausal symptoms and menopausal hormone therapy standards that include strict labeling and risk management (notably venous thromboembolism and related safety communications).

How does the market size and demand profile typically behave for menopausal hormone therapy?

Menopausal hormone therapy markets follow a structural demand pattern shaped by:

• Aging demographics (pool of postmenopausal patients)
• Treatment uptake cycles driven by labeling and prescribing guidance
• Therapeutic preference shifts between oral, transdermal, and local therapies
• Safety and risk perception that can tighten physician prescribing and patient acceptance

For drospirenone; estradiol specifically, competitive positioning is determined by:

• Oral convenience versus transdermal alternatives
• Brand familiarity and payer status in key markets
• Switching risk to other estrogen-progestin combinations and delivery routes
• Guideline alignment at the reimbursement and prescribing level

What drives competition and pricing dynamics for drospirenone; estradiol?

The competitive set includes other oral hormone therapy regimens (estrogen plus progestin) and, in several geographies, non-oral routes that can capture patients seeking a different safety or tolerability profile.

Key pricing and market-access dynamics typically include:

• Generic entry pressure once combination patents and exclusivities are out of protection
• Payer preference lists that favor lower-cost formulations after patent expirations
• Formulary tiering that impacts retail demand and adherence
• Tender and hospital procurement channels in systems with centralized purchasing (where applicable)
• Channel mix shift toward wholesalers and pharmacy networks that aggressively manage interchangeability

How does patent and exclusivity structure affect financial trajectory?

Financial trajectory for drospirenone; estradiol is dominated by two recurring effects:

1. Pre-expiry period (brand strength): pricing power holds when exclusivity reduces substitutes.
2. Post-expiry period (volume erosion): brand share declines after generic or authorized generic availability, with margin compression from payer rebates and wholesale pricing.

The typical path for a combination product is:

• Brand peak during active exclusivity
• Sequential erosion from formulary changes, then direct generic substitution
• Residual demand sustained by long-term prescribers or patient-specific reasons for staying on a known regimen

What is the likely financial trajectory pattern for drospirenone; estradiol?

Given the combination’s historical branded presence (Angeliq) and the standard behavior of menopause hormone therapy products under patent expiry, the financial trajectory generally follows this curve:

• Revenue growth or stability phase while exclusivity supports premium pricing and payer acceptance.
• Revenue decline and margin compression after generic competition begins, with:
  • Lower net pricing due to reimbursement pressure
  • Reduced share as substitution increases
  • Higher promotional spend to retain clinicians and patients
• Eventually steady-state low-margin revenue where the market matures into a cost-driven segment.

That trajectory is consistent with observed behavior in hormone therapy categories across large markets: demand persists, but competitive forces compress profitability as brands lose exclusivity.

How do safety, labeling, and risk communications shape demand and earnings?

Hormone therapy prescribing is tightly linked to evolving safety communications and clinician risk-benefit assessments. For a product with drospirenone and estradiol, commercial performance tends to be influenced by:

• Physician willingness to prescribe after guideline revisions or safety communications
• Patient continuation rates, which affect lifetime revenue more than initial prescriptions
• Switching to alternatives (other progestins or delivery routes) when risk perception shifts

This translates into financial outcomes that are often less about the existence of demand and more about:

• share of eligible patients
• duration of therapy adherence
• net price after rebates and substitution

What are the key market levers that an R&D or investment thesis should model?

For any forward-looking view of drospirenone; estradiol financial trajectory, model four levers:

1. Exclusivity timeline and competitive entry risk
   • Patent and regulatory exclusivity expiry determines the speed of share loss.
2. Reimbursement dynamics
   • Net pricing declines as payers move to lower-cost alternatives.
3. Prescriber preference and switching friction
   • Stability is higher where clinicians maintain established regimens for continuity.
4. Delivery route substitution
   • Oral-to-transdermal or oral-to-local shifts change addressable volume.

What does the competitive landscape imply for near-term performance?

Near-term performance for drospirenone; estradiol is typically defined by whether the market is:

• Still in brand-protected territory, supporting pricing and stable share, or
• In generic and payer-driven territory, supporting stable demand but reduced margins.

If generics exist in a given geography, the likely outcome is:

• Volume retention at lower price
• Lower EBITDA margin due to price competition and promotional intensity

What financial metrics should be treated as “leading indicators”?

For a combination hormone therapy product like drospirenone; estradiol, leading indicators for financial trajectory include:

• Formulary inclusion status (preferred vs non-preferred)
• Net price movement (public list price is not predictive; net after payer terms is)
• TRx stability and script-to-adherence conversion
• Share of prescription substitutions within the same therapeutic class
• Gross-to-net ratio changes as rebates rise post-generic entry

Market outlook: what is the baseline trajectory for this segment?

Menopausal hormone therapy overall tends to maintain demand over long cycles because of:

• Ongoing aging demographic trends
• Continued need for symptom management
• Clinical protocols and patient education that preserve adherence within subpopulations

For drospirenone; estradiol, baseline outlook is thus typically:

• Stable demand but compressed pricing post-exclusivity
• Defensive volume driven by brand familiarity and persistence in some patient cohorts
• Competitive share migration to lower-cost or alternative regimens

Key Takeaways

• Drospirenone; estradiol’s financial trajectory is primarily determined by exclusivity duration and generic substitution speed, with net price compression once competitive pressure arrives.
• Menopausal hormone therapy demand is structurally supported, but share and margin move based on reimbursement status, prescriber comfort, and delivery route substitution.
• The operational focus for business cases is gross-to-net, formulary placement, and TRx-to-persistence conversion, not headline list pricing.
• In mature markets, expect a pattern of revenue decline after entry followed by lower-margin steady-state rather than demand collapse.

FAQs

1) Is drospirenone; estradiol primarily an oral hormone therapy for menopausal symptoms?

Yes. It is used as an estrogen-progestin regimen for menopausal hormone therapy, with product-specific dosing and risk labeling that inform prescribing and patient continuation.

2) What most strongly impacts profitability for drospirenone; estradiol over time?

Exclusivity status and payer pricing pressure. Once generics enter or payers shift preference, net pricing falls and margins compress.

3) Does the category typically lose demand after safety and labeling changes?

Demand can persist, but prescribing behavior often shifts. Net outcomes usually show as reduced share, higher switching, and lower net price, rather than complete category collapse.

4) How should an investment model treat delivery route competition?

Treat it as a volume risk: oral-to-transdermal and alternative regimen switching reduces addressable share even if total patient need persists.

5) What leading indicators best predict revenue trajectory?

Formulary placement, TRx stability, gross-to-net changes, and persistence/adherence rates after initiation.

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References

[1] Angeliq (drospirenone/estradiol) prescribing information and product labeling (brand reference for combined drospirenone and estradiol for menopausal hormone therapy).