DROSPIRENONE; ETHINYL ESTRADIOL - Generic Drug Details

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

Drospirenone; ethinyl estradiol is the generic ingredient in sixteen branded drugs marketed by Barr, Glenmark Pharms Ltd, Hetero Labs, Jubilant Cadista, Pharmobedient, Watson Labs, Xiromed, Sun Pharm, Aurobindo Pharma Ltd, Novast Labs, Lupin Ltd, Bayer Hlthcare, Apotex, Dr Reddys Labs Sa, Naari Pte, and Watson Labs Inc, and is included in thirty-three NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sixteen suppliers are listed for this compound.

Summary for DROSPIRENONE; ETHINYL ESTRADIOL

US Patents:	2
Tradenames:	16
Applicants:	16
NDAs:	33
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	47
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DROSPIRENONE; ETHINYL ESTRADIOL
DailyMed Link:	DROSPIRENONE; ETHINYL ESTRADIOL at DailyMed

Recent Clinical Trials for DROSPIRENONE; ETHINYL 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; ETHINYL ESTRADIOL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DROSPIRENONE; ETHINYL 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; ETHINYL ESTRADIOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
YAZ	Tablets	drospirenone; ethinyl estradiol	3 mg/0.02 mg	021676	1	2006-09-29
YASMIN	Tablets	drospirenone; ethinyl estradiol	3 mg/0.03 mg	021098	1	2005-01-07

US Patents and Regulatory Information for DROSPIRENONE; ETHINYL ESTRADIOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hetero Labs	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL	211944-001	Mar 22, 2019	AB	RX	No	No
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	AB	RX	Yes	Yes	11,617,751		Y
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	AB	RX	Yes	Yes	8,617,597		Y
Xiromed	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL	202594-001	Oct 22, 2015	AB	RX	No	No
Glenmark Pharms Ltd	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL	204296-001	Aug 17, 2015	AB	RX	No	No
Novast Labs	YAELA	drospirenone; ethinyl estradiol	TABLET;ORAL-28	202015-001	Nov 19, 2014	AB	RX	No	No
Sun Pharm	KYRA	drospirenone; ethinyl estradiol	TABLET;ORAL	202318-001	Jul 23, 2019		DISCN	No	No

Expired US Patents for DROSPIRENONE; ETHINYL ESTRADIOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	RE37838
Bayer Hlthcare	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098-001	May 11, 2001	6,933,395
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	6,787,531
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	RE37564
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	5,569,652
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	6,987,101
Bayer Hlthcare	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098-001	May 11, 2001	6,787,531

Market Dynamics and Financial Trajectory for Drospirenone / Ethinyl Estradiol (Combined Oral Contraceptive)

Last updated: April 25, 2026

What is the market role of drospirenone–ethinyl estradiol?

Drospirenone / ethinyl estradiol (DRSP/EE) is a combined oral contraceptive (COC) and one of the key branded “4th-generation”/newer COCs by progestin profile. It is typically positioned for three overlapping demand drivers:

• Contraception: long-run base demand tied to women’s contraceptive prevalence.
• Cycle control and dysmenorrhea: consistent prescription use for bleeding regulation and symptom control.
• Acne/off-label use: where permitted and promoted, it can support incremental demand.

Commercial uptake is mediated by two forces that shape pricing and volume:

1. Formulation churn within the COC class (pharmacologic equivalence plus brand differentiation on dosing schedules, tolerability, and managed-care preference).
2. Cardiovascular risk perception (especially venous thromboembolism concerns associated with certain progestins), which affects prescribing mix in some geographies and payer policies.

How does the patent and generics landscape drive financial outcomes?

DRSP/EE has reached broad availability in many jurisdictions, which structurally limits long-duration price premiums. The financial trajectory for individual brands follows a classic lifecycle:

Brand trajectory pattern (high-level)

• Launch and early growth: premium pricing with payer access ramp.
• Exclusivity end: erosion from AB-rated generics and authorized generics where they launch.
• Late-cycle dynamics: brand pricing pressure plus limited incremental volume gains from switching, bundle contracts, and line extensions.

Payer-side mechanism that matters financially

COCs are often managed through:

• Preferred drug lists (PDLs) at health plans
• Step therapy or “quantity limits” for certain plan tiers
• Formulary switches triggered by wholesale acquisition cost and net price benchmarking

Once generic penetration rises, branded net revenue tends to track share retention, not market growth.

What is the expected market structure and pricing behavior?

COCs form a large category with mature demand. DRSP/EE typically competes in a multi-brand field where:

• Gross-to-net declines accelerate after generic entrants.
• Price competition compresses branded net sales even when total category demand remains stable.
• Channel mix (retail vs mail-order) and contract rebates materially affect net revenue.

Pricing behavior in mature COC categories commonly displays:

• Lower ability to raise price without volume loss after generic competition
• Higher reliance on rebates and contracting to maintain shelf share

This creates a financial pattern where top-line growth is harder, and operating income relies on cost management and mix.

What do market dynamics imply for sales volume?

Volume for DRSP/EE is driven by:

• Switching within COCs: patients change products when coverage changes or side-effect experiences occur.
• New-start scripts vs continuation: new initiations are more sensitive to payer rules and marketing, continuation is more stable.
• Demographic and utilization trends: contraceptive use rates, age distribution, and adherence patterns.

Net volume changes usually decouple from pure category growth once generics dominate. The branded product’s share becomes the primary driver.

What does the financial trajectory typically look like for DRSP/EE brands?

A realistic trajectory for a branded DRSP/EE franchise in a mature market is characterized by:

1. Peak sales before multiple generic entries
2. Sustained revenue decline post-exclusivity
3. Flooring behavior in later years if the brand retains a base through tolerability perception, clinician preference, and managed-care contracts

The core financial question becomes not whether the category grows, but whether the brand can keep share at an acceptable net price.

How do safety communications shape business performance?

COCs with drospirenone are sensitive to:

• Benefit-risk communication around thromboembolism risk
• Labeling interpretation and prescriber risk stratification
• Payer and clinical guideline alignment

For branded revenue, the practical impact is:

• More selective prescribing in high-risk populations
• Greater influence of clinical decision support in electronic prescribing systems
• Potential formulary restrictions in some plans

This safety overlay does not usually eliminate demand, but it can:

• Slow adoption relative to lower-perceived-risk competitors
• Increase churn when prescribers consolidate to favored COCs

What are the key competitive dynamics inside COCs?

Within COCs, DRSP/EE faces competition from:

• Other drospirenone-containing COCs and different progestin classes
• Broader “preferred” formulary products with stronger contract pricing
• Long-acting reversible contraception (LARC) as a competing option for some patient segments

The financial implication is that COC market share is not purely organic. It is contested by:

• Other oral options
• LARC uptake trends
• Provider practice patterns

What should be monitored to assess forward financial performance?

For business and investment decisioning, the leading indicators are:

• Net pricing and rebate intensity after generic expansion
• Share retention versus total COC category share
• Formulary status in top commercial and government formularies
• Prescription trend slope (new starts vs refills)
• Channel mix shift to mail-order (often influences contract economics)

These indicators determine whether revenue decline slows, stabilizes, or accelerates.

How could portfolio actions affect the trajectory?

Brands typically manage post-exclusivity pressure through:

• Line extensions (different dosing regimens, if available under the franchise)
• Marketing re-targeting to segments with higher continuation
• Contracting strategies that offset net price compression

However, absent fresh patent protection, these actions usually affect share and costs, not the structural headwind from generics.

Bottom-line outlook for DRSP/EE financial trajectory

Given the mature COC market and typical post-exclusivity dynamics for DRSP/EE, the financial profile is expected to:

• Transition from premium-priced brand growth to share-dependent revenue
• Show net sales erosion after generic penetration
• Stabilize only if the brand retains meaningful prescriber and payer preference through contracting and patient retention

In practical terms, the trajectory is shaped by managed-care economics and competitive COC positioning more than by scientific differentiation after generic entry.

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Key Takeaways

• Drospirenone/ethinyl estradiol is a mature combined oral contraceptive where financial outcomes track share retention and net pricing, not category growth.
• Generic and authorized-generic competition typically drives multi-year branded net revenue compression after exclusivity.
• Safety perception around thromboembolism influences prescriber and payer behavior, affecting initiation rates and formulary inclusion.
• Forward performance depends on gross-to-net dynamics, rebate intensity, and formulary position.

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FAQs

1) Why does DRSP/EE revenue decline even when contraceptive demand is stable?
Because post-exclusivity, net sales depend on brand share and contract economics while generic competition compresses net price.

2) What drives branded performance in the mature COC category?
Formulary preference, rebate intensity, and continuation share, with new-start volume more sensitive to payer rules.

3) Does the safety profile change the overall demand for DRSP/EE?
It can change prescribing mix and patient selection, affecting growth rates and formulary access even if baseline utilization remains.

4) What competitive factors matter most versus other oral contraceptives?
Net contracting, clinician preference tied to perceived risk, and switching patterns across COCs.

5) What are the highest-value metrics for projecting future DRSP/EE revenue?
Net price, gross-to-net trend, prescription new-start slope, share versus the COC class, and formulary status across major plans.

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References

[1] FDA. Labeling for drospirenone and ethinyl estradiol-containing products (Combined Oral Contraceptives). U.S. Food and Drug Administration.
[2] EMA. Product information for drospirenone/ethinyl estradiol-containing medicinal products. European Medicines Agency.
[3] WHO. Medical eligibility criteria for contraceptive use (background on contraceptive safety considerations). World Health Organization.
[4] Gaffield ME, et al. Venous thromboembolism risk and combined oral contraceptives (progestin class considerations). Contraception (peer-reviewed literature).