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US Patents and Regulatory Information for YAZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	AB	RX	Yes	Yes

YAZ Market Dynamics, Patent Exclusivity, Generic Competition, and Financial Trajectory

Last updated: November 13, 2026

YAZ, Bayer’s branded combination of drospirenone and ethinyl estradiol, generated substantial revenue as an oral contraceptive and extended its commercial life through the broader Yasmin/YAZ franchise. Its U.S. market exclusivity ended through a combination of patent expiry, generic approvals, and Paragraph IV litigation. Revenue declined sharply after generic drospirenone/ethinyl estradiol products entered the market, while safety litigation and settlements reduced the franchise’s financial value.

What is YAZ and how does the product work?

YAZ contains 3 mg of drospirenone and 0.02 mg of ethinyl estradiol in a 24 active-pill and four inert-pill regimen. The product is indicated for pregnancy prevention. The U.S. label also covers moderate acne vulgaris in females at least 14 years old and premenstrual dysphoric disorder in patients who choose an oral contraceptive for contraception.[1]

Drospirenone is a progestin with antimineralocorticoid and antiandrogenic properties. The pharmacologic profile helped Bayer position YAZ beyond contraception, particularly in acne and premenstrual symptom management.

YAZ product profile

Attribute	YAZ
Active ingredients	Drospirenone and ethinyl estradiol
Strength	3 mg / 0.02 mg
Dosage form	Oral tablet
Original sponsor	Berlex Laboratories, later Bayer
U.S. approval	2006
Primary indications	Contraception, acne, PMDD
Therapeutic category	Combined oral contraceptive
Biosimilar exposure	Not applicable
Current competitive risk	Generic oral contraceptives and lower-cost hormonal alternatives

YAZ was the lower-estrogen successor to Yasmin, which contains 3 mg of drospirenone and 0.03 mg of ethinyl estradiol. The products shared the drospirenone platform but competed in different dosage regimens and marketing segments.

How large was the YAZ market at its peak?

YAZ was one of the leading branded oral contraceptives during the late 2000s. Bayer marketed YAZ as part of a larger women’s-health portfolio that included Yasmin, Yazminelle, Angeliq and related hormonal products in different geographic markets.

Public company reporting generally aggregated sales by product family or business segment rather than reporting U.S. YAZ revenue separately. Bayer’s annual reports identified Yasmin and YAZ as major products in its Women’s Healthcare business, but exact standalone YAZ revenue is not consistently disclosed.

Commercial drivers

YAZ benefited from four primary commercial factors:

1. The drospirenone brand had established physician recognition through Yasmin.
2. The 24-day active-pill regimen differentiated YAZ from many conventional 21-day oral contraceptives.
3. U.S. approvals for acne and PMDD expanded the addressable market.
4. Bayer invested heavily in direct-to-consumer and physician marketing.

The franchise reached peak annual sales of roughly €1 billion to €1.5 billion before generic erosion, depending on whether reported figures include YAZ, Yasmin and related drospirenone products across global markets. The exact YAZ-only contribution cannot be isolated reliably from Bayer’s public disclosures.

When did YAZ lose market exclusivity?

YAZ lost effective exclusivity in the United States after generic products entered the market in 2010. Bayer’s principal composition patent, U.S. Patent No. 6,787,531, was listed in the FDA Orange Book and had an expiration date in 2020, subject to patent-term adjustments and litigation outcomes.[2][3]

The commercial loss of exclusivity occurred earlier than the nominal patent expiration because generic applicants filed Paragraph IV certifications challenging the listed patent. FDA approval of generic products allowed competition before the full patent term ended.

U.S. YAZ exclusivity timeline

Date	Event
2006	FDA approved YAZ for contraception
2006	Acne indication added to the U.S. label
2006	PMDD indication added to the U.S. label
2008-2010	Generic applicants filed Paragraph IV challenges
2010	FDA approved the first generic drospirenone/ethinyl estradiol products
2010 onward	Generic substitution accelerated revenue erosion
2016	Bayer announced major settlements resolving U.S. YAZ/Yasmin litigation
2020	Principal listed composition patent reached its stated expiration period

The practical exclusivity period therefore ended approximately a decade after U.S. approval, rather than continuing until the listed patent’s terminal date.

What patents protected YAZ?

YAZ patent protection centered on the combination of drospirenone and ethinyl estradiol, with additional protection potentially covering formulations, dosage regimens and related methods of use.

Principal U.S. patent

Patent	Subject matter	Listed expiration or terminal period	Commercial relevance
U.S. Patent No. 6,787,531	Pharmaceutical composition containing drospirenone and ethinyl estradiol	2020 period	Principal Orange Book patent associated with YAZ/Yasmin products

Patent scope and enforceability depended on the specific generic filing, the claims challenged, and the settlement terms reached with each applicant. Method-of-use claims covering acne or PMDD could not necessarily block an ANDA applicant using a Section viii “skinny label” that omitted protected indications.

What formulations were protected by YAZ patents?

The main formulation concept combined drospirenone with ethinyl estradiol in an oral tablet. Formulation protection was commercially important because generic applicants had to address the combination, dosage strengths and pharmaceutical composition claims in their ANDAs.

YAZ did not have the biologic manufacturing barriers associated with monoclonal antibodies. Its active ingredients were chemically synthesized small molecules, and the principal manufacturing challenges involved:

• Consistent synthesis and impurity control for drospirenone.
• Uniform low-dose ethinyl estradiol content.
• Tablet stability and dissolution.
• Bioequivalence under FDA ANDA requirements.
• Control of hormonal potency and batch variability.

These requirements created regulatory execution risk but did not create a durable barrier comparable with biologic process know-how.

Which companies challenged YAZ patents?

Generic manufacturers, including Barr Pharmaceuticals, Watson Pharmaceuticals and other ANDA applicants, challenged Bayer’s listed patents through Paragraph IV certifications. Barr became one of the most visible early challengers in the Yasmin/YAZ patent disputes.

Generic competition later included products marketed by companies such as Teva, Mylan, Lupin and Watson/Actavis, although the precise product sponsor and launch timing varied by dosage strength, label and market.

What is a Paragraph IV challenge?

A Paragraph IV certification asserts that a listed patent is invalid, unenforceable or not infringed by the proposed generic product. Filing a Paragraph IV certification can trigger patent litigation and may provide the first successful applicant with 180 days of generic exclusivity under the Hatch-Waxman framework.

For YAZ, Paragraph IV litigation reduced the expected value of Bayer’s remaining patent term. Once a generic applicant obtained FDA approval and launched, other generic manufacturers could enter, accelerating price compression.

What was the FDA regulatory status of YAZ?

YAZ was approved under the FDA’s new drug application pathway. Generic versions were approved under abbreviated new drug applications, which required bioequivalence to the reference listed drug rather than new clinical efficacy trials.[1][4]

Orange Book status

The FDA Orange Book identified YAZ-related patents and regulatory exclusivity information. Orange Book listings enabled generic applicants to determine which patents required certification and gave Bayer the ability to initiate Hatch-Waxman litigation after Paragraph IV notices.

The commercial significance of an Orange Book listing declined once:

• Generic applicants won or settled patent disputes.
• The FDA approved ANDAs.
• Pharmacies and payers substituted lower-cost alternatives.
• Bayer’s patent term approached expiration.

How did generic entry change YAZ pricing and market share?

Generic entry transformed YAZ from a premium branded contraceptive into a largely price-sensitive product category. Oral contraceptives have relatively low switching barriers for many patients, although physicians may preserve a branded prescription when tolerability, adherence, insurance coverage or patient preference supports continued use.

Generic launch scenarios

Scenario	Market effect
First generic launch with limited competition	Moderate initial price decline; brand may retain a niche
Multiple generic launches	Rapid wholesale price compression and payer substitution
Authorized generic or branded-generic strategy	Greater control over channel pricing but lower brand differentiation
Skinny-label generic	Generic competition may focus on contraception while omitting certain protected uses
Continued brand marketing	Higher retention among patients with established tolerability or indication-specific needs

YAZ also faced therapeutic competition from other combined oral contraceptives, progestin-only pills, transdermal patches, vaginal rings, intrauterine systems and long-acting reversible contraceptives. The competitive set was therefore broader than generic equivalents.

What litigation affected YAZ and Yasmin?

Bayer faced two distinct categories of litigation.

Patent litigation

Patent disputes concerned generic applicants’ challenges to drospirenone/ethinyl estradiol patents. Settlements allowed generic entry on negotiated dates, often before the challenged patent’s nominal expiration. The financial effect depended on whether the settlement permitted an authorized generic, the number of entrants, and the timing of commercial launch.

Product-liability litigation

YAZ and Yasmin were also subject to extensive product-liability claims involving venous thromboembolism, pulmonary embolism, stroke, gallbladder disease and other alleged injuries. Bayer disputed many claims but entered settlements to resolve substantial portions of the litigation.

In 2016, Bayer announced agreements resolving thousands of U.S. claims involving YAZ and Yasmin for approximately $2 billion, including earlier agreements and related costs.[5] Reported settlement totals changed as additional claims were resolved.

The litigation affected the franchise in three ways:

• Direct cash payments and legal costs reduced net economic returns.
• Regulatory and public-relations issues constrained promotional flexibility.
• Investors applied a lower risk-adjusted value to the remaining brand revenue.

What was YAZ’s financial trajectory?

YAZ followed a standard branded-drug lifecycle but with unusually large legal exposure.

Financial lifecycle

Phase	Financial pattern
Launch, 2006-2007	Rapid uptake supported by differentiated dosing and broad promotion
Growth, 2007-2009	Strong franchise sales across YAZ, Yasmin and international equivalents
Pre-generic period, 2009-2010	High revenue but increasing litigation and safety costs
Generic erosion, 2010 onward	Sharp decline in volume, price and branded market share
Post-exclusivity	Residual revenue from brand loyalty and selected markets
Mature stage	Value shifted from sales growth to litigation management, licensing and portfolio rationalization

Bayer’s reported sales for the broader Women’s Healthcare business remained material after YAZ lost exclusivity, but the company no longer had the same pricing power. Revenue from the drospirenone franchise was diluted by generic substitution and by competition from newer contraceptive technologies.

Revenue exposure

The largest exposure occurred before generic entry, when YAZ and Yasmin contributed meaningfully to Bayer’s consumer-facing prescription portfolio. After 2010, the economic profile changed:

• Unit volume migrated to generics.
• Average selling prices fell.
• Rebate pressure increased.
• Marketing returns declined.
• Litigation provisions became a major offset.
• The brand’s residual value became geography-specific.

YAZ remained more commercially defensible in markets where generic penetration was slower, reimbursement favored branded products, or Bayer held stronger distribution and physician relationships.

How does YAZ compare with Yasmin and generic drospirenone products?

Factor	YAZ	Yasmin	Generic drospirenone/ethinyl estradiol
Ethinyl estradiol dose	0.02 mg	0.03 mg	Usually equivalent to reference product
Active-pill regimen	24	Typically 21	Depends on approved product
Brand owner	Bayer	Bayer	Multiple generic manufacturers
Acne/PMDD positioning	Stronger label-based differentiation	Less central to YAZ’s positioning	Depends on label and indication
Price power	Historically high	Historically high	Low
Patent risk	Substantially eroded	Substantially eroded	ANDA and manufacturing compliance risk
Biosimilar risk	None	None	Not applicable

YAZ’s lower estrogen dose and 24-day regimen gave it a commercial distinction from Yasmin, but those differences did not prevent generic erosion once equivalent products became available.

What licensing deals affected YAZ?

The YAZ franchise was primarily an internally controlled Bayer asset after Bayer’s acquisition of Schering AG. Public disclosures do not identify a major licensing transaction that materially changed YAZ’s U.S. exclusivity or long-term economics.

Distribution, co-promotion and regional commercialization arrangements may have affected individual markets, but the principal value drivers were Bayer’s ownership of the brand, its patent position, generic settlements and product-liability exposure.

How strong is the YAZ patent estate?

The YAZ patent estate was commercially effective during the initial brand period but ultimately weak against coordinated generic challenges.

Strength assessment

Factor	Assessment
Composition patent	Important but vulnerable to validity and infringement challenges
Formulation protection	Supported product differentiation but did not create a permanent barrier
Method-of-use patents	Potentially useful for acne and PMDD, subject to skinny-label strategies
Small-molecule manufacturing barrier	Moderate regulatory burden, limited structural protection
Orange Book position	Enabled Hatch-Waxman enforcement
Settlement leverage	Meaningful before first generic approval, declining thereafter
Post-2020 protection	Limited ability to sustain U.S. monopoly pricing

The estate’s strongest period was before the first generic launch. Once the FDA approved multiple generic products, the patent portfolio no longer supported high-margin U.S. sales.

What generic entry risks exist for YAZ investors and licensors?

YAZ presents limited direct growth potential and substantial residual-risk exposure.

Key risks include:

• Continued price erosion in remaining branded markets.
• Additional product-liability claims or settlement obligations.
• Regulatory scrutiny of drospirenone safety communications.
• Competition from long-acting contraceptives.
• Limited ability to extend exclusivity through new indications.
• Low return on further brand promotion.
• Declining value of manufacturing and distribution agreements.

Potential residual value exists in markets with lower generic substitution, in authorized-generic strategies, and in portfolio transactions focused on established women’s-health products. Those opportunities are unlikely to recreate the pre-generic economics.

Key Takeaways

• YAZ is a drospirenone/ethinyl estradiol oral contraceptive approved by the FDA in 2006.
• Its commercial peak was part of the broader Bayer Yasmin/YAZ franchise, with reported peak sales generally estimated at roughly €1 billion to €1.5 billion across products and geographies.
• Generic competition began in the United States in 2010 after Paragraph IV litigation and ANDA approvals.
• U.S. Patent No. 6,787,531 was the principal listed composition patent associated with the product family.
• YAZ’s patent estate protected the brand during its growth phase but did not prevent early generic erosion.
• Bayer faced major product-liability litigation involving thromboembolic and other alleged injuries, with settlements totaling approximately $2 billion by 2016.
• Biosimilar risk is irrelevant because YAZ is a chemically synthesized small-molecule drug.
• The franchise’s financial trajectory shifted from high-margin branded growth to generic price erosion, litigation expense and residual international revenue.

FAQs

Is YAZ still sold in the United States?

YAZ has largely been displaced by generic drospirenone/ethinyl estradiol products in the U.S. market, although branded availability and dispensing can vary by channel, payer and manufacturer strategy.

Is generic Yaz therapeutically equivalent to the branded product?

FDA-approved generic versions must demonstrate bioequivalence to the reference product. Substitution is subject to state pharmacy law, payer policy and the prescriber’s instructions.[4]

Can YAZ patents block generic acne treatment?

A generic applicant may omit a patented indication from its label through a Section viii statement, provided the remaining label does not improperly include the protected use. The outcome depends on the listed claims and the generic’s proposed labeling.

Did Bayer settle all YAZ litigation?

No single settlement eliminated every possible claim. Bayer resolved large groups of cases through agreements and continued to manage remaining litigation and related claims.

Does YAZ have biosimilar competition?

No. Biosimilars apply to biologic products. YAZ is a small-molecule combination drug and competes with generic equivalents approved through the ANDA pathway.

References

1. U.S. Food and Drug Administration. (2012). YAZ prescribing information. FDA.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
3. United States Patent and Trademark Office. (2004). U.S. Patent No. 6,787,531: Pharmaceutical composition containing drospirenone and ethinylestradiol. USPTO.
4. U.S. Food and Drug Administration. (2023). Generic drug facts. FDA.
5. Bayer AG. (2016). Bayer reaches agreements to resolve approximately 8,200 Yaz and Yasmin product liability claims. Bayer.