Last updated: November 8, 2026
Beyaz is a legacy U.S. oral contraceptive containing drospirenone, ethinyl estradiol, and levomefolate calcium. Bayer launched it in 2010 as an extension of the Yasmin and Yaz franchise. Its commercial position has deteriorated because core hormonal-contraceptive patents expired, generic equivalents entered the market, and the brand was not a strategic growth product in Bayer’s current portfolio. Bayer does not separately disclose Beyaz revenue, so its financial trajectory must be assessed through product lifecycle data, generic competition, and Bayer’s portfolio disclosures.
What is Beyaz and how does it compare with Yaz, Yasmin, and Safyral?
Beyaz is a 28-tablet combined oral contraceptive with 24 active tablets and four inactive tablets. Each active tablet contains:
| Component |
Amount |
| Drospirenone |
3 mg |
| Ethinyl estradiol |
0.02 mg |
| Levomefolate calcium |
0.451 mg |
The formulation is pharmacologically aligned with Yaz, with the addition of folate. The FDA approved Beyaz under NDA 022676 in 2010. Its labeled indications include prevention of pregnancy, treatment of moderate acne vulgaris, and treatment of premenstrual dysphoric disorder in appropriate patients. The label also describes the product’s folate-related indication, which was intended to increase folate levels in women who choose oral contraception [1].
| Product |
Hormonal composition |
Folate component |
Commercial positioning |
| Yaz |
Drospirenone 3 mg; ethinyl estradiol 0.02 mg |
No |
Core branded contraceptive |
| Beyaz |
Drospirenone 3 mg; ethinyl estradiol 0.02 mg |
Yes |
Yaz extension with folate |
| Yasmin |
Drospirenone 3 mg; ethinyl estradiol 0.03 mg |
No |
Earlier Bayer contraceptive |
| Safyral |
Drospirenone 3 mg; ethinyl estradiol 0.03 mg |
Yes |
Yasmin extension with folate |
| Generic equivalents |
Same active ingredients and strengths |
Varies by approved product |
Price-driven substitution |
Beyaz was designed to preserve value from the drospirenone franchise after Yaz had established substantial market awareness. The folate component differentiated the product but did not create a durable pricing barrier once generic versions of the underlying combination became available.
When did Beyaz lose exclusivity?
Beyaz’s commercial exclusivity eroded in stages rather than on a single date.
The underlying oral-contraceptive technology is old. Ethinyl estradiol and drospirenone had separate patent histories, while the commercial protection for the Yaz and Beyaz products also depended on formulation, dosing regimen, and method-of-use claims. The strongest economic protection for the franchise was associated with the earlier Yaz and Yasmin products, not with a long remaining exclusivity period for Beyaz.
Key lifecycle events include:
| Event |
Approximate timing |
Commercial effect |
| Yasmin launch |
Early 2000s |
Established drospirenone franchise |
| Yaz launch |
2006 |
Expanded lower-estrogen 24/4 formulation |
| Beyaz FDA approval |
October 2010 |
Added folate-based brand extension |
| Generic Yaz litigation and settlements |
2010s |
Opened path to generic substitution |
| Generic drospirenone/ethinyl estradiol products |
2010s |
Reduced pricing power across the franchise |
| Generic Beyaz-type products |
Late 2010s onward |
Directly pressured Beyaz demand |
| Branded product decline or discontinuation |
Late 2010s to early 2020s |
Reduced commercial relevance |
The Orange Book is the controlling source for active patents, regulatory exclusivity, and listed patent certifications. It does not support a current branded-exclusivity thesis for Beyaz. The product’s commercial risk is therefore driven mainly by generic substitution rather than by an imminent single patent cliff [2].
What patents protect Beyaz?
Beyaz’s historic patent protection came from several categories:
- Drospirenone and estrogen composition claims.
- Low-dose oral-contraceptive formulations.
- 24-active-tablet and 4-placebo-tablet regimens.
- Methods of treating contraception-related conditions.
- Folate-containing contraceptive formulations.
- Manufacturing and pharmaceutical-composition claims.
The practical value of these categories has declined because the principal composition and regimen concepts are no longer new. Patent terms also run from earliest effective nonprovisional filing dates, so later Beyaz formulation patents did not necessarily provide a long commercial runway after FDA approval.
What formulation patents protected the folate component?
Beyaz’s differentiation depended on adding levomefolate calcium to the drospirenone and ethinyl estradiol regimen. That formulation could support separate patent claims from the core hormone combination. The commercial limitation was that the folate addition had modest clinical differentiation and did not prevent competition from products offering the same active ingredients or therapeutically equivalent alternatives.
The folate feature also created a narrower market opportunity. Many prescribers and patients treated Beyaz as a higher-cost version of Yaz rather than as a distinct therapy. Once generic equivalents became available, the formulation patent strategy could not sustain the original premium.
What is the FDA and Orange Book status of Beyaz?
Beyaz was approved through the FDA’s new-drug application pathway under NDA 022676. FDA labeling identifies Bayer HealthCare Pharmaceuticals as the original sponsor [1].
The relevant regulatory points are:
| Regulatory issue |
Beyaz assessment |
| FDA approval |
Approved in 2010 |
| Dosage form |
Oral tablets |
| Prescription status |
Prescription drug |
| Reference product |
NDA 022676 |
| Regulatory exclusivity |
Expired |
| Current commercial status |
Legacy product with materially reduced market relevance |
| Generic pathway |
ANDA-based competition |
| Biosimilar pathway |
Not applicable |
Beyaz is a small-molecule oral drug, not a biologic. Biosimilar risk is therefore irrelevant. The applicable competitive pathway is generic substitution under abbreviated new drug applications, subject to pharmaceutical equivalence, bioequivalence, labeling, and state substitution rules.
Which companies challenge Beyaz through generic competition?
The main competitive threat comes from generic manufacturers of drospirenone and ethinyl estradiol products, including companies that have marketed generic versions of Yaz-type and Beyaz-type formulations. The exact supplier mix changes because manufacturers enter, exit, settle patent disputes, or discontinue individual National Drug Code presentations.
Generic competition affects Beyaz in two ways:
- Direct substitution for the three-component drospirenone, ethinyl estradiol, and levomefolate formulation.
- Indirect substitution from lower-cost drospirenone and ethinyl estradiol products without folate.
The second category is commercially important. Even where a generic does not replicate every excipient or folate component, physicians and payers can shift demand toward lower-cost hormonal contraceptives. Contraceptives are highly exposed to formulary control and pharmacy-benefit substitution.
Were there Paragraph IV challenges and patent settlements?
The drospirenone contraceptive franchise generated substantial patent litigation, particularly around generic versions of Yasmin and Yaz. Paragraph IV certifications were central to those disputes because generic applicants challenged listed patents as invalid, unenforceable, or not infringed.
The litigation pattern included:
- ANDA filings for generic drospirenone and ethinyl estradiol products.
- Patent infringement actions by Bayer-related entities.
- Settlement agreements that established delayed or negotiated generic entry.
- Later generic launches after patent barriers expired or settlements became effective.
The commercially relevant point is that historic settlements may have delayed entry but did not preserve long-term exclusivity. No current litigation posture is widely associated with a material re-rating of Beyaz’s value. The major legal risk has already converted into generic competition and price erosion.
What is the financial trajectory of Beyaz?
Bayer does not report Beyaz as a separate revenue line in its annual reporting. Beyaz is embedded within broader pharmaceutical or women’s-health sales, and the company’s reporting does not provide product-level revenue, unit volume, gross margin, or cash-flow data for the brand [3].
The financial trajectory is therefore best characterized as follows:
| Period |
Financial profile |
| 2010-2012 |
Launch-stage contribution; premium brand-extension economics |
| 2013-2016 |
Revenue pressure from franchise litigation, safety-related scrutiny, and generic preparation |
| 2017-2019 |
Declining branded demand as generic drospirenone products expanded |
| 2020 onward |
Mature or residual economics; limited strategic importance |
| Current outlook |
Low standalone value unless supported by an active branded channel or licensing arrangement |
Beyaz’s revenue exposure to Bayer is immaterial relative to the company’s overall pharmaceutical business. Bayer’s major pharmaceutical assets have included products such as Xarelto, Eylea, Nubeqa, Kerendia, and other higher-value products. A legacy oral contraceptive with generic competition does not materially influence consolidated Bayer earnings.
The principal financial pressures are:
- Lower net price after generic entry.
- Reduced physician differentiation.
- Pharmacy-benefit substitution.
- Limited ability to raise price without losing volume.
- Manufacturing complexity from a multi-ingredient tablet regimen.
- Declining promotional support for a legacy brand.
How strong is the Beyaz patent estate?
Beyaz has a weak current patent estate from an investment perspective.
| Patent-estate factor |
Assessment |
| Core active ingredients |
Mature and broadly exposed to generic competition |
| 24/4 regimen |
Historically useful but no longer a strong barrier |
| Folate formulation |
Differentiating, but commercially narrow |
| Method-of-use claims |
Limited ability to prevent substitution |
| Manufacturing claims |
Potentially relevant to specific processes, not broad market control |
| Remaining exclusivity |
No material current exclusivity thesis |
| Litigation leverage |
Primarily historical |
| Generic entry risk |
High |
The estate may retain technical value for specific formulations or manufacturing routes, but that is different from having a durable blocking position over the U.S. market. For licensing or acquisition analysis, Beyaz should be valued as a mature commercial product, not as a patent-protected growth asset.
What generic launch scenarios exist for Beyaz?
Three launch scenarios are commercially plausible in a mature market:
Full-equivalent generic substitution
A generic containing drospirenone, ethinyl estradiol, and levomefolate calcium competes directly with Beyaz. This scenario produces the greatest pressure on brand volume and net price.
Partial substitution by Yaz-type generics
Patients are moved to generic drospirenone and ethinyl estradiol without folate. This expands the addressable low-cost competitive set and can reduce Beyaz demand even if direct three-component equivalents are limited.
Residual branded demand
Beyaz retains a small segment of prescribers or patients who prefer the branded product, have stable use, or face switching barriers. Residual demand typically supports a narrower and more expensive commercial channel but does not restore the original franchise economics.
How does Beyaz compare with competing contraceptive products?
Beyaz competes in a crowded market that includes generic combined oral contraceptives, progestin-only pills, long-acting reversible contraceptives, transdermal patches, vaginal rings, and emergency contraception.
Its relative advantages are the familiar drospirenone profile, the 24/4 regimen, and folate inclusion. Its disadvantages are the need for daily adherence, estrogen-related contraindications, generic price competition, and limited differentiation from lower-cost alternatives.
Long-acting reversible contraceptives create a separate competitive pressure. Products such as hormonal intrauterine systems and implants have different clinical profiles and higher upfront costs, but they reduce daily adherence burden and can receive strong payer and provider support.
What manufacturing and geographic barriers affect Beyaz?
Beyaz manufacturing requires control of a low-dose steroid combination and uniform distribution of the active ingredients. The product also requires reliable sourcing of levomefolate calcium and validated stability performance across the tablet’s shelf life.
These requirements create quality and supply-chain obligations, but they are not strong market-entry barriers for large generic manufacturers. Generic competition can use independent facilities, alternate excipients, and approved manufacturing processes if the final product meets FDA standards.
Geographically, the strongest commercial erosion has occurred in regulated markets with established generic substitution systems. U.S. value depends on Orange Book-listed patents, ANDA approvals, payer policies, and state pharmacy-substitution rules. European and other international markets have separate patent, reimbursement, and product-registration histories. U.S. exclusivity data should not be treated as a worldwide market-rights assessment.
What licensing deals affect Beyaz?
No major current licensing transaction is broadly associated with Beyaz’s commercial value. The product was developed and marketed within Bayer’s women’s-health franchise rather than as a major externally licensed asset.
Historic collaborations, distribution arrangements, or local commercialization agreements may exist by country, but they do not change the central U.S. assessment: Beyaz is a mature product with limited remaining pricing power and no visible platform value comparable to a new molecular entity or protected biologic.
Key Takeaways
- Beyaz is Bayer’s folate-containing extension of the Yaz contraceptive franchise.
- FDA approval occurred in 2010 under NDA 022676.
- Core patent and regulatory exclusivity have expired or no longer provide meaningful commercial protection.
- Generic competition is the principal market force.
- Direct three-component generics and indirect substitution by generic Yaz-type products both pressure sales.
- Bayer does not disclose standalone Beyaz revenue, so exact product-level financial exposure cannot be quantified from public filings.
- Biosimilar risk does not apply because Beyaz is a small-molecule oral drug.
- Current patent strength is weak from a blocking-rights perspective.
- The product’s likely financial profile is residual branded revenue, low strategic priority, and continued price erosion.
FAQs
Is Beyaz still available in the United States?
Beyaz has limited commercial relevance in the United States because generic products compete with the same or similar drospirenone-based formulations. FDA product records and current National Drug Code listings determine whether a specific branded presentation is actively marketed.
What is the generic name for Beyaz?
The generic description is drospirenone, ethinyl estradiol, and levomefolate calcium tablets. Generic products may differ in inactive ingredients, packaging, manufacturer, and commercial availability.
Does Beyaz have an Orange Book patent?
Beyaz’s historic protection involved formulation, regimen, and related patent claims. Those protections no longer support a meaningful current exclusivity position against generic competition. The FDA Orange Book remains the authoritative source for any product-specific listed patent.
Is Beyaz a biologic or does it face biosimilar competition?
No. Beyaz is a synthetic small-molecule oral contraceptive. Competition proceeds through generic drug applications, not biosimilar applications.
Why did Bayer develop Beyaz instead of continuing with Yaz?
Beyaz extended the Yaz franchise by combining the same principal hormonal regimen with levomefolate calcium. The strategy aimed to create product differentiation and preserve branded value as earlier drospirenone contraceptive patents approached expiration.
References
- U.S. Food and Drug Administration. (2010). Beyaz prescribing information, NDA 022676.
- U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
- Bayer AG. (2023). Annual report 2023. Leverkusen, Germany: Bayer AG.
