BEYAZ Drug Patent Profile

When do Beyaz patents expire, and what generic alternatives are available?

Beyaz is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in BEYAZ is drospirenone; ethinyl estradiol; levomefolate calcium. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.

DrugPatentWatch^® Generic Entry Outlook for Beyaz

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BEYAZ

US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	66
Drug Prices:	Drug price information for BEYAZ
Drug Sales Revenues:	Drug sales revenues for BEYAZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BEYAZ
What excipients (inactive ingredients) are in BEYAZ?	BEYAZ excipients list
DailyMed Link:	BEYAZ at DailyMed

See drug prices for BEYAZ

See drug sales revenues for BEYAZ

Paragraph IV (Patent) Challenges for BEYAZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BEYAZ	Tablets	drospirenone; ethinyl estradiol; levomefolate calcium	3 mg/0.02 mg/ 0.451 mg and 0.451 mg	022532	1	2012-11-13

US Patents and Regulatory Information for BEYAZ

BEYAZ is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	AB	RX	Yes	Yes			Y
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	AB	RX	Yes	Yes			Y

Expired US Patents for BEYAZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010

International Patents for BEYAZ

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

Country	Patent Number	Title	Estimated Expiration
Austria	263578
Canada	2194979	FORMES DE MEDICAMENTS SOLIDES CONTENANT DES CLATHRATES D'HORMONES SEXUELLES STEROIDIENNES (SOLID DRUG FORMS CONTAINING CLATHRATES OF STEROID SEX HORMONES)
Germany	122007000011
Germany	122007000013
Germany	4426709

Supplementary Protection Certificates for BEYAZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
2588114	LUC00227	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022

Last updated: June 5, 2026

BEYAZ (drospirenone/ethinyl estradiol/levomefolate): Market dynamics and financial trajectory for sales, payor behavior, and competitive pressure

BEYAZ (drospirenone 3 mg / ethinyl estradiol 0.02 mg / levomefolate 0.451 mg; oral contraceptive) remains a mature, low-growth women’s health asset in a crowded oral contraceptive market. Its commercial trajectory is shaped by (1) steady unit demand tied to contraception use, (2) payer preference for lower-cost generics and other branded OCs, and (3) competitive substitution among “24/7” and shortened-cycle regimens, plus pharmacist-led interchange. In mature branded OCs, revenue typically tracks prescriptions more than price, with profitability constrained by copay pressure and channel contracting.

No market and financial dataset is provided here (e.g., U.S. IMS/NPD sales, wholesale acquisition cost changes, payer mix, prescription counts, or company segment reporting). Without those inputs, a complete, quantified financial trajectory cannot be produced.

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What is the US market dynamic for BEYAZ and branded oral contraceptives in 2026?

Featured snippet: Branded oral contraceptives compete primarily on formulary placement and copay design, with substitution risk highest when comparable generics and therapeutically equivalent branded products are favored by payers.

Key demand drivers for oral contraceptives

• Prescriber baseline: OCs are chronic, long-duration therapies with repeat prescribing patterns; switching is driven by side-effect profile, convenience, and formulary access.
• Patient adherence: Daily dosing increases adherence stakes; regimen tolerability affects continuation and reduces churn.
• Clinical differentiation: BEYAZ’s differentiation is the inclusion of levomefolate alongside drospirenone/EE, but payer decisions still often hinge on cost and therapeutic equivalence.

Key commercial friction points for BEYAZ

• Generic substitution: Even when an OC brand has a differentiated regimen, payers increasingly prefer lower-cost options and may require prior authorization or apply high member cost sharing to branded products.
• Copay and PBM contracting: Brand revenues in OCs are sensitive to rebates and formulary tiering; a shift in tier placement can move demand quickly.
• Pharmacy interchange: In most states, pharmacists can interchange generics; for branded-to-branded switching, plan design and pharmacy benefit rules still influence dispensing.

Competitive set (category-level)

BEYAZ sits within the broader drospirenone-containing combined oral contraceptives and the general OC marketplace. Commercial impact is dominated by:

• Lower-cost drospirenone/EE generics (where available and preferred by formularies)
• Other branded OCs with favorable access terms
• Payer preference for widely used molecules/regimens, especially where plan formularies are optimized for cost

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Which competitors most influence BEYAZ prescription volume and net pricing?

Featured snippet: Competitive pressure for BEYAZ is driven less by head-to-head superiority and more by formulary access versus lower-cost generics and alternative branded OCs.

Where BEYAZ loses demand

• First-line payer preference for generics when therapeutic interchange is acceptable.
• Plan switching programs that encourage step edits, then switch to preferred alternatives.
• Channel buying behavior that can reduce brand inventory placement and promotional intensity for non-top-tier brands.

Where BEYAZ can hold share

• Patients stabilized on BEYAZ who face fewer barriers if their plan covers it without restrictive edits.
• Physician preference where levomefolate is part of the prescribing rationale and access is maintained.
• Short-term continuity after an initial fill, before a plan’s next formulary cycle re-rates coverage.

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How do payers structure coverage for oral contraceptives, and what does that do to BEYAZ margins?

Featured snippet: PBMs typically manage OCs through formularies, tiering, and utilization controls, which govern patient out-of-pocket and brand net pricing.

Common plan design levers

• Formulary tier placement: Preferred tier reduces patient copays, improving persistence.
• Prior authorization (PA): Can restrict branded access if generics or preferred alternatives exist.
• Step therapy: Requires trial of a preferred drug before the brand is covered.
• Quantity and days-supply rules: Can affect continuity and refill behavior.

Margin implications for branded OCs

• Rebate intensity: Brands typically fund rebates to maintain tier status; if tier status slips, incremental rebate spending may not fully recover demand.
• Net price volatility: Even with stable wholesale list prices, net revenue can swing with PBM contract renewals.
• Mix shift risk: If plan design changes drive more patients to generics or lower-cost brands, revenue declines faster than units.

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When do BEYAZ exclusivity risks peak, and how does that affect competitive entry?

Featured snippet: In mature branded OCs, exclusivity and IP barriers affect entry timing more than innovation; competitive substitution often accelerates around the release of authorized competitors and formulary rollovers.

Exclusivity and entry mechanics that matter commercially

• Patent expiration and generic launch: If any relevant exclusivities or patents are near expiration, generic entry risk rises and prescriber behavior shifts.
• Switching after entry: After generic launches, PBM formularies tend to move the brand down a tier.
• Contracting response: Brand manufacturers may counter with rebate increases, but this usually increases the risk of margin compression.

Data required for a precise timeline is not included in the prompt, so a date-level entry map cannot be generated here.

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What is the FDA/regulatory status of BEYAZ and how does that shape market access?

Featured snippet: FDA approval for combined OCs establishes therapeutic labeling, but market access is governed by PBM contracting, not regulatory status alone.

Regulatory elements that influence commercial use

• Approved dosing and regimen: Drives prescribing fit and substitution decisions.
• Safety labeling and contraindications: Constrains who can be prescribed the product and influences switching when alternatives have similar safety profiles.
• Bioequivalence framework (for generics): Once a generic is approved, substitution becomes administratively easy and payer-friendly.

A required Orange Book listing extraction and current FDA approval/abbreviated approval map are not provided in the prompt, so a full Orange Book status summary cannot be produced.

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What is the financial trajectory of BEYAZ: revenue drivers, headwinds, and investor-relevant KPIs?

Featured snippet: For mature branded oral contraceptives, the financial trajectory usually tracks net prescription volume and net pricing after rebates more than growth in brand awareness.

Revenue drivers to monitor for BEYAZ

• New starts and continuation rates (quarterly prescription trends)
• Net price trends driven by PBM contracts and rebate schedules
• Formulary tier movement (preferred vs non-preferred)
• Persistence after generic entry (switching rates by plan type)

KPIs investors track in OCs

• Gross-to-net erosion: Rebates and discounts as a percentage of gross sales
• Channel inventory behavior: Whether pharmacies and wholesalers increase or reduce ordering
• Share shift: Net share versus competing drospirenone OCs and preferred generics

Typical financial pattern in mature OCs

• Early branded growth: Higher share and pricing power.
• Mid-life stabilization: Demand stabilizes, but growth remains modest.
• Late-life decline risk: Margin compression from formulary erosion and generic substitution.

Quantified revenue trajectory cannot be stated without sales and financial reporting inputs.

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How does BEYAZ pricing power compare with other combined oral contraceptives?

Featured snippet: Branded OC pricing power is constrained by therapeutic equivalence; net pricing is determined by formulary access, rebates, and patient copay behavior.

Where pricing power is strongest

• Protected niche access via payer contracts that keep BEYAZ on preferred tiers.
• Reduced switching due to physician and patient stabilization.

Where pricing power collapses

• Plan redesign after PBM renegotiations that favor lowest-cost alternatives.
• Increased copay sensitivity leading to fewer brand fills.

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What generic entry risks exist for BEYAZ, and how would they impact revenue?

Featured snippet: Generic entry typically triggers rapid formulary downgrade and net sales declines, with the pace dependent on PBM policy and patient switching.

Entry-risk transmission channels

• Step edits and PA requirements increase friction for brand use.
• Auto-substitution and interchange reduce brand dispensing for equivalent indications.
• Contract repricing: Brand manufacturers often reduce net price or increase rebates to defend share, compressing margins.

A determination of specific generic launch scenarios requires the Orange Book patent/exclusivity landscape and litigation timeline, which are not supplied in the prompt.

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Key Takeaways

• BEYAZ operates in a mature, highly substitutable women’s health category where formularies and rebate contracts drive net outcomes more than clinical differentiation.
• The principal commercial levers are payer tier placement, copay design, and switching pressure from generics and alternative branded OCs.
• Without sales, prescription, and contract data, a quantified financial trajectory for BEYAZ cannot be produced from the provided information.

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FAQs

1. How sensitive is BEYAZ to PBM formulary tier changes?
   Tier shifts typically change patient copays and brand share quickly, often producing faster unit declines than list price changes.

2. Does BEYAZ face higher switching risk than other branded OCs?
   Switching risk is driven by how payers treat the regimen clinically and by the availability of preferred lower-cost alternatives, not just by brand name recognition.

3. What are the main KPIs to track for BEYAZ performance?
   Prescription volume trends, gross-to-net margin erosion, formulary coverage, and patient persistence after plan changes.

4. How do generics affect branded oral contraceptive net sales?
   Generic launches usually trigger formulary downgrades and higher patient cost sharing for the brand, accelerating share loss.

5. What commercial actions do branded OC manufacturers use to defend share?
   Contracting/rebate redesign, copay programs, and utilization management negotiations (e.g., maintaining preferred status or reducing PA friction).

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References

No sources were provided in the prompt, and no external datasets (e.g., FDA Orange Book listings, PBM formulary analyses, or company financial filings) were included.