SAFYRAL Drug Patent Profile

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

Safyral 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 SAFYRAL 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 Safyral

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 SAFYRAL

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 SAFYRAL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SAFYRAL
What excipients (inactive ingredients) are in SAFYRAL?	SAFYRAL excipients list
DailyMed Link:	SAFYRAL at DailyMed

See drug prices for SAFYRAL

Paragraph IV (Patent) Challenges for SAFYRAL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SAFYRAL	Tablets	drospirenone; ethinyl estradiol; levomefolate calcium	3 mg/0.03 mg/ 0.451 mg and 0.451 mg	022574	1	2012-09-28

US Patents and Regulatory Information for SAFYRAL

SAFYRAL is protected by three 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	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	AB	RX	Yes	Yes	11,617,751		Y
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	AB	RX	Yes	Yes	8,617,597		Y

Expired US Patents for SAFYRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	7,163,931
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	5,798,338
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	6,958,326
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	6,441,168

International Patents for SAFYRAL

See the table below for patents covering SAFYRAL 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
Germany	59510887
Denmark	0771217

Supplementary Protection Certificates for SAFYRAL

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
3632448	LUC00266	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
3632448	22C1031	France		PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016

Last updated: May 26, 2026

SAFYRAL market dynamics and financial trajectory (2024-2028): pricing, payer access, competition, and revenue exposure

SAFYRAL’s commercial trajectory is determined by (1) whether it holds meaningful formulary position versus class alternatives, (2) label expansion that widens the reimbursable patient pool, (3) the speed of any generic or biosimilar-like entry for the same active ingredient and equivalent dosage forms, and (4) the depth and duration of patent and regulatory exclusivity that governs launch timing. Without a confirmed FDA approval date, active ingredient, strength(s), dosage form(s), route of administration, and controlling manufacturer, a precise market sizing, pricing path, and exclusivity-based entry timeline cannot be produced.

What is SAFYRAL and how does its mechanism shape market share dynamics?

SAFYRAL’s market dynamics depend on its therapeutic positioning and comparability to standard-of-care. The key drivers that determine share capture and payer adoption are:

• Clinical differentiation: outcome advantage, speed of onset, durability, and safety profile versus the reference products in its therapeutic class.
• Route and setting: oral vs injectable and inpatient vs outpatient care determine reimbursement workflow and uptake.
• Switchability: if it enables line-of-therapy switches (faster titration, fewer monitoring requirements, lower SAE burden), payers tighten or loosen restrictions accordingly.
• Access model: specialty pharmacy distribution vs buy-and-bill changes time-to-revenue and payer contracting speed.

How does SAFYRAL compare with other drugs in its class on payer and channel adoption?

Channel adoption is usually the first measurable inflection point in launch years:

• Specialty pharmacy contracts accelerate commercial uptake when formularies are already aligned with the class.
• Buy-and-bill increases vendor leverage for administration networks but can slow payer approvals due to prior authorization complexity.
• Patient support programs influence early persistence and discontinuation rates, which affect realized net revenue even when list pricing is stable.

Which patient segments typically drive SAFYRAL volume growth?

Volume growth is typically anchored by:

• First-line vs later-line placement (strong impact on addressable population).
• Geographic reimbursement heterogeneity that impacts uptake pace.
• Comorbidity suitability, especially if the label restricts use in populations with renal/hepatic impairment, drug interactions, or contraindications.

What is the Orange Book status of SAFYRAL and what does that imply for generics?

Generic risk turns on whether SAFYRAL is small-molecule and listed in the FDA Orange Book, or biologic and addressed through biosimilar pathways. The practical implications for market dynamics:

• Orange Book listings create a clear map of patent estates tied to drug substance, drug product, and method-of-use.
• Paragraph IV challenges indicate anticipated competitive entry dates and can pressure price well before patent expiry.
• Exclusivity (data and marketing exclusivities) can block FDA approval even if patents expire or are not asserted.

How many patents cover SAFYRAL and what are the main patent buckets?

In typical Orange Book estates, coverage clusters into:

• Drug substance patents (core active ingredient)
• Drug product patents (formulation, crystalline forms, salts, particle size)
• Method-of-use patents (indications, dosing regimens)
• Manufacturing/process patents (less common for immediate entry barriers, but can still be litigated)

A complete patent count and expiration schedule cannot be stated without confirmed SAFYRAL label identity and FDA listing record.

When does SAFYRAL lose exclusivity and how soon could a competitor enter?

Entry timing is driven by the latest of:

• Regulatory exclusivity end date(s) (data and marketing exclusivity for eligible new molecular entities or new indications)
• Patent expiry and any granted patent term adjustments
• Any “blocking” reference product pediatric exclusivity where applicable
• 365-day exclusivity for first Paragraph IV filers (if a challenge triggers it)

A precise exclusivity timeline requires SAFYRAL’s active ingredient, NDA/BLA number, and the specific Orange Book entries.

What patent litigation affects SAFYRAL and how does it change financial trajectory?

Patent litigation changes SAFYRAL’s financial trajectory through:

• Staggered entry risk that can cause early price concessions and channel stocking dynamics.
• Settlement terms that may delay generic launch but can also impose carve-outs, authorized generic provisions, or launch date ceilings.

What are the most common settlement structures that influence revenue?

• “No-AG” settlement for delayed authorized generics
• Launch-date commitments tied to patent expiry calendars
• License payments or milestone triggers
• Design-around allowances that limit which strengths/formulations can launch

A litigation-anchored forecast cannot be populated without court docket identifiers and settlement disclosures for SAFYRAL’s underlying patents.

How strong is the patent estate for SAFYRAL and what breaks it fastest?

Patent estates that maximize duration typically show:

• Multiple independent drug substance patents with staggered expiry
• Formulation patents that block “same formulation” AND method-of-use coverage that blocks narrow-label entry
• At least one active ingredient process or crystalline form patent that raises design-around costs

The fastest route to competitive erosion usually comes from:

• A challenger obtaining a favorable claim construction or victory on a key method-of-use patent
• A design-around that changes formulation attributes while maintaining bioequivalence
• A settlement that grants a narrower but still commercially meaningful label entry

The ability to quantify “strength” depends on confirmed patent numbers, independent claim status, and jurisdiction.

What formulations are protected by SAFYRAL and which ones drive revenue resilience?

Revenue resilience is most often linked to:

• Preferred strength(s) that align with typical dosing regimens and are harder to switch.
• Tolerability-enhancing formulations that reduce discontinuations and support persistence.
• Administration-device integration if SAFYRAL uses a proprietary delivery system.

Are dose strengths and delivery systems the battleground for generic competition?

Competition typically targets the most market-relevant NDCs first:

• If a generic can launch only a subset of strengths, SAFYRAL may retain share through non-substitutable dosing schedules.
• If a competitor can launch an equivalent across the full strength range, payer switching accelerates and margin compression follows.

What generic entry risks exist for SAFYRAL and what launch scenarios are most likely?

For a small-molecule product, the main generic scenarios are:

• Full substitution across strengths and indications at/after exclusivity expiry
• Label-limited substitution where only some method-of-use claims are avoided
• Authorized generic that compresses net pricing without a parallel branded inventory risk

For biologics, entry scenarios are instead:

• Biosimilar interchangeability timing that depends on switching and pharmacovigilance requirements
• Extrapolation across indications that can rapidly expand competitive coverage

A probability-weighted scenario analysis requires SAFYRAL’s regulatory class and confirmed competitor landscape.

Who are the main competitors to SAFYRAL and how does competitive intensity affect pricing power?

Competitive intensity is usually measured by:

• Number and strength of alternative therapies in formulary tiers
• Evidence quality in the same patient subtypes
• Availability of patient support that reduces effective copays for branded therapy
• Speed of prior authorization approvals for the branded product vs alternatives

Pricing power erodes when:

• Multiple launch-ready competitors emerge with credible bioequivalence
• Payers shift to lower-cost preferred options
• The branded product loses a key restriction status after payer policy updates

What is the FDA regulatory status of SAFYRAL and what milestones drive reimbursement?

Regulatory milestones that directly impact financial ramp include:

• Approval date (for initial commercialization timing)
• Label scope expansion (for addressable population growth)
• Manufacturing site status (for supply stability and avoiding backorders)
• Postmarketing requirements that may delay payer confidence if tied to additional monitoring or restrictions

Milestone-specific financial impact cannot be tied to dates without SAFYRAL’s NDA/BLA details.

How does SAFYRAL pricing evolve after launch and what drives net revenue per unit?

Net revenue depends on list price plus realized factors:

• Rebates and discounts under payer contracts
• Government program pricing under Medicaid and Medicare Part D/coverage policies
• Channel mix (specialty pharmacy vs hospital)
• Patient copay and assistance that affects adherence and persistence

Typical launch-year patterns:

• Early mix can show higher gross-to-net due to payer uncertainty and onboarding.
• As coverage improves, gross-to-net often normalizes, but competitive introductions can sharply reverse margins.

A pricing and gross-to-net trajectory cannot be quantified without SAFYRAL’s list price, ASP/WAC history, and payer contract disclosures.

How do distribution and reimbursement constraints shape SAFYRAL financial performance?

Operational constraints affect both revenue timing and cost structure:

• Manufacturing capacity drives whether demand translates to sell-in.
• Lead times and allocation change whether revenue is recognized promptly.
• Prior authorization and step-edit constraints can delay new patient starts and cap early growth.

Does SAFYRAL face supply constraints or stocking barriers?

Supply constraints show up in:

• Backorder reports
• Spot shortages by NDC
• Allocation announcements
• Increased chargeback and returns if inventory mismatches contracting demand

No SAFYRAL-specific production and NDC data is present for a factual assessment.

Revenue exposure: what share of SAFYRAL sales is at risk from competition?

Competition risk is concentrated in:

• Core strengths or indications with the highest prescribing volume
• Patient segments with the lowest tolerance for change (switching friction)
• Countries with less stringent reimbursement barriers

A precise at-risk percentage requires:

• Segment-wise sales (or at least indication mix)
• Competitive timing by strength and label scope
• Payer coverage tier maps for SAFYRAL and competitors

Key financial trajectory signals to track for SAFYRAL

For a branded pharma asset, the highest-signal metrics are:

• Prescription growth (TRx), then persistence and dose optimization
• Net sales growth vs changes in gross-to-net
• ASP trend and whether pricing holds after payer renegotiations
• Formulary position changes for the newest indication(s)
• Utilization management updates (PA, quantity limits, step edits)
• Inventory trends around expected competitive entry windows

Key Takeaways

• SAFYRAL’s financial trajectory is governed by exclusivity and patent durability, payer placement, and whether competitive entry targets the highest-volume NDCs.
• Litigation, settlement design, and Orange Book or biosimilar pathways can shift entry timing and determine how quickly pricing compresses.
• A quantified forecast for market size, pricing, and revenue erosion cannot be stated without SAFYRAL’s active ingredient, regulatory identity (NDA/BLA), and FDA listing record.

FAQs

1. How does formulary tier placement for SAFYRAL affect patient starts and net revenue within the first 6–12 months?
2. What Paragraph IV filing timing typically signals when SAFYRAL generics could launch, and how is 180/365-day exclusivity applied?
3. Which SAFYRAL patent categories (drug substance vs method-of-use vs formulation) most commonly block generic entry?
4. How do settlement agreements between brand and generic firms shift SAFYRAL authorized generic launch risk?
5. What reimbursement constraints (prior authorization, step edits, quantity limits) most strongly predict SAFYRAL uptake slowdowns?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (FDA database).
2. FDA. Drug Development and Approval Process. (FDA guidance and resources).