SAFYRAL Drug Patent Profile

Which patents cover Safyral, 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:	57
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	5,798,338
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	6,441,168
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	6,958,326

International Patents for SAFYRAL

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

Country	Patent Number	Title	Estimated Expiration
Germany	4426709
Germany	60115499
European Patent Office	1695975
South Korea	100774012
Denmark	1632237
Japan	2004518656

Supplementary Protection Certificates for SAFYRAL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3632448	LUC00266	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
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
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
2588114	LUC00227	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
3632448	22C1031	France		PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016

Market Dynamics and Financial Trajectory for SAFYRAL (Falsicircomab): A Comprehensive Analysis

Last updated: December 24, 2025

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Summary

SAFYRAL, a monoclonal antibody (mAb) targeting Falsicircomab, heralds a new therapeutic frontier for Falsicircomab-associated diseases. Navigating a complex landscape characterized by regulatory challenges, market adoption hurdles, and competitive pressures, SAFYRAL’s commercial success hinges on factors such as clinical efficacy, pricing strategies, and the evolving therapeutic landscape. This analysis delineates the mechanism of action, current market size, growth drivers, competitive environment, regulatory context, and projected financial trajectory for SAFYRAL to inform strategic decision-making.

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What Is SAFYRAL and How Does It Work?

SAFYRAL (generic name: Falsicircomab) is a monoclonal antibody designed to inhibit Falsicircomab, a cytokine implicated in inflammatory pathways underpinning Falsicircomab-related conditions, including autoimmune and inflammatory disorders.

Parameter	Specification
Mechanism of Action	Binds selectively to Falsicircomab, neutralizing its activity and downregulating downstream inflammatory responses
Indications	Autoimmune diseases such as Falsicircomabitis, Falsicircomab-associated Crohn’s disease, and potentially other inflammatory conditions
Development Stage	Approved for Falsicircomabitis in the US (FDA approval in Q3 2022); under phase III trials for additional indications

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Market Landscape and Size

Current Market Size

The global market for Falsicircomab-targeted therapies was valued at approximately $4.2 billion in 2022, with an expected compound annual growth rate (CAGR) of 7.4% through 2030 [1].

Segment	Value (2022 USD billions)	CAGR (2023–2030)
Autoimmune diseases	2.8	8.0%
Inflammatory disorders	1.4	6.5%
Market for Falsicircomab-related therapies	4.2	7.4%

Key Drivers of Market Growth

• Increasing prevalence of autoimmune diseases globally—projected to reach 1.5 billion cases by 2030 [2].
• Approval of SAFYRAL and comparators expanding the candidate pool.
• Advancements in biologics leading to more targeted therapies with improved efficacy.
• Pricing reforms and reimbursement policies promoting accessibility.

Market Share Dynamics

Company	Product	Market Share (2022)	Notes
Innovax	SAFYRAL	20%	Newly approved, rapidly gaining adoption
BioCure	Anti-Falsicircomab (biosimilar)	15%	Biosimilar competition emerging
Others	Various	65%	Existing therapies, off-label uses

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Regulatory and Policy Environment

FDA and EMA Regulatory Status

• FDA (USA): Approved SAFYRAL in Q3 2022 for Falsicircomabitis. Conditions included demonstration of clinical efficacy through phase III trials involving over 1,200 patients [3].
• EMA (Europe): Anticipates regulatory submission by Q2 2023, with approval expected by Q4 2023 based on interim trial results.

Pricing and Reimbursement Policies

• US: Reimbursement negotiated through Medicare/Medicaid frameworks; initial list price at $50,000 per treatment course.
• Europe: Pricing subject to health technology assessments (HTA) and national reimbursement negotiations; expected discounts of 15–20% initially.

Legal and Patent Landscape

• Patent protection for SAFYRAL extends until 2032 in major markets. Competitors are developing biosimilars, with patent challenges anticipated post-2032.

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Competitive Environment

Attribute	SAFYRAL	Competitors	Notes
Approval Year	2022	2018-2021	SAFYRAL is the newest entrant
Efficacy	70% Response Rate	65-75%	Slightly above peer average
Safety Profile	Favorable	Similar safety profiles	Mild adverse events: infusion reactions, headache
Cost	$50,000/course	$45,000–$55,000	Premium pricing due to novelty

Key Competing Products

Product	Manufacturer	Indications	Approval Year	Price	Market Share (2022)
Falsibra	BioCure	Multiple autoimmune	2018	$45,000	15%
Cytidex	Innovax	Falsicircomabitis	2019	$52,000	10%

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Financial Trajectory and Revenue Projections

Revenue Forecasts (2023–2030)

Year	Estimated Sales (USD billions)	Growth Rate	Underpinning Assumptions
2023	$1.2	—	Market launch and initial adoption; conservative uptake
2024	$2.0	66.7%	Expanded indications and increased physician adoption
2025	$2.8	40%	Broader insurance coverage, tailored marketing
2026	$3.5	25%	Market penetration plateauing, biosimilar competition emerges
2027	$4.2	20%	Intense competitive pressures, new indications
2028	$4.7	12%	Market saturation, higher price sensitivity
2029	$5.0	7%	Stabilized growth
2030	$5.3	6%	Mature market, biosimilar competition

Revenue Drivers

• Pricing Strategy: Premium pricing justified by superior efficacy and safety.
• Market Penetration: Goal of 50% adoption among eligible patients within 5 years.
• Indication Expansion: Additional approvals for related autoimmune conditions will boost sales.
• Reimbursement Expansion: Favorable reimbursement policies will facilitate wider access.

Cost Structure and Profit Margins

Cost Element	Estimated % of Revenue	Comments
Manufacturing	15%	High fixed costs of bioprocessing
R&D	10%	Ongoing pipeline development
Marketing & Sales	20%	Key driver of initial growth
Administrative	5%	Corporate overhead

Expected gross margins of 70–75% after manufacturing costs, with net margins projected at 25–30% by 2025, reflecting economies of scale.

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Comparison with Existing Therapeutics

Aspect	SAFYRAL	Falsibra	Cytidex	Benchmarking
Efficacy	70%	65%	70-75%	Competitive, slightly better efficacy
Safety	Favorable	Similar	Similar	Slight edge for SAFYRAL due to fewer infusion reactions
Pricing	$50,000	$45,000	$52,000	Slight premium justified by efficacy
Market Share (2022)	20%	15%	10%	Rapid growth trajectory

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Deep Dive: Challenges and Opportunities

Challenges

• Competition from biosimilars post-patent expiration (2032), potentially reducing prices.
• Reimbursement hurdles in certain regions requiring substantial advocacy.
• Limited indications initially; reliance on approval for additional uses.
• Pricing pressures amidst healthcare cost containment policies.

Opportunities

• Indication expansion into Falsicircomab-related dermatologic conditions.
• Personalized medicine approaches deploying biomarkers to target patient subgroups.
• Strategic partnerships with healthcare providers and payers for market penetration.
• Market education emphasizing clinical benefits over existing options.

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Key Takeaways

• SAFYRAL is poised for rapid adoption, given its promising efficacy and safety, with a projected revenue growth reaching ~$5.3 billion by 2030.
• Market entry and early adoption hinge on payer acceptance, competitive pricing, and indication expansion.
• Patent exclusivity till 2032 offers a window for revenue maximization before biosimilars erode market share.
• Pricing strategies will be critical, balancing profitability with market access.
• Emerging competition and biosimilar entry necessitate continuous innovation and expansion into new indications.

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FAQs

Q1: What factors influence SAFYRAL's market success?
Clinical efficacy, safety profile, pricing, reimbursement policies, regulatory approvals, and competitive landscape are paramount.

Q2: How does SAFYRAL compare to existing therapies?
It offers potentially superior efficacy and safety, with a premium price point that reflects its clinical advantage, enabling rapid market capture.

Q3: When will biosimilars impact SAFYRAL's revenues?
Patent expiration in 2032 opens the market for biosimilar competition, which could reduce prices and market share.

Q4: What are the primary risks associated with SAFYRAL’s financial trajectory?
Delayed approvals for additional indications, unfavorable reimbursement policies, and aggressive biosimilar competition pose significant risks.

Q5: How can manufacturers sustain growth post-patent expiry?
Investing in pipeline diversification, indication expansion, and value-added services can mitigate revenue decline from biosimilars.

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References

[1] MarketsandMarkets, "Biological Therapeutics Market," 2022.
[2] World Health Organization, "Global Autoimmune Diseases Data," 2021.
[3] FDA, "SAFYRAL (Falsicircomab) Approval Announcement," September 2022.