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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 two 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:	8
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
Japan	5675759
Uruguay	27088	COMPOSICIONES DE COMPLEJOS DE ESTRÓGENO-CICLODEXTRINA
Japan	2009102424	COMPOSITIONS OF ESTROGEN-CYCLODEXTRINS COMPLEXES
Switzerland	693905	Stabile kristalline Salze von 5-Methyltetrahydrofolsäure.
Portugal	2189459

Supplementary Protection Certificates for SAFYRAL

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

SAFYRAL Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for the Drug: Safyral

Introduction

Safyral, a combined oral contraceptive (COC) developed by Bayer AG, is a significant player in the global contraceptive pills market. Understanding the market dynamics and financial trajectory of Safyral is crucial for stakeholders, including investors, pharmaceutical companies, and healthcare providers.

Global Contraceptive Pills Market Overview

The global contraceptive pills market is projected to grow significantly, with a market size expected to reach USD 29.04 billion by 2032, exhibiting a CAGR of 5.9% from 2019 to 2032[1].

Market Segmentation and Distribution

The market is segmented based on end-users, including hospital pharmacies, retail pharmacies, clinics, online channels, public channels & NGOs, and others. Retail pharmacies accounted for the highest market share in 2018, driven by the rising sales of over-the-counter (OTC) contraceptives and improved distribution networks of key companies[1].

Key Players and Market Share

Bayer AG and Allergan plc are the top players in the contraceptive pills market, with Bayer AG being a major stakeholder due to its brand Safyral. However, the market is somewhat fragmented, with numerous local and regional players operating globally[1].

Generic Competition

The approval of generic versions of Safyral, such as Tydemy by Lupin, which is a generic version of Safyral, can impact Bayer AG's market position. Generic drugs are becoming increasingly popular due to their cost-effectiveness, which could challenge the market share of branded drugs like Safyral[1][4].

Regional Growth

The Asia Pacific region is anticipated to be the fastest-growing market due to government initiatives for population control and the emergence of non-profit organizations spreading awareness about birth control methods. Latin America and the Middle East & Africa are also growing due to increasing penetration of pharmaceutical giants and rising literacy rates[1].

Financial Performance and Capitalization

The financial performance of pharmaceutical companies, including those producing contraceptive pills like Safyral, can be significantly influenced by media coverage of drug prices. Research has shown that media scrutiny on drug price increases can impact the financial outcomes of pharmaceutical companies, affecting their net margin, return on research capital, return on equity, and market capitalization[3].

Impact of Media Coverage

Media coverage of drug prices can lead to public backlash, which may reduce the stock value of pharmaceutical companies. For instance, significant media scrutiny on drug price rises has led to increased skepticism about the financial outcomes of these companies, despite expectations that price increases would improve their financial performance[3].

Regulatory and Public Health Factors

Government policies and public health initiatives play a crucial role in the market dynamics of contraceptive pills. For example, public health centers in countries like Turkey provide free contraceptive supplies, which can affect the demand and accessibility of drugs like Safyral[1].

Clinical Benefits and Side Effects

Safyral, like other COCs, has several clinical benefits but also comes with potential side effects. It is essential to monitor patients for thromboembolic disorders, gallbladder disease, carbohydrate and lipid metabolic effects, and other vascular problems. These factors can influence patient adherence and overall market demand[5].

Online Channels and Distribution

The online channel segment is expected to register the highest CAGR during the forecast period due to increased investment by key companies to establish a strong presence on online pharmacy platforms. This trend is particularly significant in developed regions and can impact the distribution and sales of Safyral[1].

Market Trends

Adoption of contraceptive pills in both urban and rural areas, along with initiatives by public and private players to improve sex education, are key trends driving the market. The rising prevalence of unintended pregnancies and government participation in spreading awareness about contraception also contribute to the market growth[1].

Capacity Constraints and Supply Chain

Capacity constraints at manufacturing sites, such as those experienced by Bayer and Pfizer between June and August 2019, can affect the stock and availability of drugs like Safyral. This can open opportunities for local and regional manufacturers to fill the gap in the market[1].

Financial Projections

Given the overall growth of the contraceptive pills market, Safyral is likely to continue generating significant revenue for Bayer AG. However, the impact of generic competition, media scrutiny on drug prices, and capacity constraints will need to be carefully managed to maintain market share and financial performance.

Key Takeaways

• The global contraceptive pills market is projected to reach USD 29.04 billion by 2032.
• Retail pharmacies and online channels are key distribution segments.
• Bayer AG and Allergan plc are major players, but generic competition is increasing.
• Media coverage of drug prices can significantly impact financial performance.
• Government policies and public health initiatives influence market dynamics.
• Clinical benefits and side effects of Safyral must be carefully managed.
• Online channels are expected to grow significantly.

FAQs

What is the projected market size for the global contraceptive pills market by 2032?

The global contraceptive pills market is projected to reach USD 29.04 billion by 2032, exhibiting a CAGR of 5.9% from 2019 to 2032[1].

Who are the key players in the contraceptive pills market?

Bayer AG and Allergan plc are the top players in the market, with Bayer AG being a major stakeholder due to its brand Safyral[1].

How does generic competition affect the market share of Safyral?

The approval of generic versions of Safyral can impact Bayer AG's market position, as generic drugs are becoming increasingly popular due to their cost-effectiveness[1][4].

What role does media coverage play in the financial performance of pharmaceutical companies?

Media coverage of drug prices can significantly impact the financial outcomes of pharmaceutical companies, affecting their net margin, return on research capital, return on equity, and market capitalization[3].

How do government policies influence the market dynamics of contraceptive pills?

Government policies and public health initiatives, such as providing free contraceptive supplies, can affect the demand and accessibility of drugs like Safyral[1].

What are the potential side effects of Safyral that could influence market demand?

Safyral has potential side effects including thromboembolic disorders, gallbladder disease, carbohydrate and lipid metabolic effects, and other vascular problems, which must be carefully monitored[5].

Sources

1. Fortune Business Insights, Contraceptive Pills Market Size, Share & Growth | Global Report, 2032.
2. United Nations Office on Drugs and Crime, Illicit Financial Flows - United Nations Office on Drugs and Crime.
3. ScholarWorks at Walden University, Relationship Over Time Between Drug Price News and U.S. Pharmaceutical Companies’ Financial Results.
4. Visiongain, Generic Drugs Market Report 2020-2030.
5. FDA, Safyral - accessdata.fda.gov.