Drospirenone - Generic Drug Details

What are the generic drug sources for drospirenone and what is the scope of patent protection?

Drospirenone is the generic ingredient in twenty branded drugs marketed by Exeltis Usa Inc, Mayne Pharma, Bayer Hlthcare, Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Watson Labs, Xiromed, Sun Pharm, Aurobindo Pharma Ltd, Novast Labs, Lupin Ltd, Apotex, Dr Reddys Labs Sa, Naari Pte Ltd, and Watson Labs Inc, and is included in thirty-seven NDAs. There are twenty-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Drospirenone has sixty-nine patent family members in thirty-one countries.

There are eleven drug master file entries for drospirenone. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for drospirenone

International Patents:	69
US Patents:	23
Tradenames:	20
Applicants:	18
NDAs:	37
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	101
Patent Applications:	3,895
Drug Prices:	Drug price trends for drospirenone
Drug Sales Revenues:	Drug sales revenues for drospirenone
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for drospirenone
What excipients (inactive ingredients) are in drospirenone?	drospirenone excipients list
DailyMed Link:	drospirenone at DailyMed

See drug prices for drospirenone

See drug sales revenues for drospirenone

Recent Clinical Trials for drospirenone

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4
Eli Lilly and Company	Phase 1
Bristol-Myers Squibb	Phase 1

See all drospirenone clinical trials

Generic filers with tentative approvals for DROSPIRENONE

Applicant	Application No.	Strength	Dosage Form
		4MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for drospirenone

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for DROSPIRENONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SLYND	Tablets	drospirenone	4 mg	211367	1	2022-01-07

US Patents and Regulatory Information for drospirenone

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
Exeltis Usa Inc	DROSPIRENONE	drospirenone	TABLET, CHEWABLE;ORAL	216285-001	Jun 29, 2022		DISCN	Yes	No	11,478,487		Y
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	AB	RX	Yes	Yes	8,617,597		Y
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	AB	RX	Yes	Yes	8,617,597		Y
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes	11,964,055		Y

International Patents for drospirenone

Country	Patent Number	Title	Estimated Expiration
Slovenia	3632448
San Marino	T202000063
Chile	2012003685	Kit farmaceutico que comprende una o mas unidades de envasado que comprenden 21 a 28 unidades de dosificacion activas diarias en que cada una comprende por lo menos 2 mg de drosperidona, sin estrogernos; uso del kit y de una composicion farmaceutica que comprende drosperidona para preparar un medicamento util como anticonceptivo.
Portugal	3632448
San Marino	T202200129

Supplementary Protection Certificates for drospirenone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3632448	CA 2022 00016	Denmark		PRODUCT NAME: DROSPIRENON; NAT. REG. NO/DATE: 61678 20191016; FIRST REG. NO/DATE: DK 61678 20191016
3632448	LUC00266	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
3632448	C202230031	Spain		PRODUCT NAME: DROSPIRENONA; NATIONAL AUTHORISATION NUMBER: 84603-SE/H/1869/001/DC; DATE OF AUTHORISATION: 20191025; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SE/H/1809/001/DC; DATE OF FIRST AUTHORISATION IN EEA: 20191016
3632448	22C1031	France		PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016
3632448	301186	Netherlands		PRODUCT NAME: SLINDA; NATIONAL REGISTRATION NO/DATE: RVG 127386 20210317; FIRST REGISTRATION: DK 61678 20191022

Market Dynamics and Financial Trajectory for Drospirenone

Introduction to Drospirenone

Drospirenone is a synthetic progestin used in various contraceptive formulations, particularly in combination with ethinyl estradiol. It is known for its efficacy in preventing pregnancy and managing certain gynecological conditions.

Global Market Size and Growth

The global drospirenone market has been experiencing significant growth, driven by increasing demand for effective contraceptive methods and treatments for gynecological disorders. As of 2023, the global drospirenone market size was substantial, with a compound annual growth rate (CAGR) projected to be notable from 2024 to 2031[1][3].

Market Segmentation

The drospirenone market is segmented based on several factors, including type, application, and geography.

By Type

The market is segmented into different purity levels, with the Purity≥98% segment accounting for a significant share in 2023 and expected to continue growing[1].

By Application

Drospirenone is used in various applications, including contraceptive pills, particularly in combination with ethinyl estradiol. The drospirenone and ethinyl estradiol tablets segment is expected to expand significantly, retaining its position throughout the forecast period[1][3].

By Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own growth trajectory, with Asia-Pacific showing promising growth due to increasing healthcare demands and improving economic conditions[1][3].

Market Drivers

Several factors drive the growth of the drospirenone market:

Increasing Demand for Contraceptives

The global demand for effective and safe contraceptive methods is on the rise, driven by population growth and increasing awareness about family planning[3].

Technological Advancements

Advancements in pharmaceutical manufacturing and the development of high-quality chemicals are boosting the production and efficacy of drospirenone-based products[1].

Expanding End-Use Sectors

Drospirenone is used not only in contraceptives but also in treating gynecological conditions such as endometriosis and polycystic ovary syndrome (PCOS), expanding its market reach[2].

Market Restraints

Despite the growth, there are several restraints to consider:

Regulatory Challenges

Stringent regulatory requirements and the need for continuous clinical trials can slow down market growth and increase costs for manufacturers[3].

Side Effects and Safety Concerns

Drospirenone, like other hormonal contraceptives, can have side effects and safety concerns, which may deter some users and affect market growth[5].

Competitive Landscape

The drospirenone market is competitive, with several key players:

Major Players

Companies such as Bayer Pharma, Beijing Keyifeng Biology, Camber Pharmaceuticals, and Lupin Pharmaceuticals are prominent in the market. These companies are focusing on strengthening their product portfolios and expanding their global presence[1][3].

Market Strategies

Key strategies include product innovation, strategic partnerships, and expansion into new markets. For example, Bayer AG has been a leading player in the drospirenone market, continuously innovating and expanding its product line[3].

Financial Trajectory

The financial trajectory of the drospirenone market is positive, with significant growth projected over the next several years.

Revenue Projections

The market size of drospirenone and ethinyl estradiol tablets is expected to increase at a CAGR of 3 to 5 percent from 2023 to 2031, reaching a substantial valuation in USD million[3].

Regional Contributions

North America and Europe are currently significant contributors to the market revenue, but the Asia-Pacific region is expected to show rapid growth due to increasing healthcare spending and a large population base[1][3].

Market Trends and Opportunities

Several trends and opportunities are shaping the drospirenone market:

Online Sales and Distribution

The rise of online pharmacies and clinics is providing new distribution channels for drospirenone-based products, expanding their reach and accessibility[3].

Emerging Markets

Emerging markets in Asia and Latin America offer significant growth opportunities due to their large and growing populations and increasing healthcare needs[1].

Technological Innovations

Continuous technological innovations in pharmaceutical manufacturing are expected to improve the quality and efficacy of drospirenone products, further driving market growth[1].

Challenges and Opportunities in the Forecast Period

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the market. While it disrupted supply chains, it also increased the demand for telehealth services and online pharmacies, which benefited the market in some aspects[1].

Economic Factors

Economic stability and growth in various regions will play a crucial role in the market's financial trajectory. Regions with stable economies are likely to see higher growth rates in the drospirenone market[3].

Consumer Behavior Analysis

Consumer behavior is a critical factor in the drospirenone market. Increasing awareness about reproductive health and the importance of family planning are driving the demand for effective and safe contraceptive methods.

Quality and Safety

Consumers are increasingly looking for high-quality and safe products, which is driving the demand for purity levels such as Purity≥98%[1].

Convenience and Accessibility

The rise of online pharmacies and clinics has made drospirenone-based products more accessible, which is a significant factor in consumer preference[3].

Key Takeaways

• The global drospirenone market is expected to grow significantly from 2024 to 2031, driven by increasing demand for contraceptives and gynecological treatments.
• The market is segmented by type, application, and geography, with the Purity≥98% segment and drospirenone and ethinyl estradiol tablets being key segments.
• Technological advancements and expanding end-use sectors are major drivers of the market.
• Regulatory challenges and safety concerns are restraints that need to be addressed.
• The competitive landscape is dominated by key players like Bayer Pharma and Beijing Keyifeng Biology.
• The financial trajectory is positive, with significant revenue growth projected over the next several years.

FAQs

What is the projected CAGR for the drospirenone market from 2024 to 2031?

The projected CAGR for the drospirenone market from 2024 to 2031 is expected to be notable, though the exact percentage varies depending on the source[1][3].

Which segment of the drospirenone market is expected to grow the most?

The drospirenone and ethinyl estradiol tablets segment is expected to expand significantly and retain its position throughout the forecast period[1][3].

What are the major drivers of the drospirenone market?

Major drivers include increasing demand for contraceptives, technological advancements in pharmaceutical manufacturing, and expanding end-use sectors such as gynecological treatments[1][3].

Which regions are expected to show the most growth in the drospirenone market?

The Asia-Pacific region is expected to show rapid growth due to increasing healthcare spending and a large population base[1][3].

How has the COVID-19 pandemic impacted the drospirenone market?

The COVID-19 pandemic has had a mixed impact, disrupting supply chains but also increasing demand for telehealth services and online pharmacies[1].

Sources

1. Global Drospirenone Market Report 2024 Edition - Cognitive Market Research
2. Efficacy and safety of the combination of estetrol 15 mg and drospirenone 3 mg for the treatment of endometriosis-associated pelvic pain - Fertility and Sterility
3. Drospirenone And Ethinyl Estradiol Tablets Market Size And Forecast - Market Research Intellect
4. Global Drospirenone and Ethinyl Estradiol Tablets Market 2024 by Manufacturers, Regions, Type and Application, Forecast to 2030 - Market Research Reports
5. Impact of Body Weight on Drospirenone Serum Concentrations with Drospirenone-Only Contraceptive Pill Use - Contraception Journal

Last updated: 2024-12-16