You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: January 1, 2025

Drospirenone; estradiol - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for drospirenone; estradiol and what is the scope of freedom to operate?

Drospirenone; estradiol is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Drospirenone; estradiol has twenty-one patent family members in sixteen countries.

One supplier is listed for this compound.

Summary for drospirenone; estradiol
International Patents:21
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 49
DailyMed Link:drospirenone; estradiol at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for drospirenone; estradiol
Generic Entry Date for drospirenone; estradiol*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for drospirenone; estradiol

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

SponsorPhase
McGill University Health Centre/Research Institute of the McGill University Health CentrePhase 4
Eli Lilly and CompanyPhase 1
Bristol-Myers SquibbPhase 1

See all drospirenone; estradiol clinical trials

Pharmacology for drospirenone; estradiol
Drug ClassEstrogen
Progestin
Mechanism of ActionEstrogen Receptor Agonists
Paragraph IV (Patent) Challenges for DROSPIRENONE; ESTRADIOL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ANGELIQ Tablets drospirenone; estradiol 0.25 mg/0.5 mg 021355 1 2015-01-08
ANGELIQ Tablets drospirenone; estradiol 0.5 mg/1 mg 021355 1 2007-12-26

US Patents and Regulatory Information for drospirenone; estradiol

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Bayer Hlthcare ANGELIQ drospirenone; estradiol TABLET;ORAL 021355-001 Feb 29, 2012 RX Yes No 8,906,890 ⤷  Subscribe Y ⤷  Subscribe
Bayer Hlthcare ANGELIQ drospirenone; estradiol TABLET;ORAL 021355-002 Sep 28, 2005 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 2 of 2 entries

International Patents for drospirenone; estradiol

CountryPatent NumberTitleEstimated Expiration
Argentina 080912 FORMAS DE DOSIFICACION SOLIDAS ORALES CON DOSIS MUY BAJAS PARA LA HRT ⤷  Subscribe
South Korea 20130097073 VERY LOW-DOSED SOLID ORAL DOSAGE FORMS FOR HRT ⤷  Subscribe
Uruguay 33343 FORMAS DE DOSIFICACIÓN SÓLIDAS ORALES CON DOSIS MUY BAJAS PARA LA HRT ⤷  Subscribe
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 3 of 3 entries

Supplementary Protection Certificates for drospirenone; estradiol

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
0398460 04C0022 France ⤷  Subscribe PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
3632448 LUC00266 Luxembourg ⤷  Subscribe PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
0398460 SPC/GB04/032 United Kingdom ⤷  Subscribe PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 3 of 3 entries

Drospirenone; estradiol Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Drospirenone and Ethinyl Estradiol Tablets

Introduction

Drospirenone and ethinyl estradiol tablets are a combination hormonal contraceptive used to prevent pregnancy, treat premenstrual dysphoric disorder (PMDD), and acne. The market for these tablets is experiencing significant growth, driven by various factors. Here, we delve into the market dynamics and financial trajectory of this pharmaceutical product.

Market Size and Forecast

The global market for drospirenone and ethinyl estradiol tablets is projected to grow at a Compound Annual Growth Rate (CAGR) of 3 to 5 percent from 2023 to 2031. This growth is anticipated due to the increasing demand for effective birth control methods and treatments for PMDD and acne[1][4].

Segmentation

The market is segmented based on several criteria:

  • Application: Pharmacy, Hospital, Clinic, and Online Store. Online stores are increasingly popular due to convenience and privacy.
  • Product: The tablets are available in different dosages, such as 3mg/0.03mg and 3mg/0.02mg.
  • Geography: The market is analyzed across regions including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1][4].

Drivers of Growth

Several factors are driving the growth of this market:

  • Increasing Demand for Birth Control: The need for effective and convenient birth control methods continues to rise, especially among younger demographics.
  • Treatment of PMDD and Acne: The efficacy of drospirenone and ethinyl estradiol in treating PMDD and acne adds to the market demand. Studies have shown that this combination significantly reduces symptoms associated with PMDD[2].
  • Advancements in Healthcare: Improvements in healthcare infrastructure and access to medical services in developing regions are also contributing to market growth.

Key Players

The market is dominated by several key players:

  • Bayer AG
  • Camber Pharmaceuticals
  • Morningside Pharmaceuticals
  • Lupin Pharmaceuticals
  • Xiromed
  • Sun Pharmaceutical
  • Hetero Drugs
  • Jubilant Cadista
  • Mylan

These companies are profiled in market reports, providing insights into their market entry, product offerings, and other market-related factors[1].

Market Dynamics

Drivers

  • Efficacy and Convenience: The combination of drospirenone and ethinyl estradiol is highly effective in preventing pregnancy and treating PMDD and acne, making it a preferred choice for many women.
  • Government Initiatives: Various government initiatives aimed at improving women's health and family planning also drive the demand for these tablets.

Restraints

  • Side Effects: The medication can have several side effects, including mood changes, weight gain, and increased risk of blood clots, which can deter some users[5].
  • Regulatory Challenges: Strict regulatory requirements and the need for continuous clinical trials can slow down market growth.

Opportunities

  • Emerging Markets: Growing healthcare needs in emerging economies present significant opportunities for market expansion.
  • Online Sales: The rise of online pharmacies and telehealth services offers new distribution channels for these tablets.

Challenges

  • Competition: The market faces competition from other birth control methods and treatments for PMDD and acne.
  • Economic Factors: Economic downturns can affect consumer spending on healthcare products.

Financial Trajectory

The financial trajectory of the drospirenone and ethinyl estradiol tablets market is positive, with projected significant growth over the forecast period. Here are some key financial indicators:

  • Market Value: The market was valued at USD million in 2023 and is expected to reach a readjusted size by 2031[4].
  • Revenue Growth: The revenue is expected to increase steadily, driven by the growing demand and expanding distribution channels.
  • Investment: Pharmaceutical companies are investing heavily in research and development to improve the formulation and efficacy of these tablets.

Regional Analysis

The market is analyzed across various geographical regions:

  • North America: This region is a significant market due to high healthcare spending and advanced healthcare infrastructure.
  • Europe: Europe also represents a substantial market, with a strong focus on women's health initiatives.
  • Asia-Pacific: This region is expected to show rapid growth due to increasing healthcare needs and improving economic conditions[1].

Consumer Behavior

Consumer behavior plays a crucial role in the market dynamics:

  • Awareness and Education: Increased awareness about the benefits and risks of hormonal contraceptives influences consumer choices.
  • Convenience and Privacy: The preference for online purchases and telehealth services reflects the desire for convenience and privacy[1].

Economic, Political, and Social Landscapes

The economic, political, and social landscapes of countries significantly impact the market:

  • Economic Stability: Economic stability in regions can increase consumer spending on healthcare products.
  • Government Policies: Government policies and initiatives related to women's health and family planning can boost the market.
  • Social Acceptance: Social acceptance of hormonal contraceptives varies across regions, influencing market demand[1].

Key Takeaways

  • The drospirenone and ethinyl estradiol tablets market is expected to grow at a CAGR of 3 to 5 percent from 2023 to 2031.
  • The market is driven by increasing demand for birth control, treatment of PMDD and acne, and advancements in healthcare.
  • Key players dominate the market, with a focus on product innovation and distribution expansion.
  • The market faces challenges such as side effects and regulatory hurdles but presents opportunities in emerging markets and online sales.

FAQs

What are the primary uses of drospirenone and ethinyl estradiol tablets?

Drospirenone and ethinyl estradiol tablets are primarily used to prevent pregnancy, treat premenstrual dysphoric disorder (PMDD), and acne in women[5].

What is the expected growth rate of the drospirenone and ethinyl estradiol tablets market?

The market is expected to grow at a CAGR of 3 to 5 percent from 2023 to 2031[1][4].

Which regions are expected to show significant growth in the market?

North America, Europe, and the Asia-Pacific region are expected to show significant growth due to various factors including healthcare infrastructure and increasing demand[1].

What are the common side effects of drospirenone and ethinyl estradiol tablets?

Common side effects include mood changes, weight gain, and increased risk of blood clots. Other side effects can include dizziness, headache, and stomach pain[5].

Who are the key players in the drospirenone and ethinyl estradiol tablets market?

Key players include Bayer AG, Camber Pharmaceuticals, Morningside Pharmaceuticals, Lupin Pharmaceuticals, Xiromed, Sun Pharmaceutical, Hetero Drugs, Jubilant Cadista, and Mylan[1].

Sources

  1. Market Research Intellect, "Drospirenone And Ethinyl Estradiol Tablets Market Size And Forecast," December 2024.
  2. PubMed, "Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder," 2005.
  3. Aalborg Universitet, "Effect of nurse-led medication reviews," 2013.
  4. Market Research Reports, "Global Drospirenone and Ethinyl Estradiol Tablets Market 2024 by Manufacturers, Regions, Type and Application, Forecast to 2030," October 11, 2024.
  5. Mayo Clinic, "Drospirenone and ethinyl estradiol (oral route)," September 30, 2024.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.