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Last Updated: December 22, 2024

AFIRMELLE Drug Patent Profile


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When do Afirmelle patents expire, and when can generic versions of Afirmelle launch?

Afirmelle is a drug marketed by Aurobindo Pharma and is included in one NDA.

The generic ingredient in AFIRMELLE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

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Summary for AFIRMELLE
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 3
DailyMed Link:AFIRMELLE at DailyMed
Drug patent expirations by year for AFIRMELLE

US Patents and Regulatory Information for AFIRMELLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma AFIRMELLE ethinyl estradiol; levonorgestrel TABLET;ORAL-28 206886-001 Nov 14, 2016 AB1 RX No No ⤷  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

AFIRMELLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Contraceptive Drugs: A Focus on AFIRMELLE

Global Contraceptive Drugs Market Overview

The global contraceptive drugs market is experiencing significant growth, driven by increasing awareness about birth control, rising demand for over-the-counter (OTC) contraceptive drugs, and favorable regulatory policies. The market was valued at USD 18.57 billion in 2023 and is projected to reach USD 37.22 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 8.2% during the forecast period of 2024-2032[1].

Market Segmentation and Growth Drivers

By Product

The oral segment dominates the market, driven by the higher adoption of oral drugs in both developed and developing countries. Oral contraceptives like AFIRMELLE, which is a combination of ethinyl estradiol and levonorgestrel, offer undue clinical benefits and ease of administration, contributing to their popularity[1].

Distribution Channels

The retail pharmacy segment leads the market, thanks to the growing demand for OTC contraceptive drugs and favorable regulatory policies in several countries, including Brazil, Mexico, China, and India. Online channels are also growing rapidly due to their wide distribution network and attractive offers[1].

Regional Analysis

North America

North America, particularly the U.S., holds a significant share of the global market. The region's high awareness about birth control pills, growing childbearing women population, and increasing fertility rates are key factors driving this dominance. The U.S. contraceptive drugs market is projected to reach USD 12.06 billion by 2032[1].

Europe and Asia-Pacific

Europe holds the second-largest market share, driven by a well-established healthcare infrastructure and an increasing number of women opting for modern contraceptive methods. The Asia-Pacific region is expected to register the highest CAGR during the forecast period, driven by government initiatives to expand access to contraceptive drugs and a growing emphasis on family planning[1].

Key Players and Competitive Landscape

Top market players such as Johnson & Johnson, AbbVie Inc., and Bayer AG focus on strategic collaborations to gain a competitive advantage. Other key players include Agile Therapeutics, Allergan Plc, GlaxoSmithKline Plc, Pfizer Inc., Novartis AG, and Teva Pharmaceutical Industries Ltd.[4].

Financial Trajectory for AFIRMELLE

Market Position

AFIRMELLE, a combination oral contraceptive, benefits from the overall growth in the oral segment. As part of the broader contraceptive drugs market, AFIRMELLE's financial trajectory is influenced by the increasing demand for OTC contraceptive drugs and the expanding retail pharmacy segment.

Price Dynamics

The introduction of generic versions can impact the pricing of brand-name drugs like AFIRMELLE. However, studies suggest that brand prices may moderate after generic entry, and in some cases, brands may lower their prices to compete with generics. Markets with a single generic manufacturer tend to have shallower price decreases and slower uptake of generic share[3].

Sales and Revenue

Given the dominance of the oral segment and the growing demand for OTC contraceptive drugs, AFIRMELLE is likely to see increased sales. The ease of administration and clinical benefits of oral contraceptives contribute to their popularity, which in turn drives revenue growth.

Impact of Regulatory Approvals

Recent approvals, such as the U.S. FDA's approval of Lupin’s Drospirenone tablets in November 2022, indicate a favorable regulatory environment. Such approvals can increase competition but also validate the market demand for contraceptive drugs, potentially benefiting AFIRMELLE through increased market visibility and consumer trust[1].

Consumer Awareness and Education

Increasing consumer awareness about birth control pills, driven by public programs and growing insurance coverage, is a significant driver for the market. This awareness is expected to boost the adoption rate of AFIRMELLE and other contraceptive drugs, contributing to their financial growth[1].

Online Channels and Distribution

The growing adoption of online channels for purchasing contraceptive drugs, including AFIRMELLE, offers additional revenue streams. Online channels provide a wide distribution network and attractive offers, which can enhance the market reach and sales of these products[1].

Government Initiatives and Public Programs

Government initiatives to expand access to contraceptive drugs, particularly in regions like the Asia-Pacific, are crucial for market growth. These initiatives, combined with public programs aimed at increasing awareness about birth control, are expected to drive the demand for AFIRMELLE and other contraceptive drugs[4].

Key Takeaways

  • The global contraceptive drugs market is projected to grow significantly, driven by increasing awareness and demand for OTC drugs.
  • The oral segment, which includes AFIRMELLE, dominates the market due to its clinical benefits and ease of administration.
  • Retail pharmacies and online channels are key distribution channels driving market growth.
  • North America, particularly the U.S., holds a significant market share, while the Asia-Pacific region is expected to grow at the fastest pace.
  • Regulatory approvals and government initiatives are crucial for market expansion.

Frequently Asked Questions

Q: What is the projected growth rate of the global contraceptive drugs market? A: The global contraceptive drugs market is projected to grow at a CAGR of 8.2% from 2024 to 2032[1].

Q: Which segment dominates the contraceptive drugs market? A: The oral segment dominates the market, driven by the higher adoption of oral drugs globally[1].

Q: What are the key distribution channels for contraceptive drugs? A: Retail pharmacies and online channels are the key distribution channels driving market growth[1].

Q: Which region is expected to grow at the fastest pace in the contraceptive drugs market? A: The Asia-Pacific region is expected to register the highest CAGR during the forecast period[1].

Q: How do regulatory approvals impact the market for contraceptive drugs like AFIRMELLE? A: Regulatory approvals can increase competition but also validate market demand, potentially benefiting AFIRMELLE through increased market visibility and consumer trust[1].

Cited Sources:

  1. Fortune Business Insights - Contraceptive Drugs Market Size, Share | Global Report, 2032
  2. ScienceDirect - Transdermal hormone delivery: strategies, application and modality
  3. SSRN - Changing Market Dynamics in the Pharmaceutical Industry: Analysis ...
  4. Allied Market Research - Contraceptive Drugs Market Size, Share | Statistics - 2035

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