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Last Updated: December 22, 2024

PLAN B ONE-STEP Drug Patent Profile


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Which patents cover Plan B One-step, and when can generic versions of Plan B One-step launch?

Plan B One-step is a drug marketed by Fdn Consumer and is included in one NDA.

The generic ingredient in PLAN B ONE-STEP is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Plan B One-step

A generic version of PLAN B ONE-STEP was approved as levonorgestrel by NOVEL LABS INC on February 22nd, 2013.

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Summary for PLAN B ONE-STEP
Drug patent expirations by year for PLAN B ONE-STEP
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US Patents and Regulatory Information for PLAN B ONE-STEP

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fdn Consumer PLAN B ONE-STEP levonorgestrel TABLET;ORAL 021998-001 Jul 10, 2009 OTC 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

PLAN B ONE-STEP Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Plan B One-Step

Market Overview

The U.S. emergency contraceptive pills (ECPs) market, in which Plan B One-Step is a key player, has been experiencing significant growth. As of 2022, the market size was estimated at USD 3.4 billion and is projected to grow at a compound annual growth rate (CAGR) of 5.24% from 2023 to 2030[3].

Increasing Demand and Awareness

The demand for emergency contraceptive pills, including Plan B One-Step, has been driven by increasing awareness about contraception and family planning. A study by the Kaiser Family Foundation revealed that 28% of sexually active women aged 15 to 44 have used ECPs at least once in their lives, marking a substantial rise from the 4% reported in 2002[3].

Regulatory History

Plan B One-Step, a single-dose tablet containing 1.5 mg of levonorgestrel, has undergone several regulatory changes. Initially approved for prescription use in 1999, it was later approved for nonprescription use for women 18 years and older in 2006. By 2009, it was available without a prescription for women 17 years and older, and in 2013, it was approved for nonprescription use without any age restrictions[4].

Mechanism of Action

The FDA has determined that Plan B One-Step works by inhibiting or delaying ovulation and the midcycle hormonal changes, with no direct effect on fertilization or implantation. This understanding has been reflected in the updated labeling of the product[4].

Market Segmentation

The market for ECPs is segmented into different types, with the progesterone pills segment, which includes Plan B One-Step, holding the largest revenue share of 45.3% in 2022. This segment's growth is driven by the high efficacy rate of 85% when used perfectly[3].

Progesterone Pills Segment

  • This segment dominates the market due to the introduction of multiple products and their high efficacy rates.
  • Plan B One-Step, being a single-dose levonorgestrel tablet, is a key product in this segment[3].

Combination Pills Segment

  • Although not as dominant as progesterone pills, combination pills are also widely used and are expected to witness significant growth.
  • These pills include estrogen-progestin birth control pills and have an efficacy rate of 75%[3].

Distribution Channels

The distribution of Plan B One-Step and other ECPs is crucial for their accessibility. Key channels include:

Online Stores

  • The online store segment is anticipated to witness the fastest growth due to increasing internet accessibility and growing awareness among women about emergency contraceptives[3].

Hospital Pharmacies

  • Hospital pharmacies play a significant role in providing comprehensive services, including medical prescriptions, making them a preferred choice for women seeking emergency contraception[3].

Regional Dynamics

The U.S. emergency contraceptive pills market is regionally diverse, with different regions experiencing different growth rates:

Southeast Region

  • This region dominated the market with the largest revenue share of 28.6% in 2022, primarily due to the high prevalence of unplanned pregnancies and abortion bans in several states[3].

Midwest Region

  • The Midwest is expected to witness the fastest growth rate due to an increase in abortion bans, leading to a greater need for accessible and effective emergency contraception options[3].

Financial Trajectory

Divestiture and Financial Impact

In 2017, Teva Pharmaceutical Industries Ltd. completed the sale of Plan B One-Step and its value brands of emergency contraception to Foundation Consumer Healthcare for $675 million. This transaction was part of Teva's strategy to divest non-core businesses and focus on more competitive areas, also helping to repay term loan debt[1].

Market Growth and Revenue

The U.S. ECPs market, driven by increasing demand and awareness, is expected to continue growing. For instance, in 2019, around 15 million units of Plan B medication were sold, representing a 59% increase compared to 2018. This trend highlights the rising preference for accessible and reliable emergency contraception[3].

Key Players

The market for ECPs includes several key players:

  • Afaxys Pharma LLC
  • Teva Pharmaceutical Industries Ltd.
  • Syzygy Healthcare, LLC
  • Gedeon Richter USA, Inc.
  • Rapha Pharmaceuticals, Inc.
  • Perrigo Company plc
  • Foundation Consumer Healthcare LLC
  • Wockhardt USA
  • Pfizer Inc.
  • Bayer plc[3].

Conclusion

The market dynamics for Plan B One-Step are characterized by increasing demand, regulatory support, and a strong financial trajectory. As awareness about emergency contraception continues to grow, and with the ongoing need for effective and accessible contraception options, the market is poised for further expansion.

Key Takeaways

  • The U.S. emergency contraceptive pills market is growing at a CAGR of 5.24% from 2023 to 2030.
  • Plan B One-Step is a dominant product in the progesterone pills segment.
  • The product's distribution through online stores and hospital pharmacies is crucial for its accessibility.
  • Regional dynamics, particularly in the Southeast and Midwest, are influenced by abortion policies and unplanned pregnancy rates.
  • The financial trajectory of Plan B One-Step has been impacted by divestitures and is expected to continue growing with the expanding market.

FAQs

Q: What is the current market size of the U.S. emergency contraceptive pills market?

The U.S. emergency contraceptive pills market size was estimated at USD 3.4 billion in 2022[3].

Q: How does Plan B One-Step work?

Plan B One-Step works by inhibiting or delaying ovulation and the midcycle hormonal changes, with no direct effect on fertilization or implantation[4].

Q: Who are the key players in the U.S. emergency contraceptive pills market?

Key players include Afaxys Pharma LLC, Teva Pharmaceutical Industries Ltd., Syzygy Healthcare, LLC, and others[3].

Q: What was the impact of the divestiture of Plan B One-Step by Teva Pharmaceutical Industries Ltd.?

The divestiture to Foundation Consumer Healthcare generated $675 million in cash proceeds, helping Teva to repay term loan debt and focus on core businesses[1].

Q: Which region dominates the U.S. emergency contraceptive pills market?

The Southeast region dominated the market with the largest revenue share of 28.6% in 2022[3].

Sources:

  1. Teva Announces Completion of Plan B One-StepĀ® Divestiture to Foundation Consumer Healthcare - Teva Pharmaceutical Industries Ltd.
  2. Report and consolidated financial statements - Plan B Media - Plan B Media Public Company Limited
  3. U.S. Emergency Contraceptive Pills Market Report, 2030 - Grand View Research
  4. Plan B One-Step (1.5 mg levonorgestrel) Information - FDA
  5. 1Q 2023 EARNINGS PRESENTATION - Plan B Media - Plan B Media Public Company Limited

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