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Last Updated: December 22, 2024

PLAN B Drug Patent Profile


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When do Plan B patents expire, and what generic alternatives are available?

Plan B is a drug marketed by Fdn Consumer and is included in two NDAs.

The generic ingredient in PLAN B 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

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

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Summary for PLAN B
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 104
Patent Applications: 3,664
What excipients (inactive ingredients) are in PLAN B?PLAN B excipients list
DailyMed Link:PLAN B at DailyMed
Drug patent expirations by year for PLAN B
Drug Sales Revenue Trends for PLAN B

See drug sales revenues for PLAN B

US Patents and Regulatory Information for PLAN B

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 levonorgestrel TABLET;ORAL 021045-001 Jul 28, 1999 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fdn Consumer PLAN B levonorgestrel TABLET;ORAL 021045-002 Aug 24, 2006 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Plan B

Market Overview

The U.S. emergency contraceptive pills (ECPs) market, which includes Plan B, has been experiencing significant growth driven by several key factors.

Increasing Awareness and Demand

The market for ECPs, including Plan B, has seen a surge in demand due to increasing awareness about contraception and family planning. This trend is reflected in the growing market size, which was estimated at USD 3.4 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 5.24% from 2023 to 2030[1].

Impact of Abortion Restrictions

The overturning of the Roe v. Wade ruling has significantly impacted the demand for emergency contraceptive pills. States with near-total abortion bans have seen a rise in the demand for ECPs, although there has been a contradictory effect in some areas. For instance, while overall demand has increased, the use of Plan B specifically fell by 60% in states with strict abortion bans due to clinic closures and misinformation[4].

Product Segments

Progesterone Pills

The progesterone pills segment, which includes Plan B One-Step, dominated the market with a 45.3% revenue share in 2022. This segment's growth is driven by the high efficacy rate of 85% when used perfectly and the introduction of multiple products from various market players[1].

Combination Pills

Combination pills, which include estrogen-progestin birth control pills, are also a significant segment. Although they have a lower efficacy rate of 75% compared to progesterone pills, they remain widely used and are expected to witness the fastest CAGR during the forecast period[1].

Distribution Channels

Over-The-Counter (OTC) Sales

Plan B and other ECPs are widely preferred in OTC form due to their convenience and accessibility. The OTC availability of Plan B, approved for women ages 17 and older, has been a crucial factor in its market success. This distribution channel allows for easy access in emergency situations, contributing to the market's growth[1][5].

Online and Retail Stores

The distribution of Plan B through online stores and retail pharmacies has also been instrumental in its market penetration. Companies like Wisp have seen significant surges in demand, with a 3,000% increase in June 2022, highlighting the importance of these distribution channels[1].

Regional Dynamics

Southeast Region

The Southeast region dominated the U.S. ECPs market with a revenue share of over 28% in 2022. This is primarily due to the high prevalence of unplanned pregnancies and the implementation of abortion bans in many states within the region[1].

Midwest Region

The Midwest is expected to witness the fastest growth rate during the forecast period due to an increase in abortion bans, leading to a greater need for accessible and effective emergency contraception options[1].

Financial Trajectory

Market Size and Growth

The U.S. ECPs market, including Plan B, is projected to grow from USD 3.4 billion in 2022 to USD 5.1 billion by 2030, at a CAGR of 5.24% from 2023 to 2030. This growth is driven by increasing awareness, rising demand for OTC products, and the impact of abortion restrictions[1].

Sales and Revenue

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, further propelling the market's expansion[1].

Key Players and Transactions

Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd. completed the sale of Plan B One-Step and its value brands of emergency contraception to Foundation Consumer Healthcare in a $675 million cash transaction in 2017. This divestiture was part of Teva's strategy to focus on core businesses and reduce debt[2].

Regulatory and Clinical Aspects

FDA Approvals and Regulatory History

Plan B was initially approved as a prescription-only emergency contraception in 1999. It was later approved for OTC marketing for women ages 18 and older in 2006, and for women ages 17 and older in 2009. The regulatory history of Plan B has been complex, involving multiple sponsors and applicants over the years[5].

Challenges and Opportunities

Clinic Closures and Misinformation

The closure of family planning clinics and misinformation about the legality of emergency contraception in states with strict abortion bans have posed significant challenges to the market. However, these challenges also highlight the need for reliable and accessible emergency contraception options, presenting opportunities for market growth[4].

Cost and Accessibility

Efforts to reduce drug costs, such as the Inflation Reduction Act's provisions for Medicare to negotiate drug prices and impose inflation penalties, can impact the financial trajectory of Plan B and other ECPs. These measures aim to make prescription drugs more affordable, which could further boost demand[3][4].

Key Takeaways

  • The U.S. emergency contraceptive pills market, including Plan B, is expected to grow significantly due to increasing awareness and demand.
  • The market is driven by the preference for OTC products and the impact of abortion restrictions.
  • Progesterone pills, such as Plan B One-Step, dominate the market due to their high efficacy rate.
  • Regional dynamics, particularly in the Southeast and Midwest, play a crucial role in market growth.
  • Key players like Teva and Foundation Consumer Healthcare influence market dynamics through transactions and product availability.
  • Regulatory and clinical aspects, including FDA approvals and distribution channels, are vital for market success.

FAQs

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[1].

How is the market for Plan B and other ECPs expected to grow?

The market is expected to grow at a CAGR of 5.24% from 2023 to 2030, reaching USD 5.1 billion by 2030[1].

What factors are driving the growth of the ECPs market?

Increasing awareness about contraception, rising demand for OTC products, and the impact of abortion restrictions are key drivers of market growth[1].

Which region dominates the U.S. ECPs market?

The Southeast region dominated the market with a revenue share of over 28% in 2022[1].

What was the impact of the Roe v. Wade ruling overturn on Plan B use?

The use of Plan B fell by 60% in states that implemented near-total abortion bans after the ruling, due to clinic closures and misinformation[4].

Who are some of the key players in the U.S. ECPs market?

Key players include Afaxys Pharma LLC, Teva Pharmaceutical Industries Ltd., Foundation Consumer Healthcare LLC, and Bayer plc, among others[1].

More… ↓

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