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Last Updated: December 22, 2024

MIFEPREX Drug Patent Profile


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Which patents cover Mifeprex, and when can generic versions of Mifeprex launch?

Mifeprex is a drug marketed by Danco Labs Llc and is included in one NDA.

The generic ingredient in MIFEPREX is mifepristone. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mifepristone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Mifeprex

A generic version of MIFEPREX was approved as mifepristone by GENBIOPRO on April 11th, 2019.

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Summary for MIFEPREX
Drug patent expirations by year for MIFEPREX
Recent Clinical Trials for MIFEPREX

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

SponsorPhase
RTI InternationalPhase 1
Rochester General HospitalPhase 1
Nova Southeastern UniversityPhase 1

See all MIFEPREX clinical trials

US Patents and Regulatory Information for MIFEPREX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Danco Labs Llc MIFEPREX mifepristone TABLET;ORAL 020687-001 Sep 28, 2000 AB 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

Expired US Patents for MIFEPREX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Danco Labs Llc MIFEPREX mifepristone TABLET;ORAL 020687-001 Sep 28, 2000 ⤷  Subscribe ⤷  Subscribe
Danco Labs Llc MIFEPREX mifepristone TABLET;ORAL 020687-001 Sep 28, 2000 ⤷  Subscribe ⤷  Subscribe
Danco Labs Llc MIFEPREX mifepristone TABLET;ORAL 020687-001 Sep 28, 2000 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for MIFEPREX

See the table below for patents covering MIFEPREX around the world.

Country Patent Number Title Estimated Expiration
Canada 1261262 METHODE D'INDUCTION DU TRAVAIL OU D'INTERRUPTION D'UNE GROSSESSE, AYANT RECOURS A DES PROSTAGLANDINES ET A UN ANTIPROGESTATIF, ET TAMPONS ET PREPARATIONS UTILISES A CETTE FIN (METHOD OF INDUCING LABOUR OR TERMINATING A PREGNANCY USING A PROSTAGLANDIN AND AN ANTIGESTAGEN AND PACKS AND PREPARATIONS SUITABLE THEREFOR) ⤷  Subscribe
Canada 1220780 PROCEDE DE PREPARATION DE NOUVEAUX 19-NOR STEROIDES SUBSTITUES EN 11.beta. ET EVENTUELLEMENT EN 2 (PROCESS FOR THE PREPARATION OF NEW 19-NOR STEROIDS SUBSTITUDED IN THE POSITION 11B AND EVENTUALLY 2) ⤷  Subscribe
South Korea 870001936 ⤷  Subscribe
Japan H0234958 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

MIFEPREX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mifeprex (Mifepristone)

Market Size and Growth Projections

The abortion drugs market, which includes Mifeprex (mifepristone), was valued at over USD 24.42 billion in 2023. This market is projected to grow at a Compound Annual Growth Rate (CAGR) of 8.2% from 2024 to 2032, reaching an estimated value of over USD 49.27 billion by 2032[1][3].

Key Drivers of Growth

Increasing Demand for Abortion Services

The rising rate of abortions globally is a significant driver of the demand for mifepristone. Healthcare providers are prescribing this medication more frequently to meet the growing need for safe and effective abortion options[1][3].

Regulatory Approvals and Reforms

Regulatory changes and approvals are facilitating broader access to mifepristone. For instance, the FDA's decision to allow pharmacies to dispense abortion pills has expanded the distribution channels and convenience for individuals seeking medical abortion options[1].

Technological Advancements and Telemedicine

The integration of telemedicine and online pharmacies is enhancing the accessibility and convenience of abortion drugs. This trend is particularly significant in regions like North America, where improved healthcare infrastructure supports greater access to these medications[3].

Market Segments and Distribution Channels

Drug Class

The mifepristone segment is expected to record a CAGR of 8.6% from 2024 to 2032, driven by its pivotal role in abortion procedures. Mifepristone is often used in conjunction with other medications, such as misoprostol, to ensure safe and effective abortion care[3].

Distribution Channels

Hospital pharmacies are expected to play a crucial role in the distribution of abortion drugs, including mifepristone. By 2032, the hospital pharmacies segment may reach over USD 29.6 billion, as these pharmacies adhere to strict regulations and provide comprehensive patient care[3].

Regional Analysis

North America

North America is anticipated to hold the largest market share in the global abortion drugs market, driven by increasing approvals of drugs for the termination of pregnancy. The region's advanced healthcare infrastructure and the growing use of telemedicine and online pharmacies are key factors contributing to this growth[3][4].

Financial Impact and Access Barriers

Financial Hardship

Studies have shown that restricting access to abortion services, including mifepristone, can have significant and long-lasting negative effects on individuals' economic well-being. For example, a study found that people denied abortions experienced greater financial stress, including increased debt and negative credit reports, compared to those who received abortions[2].

Cost and Affordability

The high cost associated with mifepristone is a significant barrier to access. In the U.S., the cost of mifepristone can be as high as $83.33 per 200mg tablet, which, combined with limited insurance coverage, restricts affordability for many individuals[4].

Legal and Regulatory Challenges

Judicial Rulings

Recent judicial rulings have created uncertainty around the availability of mifepristone. For instance, a federal judge in Texas suspended the FDA's approval of mifepristone, although this ruling was later stayed, and the drug remains available pending further legal action[2].

Regulatory Changes

Despite these challenges, regulatory reforms are aimed at streamlining access to abortion drugs. The FDA's decision to allow pharmacies to dispense mifepristone is a significant step towards broader access and convenience for individuals seeking medical abortion options[1].

Side Effects and Safety Concerns

Common Side Effects

Mifepristone is associated with several side effects, including fever, vomiting, nausea, diarrhea, and severe pelvic pain. These side effects are a restraint on the market growth, as they can deter some individuals from using the medication[4].

Key Players and Market Competition

The global abortion drugs market, including mifepristone, is competitive with several key players such as Corcept Therapeutics Inc., Danco Laboratories LLC, GenBioPro, Inc., Sandoz Inc, and others. These companies are focused on ensuring the availability and developing improved formulations of mifepristone to enhance patient outcomes[4].

Future Outlook and Innovations

Ongoing Research and Development

Pharmaceutical companies are investing in research to refine the application of mifepristone, minimize risks, and enhance efficacy. This ongoing research is expected to expand access and optimize the use of mifepristone for reproductive health[1][3].

Expanding Distribution Channels

The integration of telemedicine and online pharmacies is expected to continue, transforming the way abortion drugs are accessed and utilized. This expansion will enhance convenience and accessibility, particularly in remote areas[3].

Key Takeaways

  • The abortion drugs market, including mifepristone, is projected to grow significantly, reaching over USD 49.27 billion by 2032.
  • Regulatory approvals and reforms are crucial in facilitating broader access to mifepristone.
  • The high cost and limited insurance coverage of mifepristone remain significant barriers to access.
  • Ongoing research and the integration of telemedicine are expected to enhance the efficacy and accessibility of mifepristone.
  • Legal and regulatory challenges continue to impact the market dynamics of mifepristone.

FAQs

1. What is the current market size of the abortion drugs market, and how is it expected to grow? The abortion drugs market was valued at over USD 24.42 billion in 2023 and is estimated to grow at an 8.2% CAGR from 2024 to 2032, reaching over USD 49.27 billion by 2032[1][3].

2. What are the key drivers of the growth in the mifepristone market? Key drivers include the rising rate of abortions, regulatory approvals and reforms, and the integration of telemedicine and online pharmacies[1][3].

3. What are the common side effects associated with mifepristone? Common side effects include fever, vomiting, nausea, diarrhea, and severe pelvic pain[4].

4. How do legal and regulatory challenges impact the availability of mifepristone? Recent judicial rulings and regulatory changes have created uncertainty around the availability of mifepristone, although regulatory reforms aim to streamline access[1][2].

5. What is the impact of restricting access to mifepristone on individuals' financial well-being? Restricting access to mifepristone can lead to significant and long-lasting negative effects on individuals' economic well-being, including increased debt and negative credit reports[2].

Sources

  1. Global Market Insights - Abortion Drugs Market Size - Global Market Insights
  2. PBS - The Fight Over the Abortion Pill Mifepristone and the Financial Impact of Abortion Access
  3. Global Market Insights - Abortion Drugs Market Share – Trends Report, 2032
  4. Coherent Market Insights - Abortion Drugs Market - Share, Size and Industry Analysis
  5. Guttmacher Institute - Supreme Court of the United States - Guttmacher Institute

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