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Last Updated: December 22, 2024

NORGESTREL - Generic Drug Details


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What are the generic sources for norgestrel and what is the scope of freedom to operate?

Norgestrel is the generic ingredient in one branded drug marketed by Laboratoire Hra and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are twenty-five drug master file entries for norgestrel. One supplier is listed for this compound.

Summary for NORGESTREL
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 25
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 104
Clinical Trials: 13
Patent Applications: 6,238
What excipients (inactive ingredients) are in NORGESTREL?NORGESTREL excipients list
DailyMed Link:NORGESTREL at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NORGESTREL
Generic Entry Date for NORGESTREL*:
Constraining patent/regulatory exclusivity:
RX TO OTC SWITCH OR OTC USE
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 NORGESTREL

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

SponsorPhase
Sohag UniversityEarly Phase 1
HRA PharmaPhase 2
Health DecisionsPhase 2

See all NORGESTREL clinical trials

Medical Subject Heading (MeSH) Categories for NORGESTREL

US Patents and Regulatory Information for NORGESTREL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Laboratoire Hra OPILL norgestrel TABLET;ORAL 017031-001 Approved Prior to Jan 1, 1982 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

Expired US Patents for NORGESTREL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Laboratoire Hra OPILL norgestrel TABLET;ORAL 017031-001 Approved Prior to Jan 1, 1982 3,666,858 ⤷  Subscribe
Laboratoire Hra OPILL norgestrel TABLET;ORAL 017031-001 Approved Prior to Jan 1, 1982 3,959,322 ⤷  Subscribe
Laboratoire Hra OPILL norgestrel TABLET;ORAL 017031-001 Approved Prior to Jan 1, 1982 3,850,911 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

NORGESTREL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Norgestrel

Market Overview

The global contraceptive market, within which norgestrel plays a significant role, is experiencing robust growth driven by increasing awareness, technological innovations, and favorable regulatory environments.

Global Contraceptive Market Size and Growth

The global contraceptive market was valued at USD 29.57 billion in 2023 and is expected to grow at a CAGR of 5.92% from 2024 to 2030[4].

Norgestrel: A Key Player in the Market

Approval and Availability

In a significant development, the U.S. Food and Drug Administration (FDA) approved norgestrel 0.075 mg (Opill) as the first nonprescription oral contraceptive pill in July 2023. This approval marks a pivotal shift in the accessibility of effective contraception, allowing consumers to purchase this progestin-only pill over-the-counter (OTC) at various retail outlets, including drug stores, convenience stores, grocery stores, and online platforms[2][4].

Historical Context

Norgestrel was originally FDA-approved in 1973 as a prescription-only medication under the brand name Ovrette. However, its distribution ceased in 2005 due to marketing reasons, not safety or effectiveness concerns. Recent studies have supported its conversion to nonprescription status to enhance access to safe and effective contraception[2].

Market Segments and Distribution Channels

Product Segments

The oral segment, which includes norgestrel, dominates the market due to its higher adoption rates in both developed and developing countries. The ease of administration and widespread availability of oral pills in pharmacies, public hospitals, and other outlets contribute to this dominance[1].

Distribution Channels

The retail pharmacy segment is the leading distribution channel for contraceptive drugs, including norgestrel. This is driven by the growing demand for OTC contraception and favorable regulatory policies in several countries such as Brazil, Mexico, China, and India. Online channels are also experiencing high growth due to the convenience and availability of various brands and products[1].

Regional Analysis

North America

The North American market, particularly the U.S., holds a significant share of the global contraceptive market. The region's high awareness of reproductive health, preference for modern contraceptive methods, and government initiatives such as Title X and the Affordable Care Act contribute to its dominance. The U.S. contraceptive market is expected to continue growing, driven by the increasing use of modern contraceptives and publicly funded family planning services[1][4].

Europe

Europe is anticipated to experience significant growth due to increasing cases of STDs and unintended pregnancies. Investments by companies, such as Bayer's new manufacturing facility in Finland, aim to increase the production of long-acting reversible contraceptives (LARCs) like hormonal IUDs and implants[4].

Asia Pacific and Other Regions

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. Latin America and the Middle East & Africa also show promising growth due to increasing awareness and government initiatives[1].

Financial Trajectory

Market Size and Growth Projections

The global contraceptive drugs market, which includes norgestrel, was valued at USD 18.57 billion in 2023 and is projected to grow to USD 37.22 billion by 2032, exhibiting a CAGR of 8.2% during the forecast period (2024-2032)[1].

Revenue Share and Growth Drivers

The U.S. contraceptive drugs market, a significant segment for norgestrel, is projected to reach USD 12.06 billion by 2032. Key drivers include increasing consumer awareness about birth control pills, growing insurance coverage, and the introduction of OTC contraceptive products[1].

Competitive Landscape

Top Market Players

Companies like Johnson & Johnson Services, Inc., AbbVie Inc., and Bayer AG are key players in the contraceptive market. These companies focus on strategic collaborations and innovations to gain a competitive advantage. The approval of norgestrel as an OTC product is expected to further intensify competition in the market[1].

Impact of Norgestrel's Nonprescription Approval

Efficacy and Safety

Norgestrel has been shown to be highly effective in preventing pregnancy, with failure rates ranging from 0 to 2.4 per hundred woman-years with typical use. The product's safety profile is supported by extensive clinical studies, although common adverse effects include changes in bleeding patterns, headache, dizziness, and other minor symptoms[2].

Public Health Impact

The nonprescription approval of norgestrel is expected to significantly expand patient access to a safe and effective contraceptive method, potentially reducing the risk of unintended pregnancies. The widespread availability of this product in various retail outlets and online platforms will be crucial in achieving this public health goal[2].

Key Takeaways

  • Market Growth: The global contraceptive market is projected to grow significantly, driven by increasing awareness and technological innovations.
  • Norgestrel Approval: The FDA's approval of norgestrel as the first nonprescription oral contraceptive pill marks a significant milestone in enhancing access to effective contraception.
  • Distribution Channels: Retail pharmacies and online channels are key distribution segments, driven by consumer preference for OTC products.
  • Regional Dynamics: North America, Europe, and the Asia Pacific region are expected to be major contributors to the market growth.
  • Financial Projections: The market is expected to grow at a CAGR of 8.2% from 2024 to 2032, reaching USD 37.22 billion by 2032.
  • Competitive Landscape: Top players are focusing on strategic collaborations and innovations to maintain market share.

FAQs

What is norgestrel, and how is it used?

Norgestrel is a progestin used in oral contraception to prevent pregnancy in women. It is available in combination with ethinyl estradiol and as a standalone progestin-only pill, such as Opill, which was recently approved for nonprescription use[2][5].

What is the significance of norgestrel's nonprescription approval?

The nonprescription approval of norgestrel significantly expands patient access to a safe and effective contraceptive method, potentially reducing the risk of unintended pregnancies. It allows consumers to purchase the product OTC at various retail outlets and online platforms[2][4].

What are the common adverse effects of norgestrel?

Common adverse effects of norgestrel include changes in bleeding patterns, such as breakthrough bleeding and spotting, as well as other minor symptoms like headache, dizziness, and nausea[2].

How does norgestrel compare to other contraceptive methods?

Norgestrel is more effective than other currently available nonprescription contraceptive options when used as directed. Its efficacy is supported by extensive clinical studies, making it a reliable choice for pregnancy prevention[2].

What are the key drivers of the global contraceptive market?

Key drivers include increasing consumer awareness about birth control pills, growing insurance coverage, the introduction of OTC contraceptive products, and government initiatives to improve access to contraception[1][4].

Sources

  1. Fortune Business Insights: Contraceptive Drugs Market Size, Share | Global Report, 2032
  2. MDedge: Norgestrel for nonprescription contraception - MDedge
  3. SSRN: The Competitive Efficacy of Divestitures: An Empirical Analysis of ...
  4. Grand View Research: Contraceptive Market Size, Share And Growth Report, 2030
  5. DrugBank Online: Norgestrel: Uses, Interactions, Mechanism of Action | DrugBank Online

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