ORTHO-CEPT Drug Patent Profile

When do Ortho-cept patents expire, and when can generic versions of Ortho-cept launch?

Ortho-cept is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in ORTHO-CEPT is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ortho-cept

A generic version of ORTHO-CEPT was approved as desogestrel; ethinyl estradiol by DURAMED PHARMS BARR on August 12^th, 1999.

Summary for ORTHO-CEPT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	4
Patent Applications:	217
DailyMed Link:	ORTHO-CEPT at DailyMed

See drug sales revenues for ORTHO-CEPT

US Patents and Regulatory Information for ORTHO-CEPT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	ORTHO-CEPT	desogestrel; ethinyl estradiol	TABLET;ORAL-21	020301-001	Dec 14, 1992		DISCN	Yes	No
Janssen Pharms	ORTHO-CEPT	desogestrel; ethinyl estradiol	TABLET;ORAL-28	020301-002	Dec 14, 1992		DISCN	Yes	No

Expired US Patents for ORTHO-CEPT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO-CEPT	desogestrel; ethinyl estradiol	TABLET;ORAL-21	020301-001	Dec 14, 1992
Janssen Pharms	ORTHO-CEPT	desogestrel; ethinyl estradiol	TABLET;ORAL-28	020301-002	Dec 14, 1992

International Patents for ORTHO-CEPT

See the table below for patents covering ORTHO-CEPT around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	54128
Spain	421253
Belgium	808391

ORTHO-CEPT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ORTHO-CEPT

Introduction

ORTHO-CEPT, a combination oral contraceptive containing desogestrel and ethinyl estradiol, is a widely used medication for preventing pregnancy. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Overview

The oral contraceptive market is highly competitive and influenced by various factors, including regulatory approvals, generic competition, and consumer demand.

Generic Competition

The launch of generic versions of ORTHO-CEPT has significantly impacted the market. For instance, Mayne Pharma Group Limited launched a generic version of ORTHO-CEPT in the US, which is part of their expanded Women’s Health portfolio. This portfolio now covers approximately 80% of Obstetrician/Gynaecologist oral contraceptive prescription volumes[1].

Market Size and Sales

The annual US market sales for oral contraceptives, including ORTHO-CEPT and its generic equivalents, were approximately $315 million in the twelve months ending January 2021. This figure includes sales from other popular oral contraceptives like LOESTRIN® 24 FE, ORTHO CYCLEN®, and ORTHO TRI-CYCLEN®[1].

Regulatory Environment

Regulatory bodies play a critical role in shaping the market dynamics of pharmaceuticals.

Antitrust Concerns

The Federal Trade Commission (FTC) closely monitors mergers and acquisitions in the pharmaceutical industry to ensure competition is not substantially lessened. For example, in the case of Teva and Barr, the FTC required divestitures in several markets, including those for generic oral contraceptives like ORTHO-CEPT, to prevent anticompetitive effects[3].

Pricing and Cost

The pricing of ORTHO-CEPT and its generic versions is influenced by several factors, including production costs, market competition, and regulatory approvals.

Cost of Generic Versions

Generic versions of ORTHO-CEPT are generally more affordable than the brand-name product, which can lead to higher market penetration. The cost savings from generics can be significant, making these products more accessible to a wider population[1].

Consumer Demand and Efficacy

Consumer demand for oral contraceptives is driven by their efficacy and safety profile.

Efficacy of ORTHO-CEPT

ORTHO-CEPT has been shown to be highly effective in preventing pregnancy. In clinical trials, the typical user-efficacy pregnancy rate was 1.12 per 100 women-years, which includes patients who did not take the drug correctly[4].

Financial Trajectory

The financial performance of ORTHO-CEPT and its generic versions is tied to several key factors.

Revenue Streams

The revenue generated from ORTHO-CEPT and its generics comes from prescription sales. The annual sales figure of $315 million for related oral contraceptives indicates a significant revenue stream for pharmaceutical companies involved in this market[1].

Impact of Generic Launches

The launch of generic versions can erode the market share of the brand-name product but also expands the overall market by making the medication more affordable. Mayne Pharma’s launch of a generic ORTHO-CEPT, for example, has helped the company expand its market presence and revenue in the Women’s Health segment[1].

Competitive Landscape

The competitive landscape for ORTHO-CEPT includes both brand-name and generic competitors.

Key Players

Companies like Mayne Pharma, Teva, and Barr are significant players in the oral contraceptive market. These companies often engage in strategic acquisitions and divestitures to maintain or enhance their market positions[1][3].

Future Outlook

The future outlook for ORTHO-CEPT and similar oral contraceptives is influenced by ongoing trends in healthcare and pharmaceuticals.

Emerging Trends

There is a growing focus on affordability and accessibility in healthcare, which could further drive the demand for generic oral contraceptives. Additionally, advancements in women’s health care and changes in regulatory policies can impact the market dynamics of these medications[1].

Conclusion

The market dynamics and financial trajectory of ORTHO-CEPT are complex and multifaceted. The drug operates within a highly competitive market influenced by generic competition, regulatory approvals, and consumer demand. Understanding these factors is essential for navigating the pharmaceutical industry and ensuring the continued availability and affordability of essential medications like ORTHO-CEPT.

Key Takeaways

• Generic Competition: The launch of generic versions significantly impacts the market share and pricing of ORTHO-CEPT.
• Regulatory Environment: Antitrust regulations play a crucial role in maintaining competition in the pharmaceutical market.
• Consumer Demand: The efficacy and safety profile of ORTHO-CEPT drive consumer demand.
• Financial Trajectory: Revenue streams are influenced by prescription sales and the impact of generic launches.
• Competitive Landscape: Key players in the market include companies like Mayne Pharma, Teva, and Barr.

FAQs

Q: What is ORTHO-CEPT used for?

ORTHO-CEPT is a combination oral contraceptive used for preventing pregnancy.

Q: Who launched a generic version of ORTHO-CEPT in the US?

Mayne Pharma Group Limited launched a generic version of ORTHO-CEPT in the US[1].

Q: How effective is ORTHO-CEPT in preventing pregnancy?

ORTHO-CEPT has a typical user-efficacy pregnancy rate of 1.12 per 100 women-years[4].

Q: What is the annual market sales figure for related oral contraceptives?

The annual US market sales for related oral contraceptives, including ORTHO-CEPT, were approximately $315 million in the twelve months ending January 2021[1].

Q: Why are generic versions of ORTHO-CEPT important?

Generic versions make the medication more affordable and accessible to a wider population, expanding the overall market[1].

Sources

1. Mayne Pharma Group Limited. Mayne Pharma launches another generic oral contraceptive. PR Newswire, 4 Mar. 2021.
2. Aljuhani, W., & Sayyad, Y. Orthopedic Research Funding: Assessing the Relationship between Investments and Breakthroughs. Orthopedic Reviews, 2024.
3. Wilson Sonsini Goodrich & Rosati. Antitrust Health Care Chronicle - February 2009.
4. RxList. Ortho-Cept (Desogestrel and Ethinyl Estradiol Tablets). RxList, [n.d.].