OVRAL Drug Patent Profile

Which patents cover Ovral, and what generic alternatives are available?

Ovral is a drug marketed by Wyeth Pharms and is included in two NDAs.

The generic ingredient in OVRAL is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.

Summary for OVRAL

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	5
Patent Applications:	277
DailyMed Link:	OVRAL at DailyMed

US Patents and Regulatory Information for OVRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms	OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	016672-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Wyeth Pharms	OVRAL-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	016806-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for OVRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	016672-001	Approved Prior to Jan 1, 1982	3,666,858
Wyeth Pharms	OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	016672-001	Approved Prior to Jan 1, 1982	3,959,322
Wyeth Pharms	OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	016672-001	Approved Prior to Jan 1, 1982	3,850,911

International Patents for OVRAL

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

Country	Patent Number	Title	Estimated Expiration
Austria	281313
Philippines	11433	SYNTHESIS OF 13-POLYCARBONALKYL GONA-2,5(10)-DIEN-17-OLS
Netherlands	146502
United Kingdom	1041273
France	1503559	Procédé de préparation de nouveaux gonahexaènes
Philippines	11431	13-POLYCARBONALKYL-8,14-SECOGONA-1,3,5(10),9(11)-TETRAENE-4,17-DIONES

Supplementary Protection Certificates for OVRAL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124

OVRAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Contraceptive Drugs: A Focus on OVRAL

Global Contraceptive Drugs Market Overview

The global contraceptive drugs market is experiencing significant growth, driven by increasing awareness about birth control methods, improving healthcare infrastructure, and shifting societal attitudes toward reproductive autonomy.

• The global contraceptive drugs market was valued at USD 18.57 billion in 2023 and is projected to reach USD 37.22 billion by 2032, growing at a CAGR of 8.2% during the forecast period (2024-2032)[1][4].

Segmentation and Market Share

By Product

The oral contraceptive segment, which includes drugs like OVRAL, dominates the market due to its higher adoption rates in both developed and developing countries. The ease of administration and clinical benefits of oral contraceptives over other methods, such as injectables and patches, contribute to their market lead[1][4].

Distribution Channels

The retail pharmacy segment holds the largest revenue share, driven by the growing demand for over-the-counter (OTC) contraceptive drugs. Countries like Brazil, Mexico, China, and India allow birth control pills to be sold OTC, increasing consumer preference for retail pharmacies. Online channels are also growing rapidly due to their convenience and various online offers[1][4].

Regional Analysis

North America

North America, particularly the U.S., is a significant market for contraceptive drugs. The U.S. market was valued at USD 4.77 billion in 2023 and is expected to grow to USD 8.92 billion by 2033, with a CAGR of 6.5% from 2024 to 2033. High awareness about birth control pills, a growing childbearing population, and favorable regulatory policies are key drivers in this region[1][4].

Other Regions

Europe holds the second-largest market share due to its well-established healthcare infrastructure and increasing adoption of modern contraceptive methods. The Asia-Pacific region is expected to be the fastest-growing market, driven by increasing awareness and access to healthcare[1][4].

Financial Trajectory for Oral Contraceptives like OVRAL

Market Size and Growth

The oral contraceptive segment, which includes OVRAL, is expected to continue its dominance. The global market for oral contraceptives is driven by their clinical advantages, ease of administration, and growing availability in pharmacies and online channels[1][4].

Revenue Projections

Given the overall market growth, the revenue from oral contraceptives is anticipated to increase significantly. For instance, the global contraceptive drugs market is projected to reach USD 37.22 billion by 2032, with oral contraceptives likely to maintain a substantial share of this market[1].

Key Drivers and Challenges

Drivers

• Increasing Awareness and Access: Growing awareness about family planning and increased access to healthcare are key drivers. Public programs and insurance coverage also play a crucial role in promoting the use of contraceptive drugs[1][3][4].
• Regulatory Approvals: Recent approvals of new products, such as Lupin’s Drospirenone tablets, contribute to market growth[1].
• OTC Availability: The availability of birth control pills over the counter in several countries enhances consumer access and preference for retail pharmacies[1][4].

Challenges

• Side Effects and Safety Concerns: Hormonal contraceptives can have side effects such as weight changes, mood swings, and rare cases of blood clots. These concerns necessitate careful consultation with healthcare providers[3][5].
• Access Disparities: Despite growing access, disparities in healthcare infrastructure and regulatory scrutiny can impact market dynamics[3].

Product-Specific Insights for OVRAL

Clinical Trials and Safety

OVRAL, a combination of norgestrel and ethinyl estradiol, has been evaluated in several clinical trials. Common adverse reactions include weight changes, cervical erosion, acne, and dysmenorrhea. About 8% of subjects discontinued the trials due to adverse reactions such as unscheduled bleeding and headaches[5].

Market Position

As an oral contraceptive, OVRAL benefits from the overall growth in the oral segment. Its market position is strengthened by its approval and widespread availability in pharmacies and online channels.

Launch and Market Performance

Launch Strategies

Successful drug launches, including those for contraceptive drugs like OVRAL, depend on meeting analyst forecasts, adequate resource allocation for launch activities, and avoiding unfavorable clinical findings or unexpected events such as supply chain disruptions[2].

Performance Metrics

Products that meet analyst forecasts in the first year have a higher probability of continued success in subsequent years. For oral contraceptives, consistent performance over time is crucial, especially given the competitive nature of the general medicine market[2].

Innovation and Future Trends

Innovative Delivery Methods

The future of the contraceptive drugs market will see innovations in delivery methods, reduced side effects, and a focus on personalized medicine. Products like the reusable silicone vaginal ring, Annovera, which received FDA approval, are expected to drive growth in other segments as well[4].

Regulatory Scrutiny

Regulatory bodies will continue to scrutinize the safety and efficacy of contraceptive drugs, which may impact market dynamics and drive the development of safer and more effective products[3].

Key Takeaways

• The global contraceptive drugs market is projected to grow significantly, driven by increasing awareness and access to healthcare.
• Oral contraceptives, including OVRAL, dominate the market due to their clinical benefits and ease of administration.
• Retail pharmacies and online channels are key distribution channels, with online channels growing rapidly.
• North America, particularly the U.S., is a major market for contraceptive drugs.
• Side effects and access disparities are significant challenges that need to be addressed.
• Innovative delivery methods and personalized medicine are expected to shape the future of the market.

Frequently Asked Questions (FAQs)

1. What is the projected growth rate of the global contraceptive drugs market? The global contraceptive drugs market is expected to grow at a CAGR of 8.2% from 2024 to 2032[1].

2. Which segment dominates the contraceptive drugs market? The oral contraceptive segment dominates the market due to its higher adoption rates and clinical benefits[1][4].

3. What are the key drivers of the contraceptive drugs market? Key drivers include increasing awareness about family planning, growing access to healthcare, and the availability of OTC contraceptive products[1][3][4].

4. What are some common side effects of oral contraceptives like OVRAL? Common side effects include weight changes, cervical erosion, acne, and dysmenorrhea. Rare cases can include blood clots and other arterial events[5].

5. How is the online distribution channel impacting the market? The online distribution channel is growing rapidly due to the convenience it offers, along with various online discounts and offers that attract customers[1][4].

Cited Sources:

1. Fortune Business Insights - Contraceptive Drugs Market Size, Share | Global Report, 2032
2. Deloitte - Drug launches reflect overall company performance
3. GlobeNewswire - Hormonal Contraceptive Market Projected to Reach 26.7 Billion by 2032
4. Precedence Research - Contraceptive Drugs Market Size, Report 2024-2033
5. FDA - LO/OVRAL – 28 Tablets (NORGESTREL AND ETHINYL ESTRADIOL) Label[5]