OVRAL-28 Drug Patent Profile

When do Ovral-28 patents expire, and what generic alternatives are available?

Ovral-28 is a drug marketed by Wyeth Pharms and is included in one NDA.

The generic ingredient in OVRAL-28 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-28

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
DailyMed Link:	OVRAL-28 at DailyMed

US Patents and Regulatory Information for OVRAL-28

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-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	016806-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for OVRAL-28

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	OVRAL-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	016806-001	Approved Prior to Jan 1, 1982
Wyeth Pharms	OVRAL-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	016806-001	Approved Prior to Jan 1, 1982
Wyeth Pharms	OVRAL-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	016806-001	Approved Prior to Jan 1, 1982

International Patents for OVRAL-28

See the table below for patents covering OVRAL-28 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-28

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-28 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OVRAL-28

Introduction to OVRAL-28

OVRAL-28, a combination oral contraceptive, contains ethinyl estradiol and norgestrel. It is used to prevent pregnancy and may also be prescribed for other conditions such as acne and premenstrual dysphoric disorder. Understanding the market dynamics and financial trajectory of OVRAL-28 involves analyzing the broader contraceptive drugs market, distribution channels, and regulatory approvals.

Global Contraceptive Drugs Market Overview

The global contraceptive drugs market is experiencing significant growth. As of 2023, the market size was valued at approximately USD 18.57 billion and is projected to reach USD 37.22 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 8.2% during the forecast period of 2024-2032[1][3].

Market Segmentation by Product

The oral segment, which includes drugs like OVRAL-28, dominates the market due to its higher adoption rates in both developed and developing countries. The ease of administration and wide availability of oral contraceptives in pharmacies, public hospitals, and other distribution channels contribute to their popularity. The oral segment is expected to continue leading the market, driven by clinical benefits and increasing product approvals[1].

Distribution Channels

The retail pharmacy segment is the dominant distribution channel for contraceptive drugs, including OVRAL-28. This is due to the growing demand for over-the-counter (OTC) contraceptive drugs and favorable regulatory policies in several countries that allow birth control pills to be sold OTC. Online channels are also growing rapidly, offering convenience and various discounts, which attract more customers[1].

Regional Market Analysis

North America, particularly the U.S., holds a significant share of the contraceptive drugs market. In 2023, the North American market was valued at USD 7.27 billion. The high awareness about birth control pills and the growing childbearing women population in this region are key factors driving this market. Europe follows as the second-largest market, while the Asia Pacific region is expected to register the highest CAGR during the forecast period due to increasing government initiatives and awareness about family planning[1].

Regulatory Approvals and Generic Versions

Recent regulatory approvals have impacted the market dynamics of OVRAL-28. For instance, in August 2023, the FDA approved Lupin's Turqoz (Norgestrel and Ethinyl Estradiol Tablets USP), a generic version of Lo/Ovral-28 tablets. Such approvals increase competition and can affect the pricing and market share of brand-name products like OVRAL-28[3].

Side Effects and Safety Considerations

While OVRAL-28 is effective, it comes with potential side effects, including mild nausea, breast tenderness, and changes in menstrual periods. Serious side effects can include an increased risk of breast cancer, particularly in individuals with a family history of breast cancer. These safety considerations can influence consumer preferences and prescribing patterns[2][4].

Financial Trajectory

The financial trajectory of OVRAL-28 is closely tied to the overall growth of the contraceptive drugs market. As the market expands, driven by increasing awareness, government initiatives, and favorable regulatory policies, the demand for oral contraceptives like OVRAL-28 is expected to rise. However, the introduction of generic versions and increasing competition from other contraceptive methods may impact the market share and revenue of OVRAL-28.

Competitive Landscape

The contraceptive drugs market is highly competitive, with major players such as Johnson & Johnson, AbbVie, Bayer AG, and Pfizer. These companies focus on strategic collaborations, product innovations, and expanding their distribution channels to gain a competitive advantage. The approval of generic versions by companies like Lupin further intensifies the competition[1][3].

Key Drivers and Challenges

• Key Drivers:

  • Increasing awareness about birth control methods
  • Growing demand for OTC contraceptive drugs
  • Favorable regulatory policies
  • Expanding distribution channels, including online pharmacies
  • Government initiatives to promote family planning[1][3].

• Challenges:

  • Side effects and safety concerns associated with OVRAL-28
  • Competition from generic versions and other contraceptive methods
  • Regulatory changes and patent expirations
  • Variations in regional market dynamics and consumer preferences[2][4].

Future Outlook

The future outlook for OVRAL-28 and similar oral contraceptives is positive, driven by the growing demand for effective and convenient birth control methods. However, the market will continue to be shaped by regulatory approvals, the introduction of generic versions, and evolving consumer preferences.

"The global contraceptive drugs market size was valued at USD 18.57 billion in 2023 and is projected to grow from USD 19.80 billion in 2024 to USD 37.22 billion by 2032, exhibiting a CAGR of 8.2% during the forecast period (2024-2032)"[1].

Key Takeaways

• The global contraceptive drugs market is growing rapidly, driven by increasing awareness and favorable regulatory policies.
• Oral contraceptives like OVRAL-28 dominate the market due to their ease of administration and wide availability.
• The retail pharmacy segment is the leading distribution channel, with online channels growing rapidly.
• Regulatory approvals of generic versions can impact the market share of brand-name products.
• Side effects and safety considerations are crucial factors influencing consumer preferences.

FAQs

1. What is the projected growth rate of the global contraceptive drugs market?

   • The global contraceptive drugs market is projected to grow at a CAGR of 8.2% from 2024 to 2032[1].

2. Which segment dominates the contraceptive drugs market?

   • The oral segment dominates the market due to the higher adoption rates of oral drugs globally[1].

3. What are the key distribution channels for contraceptive drugs?

   • The retail pharmacy segment is the dominant distribution channel, followed by growing online channels[1].

4. What are some of the side effects associated with OVRAL-28?

   • Side effects include mild nausea, breast tenderness, changes in menstrual periods, and an increased risk of breast cancer in some individuals[2][4].

5. How do generic versions impact the market for OVRAL-28?

   • Generic versions, such as Lupin's Turqoz, increase competition and can affect the pricing and market share of brand-name products like OVRAL-28[3].

Sources:

1. Fortune Business Insights. Contraceptive Drugs Market Size, Share | Global Report, 2032.
2. Drugs.com. Lo Ovral: Uses, Dosage & Side Effects.
3. Spherical Insights. Global Contraceptive Drugs Market Analysis, Size, Scope 2033.
4. Netmeds. Ovral 28 Tablet 28'S : Price, Uses, Side Effects.
5. Drugs.com. Generic Lo/Ovral-28 Availability.