PREVEN EMERGENCY CONTRACEPTIVE KIT Drug Patent Profile

When do Preven Emergency Contraceptive Kit patents expire, and what generic alternatives are available?

Preven Emergency Contraceptive Kit is a drug marketed by Teva Branded Pharm and is included in one NDA.

The generic ingredient in PREVEN EMERGENCY CONTRACEPTIVE KIT is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for PREVEN EMERGENCY CONTRACEPTIVE KIT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
Patent Applications:	277
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREVEN EMERGENCY CONTRACEPTIVE KIT
DailyMed Link:	PREVEN EMERGENCY CONTRACEPTIVE KIT at DailyMed

US Patents and Regulatory Information for PREVEN EMERGENCY CONTRACEPTIVE KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	PREVEN EMERGENCY CONTRACEPTIVE KIT	ethinyl estradiol; levonorgestrel	TABLET;ORAL	020946-001	Sep 1, 1998		DISCN	No	No

Expired US Patents for PREVEN EMERGENCY CONTRACEPTIVE KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	PREVEN EMERGENCY CONTRACEPTIVE KIT	ethinyl estradiol; levonorgestrel	TABLET;ORAL	020946-001	Sep 1, 1998

International Patents for PREVEN EMERGENCY CONTRACEPTIVE KIT

See the table below for patents covering PREVEN EMERGENCY CONTRACEPTIVE KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2000511890
Australia	2558297
European Patent Office	0904084
World Intellectual Property Organization (WIPO)	9742959
Canada	2253289

Supplementary Protection Certificates for PREVEN EMERGENCY CONTRACEPTIVE KIT

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

PREVEN EMERGENCY CONTRACEPTIVE KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Preven Emergency Contraceptive Kit

Introduction

The Preven Emergency Contraceptive Kit, one of the pioneering products in the emergency contraception market, was first FDA-approved in 1998. This kit, produced by Gynetics Medical Products, marked a significant milestone in the availability of emergency contraceptive options. Here, we delve into the market dynamics and financial trajectory of emergency contraceptive pills, with a focus on the context surrounding products like Preven.

Market Growth and Drivers

The global emergency contraceptive pills (ECPs) market is experiencing steady growth, driven by several key factors:

• Increasing Awareness and Acceptance: Initiatives by organizations such as the Asia Pacific Council on Contraception, European Society of Cardiology, and International Planned Parenthood Federation have significantly increased awareness about family planning and the use of ECPs. This has led to higher demand in both developed and developing countries[1].
• Government Initiatives: In many developing countries, government initiatives to make ECPs easily accessible have boosted their popularity. Effective use of ECPs can prevent morbidity and mortality related to pregnancy and abortion[1].
• Technological Advancements: The use of technology and innovation in developing new and effective contraceptives is a key trend in the market. This includes the development of more effective and convenient ECPs like those containing ulipristal acetate and levonorgestrel[1].

Market Size and Forecast

The global ECP market is estimated to grow by USD 240.3 million from 2024 to 2028, with a Compound Annual Growth Rate (CAGR) of 4.36% during the forecast period. This growth is driven by the increasing need for effective and convenient contraceptive solutions[1].

Regional Market Dynamics

• North America and Europe: These regions currently dominate the market due to high awareness and availability of ECPs. Products like Preven, although no longer the market leader, have paved the way for more advanced ECPs in these regions[1].
• South America and Asia: These regions are expected to show rapid growth in the coming years due to increasing awareness and government initiatives to improve access to ECPs[1].

Product Evolution

The Preven Emergency Contraceptive Kit, which contained four pills in two pairs (each pair consisting of 0.25mg levonorgestrel and 0.05mg ethinyl estradiol), was the first FDA-approved product specifically for emergency contraception. However, the market has since evolved:

• Single-Dose ECPs: The World Health Organization (WHO) now recommends a single dose of 1.5 mg levonorgestrel for emergency contraception, which is more effective and has fewer side effects compared to combined estrogen/progestin ECPs like Preven[4].
• Current Market Leaders: Products like Plan B, NorLevo, and others containing levonorgestrel have become more popular due to their efficacy and convenience[4].

Financial Impact and Cost Savings

The use of ECPs, including those like Preven, has significant financial implications:

• Cost Savings: Studies have shown that each dollar spent on ECPs can save between $1.19 to $12.23, depending on the regular contraception method and the consistency of ECP use. This is due to the prevention of unintended pregnancies and related medical costs[2].
• Market Revenue: The growing demand for ECPs translates into increased revenue for manufacturers. However, regulatory and reimbursement challenges can impact market penetration and revenue potential[1].

Regulatory and Reimbursement Challenges

The market for ECPs, including products like Preven, faces several regulatory and reimbursement challenges:

• Access Restrictions: In some regions, especially in the US, access to ECPs is restricted. For example, some states permit pharmacists to dispense ECPs without prescriptions, while others prohibit it. Reimbursement policies also vary, which can limit market penetration[1].
• Impact on Revenue: These restrictions can result in potential revenue loss for vendors, despite the overall growing demand for ECPs[1].

Consumer Behavior and Usage Trends

Consumer behavior plays a crucial role in the market dynamics of ECPs:

• Usage Statistics: According to the CDC, in 2006-2010, about 11% of sexually experienced women aged 15-44 had used emergency contraception at least once. Young adult women aged 20-24 were the most likely to have used ECPs[3].
• Reasons for Use: The primary reasons for using ECPs include fear of method failure and unprotected sex. These reasons highlight the need for reliable and accessible emergency contraceptive options[3].

Key Players and Market Competition

The ECP market is competitive, with several key players:

• Major Manufacturers: Companies like AbbVie Inc., Bayer AG, Pfizer Inc., and Teva Pharmaceutical Industries Ltd. are significant players in the market. These companies focus on developing new and effective contraceptives to cater to the increasing demand[1].
• Market Competition: The competition is driven by innovation, regulatory compliance, and market accessibility. Manufacturers that can navigate these factors effectively are likely to dominate the market[1].

Conclusion

The Preven Emergency Contraceptive Kit, while no longer a market leader, has contributed to the evolution of the ECP market. The current market is driven by increasing awareness, government initiatives, and technological advancements. Despite regulatory challenges, the financial trajectory of the ECP market is positive, with significant cost savings and revenue growth anticipated.

Key Takeaways

• The global ECP market is growing at a CAGR of 4.36% from 2024 to 2028.
• Increasing awareness and government initiatives are key drivers of market growth.
• Single-dose levonorgestrel ECPs are now preferred over combined estrogen/progestin ECPs like Preven.
• Regulatory and reimbursement challenges impact market penetration and revenue.
• ECPs offer significant cost savings by preventing unintended pregnancies.

FAQs

1. What is the current market size of the global emergency contraceptive pills market?

   • The global ECP market is estimated to grow by USD 240.3 million from 2024 to 2028[1].

2. Which regions dominate the ECP market?

   • North America and Europe currently dominate the market due to high awareness and availability of ECPs[1].

3. What are the common active ingredients in ECPs?

   • Common active ingredients include ulipristal acetate and levonorgestrel[1].

4. How do regulatory challenges affect the ECP market?

   • Regulatory challenges, such as varying access restrictions and reimbursement policies, can limit market penetration and revenue potential[1].

5. What are the cost savings associated with using ECPs?

   • Each dollar spent on ECPs can save between $1.19 to $12.23, depending on the regular contraception method and the consistency of ECP use[2].

Cited Sources

1. Technavio: Emergency Contraceptive Pills Market size is set to grow by USD 240.3 million from 2024-2028[1].
2. PubMed: Cost savings from emergency contraceptive pills in Canada[2].
3. CDC: Use of Emergency Contraception Among Women Aged 15–44[3].
4. PATH: Regulation, Procurement, and Distribution of a Progestin-Only ECP[4].
5. Smithsonian Institution: Preven Emergency Contraceptive Kit[5].