ETHINYL ESTRADIOL; SEGESTERONE ACETATE - Generic Drug Details

What are the generic sources for ethinyl estradiol; segesterone acetate and what is the scope of patent protection?

Ethinyl estradiol; segesterone acetate is the generic ingredient in one branded drug marketed by Mayne Pharma and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ethinyl estradiol; segesterone acetate has fourteen patent family members in fourteen countries.

Two suppliers are listed for this compound.

Summary for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

International Patents:	14
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	2
DailyMed Link:	ETHINYL ESTRADIOL; SEGESTERONE ACETATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

Constraining patent/regulatory exclusivity:

10,918,649

Dosage:

RING;VAGINAL

^*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 ETHINYL ESTRADIOL; SEGESTERONE ACETATE

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

Sponsor	Phase
TherapeuticsMD	Phase 1

See all ETHINYL ESTRADIOL; SEGESTERONE ACETATE clinical trials

Pharmacology for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes	10,940,157		Y
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes	11,850,251
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes	10,780,047

International Patents for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

Country	Patent Number	Title	Estimated Expiration
Brazil	112021025853	Sistema para fornecimento de controle de natalidade
South Korea	20220027979	산아 제한을 제공하기 위한 시스템
Colombia	2021017509	Sistema para proporcionar control de la natalidad

Supplementary Protection Certificates for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

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
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211

ETHINYL ESTRADIOL; SEGESTERONE ACETATE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Annovera (Segesterone Acetate and Ethinyl Estradiol Vaginal System)

Introduction

Annovera, a combined hormonal contraceptive vaginal system containing segesterone acetate and ethinyl estradiol, was approved by the FDA in August 2018. This innovative contraceptive offers a unique combination of convenience, efficacy, and user control, making it an attractive option in the contraceptive market.

Market Potential

The market for contraceptives is significant, driven by the need for effective and convenient methods to prevent pregnancy. Annovera fills a niche by providing a long-lasting, user-controlled hormonal contraceptive that does not require daily administration or special storage conditions. This convenience is particularly appealing, as it addresses the issue of inconsistent or incorrect use of contraceptives, which is a common reason for unintended pregnancies[1].

User Experience and Acceptance

Clinical trials and post-marketing data indicate that Annovera is well-accepted by users. The vaginal ring is inserted for 21 days and removed for 7 days each cycle, and the same ring can be used for up to 13 cycles (one year). This regimen is associated with a highly favorable and consistent bleeding pattern, leading to very low discontinuation rates[3].

Efficacy and Safety

Annovera has demonstrated efficacy comparable to other combined hormonal contraceptives. The pooled efficacy data from Phase 3 studies showed a pregnancy incidence (PI) of 2.98 per 100 woman-years, which is within the range of other recently approved products for the same indication[1].

However, like other combination hormonal contraceptives, Annovera carries a risk of venous thromboembolism (VTE). The estimated rate of VTE for Annovera was higher than some other combination hormonal contraceptives, with 24 cases per 10,000 woman-years, although this estimate is associated with a wide confidence interval indicating uncertainty. Further postmarketing studies are planned to evaluate this risk more thoroughly[5].

Financial Performance

Since its launch, Annovera has shown promising financial performance, although it has faced some challenges.

Revenue

In the third quarter of 2022, Annovera generated net product revenue of $10.4 million, which was a decrease from $11.8 million in the third quarter of 2021. Despite this, the total prescriptions for Annovera grew by 10% compared to the third quarter of 2021[2].

Prescription Trends

Approximately 9,200 Annovera prescriptions were dispensed to patients during the third quarter of 2022. Over 15,000 healthcare providers have prescribed Annovera since its launch, with more than 1,500 new prescribers added in the third quarter of 2022 alone[2].

Market Adoption

The product has been adopted by a significant number of healthcare providers and patients. The growth in prescriptions and the expansion of the prescriber base indicate a positive market reception. However, the company has had to navigate inventory issues and other operational challenges, which have impacted revenue in some quarters[2].

Competitive Landscape

Annovera is the second FDA-approved combination hormonal vaginal ring contraceptive in the U.S., following the etonogestrel/ethinyl estradiol ring (Nuvaring, Eluryng, and equivalents). The unique selling point of Annovera is its long-lasting use – one ring can be used for up to a year without the need for refrigeration prior to dispensing, which adds to its convenience and user appeal[3][5].

Future Outlook

Despite some initial challenges, the market dynamics suggest a promising future for Annovera. The convenience, efficacy, and user-controlled nature of the product are likely to continue attracting users. However, ongoing monitoring of the VTE risk and further postmarketing studies will be crucial in maintaining and enhancing its market position.

Postmarketing Commitments

The FDA has required postmarketing studies to further evaluate the risk of VTE associated with Annovera, particularly in women with a BMI >29 kg/m². These studies will help in refining the safety profile and potentially expanding the product's use in different populations[5].

Market Expansion

With the wholesale network now fully stocked and inventory issues resolved, TherapeuticsMD, the company behind Annovera, is well-positioned to continue growing its market share. The addition of new prescribers and the stable prescription trends indicate a strong foundation for future growth[2].

Key Takeaways

• Convenience and Efficacy: Annovera offers a convenient, long-lasting, and user-controlled hormonal contraceptive option.
• Market Adoption: The product has been well-received by healthcare providers and patients, with growing prescription trends.
• Financial Performance: Despite some revenue fluctuations, Annovera has shown promising financial performance and growth potential.
• Safety Monitoring: Ongoing postmarketing studies are crucial for refining the safety profile, particularly regarding VTE risk.
• Competitive Advantage: Annovera's unique features, such as its long-lasting use and lack of need for refrigeration, differentiate it in the market.

FAQs

Q: What is Annovera, and how is it used?

A: Annovera is a combined hormonal contraceptive vaginal system containing segesterone acetate and ethinyl estradiol. It is inserted vaginally for 21 days and removed for 7 days each cycle, with the same ring usable for up to 13 cycles (one year)[1].

Q: How effective is Annovera in preventing pregnancy?

A: Annovera has demonstrated an efficacy comparable to other combined hormonal contraceptives, with a pregnancy incidence of 2.98 per 100 woman-years[1].

Q: What are the potential risks associated with Annovera?

A: Like other combination hormonal contraceptives, Annovera carries a risk of venous thromboembolism (VTE). The estimated rate of VTE for Annovera is higher than some other products, and further postmarketing studies are planned to evaluate this risk[5].

Q: How has Annovera performed financially since its launch?

A: Annovera generated $10.4 million in net product revenue in the third quarter of 2022, with a 10% growth in prescriptions compared to the third quarter of 2021. Despite some revenue fluctuations, the product has shown promising financial performance and growth potential[2].

Q: What are the unique selling points of Annovera compared to other contraceptives?

A: Annovera's unique features include its long-lasting use (up to one year without replacement), lack of need for refrigeration prior to dispensing, and a convenient dosing regimen that does not require daily administration[1][3].

Sources

1. FDA Multi-disciplinary Review and Evaluation: Annovera - accessdata.fda.gov
2. TherapeuticsMD Announces Third Quarter 2022 Financial Results - ir.therapeuticsmd.com
3. A Technology Evaluation of Annovera - ohsu.elsevierpure.com
4. NDA/BLA Multi-disciplinary Review and Evaluation: Annovera - fda.gov
5. Segesterone Acetate/Ethinyl Estradiol Contraceptive Vaginal Ring (Annovera) - va.gov/formularyadvisor