~ Buy the NEXTSTELLIS (drospirenone; estetrol) Drug Profile, 2024 PDF Report in the Report Store ~

NEXTSTELLIS Drug Patent Profile

When do Nextstellis patents expire, and when can generic versions of Nextstellis launch?

Nextstellis is a drug marketed by Mayne Pharma and is included in one NDA. There are four patents protecting this drug.

This drug has two hundred and two patent family members in forty-seven countries.

The generic ingredient in NEXTSTELLIS is drospirenone; estetrol. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the drospirenone; estetrol profile page.

DrugPatentWatch^® Generic Entry Outlook for Nextstellis

Nextstellis will be eligible for patent challenges on April 15, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 15, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for NEXTSTELLIS

International Patents:	202
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	1
Drug Prices:	Drug price information for NEXTSTELLIS
What excipients (inactive ingredients) are in NEXTSTELLIS?	NEXTSTELLIS excipients list
DailyMed Link:	NEXTSTELLIS at DailyMed

See drug prices for NEXTSTELLIS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NEXTSTELLIS

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

214154

Dosage:

TABLET;ORAL

^*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 NEXTSTELLIS

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

Sponsor	Phase
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4

See all NEXTSTELLIS clinical trials

US Patents and Regulatory Information for NEXTSTELLIS

NEXTSTELLIS is protected by four US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes	7,732,430		Y
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes	11,964,055		Y
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes	11,957,694		Y
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes	11,793,760		Y
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes

EU/EMA Drug Approvals for NEXTSTELLIS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Estetra SPRL	Lydisilka	estetrol, drospirenone	EMEA/H/C/005382 Oral contraception.The decision to prescribe Lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Lydisilka compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).	Authorised	no	no	no	2021-05-19
Gedeon Richter Plc.	Drovelis	estetrol, drospirenone	EMEA/H/C/005336 oral contraceptive	Authorised	no	no	no	2021-05-19

International Patents for NEXTSTELLIS

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

Country	Patent Number	Title	Estimated Expiration
Canada	2448270
Serbia	50909	FARMACEUTSKE KOMPOZICIJE KOJE SE SASTOJE OD JEDNOG ILI VIŠE STEROIDA, JEDNE ILI VIŠE TETRAHIDROFOLATNE KOMPONENTE I VITAMINA B12 (PHARMACEUTICAL COMPOSITIONS COMPRISING ONE OR MORE STEROIDS ONE OR MORE TETRAHYDROFOLATE COMPONENTS AND VITAMIN B12)
Colombia	2017012670	Unidad de dosificación orodispersable que contiene un componente estetrol
World Intellectual Property Organization (WIPO)	02094280
Eurasian Patent Organization	200401014

Supplementary Protection Certificates for NEXTSTELLIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3632448	LUC00266	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
3701944	PA2022508	Lithuania		PRODUCT NAME: DROSPIRENONAS DERINYJE SU ESTETROLIU; REGISTRATION NO/DATE: EU/1/21/1547 20210519
0398460	SPC/GB04/032	United Kingdom		PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
3701944	PA2022508,C3701944	Lithuania		PRODUCT NAME: DROSPIRENONAS DERINYJE SU ESTETROLIU; REGISTRATION NO/DATE: EU/1/21/1547 20210519
2588114	LUC00227	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022

NEXTSTELLIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NEXTSTELLIS

Introduction to NEXTSTELLIS

NEXTSTELLIS is a novel, combined oral contraceptive (COC) developed by Mayne Pharma in collaboration with Mithra Pharmaceuticals SA. It contains 3 mg of drospirenone (DRSP) and 14.2 mg of estetrol (E4), a naturally occurring estrogen produced by the human fetal liver during pregnancy and now derived from a plant source[3][4].

Market Context

NEXTSTELLIS enters a competitive market valued at $US3.4 billion for short-acting combined hormonal contraceptives (CHCs), with nearly 10 million American women using these products[5].

Regulatory Approval and Launch

The U.S. Food and Drug Administration (FDA) approved NEXTSTELLIS in April 2021, marking a significant milestone in the product's journey to market. This approval was based on comprehensive clinical studies involving over 3,725 women aged 16 to 50 years, including those with a body mass index (BMI) of up to 35 kg/m²[3].

Clinical Evidence and Safety Profile

The clinical data presented at the International Society for the Study of Women’s Sexual Health (ISSWSH) highlighted NEXTSTELLIS's selective impact on endocrine markers. It showed limited changes in hormone binding globulins and circulating androgens compared to traditional COCs based on ethinyl-estradiol (EE). Specifically, NEXTSTELLIS resulted in lower increases in sex hormone-binding globulin (SHBG) and similar decreases in total and free testosterone levels compared to other COCs[1][4].

Market Acceptance and Uptake

The market acceptance of NEXTSTELLIS is crucial for its financial success. Given its unique estrogen component and favorable safety and tolerability profile, NEXTSTELLIS is positioned to attract women and healthcare providers looking for alternative contraceptive options. Mayne Pharma anticipates that the novel nature of estetrol (E4) will differentiate NEXTSTELLIS in a market dominated by products containing synthetic estrogen[3].

Financial Implications

Mayne Pharma is banking on NEXTSTELLIS to restore its financial health. The company has a significant stake in the women’s health portfolio, and the success of NEXTSTELLIS could bolster its financial performance. Here are some key financial considerations:

Revenue Potential

• With a large and established market for CHCs, NEXTSTELLIS has the potential to generate substantial revenue. Mayne Pharma’s ability to capture a significant share of this $US3.4 billion market will be critical to its financial recovery[5].

Competitive Landscape

• The contraceptive market is highly competitive, with numerous established brands. NEXTSTELLIS must compete effectively against these brands to gain market share. Mayne Pharma’s extensive experience in drug delivery and its strong women’s health portfolio could be advantageous in this regard[1][4].

Manufacturing and Distribution

• Mayne Pharma has partnered with Mithra Pharmaceuticals SA for the development and manufacturing of NEXTSTELLIS. This partnership ensures a reliable supply chain, which is essential for maintaining market presence and meeting demand[3].

Regulatory and Compliance Costs

• The company will need to comply with ongoing regulatory requirements, which can be costly. Failure to comply could result in penalties, including market withdrawal, which would negatively impact financial performance[2].

Challenges and Risks

Market Competition

• NEXTSTELLIS faces competition from well-established contraceptive brands. The ability to differentiate itself through its unique estrogen component and clinical evidence will be crucial for market acceptance[5].

Regulatory Risks

• Regulatory environments can be unpredictable, and changes in legislation or regulatory requirements could increase the difficulty and cost of commercializing NEXTSTELLIS[2].

Financial Sustainability

• Mayne Pharma has a history of operating losses and will need to secure additional financing to support the commercialization of NEXTSTELLIS. The company’s ability to manage its financial resources effectively will be vital to its long-term sustainability[2].

Future Outlook

The approval and launch of NEXTSTELLIS mark a significant step forward for Mayne Pharma. Here are some key aspects of its future outlook:

Commercial Launch

• The commercial launch of NEXTSTELLIS, anticipated by the end of June 2021, is a critical milestone. Successful marketing and distribution strategies will be essential for capturing market share[3].

Expansion and Growth

• If NEXTSTELLIS gains traction, it could lead to expansion opportunities within the women’s health segment. Mayne Pharma’s extensive pipeline, including other branded and generic contraceptives, positions the company for potential future growth[4].

Patient and Provider Adoption

• The adoption rate among patients and healthcare providers will be a key indicator of NEXTSTELLIS's success. Positive clinical evidence and effective marketing will play crucial roles in driving this adoption[1].

Key Takeaways

• Unique Formulation: NEXTSTELLIS contains a novel estrogen, estetrol (E4), which differentiates it from traditional COCs.
• Regulatory Approval: FDA approval in April 2021 marked a significant milestone.
• Market Potential: The product enters a $US3.4 billion market with nearly 10 million potential users in the U.S.
• Financial Implications: Success of NEXTSTELLIS is crucial for Mayne Pharma’s financial recovery.
• Challenges: The product faces competition, regulatory risks, and financial sustainability challenges.

FAQs

Q: What is NEXTSTELLIS, and how is it different from other oral contraceptives? A: NEXTSTELLIS is a combined oral contraceptive containing 3 mg drospirenone (DRSP) and 14.2 mg estetrol (E4), a naturally occurring estrogen. It is the first contraceptive to use estetrol, distinguishing it from other COCs that use synthetic estrogen.

Q: When was NEXTSTELLIS approved by the FDA? A: NEXTSTELLIS was approved by the FDA in April 2021[3].

Q: What are the key clinical findings related to NEXTSTELLIS? A: Clinical data showed that NEXTSTELLIS resulted in limited changes in endocrine markers, including lower increases in SHBG and similar decreases in total and free testosterone levels compared to traditional COCs[1][4].

Q: What is the market potential for NEXTSTELLIS? A: NEXTSTELLIS enters a $US3.4 billion market for short-acting combined hormonal contraceptives, with nearly 10 million American women using these products[5].

Q: What are the financial risks associated with the launch of NEXTSTELLIS? A: Mayne Pharma faces risks related to market competition, regulatory compliance costs, and the need for additional financing to support commercialization[2].

Sources

1. Biospace: New Data Show NEXTSTELLIS® Has Selective Impact On Endocrine Markers Compared With Common Combined Oral Contraceptives[1].
2. United States Securities and Exchange Commission: Agile Therapeutics Annual Report on Form 10-K[2].
3. Biospace: U.S. FDA Approves NEXTSTELLIS®, New Oral Contraceptive[3].
4. PR Newswire: New Data Show NEXTSTELLIS® Has Selective Impact On Endocrine Markers Compared With Common Combined Oral Contraceptives[4].
5. InDaily: Mayne Pharma banks on new pill to restore financial health[5].