Drospirenone; estetrol - Generic Drug Details

What are the generic drug sources for drospirenone; estetrol and what is the scope of freedom to operate?

Drospirenone; estetrol is the generic ingredient in one branded drug marketed by Mayne Pharma and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Drospirenone; estetrol has two hundred and ten patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for drospirenone; estetrol

International Patents:	210
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	10
DailyMed Link:	drospirenone; estetrol at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for drospirenone; estetrol

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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 drospirenone; estetrol

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

Sponsor	Phase
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4
Quotient Sciences	Phase 1
Estetra	Phase 2

See all drospirenone; estetrol clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for drospirenone; estetrol

G03AA	Progestogens and estrogens, fixed combinations
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for drospirenone; estetrol

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
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes			Y
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes			Y
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes			Y
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes			Y

EU/EMA Drug Approvals for drospirenone; estetrol

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 drospirenone; estetrol

Country	Patent Number	Title	Estimated Expiration
Denmark	1390042
Portugal	3106148
Singapore	10202010432U
Portugal	1390040
European Patent Office	1293210	Kit et méthode contraceptive hormonale (Means and method for hormonal contraception)
Eurasian Patent Organization	007599	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ОДИН ИЛИ НЕСКОЛЬКО СТЕРОИДОВ, ОДИН ИЛИ НЕСКОЛЬКО ТЕТРАГИДРОФОЛАТНЫХ КОМПОНЕНТОВ И ВИТАМИН В (PHARMACEUTICAL COMPOSITIONS COMPRISING ONE OR MORE STEROIDS ONE OR MORE TETRAHYDROPOLATE COMPONENTS AND VITAMIN B)

Supplementary Protection Certificates for drospirenone; estetrol

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
3632448	LUC00266	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
3632448	22C1031	France		PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016
0398460	04C0022	France		PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211

Market Dynamics and Financial Trajectory for the Drug: Drospirenone and Estetrol

Introduction

The combination of drospirenone and estetrol, marketed as Nextstellis, represents a significant advancement in the field of oral contraception. This article delves into the market dynamics and financial trajectory of this drug, highlighting its approval, market performance, and the impact on the pharmaceutical industry.

Approval and Regulatory Landscape

On April 15, 2021, the FDA approved Nextstellis, a combination of drospirenone and estetrol, for use as an oral contraceptive. This approval marked the first new estrogen introduced in the USA in over 50 years and the first approved estetrol product globally[1][4].

Market Entry and Commercialization

Nextstellis was developed by Mithra Pharmaceuticals and is marketed by Searchlight Pharma in Canada and by Mayne Pharma Group Limited in the United States. The drug's commercialization began in the first half of 2021, following FDA approval. This new product offers a favorable safety profile, making it an attractive option for women seeking contraceptive therapy[1][3].

Market Dynamics

The introduction of Nextstellis enters a market characterized by intense competition and significant regulatory and economic challenges. The US generic pharmaceutical industry has faced disruptions due to customer consolidation and the increased speed of FDA approvals, leading to price deflation and pressure on trading terms. Companies like Mayne Pharma have had to reposition their business towards more protectable revenue streams, focusing on areas such as women’s health, dermatology, and infectious diseases[3].

Competitive Landscape

The contraceptive market is highly competitive, with established products like YAZ (drospirenone and ethinyl estradiol) tablets. However, Nextstellis offers a unique selling point with estetrol, a native estrogen that is safer and more potent than synthetic estrogens like ethinylestradiol (EE2). This differentiation could help Nextstellis carve out a significant market share[1][4].

Pricing and Revenue

Given the competitive nature of the market, pricing strategies will be crucial. Mayne Pharma, facing declining sales and earnings in their generic division, sees Nextstellis as a key growth product. The company has invested heavily in commercial infrastructure to support the launch of this and other branded products, which is expected to improve their financial performance in the future[3].

Financial Trajectory

Impact on Mayne Pharma

Mayne Pharma's financial performance has been impacted by the challenging market dynamics in the generic pharmaceutical industry. However, the company is repositioning itself with a focus on women’s health, among other areas. The launch of Nextstellis is expected to be a significant contributor to their revenue growth. In 2019, Mayne Pharma reported an EBITDA of $131 million, down 20% from the previous year, but the company anticipates improved financials with the commercialization of new products like Nextstellis[3].

Revenue Projections

While specific revenue projections for Nextstellis are not publicly disclosed, the drug is expected to become a key contributor to Mayne Pharma's women’s health portfolio. The company's focus on branded generic contraceptives and the pipeline that includes Nextstellis suggests a positive financial outlook for this segment[3].

Clinical and Safety Profile

Efficacy and Safety

Clinical trials have shown that the combination of drospirenone and estetrol is safe and effective for contraception. It also has a potentially decreased risk of thromboembolic events compared to other oral contraceptives, making it an attractive option for women[5].

Environmental Impact

Estetrol is noted for its reduced environmental impact compared to synthetic estrogens. It does not contribute to the accumulation of unwanted endocrine-disrupting chemicals (EDCs), which can have harmful epigenetic effects[1].

Market Expansion and Future Prospects

Therapeutic Areas

Beyond contraception, estetrol has potential applications in various therapeutic areas, including menopause and possibly endometriosis treatment. This broader therapeutic potential could further expand the market for Nextstellis and similar products[3][5].

Global Market

The approval and commercialization of Nextstellis in the US and Canada are expected to pave the way for global market expansion. As more countries approve this combination, it is likely to become a significant player in the global oral contraceptive market.

Challenges and Opportunities

Regulatory Challenges

Despite the FDA approval, the pharmaceutical industry faces ongoing regulatory challenges. Companies must navigate complex approval processes and ensure compliance with evolving regulatory standards. However, the approval of Nextstellis demonstrates that innovative products can successfully navigate these challenges[4].

Market Opportunities

The introduction of Nextstellis opens up new opportunities in the women’s health segment. With its favorable safety profile and unique estrogen component, it has the potential to capture a significant share of the market. Additionally, the focus on women’s health and other protectable revenue streams is expected to drive long-term growth for companies like Mayne Pharma[3].

Key Takeaways

• Approval and Commercialization: Nextstellis, a combination of drospirenone and estetrol, was approved by the FDA in April 2021 and is marketed by Mayne Pharma Group Limited and Searchlight Pharma.
• Market Dynamics: The drug enters a competitive market with significant regulatory and economic challenges but offers a unique selling point with estetrol.
• Financial Trajectory: The launch of Nextstellis is expected to contribute significantly to Mayne Pharma's revenue growth, particularly in the women’s health segment.
• Clinical and Safety Profile: The combination is safe and effective, with a potentially decreased risk of thromboembolic events.
• Market Expansion: Estetrol has broader therapeutic potential, including menopause and endometriosis treatment, which could expand the market for Nextstellis.

FAQs

What is the unique selling point of Nextstellis compared to other oral contraceptives?

Nextstellis contains estetrol, a native estrogen that is safer and more potent than synthetic estrogens like ethinylestradiol (EE2), and has a reduced environmental impact.

When was Nextstellis approved by the FDA?

Nextstellis was approved by the FDA on April 15, 2021.

Who are the key players involved in the development and marketing of Nextstellis?

The key players involved are Mithra Pharmaceuticals, Mayne Pharma Group Limited, and Searchlight Pharma.

What are the potential therapeutic areas for estetrol beyond contraception?

Estetrol has potential applications in menopause and possibly endometriosis treatment.

How does the financial performance of Mayne Pharma relate to the launch of Nextstellis?

The launch of Nextstellis is expected to improve Mayne Pharma's financial performance, particularly in the women’s health segment, as the company repositions itself towards more protectable revenue streams.

Sources

1. DrugBank Online: Estetrol: Uses, Interactions, Mechanism of Action.
2. Synapse: Drospirenone/Estetrol - Drug Targets, Indications, Patents.
3. ASX Announcement: Mayne Pharma’s recent performance and future outlook.
4. FDA: 214154Orig1s000ChemR.pdf - NEXTSTELLIS (drospirenone and estetrol) tablets.
5. Fertility and Sterility: Efficacy and safety of the combination of estetrol 15 mg and drospirenone 3 mg in a 24/4-day regimen for contraception.