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BIJUVA Drug Patent Profile

Which patents cover Bijuva, and when can generic versions of Bijuva launch?

Bijuva is a drug marketed by Mayne Pharma and is included in one NDA. There are twenty-four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy-one patent family members in twenty-one countries.

The generic ingredient in BIJUVA is estradiol; progesterone. There are seventy-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the estradiol; progesterone profile page.

DrugPatentWatch^® Generic Entry Outlook for Bijuva

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BIJUVA

International Patents:	171
US Patents:	24
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Drug Prices:	Drug price information for BIJUVA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BIJUVA
What excipients (inactive ingredients) are in BIJUVA?	BIJUVA excipients list
DailyMed Link:	BIJUVA at DailyMed

See drug prices for BIJUVA

Pharmacology for BIJUVA

Drug Class	Estrogen Progesterone
Mechanism of Action	Estrogen Receptor Agonists

Paragraph IV (Patent) Challenges for BIJUVA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BIJUVA	Capsules	estradiol; progesterone	1 mg/100 mg	210132	1	2020-01-06

US Patents and Regulatory Information for BIJUVA

BIJUVA is protected by twenty-four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	11,529,360		Y
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	11,103,513
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	8,993,549		Y
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	11,793,819

International Patents for BIJUVA

When does loss-of-exclusivity occur for BIJUVA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

European Patent Office

France

Hungary

Israel

Japan

Lithuania

Mexico

Poland

Portugal

Russian Federation

Serbia

South Africa

South Korea

Spain

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

See the table below for additional patents covering BIJUVA around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	2014015899
Mexico	2014015898	FORMULACIONES Y TERAPIAS DE REEMPLAZO DE COMBINACION DE HORMONAS NATURALES. (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES.)
Argentina	127914	COMPOSICIONES FARMACÉUTICAS DE ESTRADIOL INSERTADAS EN LA VAGINA Y PROCEDIMIENTOS
Serbia	62297	PRIRODNE KOMBINOVANE HORMONSKE SUPSTITUCIONE FORMULACIJE I TERAPIJE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)

Supplementary Protection Certificates for BIJUVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2861072	2024C/512	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL, EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS SOUS FORME HEMIHYDRATEE) ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
2782584	21C1058	France		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406
2782584	C202130068	Spain		PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL (17BETA-ESTRADIOL), INCLUYENDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406
2782584	132021000000197	Italy		PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517

BIJUVA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BIJUVA

Introduction to BIJUVA

BIJUVA, developed by TherapeuticsMD, is the first and only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral daily capsule. It is designed to treat moderate-to-severe vasomotor symptoms (hot flashes or flushes) in menopausal women with a uterus[1][3].

Market Need and Target Audience

BIJUVA addresses a significant unmet need in the market by offering an FDA-approved bio-identical alternative to synthetic hormone combinations and the combined use of separate estrogen and progesterone products. The target audience includes menopausal women, particularly those experiencing moderate to severe hot flashes, which affect up to 80% of menopausal women[1].

FDA Approval and Clinical Trials

BIJUVA received FDA approval in October 2018 based on the pivotal Phase III Replenish Trial. This trial evaluated the safety and efficacy of BIJUVA in postmenopausal women with a uterus, demonstrating a statistically significant reduction in the frequency and severity of hot flashes compared to placebo, while also reducing the risks to the endometrium[3].

Commercial Availability and Insurance Coverage

BIJUVA became commercially available in the United States in the second quarter of 2019. It is covered by several major commercial payers, including Express Scripts, Anthem, and Aetna, which has been a significant factor in its market adoption[1].

Financial Performance

Revenue Trends

• In the second quarter of 2022, BIJUVA net product revenue was $2.7 million, an increase of $0.5 million compared to the same period in 2021. This included $0.3 million from export sales through an international licensing agreement[2].
• For the third quarter of 2022, BIJUVA net product revenue was $2.7 million, a decrease of $0.6 million compared to the third quarter of 2021. This also included $0.4 million from export sales[5].

Gross Margin and Cost of Goods Sold

• The product gross margin for BIJUVA has been consistently high, with an 83% gross margin in the second quarter of 2022 and an 82% gross margin in the third quarter of 2022. This is attributed to changes in the product sales mix and increased sales volumes[2][5].

Operating Expenses and Net Loss

• Despite the revenue, TherapeuticsMD has reported net losses. For the third quarter of 2022, the net loss was $29.0 million, or $3.13 per basic and diluted share, which is an improvement from the $47.4 million net loss in the third quarter of 2021[5].

Market Adoption and Prescriber Base

• The adoption of BIJUVA has been supported by its unique positioning as an FDA-approved bio-identical hormone therapy. Healthcare providers and patients have shown interest in this product, contributing to its growing prescriber base and patient prescriptions[1][5].

Patent Protection and Generic Challenges

• BIJUVA is protected by 24 US patents and 171 international patent family members. However, there has been one Paragraph IV challenge, indicating potential generic competition in the future[4].

International Sales and Licensing

• TherapeuticsMD has an international licensing and supply agreement with Theramex HQ UK Limited, which has contributed to export sales of BIJUVA. This agreement has helped expand the product's reach beyond the US market[2][5].

Competitive Landscape

• BIJUVA competes in a market that includes other hormone therapies, both synthetic and bio-identical. Its unique FDA approval and bio-identical composition set it apart, but it faces competition from other products like ANNOVERA and IMVEXXY, also developed by TherapeuticsMD[1][5].

Future Outlook

• The financial trajectory of BIJUVA is influenced by several factors, including market adoption, insurance coverage, and potential generic competition. Despite some fluctuations in revenue, the product's unique positioning and growing prescriber base suggest continued relevance in the women’s healthcare market[1][2][5].

Key Takeaways

• FDA Approval: BIJUVA is the first FDA-approved bio-identical hormone therapy combination of estradiol and progesterone.
• Market Need: It addresses a significant need for menopausal women experiencing hot flashes.
• Financial Performance: Revenue has shown mixed trends, but gross margins remain high.
• Patent Protection: Protected by multiple US and international patents, but faces potential generic challenges.
• International Sales: Export sales contribute to its revenue through licensing agreements.
• Competitive Landscape: Competes with other hormone therapies, but its unique FDA approval is a key differentiator.

FAQs

What is BIJUVA used for?

BIJUVA is used for the treatment of moderate-to-severe vasomotor symptoms (hot flashes or flushes) due to menopause in women with a uterus[1].

When was BIJUVA approved by the FDA?

BIJUVA was approved by the FDA in October 2018[3].

What makes BIJUVA unique?

BIJUVA is the first and only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral daily capsule[1].

How is BIJUVA covered by insurance?

BIJUVA is covered by several major commercial payers, including Express Scripts, Anthem, and Aetna[1].

What are the common side effects of BIJUVA?

Common side effects include breast tenderness, headache, vaginal bleeding, vaginal discharge, and pelvic pain[3].

Sources

1. TherapeuticsMD Announces Commercial Availability of BIJUVA™ in the U.S. - Biospace
2. TherapeuticsMD Announces Second Quarter 2022 Financial Results - Biospace
3. TherapeuticsMD Announces FDA Approval of TX-001HR: BIJUVA™ - Business Wire
4. BIJUVA Drug Patent Profile - DrugPatentWatch
5. TherapeuticsMD Announces Third Quarter 2022 Financial Results - TherapeuticsMD IR