MINIVELLE Drug Patent Profile

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

Minivelle is a drug marketed by Noven and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has twenty-three patent family members in fifteen countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Minivelle

A generic version of MINIVELLE was approved as estradiol by BARR LABS INC on October 22^nd, 1997.

Summary for MINIVELLE

International Patents:	23
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	102
Drug Prices:	Drug price information for MINIVELLE
Drug Sales Revenues:	Drug sales revenues for MINIVELLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MINIVELLE
What excipients (inactive ingredients) are in MINIVELLE?	MINIVELLE excipients list
DailyMed Link:	MINIVELLE at DailyMed

See drug prices for MINIVELLE

See drug sales revenues for MINIVELLE

Pharmacology for MINIVELLE

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Paragraph IV (Patent) Challenges for MINIVELLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MINIVELLE	Transdermal System	estradiol	0.025 mg/day	203752	1	2015-05-08
MINIVELLE	Transdermal System	estradiol	0.0375 mg/day 0.05 mg/day 0.075 mg/day 0.1 mg/day	203752	1	2014-08-18

US Patents and Regulatory Information for MINIVELLE

MINIVELLE is protected by 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
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-005	Sep 23, 2014	AB3	RX	Yes	No	9,730,900		Y
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-001	Oct 29, 2012	AB3	RX	Yes	No	8,231,906		Y	Y
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-005	Sep 23, 2014	AB3	RX	Yes	No	9,724,310		Y	Y
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-002	Oct 29, 2012	AB3	RX	Yes	No	9,833,419		Y
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-003	Oct 29, 2012	AB3	RX	Yes	No	9,730,900

Expired US Patents for MINIVELLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-002	Oct 29, 2012	5,656,286
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-004	Oct 29, 2012	5,656,286
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-005	Sep 23, 2014	6,841,716
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-002	Oct 29, 2012	6,024,976
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-004	Oct 29, 2012	6,841,716

International Patents for MINIVELLE

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

Country	Patent Number	Title	Estimated Expiration
Brazil	9506470	COMPOSIÇÃO ADESIVA SENSÍVEL À PRESSÃO E SISTEMA DE DISTRIBUIÇÃO TRANSDÉRMICA DE DROGA.
Germany	69214938
Hong Kong	1155942	經皮雌二醇裝置和遞送 (TRANSDERMAL ESTRADIOL DEVICE AND DELIVERY)
Finland	935833
Canada	2044132	SYSTEME D'ADMINISTRATION TRANSDERMIQUE DE MEDICAMENTS EN ACRYLIQUE MULTIPOLYMERE (TRANSDERMAL ACRYLIC MULTIPOLYMER DRUG DELIVERY SYSTEM)

Supplementary Protection Certificates for MINIVELLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	C 2015 029	Romania		PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
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
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
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

Market Dynamics and Financial Trajectory for Minivelle (Estradiol Transdermal System)

Introduction

Minivelle, an estradiol transdermal system, is a prescription medication developed by Noven Pharmaceuticals, Inc. It is designed to treat moderate to severe vasomotor symptoms (VMS) due to menopause, commonly known as hot flashes and night sweats, and to prevent postmenopausal osteoporosis. Here, we delve into the market dynamics and financial trajectory of Minivelle.

FDA Approval and Indications

Minivelle was initially approved by the FDA in October 2012 for the treatment of moderate to severe VMS due to menopause. In September 2014, the FDA expanded its indication to include the prevention of postmenopausal osteoporosis for all doses of Minivelle, with the 0.025 mg/day dose specifically approved for this indication[1][4].

Market Positioning

Minivelle is marketed as the smallest estrogen therapy patch available, which is a significant selling point. It is 34% smaller than Vivelle-Dot®, another product from Noven Pharmaceuticals, and at its lowest strength (0.0375 mg/day), it has a surface area nearly the same as a dime[4].

Dosage Options

Minivelle is available in five dosing options: 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day. The higher doses are indicated for treating VMS, while the 0.025 mg/day dose is specifically for preventing postmenopausal osteoporosis[1][4].

Pricing and Cost

The cost of Minivelle varies depending on the dosage and pharmacy. For example, an 8-film supply of the 0.025 mg/day dose costs around $254, which translates to approximately $31.79 per film. Noven offers a savings program to help reduce co-pays for eligible patients, allowing them to pay no more than $15 for a one-month supply on co-pays up to $70, and up to $55 in savings for co-pays exceeding $70[2].

Competitive Landscape

Minivelle competes in the estrogen therapy market, which includes other transdermal systems like Vivelle-Dot®. The unique selling point of Minivelle is its small size and the variety of dosing options, making it appealing to women with different needs and preferences. However, the market is subject to generic competition, although a generic version of Minivelle is not yet commercially available[2].

Patient and Physician Preferences

The small size and discreet nature of Minivelle make it a preferred option for many women. As noted by Dr. Mary Jane Minkin, "Hot flashes and night sweats are the most commonly reported symptoms of menopause among women," and Minivelle's design addresses these symptoms effectively while being unobtrusive[4].

Safety and Efficacy

Minivelle contains bioidentical estradiol, which is chemically identical to the estrogen produced naturally by a woman's body. It is bioequivalent to Vivelle®, with the same demonstrated safety and efficacy for treating VMS. Common adverse events include headache, breast tenderness, back and limb pain, and others, similar to those reported for Vivelle®[1][4].

Economic Implications of Drug Development

The development and pricing of Minivelle reflect broader trends in pharmaceutical economics. The ability to target specific patient populations with precision medicines, like Minivelle's various dosing options, can influence pricing strategies and profitability. For drugs targeting smaller patient populations, firms may charge higher prices to justify the research and development investments[3].

Market Size and Competition

The market size for estrogen therapies is significant, given the prevalence of menopause symptoms. However, the competition from other estrogen therapies and the potential for generic entry can impact Minivelle's market share. The lack of generic competition for Minivelle currently allows Noven to maintain a strong market position, but this could change if a generic version becomes available[2][3].

Financial Trajectory

The financial trajectory of Minivelle is influenced by its pricing, market demand, and competition. With a robust savings program in place, Noven aims to make Minivelle more accessible to patients, which can help in maintaining or increasing market share. The drug's unique features, such as its small size and multiple dosing options, contribute to its financial success by appealing to a broad range of patients[1][2].

Future Outlook

As the pharmaceutical market continues to evolve, Minivelle's future outlook will depend on several factors, including the emergence of generic competitors, changes in patient preferences, and advancements in estrogen therapy technologies. Noven's continued innovation and marketing efforts will be crucial in maintaining Minivelle's position in the market.

Key Takeaways

• FDA Approval: Minivelle is approved for treating VMS and preventing postmenopausal osteoporosis.
• Dosage Options: Available in five dosing options to cater to different patient needs.
• Pricing: Costs around $254 for an 8-film supply, with savings programs available.
• Market Positioning: Known for being the smallest estrogen therapy patch.
• Safety and Efficacy: Bioequivalent to Vivelle®, with similar safety and efficacy profiles.
• Economic Implications: Reflects trends in precision medicine and targeted patient populations.
• Market Size and Competition: Significant market size but potential for future generic competition.

FAQs

What is Minivelle used for?

Minivelle is used to treat moderate to severe vasomotor symptoms (VMS) due to menopause, such as hot flashes and night sweats, and to prevent postmenopausal osteoporosis.

How many dosing options are available for Minivelle?

Minivelle is available in five dosing options: 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day.

What makes Minivelle unique?

Minivelle is the smallest estrogen therapy patch available, making it discreet and convenient for patients.

How much does Minivelle cost?

The cost of Minivelle is around $254 for an 8-film supply, depending on the pharmacy and dosage. Noven offers a savings program to reduce co-pays.

Is a generic version of Minivelle available?

A generic version of Minivelle has been approved by the FDA but is not yet commercially available.

Sources

1. Biospace: New Minivelle (Estradiol Transdermal System) 0.025 mg/day Dose Now Available by Prescription in U.S. Pharmacies.
2. Drugs.com: Minivelle Prices, Coupons, Copay Cards & Patient Assistance.
3. NBER: The Economics of Drug Development: Pricing and Innovation in a Changing Market.
4. FiercePharma: Minivelle (Estradiol Transdermal System), The Smallest Estrogen Patch, Now Available in U.S. Pharmacies.