ACTIVELLA Drug Patent Profile

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

Activella is a drug marketed by Amneal and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Activella

A generic version of ACTIVELLA was approved as estradiol; norethindrone acetate by BRECKENRIDGE PHARM on April 17^th, 2008.

Summary for ACTIVELLA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	6
Drug Prices:	Drug price information for ACTIVELLA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACTIVELLA
What excipients (inactive ingredients) are in ACTIVELLA?	ACTIVELLA excipients list
DailyMed Link:	ACTIVELLA at DailyMed

See drug prices for ACTIVELLA

See drug sales revenues for ACTIVELLA

Recent Clinical Trials for ACTIVELLA

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

Sponsor	Phase
AbbVie	Phase 3
Gretchen Wells	Phase 4
AbbVie	Phase 2

See all ACTIVELLA clinical trials

Pharmacology for ACTIVELLA

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for ACTIVELLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-001	Nov 18, 1998	AB	RX	Yes	Yes
Amneal	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-002	Dec 28, 2006		DISCN	Yes	No

Expired US Patents for ACTIVELLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amneal	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-001	Nov 18, 1998	RE36247

International Patents for ACTIVELLA

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

Country	Patent Number	Title	Estimated Expiration
Denmark	175317
European Patent Office	0136011	Méthode de traitement hormonal de troubles de la périménopause, ménopause et postménopause et emballage à préparations multiples dans ce but (A method of hormonal treatment of peri-menopausal, menopausal and post-menopausal disorders and multi-preparation pack therefor)
Luxembourg	91096
Mexico	9203720	METODO PARA EL TRATAMIENTO DE DESORDENES PERIMENOPAUSALES, MENOPAUSALES Y POSTMENOPAUSALES COMPOSICIONES Y UN PAQUETE DE MULTIPLES PREPARACIONES PARA ESTE METODO.
Netherlands	970037
Philippines	24052	A METHOD OF HORMONAL TREATMENT OF PERIMENOPAUSAL,MENOPAUSAL AND POST-MENOPAUSAL DISORDERS

Supplementary Protection Certificates for ACTIVELLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
0136011	980038	Netherlands		980038, 20090801, EXPIRES: 20130305
0136011	C00136011/03	Switzerland		PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211

Market Dynamics and Financial Trajectory for Activella (Estradiol/Norethindrone Acetate)

Market Overview

The global market for Estradiol Norethindrone Acetate, a combination hormone replacement therapy (HRT) drug, is experiencing significant growth driven by several key factors. Activella, a brand of Estradiol Norethindrone Acetate, is a prominent player in this market.

Market Drivers

Increasing Prevalence of Menopausal Conditions

The primary driver for the Activella market is the increasing prevalence of menopausal and post-menopausal conditions among the aging global population. As women reach menopause, they experience a decline in natural estrogen production, leading to symptoms such as hot flashes, night sweats, vaginal dryness, and mood changes. This demographic shift is driving the demand for effective HRT solutions like Activella[1].

Growing Awareness and Acceptance of HRT

The growing awareness and acceptance of HRT as a treatment option for managing menopausal symptoms have also contributed to the market's expansion. HRT, which includes the administration of synthetic estrogen and progestin, provides relief from menopausal symptoms and may offer additional benefits such as maintaining bone health and reducing the risk of osteoporosis[1].

Regional Analysis

North America

North America, particularly the United States, is the largest regional market for Activella. This is attributed to the high prevalence of menopausal and post-menopausal conditions, a well-established healthcare infrastructure, and the availability of advanced treatment options. The U.S. accounts for the majority of the North American market, driven by robust demand for effective HRT solutions among the aging female population[1].

Europe

Europe is the second-largest market, with significant contributions from countries like Germany, the United Kingdom, and France. The European market is characterized by a strong regulatory framework, with the European Medicines Agency (EMA) playing a crucial role in the approval and management of HRT products[1].

Asia-Pacific

The Asia-Pacific region is expected to witness the fastest growth during the forecast period. This growth is driven by the large patient population, the rising prevalence of menopausal and post-menopausal conditions, and the improving healthcare infrastructure in countries like China, Japan, and India[1].

Latin America and Middle East & Africa

These regions also present opportunities for growth, albeit at a slower pace, as awareness and access to healthcare services continue to improve. However, economic and political instability, as well as limited healthcare resources, may pose challenges in these markets[1].

Competitive Landscape

The Activella market is moderately competitive, with both large pharmaceutical companies and smaller specialized players. Key players include Allergan (a subsidiary of AbbVie), Teva Pharmaceutical Industries, Mylan, Amneal Pharmaceuticals, and Perrigo. Allergan, with its Activella brand, is a market leader due to its strong brand recognition, extensive research and development capabilities, and global distribution network[1].

Financial Trajectory

Market Size and Growth

The global Estradiol Norethindrone Acetate Drug market, including Activella, is projected to grow at a CAGR of around 4% during the forecast period. This growth is driven by the increasing demand for HRT solutions and the expanding aging population[1].

Revenue and Sales

The financial performance of Activella is closely tied to the overall market trends. With a strong brand presence and extensive distribution network, Activella generates significant revenue. For instance, the overall HRT market, which includes products like Activella, benefits from high demand and robust sales, particularly in North America and Europe[1].

Pricing and Affordability

The pricing strategy for Activella and similar HRT products is crucial for market success. Companies often implement affordability programs to increase patient compliance and adherence. For example, TherapeuticsMD, another player in the HRT market, has seen success with affordability programs that reduce the maximum out-of-pocket costs for patients, thereby driving incremental fills and net revenues[3].

Future Outlook

Personalized and Tailored Approaches

The future outlook for Activella remains positive, driven by the growing emphasis on personalized and tailored approaches to menopausal and post-menopausal management. The development of novel delivery mechanisms, such as transdermal patches or vaginal rings, can enhance patient convenience and potentially improve adherence to therapy[1].

Regulatory Environment

The regulatory environment, particularly in regions like Europe and North America, continues to play a significant role in the market's growth. Regulatory approvals and guidelines set by agencies like the EMA and FDA are critical for the introduction and continued use of HRT products like Activella[1].

Challenges and Risks

Potential Side Effects

Despite the market's positive outlook, potential side effects associated with HRT, such as an increased risk of certain medical conditions like breast cancer, endometrial cancer, and cardiovascular disorders, may restrain the market's growth. These risks necessitate careful monitoring and regular health check-ups for patients on HRT[2][4].

Alternative Therapies

The availability of alternative therapies may also impact the market. Patients and healthcare providers may opt for other treatment options, which could reduce the demand for Activella and similar HRT products[1].

Key Takeaways

• Growing Demand: The market for Activella is driven by the increasing prevalence of menopausal and post-menopausal conditions.
• Regional Variations: North America and Europe are significant markets, with the Asia-Pacific region expected to grow rapidly.
• Competitive Landscape: The market is moderately competitive, with Allergan being a key player.
• Financial Performance: The market is projected to grow at a CAGR of around 4%, with significant revenue generated from HRT solutions.
• Future Outlook: Personalized approaches and novel delivery mechanisms are expected to drive future growth.
• Challenges: Potential side effects and alternative therapies are key challenges to consider.

FAQs

What are the primary drivers for the Activella market?

The primary drivers include the increasing prevalence of menopausal and post-menopausal conditions and the growing awareness and acceptance of HRT as a treatment option.

Which regions are the largest markets for Activella?

North America, particularly the United States, and Europe are the largest regional markets.

What are the potential side effects associated with Activella?

Potential side effects include an increased risk of breast cancer, endometrial cancer, and cardiovascular disorders.

Who are the key players in the Activella market?

Key players include Allergan (a subsidiary of AbbVie), Teva Pharmaceutical Industries, Mylan, Amneal Pharmaceuticals, and Perrigo.

What is the projected growth rate for the Estradiol Norethindrone Acetate Drug market?

The market is projected to grow at a CAGR of around 4% during the forecast period.

Sources

1. DataHorizon Research: Estradiol Norethindrone Acetate Drug Market Size, Share & Forecast.
2. Drugs.com: Activella: Package Insert / Prescribing Information.
3. TherapeuticsMD Inc: Oppenheimer NDR_TXMD Final 3.
4. RxList: Activella (Estradiol, Norethindrone Acetate).