ELESTRIN Drug Patent Profile

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

Elestrin is a drug marketed by Mylan Speciality Lp and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Elestrin

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

Summary for ELESTRIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	1
Patent Applications:	5,529
Drug Prices:	Drug price information for ELESTRIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ELESTRIN
What excipients (inactive ingredients) are in ELESTRIN?	ELESTRIN excipients list
DailyMed Link:	ELESTRIN at DailyMed

See drug prices for ELESTRIN

See drug sales revenues for ELESTRIN

Recent Clinical Trials for ELESTRIN

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

Sponsor	Phase
University of Missouri-Columbia	N/A

See all ELESTRIN clinical trials

Pharmacology for ELESTRIN

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for ELESTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Speciality Lp	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006		RX	Yes	Yes

Expired US Patents for ELESTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006	7,198,801
Mylan Speciality Lp	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006	7,470,433

International Patents for ELESTRIN

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

Country	Patent Number	Title	Estimated Expiration
Spain	2283425
Brazil	PI0408153
Spain	2377932

Supplementary Protection Certificates for ELESTRIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2782584	301153	Netherlands		PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
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

ELESTRIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Elestrin

Introduction to Elestrin

Elestrin is a topical estradiol gel used in the treatment of moderate to severe vasomotor symptoms due to menopause. It is part of the broader category of drugs for hormonal replacement therapy (HRT).

Market Context

The global market for HRT drugs, which includes Elestrin, has experienced significant fluctuations in recent years. Here are some key points that shape the market dynamics:

Global HRT Market Size and Growth

The global HRT market declined from $15.6 billion in 2019 to $13.2 billion in 2020, primarily due to the COVID-19 pandemic and associated lockdown measures. However, the market is expected to recover and grow at a CAGR of 3.5% from 2021 to reach $16.9 billion by 2023[1].

Segmentation and Distribution

Therapy Type

Elestrin falls under the category of estrogen replacement therapy, which is a significant segment within the HRT market. This segment includes various forms of estrogen therapy, such as transdermal gels, patches, and sprays[1].

Distribution Channels

The distribution of HRT drugs, including Elestrin, occurs through hospital pharmacies, retail pharmacies, and online pharmacies. The retail pharmacy segment is particularly important for topical treatments like Elestrin, as they are often prescribed for long-term use and require frequent refills[1].

Historical Ownership and Partnerships

Acquisition and Partnership

Elestrin was acquired by Meda in 2012 from Jazz Pharmaceuticals. Since the acquisition, Meda has focused on enhancing its US sales force to promote Elestrin, leading to significant growth in the product's market presence[2].

Regulatory Environment

FDA Regulations

The FDA plays a crucial role in regulating HRT drugs, including Elestrin. In 2018, the FDA revised the requirements for specific hormone-containing drug products to ensure effectiveness and safety. These regulations include boxed warnings for estrogen and estrogen-plus-progestin therapies due to risks such as stroke, deep vein thrombosis, and breast cancer[1][3].

Safety and Side Effects

Risks Associated with HRT

HRT drugs, including Elestrin, come with several potential side effects and risks. These include vaginal dryness, irregular heartbeat, breast swelling, osteoporosis, and more severe conditions like blood clots, heart attack, and breast cancer. The Women’s Health Initiative (WHI) studies have highlighted these risks, leading to a cautious approach in prescribing these medications[1][3].

Financial Performance

Revenue Growth

Despite the overall decline in the HRT market during the COVID-19 pandemic, Elestrin has shown resilience. Meda's enhanced focus on the US market has contributed to the product's growth. However, specific financial figures for Elestrin are not publicly disclosed in the available sources, but it is part of the larger HRT market that is expected to recover and grow[1][2].

Competitive Landscape

Major Players

The HRT market is dominated by several major pharmaceutical companies, including Novartis AG, Bayer AG, Pfizer Inc., Novo Nordisk A/S, and Eli Lilly and Company. While Elestrin is not specifically mentioned among the top products of these companies, it competes within the same market space and benefits from the overall trends and innovations in HRT[1].

Innovations and Novel Drug Delivery Mechanisms

Transdermal Delivery

Elestrin, as a transdermal estradiol gel, represents one of the novel drug delivery mechanisms in the HRT market. This form of delivery is preferred for its ease of use and reduced risk of certain side effects compared to oral formulations. Companies like Novo Nordisk are also developing low-dose HRT drugs with better safety profiles, which aligns with the trend of improving patient safety and compliance[1].

Key Takeaways

• Market Recovery: The HRT market, including Elestrin, is expected to recover from the COVID-19 pandemic-induced decline.
• Regulatory Compliance: Strict FDA regulations ensure the safety and effectiveness of HRT drugs.
• Safety Concerns: Despite benefits, HRT drugs carry significant risks that must be managed.
• Innovative Delivery: Transdermal gels like Elestrin offer a safer and more convenient alternative to traditional oral HRT.
• Competitive Market: Elestrin competes in a market dominated by major pharmaceutical companies.

FAQs

Q: What is Elestrin used for? A: Elestrin is used to treat moderate to severe vasomotor symptoms due to menopause.

Q: Who acquired Elestrin in 2012? A: Meda acquired Elestrin from Jazz Pharmaceuticals in 2012.

Q: What are the potential side effects of Elestrin? A: Potential side effects include vaginal dryness, irregular heartbeat, breast swelling, osteoporosis, and more severe conditions like blood clots and breast cancer.

Q: How does the FDA regulate HRT drugs like Elestrin? A: The FDA regulates HRT drugs with strict guidelines, including boxed warnings for certain risks and requirements for safety and effectiveness.

Q: What is the expected growth trajectory for the HRT market? A: The HRT market is expected to grow at a CAGR of 3.5% from 2021 to reach $16.9 billion by 2023.

Sources

1. Global Hormonal Replacement Therapy (HRT) Drugs Market Report 2020-30: COVID-19 Impact and Recovery - ResearchAndMarkets.com
2. Meda enters partnership for Elestrin in the US market - Cision
3. CENTER FOR DRUG EVALUATION AND RESEARCH - FDA
4. Prescription Drug Price Growth Report Data - Minnesota Department of Health
5. Jazz Pharmaceuticals Completes Sale of its Women's Health Business - Jazz Pharmaceuticals Investor Relations