ESTRADERM Drug Patent Profile

When do Estraderm patents expire, and what generic alternatives are available?

Estraderm is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in ESTRADERM 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 Estraderm

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

Summary for ESTRADERM

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	2
Patent Applications:	4,229
DailyMed Link:	ESTRADERM at DailyMed

Recent Clinical Trials for ESTRADERM

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

Sponsor	Phase
National Institute on Aging (NIA)	Phase 1/Phase 2
Massachusetts General Hospital	Phase 1/Phase 2
Massachusetts General Hospital	Phase 2/Phase 3

See all ESTRADERM clinical trials

US Patents and Regulatory Information for ESTRADERM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-002	Sep 10, 1986		DISCN	Yes	No
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-003	Sep 10, 1986		DISCN	Yes	No

Expired US Patents for ESTRADERM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-003	Sep 10, 1986	4,144,317
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-002	Sep 10, 1986	3,948,262
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-003	Sep 10, 1986	4,379,454
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-003	Sep 10, 1986	3,948,262
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-002	Sep 10, 1986	4,379,454
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-002	Sep 10, 1986	4,144,317

International Patents for ESTRADERM

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

Country	Patent Number	Title	Estimated Expiration
Belgium	769155
Switzerland	657055	DOSIERUNGSEINHEIT ZUR GLEICHZEITIGEN VERABREICHUNG VON WIRKSTOFFEN UND DIE PERKUTANE RESORPTION VERSTAERKENDEN MITTELN.
Germany	3205258
Japan	S5541206
Ireland	52930	DOSAGE FORM FOR COADMINISTERING DRUG AND PERCUTANEOUS ABSORPTION ENHANCER
Sweden	396695	ANORDNING FOR FRIGORANDE AV ETT AKTIVT MEDEL I EN REGLERAD MENGD PER TIDSENHET UNDER LENGRE TIDSPERIODER

Supplementary Protection Certificates for ESTRADERM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
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
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
0770388	PA2009004,C0770388	Lithuania		PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
2782584	2021C/558	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612

ESTRADERM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ESTRADERM and Transdermal Hormone Replacement Therapy

Introduction to ESTRADERM and Transdermal Patches

ESTRADERM, a brand of transdermal estradiol patches, is a key player in the hormone replacement therapy (HRT) market. These patches are designed to deliver a steady dose of estradiol, a form of estrogen, through the skin, providing relief from menopausal symptoms and other hormonal imbalances.

Market Size and Growth

The global transdermal skin patches market, which includes hormone replacement therapy patches like ESTRADERM, was estimated at USD 7.82 billion in 2023. This market is projected to grow at a compound annual growth rate (CAGR) of 5.0% from 2024 to 2030, reaching USD 10.95 billion by 2030[1].

Drivers of Market Growth

Several factors are driving the growth of the transdermal skin patches market, including:

Rising Prevalence of Chronic Diseases

The increasing prevalence of chronic diseases such as cardiovascular disorders, diabetes, and chronic pain is boosting the demand for effective and convenient treatment options like transdermal patches[1].

Consumer Preference for Minimally Invasive Treatments

Patients and healthcare providers are increasingly favoring minimally invasive treatments due to reduced pain, lower infection risk, and fewer side effects compared to oral medications or injections[1].

Technological Advancements

Advancements in transdermal drug delivery systems have enhanced the efficacy and convenience of these patches, making them more attractive for managing chronic conditions[1].

Aging Global Population

The aging global population is another significant driver, as older individuals are more likely to require treatments for chronic conditions that can be managed with transdermal patches[1].

Application Outlook: Hormone Replacement Therapy

Hormone replacement therapy (HRT) is a significant application segment within the transdermal skin patches market. Transdermal systems, such as ESTRADERM patches, are widely used for HRT due to their ability to provide a steady hormone release, minimizing side effects associated with fluctuating hormone levels seen with oral HRT[1].

Estrogen Replacement Therapy Market

The estrogen replacement therapy market, which includes products like ESTRADERM, is estimated to grow at a CAGR of 5.7% from 2022 to 2027, reaching $13.2 billion by 2027. This growth is driven by the increasing awareness of menopausal symptoms and the need for HRT[2].

Distribution Channels and Online Pharmacies

The distribution of transdermal patches, including those for HRT, is seeing a significant shift towards online pharmacies. Online pharmacies are expected to grow at the fastest CAGR of 5.4% during the forecast period, driven by the increasing adoption of e-commerce and the convenience of shopping from home, especially accelerated by the COVID-19 pandemic[1].

Regional Outlook

North America

North America dominates the transdermal skin patches market, with a revenue share of 35.90% in 2023. This is due to the advanced healthcare infrastructure and regulatory frameworks that facilitate the development and approval of innovative transdermal patch technologies. The high prevalence of chronic diseases in this region also fuels the demand for these patches[1].

Europe

Europe is another significant market, characterized by stringent regulations and a focus on innovation. Countries like Germany, the UK, and France are at the forefront of developing new formulations and delivery mechanisms for transdermal patches[1].

Supply and Demand Dynamics

Global Supply Issues

There are current global supply issues affecting oestradiol patches, including ESTRADERM. For instance, in New Zealand, the demand for oestradiol patches has grown significantly, leading to supply gaps. Pharmac, the country's drug funding agency, is working to secure alternative brands and ensure continuity of supply[5].

Key Players and Competitive Landscape

The transdermal skin patches market, including HRT patches like ESTRADERM, is highly competitive. Key players such as Novartis AG, Hisamitsu Pharmaceutical Co., Inc., and Pfizer Inc. are investing heavily in research and development, forming strategic partnerships, and launching new products to differentiate themselves[1][2].

Recent Developments

For example, Corium, LLC, recently published data confirming the success of its donepezil transdermal system, ADLARITY, which is the first U.S. FDA-approved donepezil transdermal system for patients with mild, moderate, and severe Alzheimer's dementia. Such innovations are driving market growth and competition[1].

Financial Trajectory

Revenue Projections

The financial trajectory for ESTRADERM and similar transdermal HRT patches is positive, given the growing demand and expanding market size. The global transdermal skin patches market is expected to reach USD 10.95 billion by 2030, with the HRT segment contributing significantly to this growth[1].

Cost and Accessibility

Despite the growing demand, there are challenges related to cost and accessibility. For instance, in regions experiencing supply issues, patients may face additional costs or restrictions on the number of patches they can receive per month[5].

Challenges and Limitations

Side Effects and Health Risks

One of the major challenges facing the HRT market, including transdermal patches like ESTRADERM, is the potential health risks associated with hormone replacement therapy. These include increased risks of heart attack, blood clots, breast cancer, stroke, or uterine cancer, which can hamper market growth[2].

Regulatory Frameworks

Stringent regulations, particularly in regions like Europe, can impact the approval and monitoring of these products. However, these regulations also foster consumer trust and market growth by ensuring the safety and efficacy of the patches[1].

Key Takeaways

• The global transdermal skin patches market, including HRT patches like ESTRADERM, is growing at a CAGR of 5.0% from 2024 to 2030.
• The market is driven by the rising prevalence of chronic diseases, consumer preference for minimally invasive treatments, and technological advancements.
• Online pharmacies are becoming a significant distribution channel, driven by the convenience and accessibility they offer.
• North America and Europe are key regions, with North America dominating the market due to its advanced healthcare infrastructure.
• Supply issues and potential health risks are challenges that need to be addressed.
• Key players are investing in R&D and strategic partnerships to drive innovation and market growth.

FAQs

1. What is the current market size of the global transdermal skin patches market?

The global transdermal skin patches market was estimated at USD 7.82 billion in 2023[1].

2. What is the projected growth rate of the transdermal skin patches market from 2024 to 2030?

The market is projected to grow at a CAGR of 5.0% from 2024 to 2030[1].

3. Which region dominates the transdermal skin patches market?

North America dominates the market with a revenue share of 35.90% in 2023[1].

4. What are the key drivers of the HRT market, including transdermal patches like ESTRADERM?

Key drivers include the rising prevalence of chronic diseases, consumer preference for minimally invasive treatments, and technological advancements in transdermal drug delivery systems[1].

5. Are there any current supply issues affecting oestradiol patches like ESTRADERM?

Yes, there are global supply issues affecting oestradiol patches, leading to supply gaps and alternative sourcing efforts by regulatory bodies like Pharmac in New Zealand[5].

Cited Sources:

1. Grand View Research - Transdermal Skin Patches Market Size & Share Report, 2030
2. IndustryARC - Estrogen Replacement Therapy Market Report, 2022-2027
3. FDA - Draft Guidance for Industry: Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Moderate to Severe Vulvar and Vaginal Atrophy
4. Health Canada - PrESTRADERM25 ESTRADERM100
5. Pharmac New Zealand - Oestradiol (Estradot) patches: Supply issue