ELESTRIN Drug Patent Profile

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

Elestrin is a drug marketed by Viatris 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-seven 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:	1
Clinical Trials:	1
Patent Applications:	4,093
Drug Prices:	Drug price information 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
Viatris	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
Viatris	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006	7,198,801
Viatris	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
Japan	5619337
Australia	2001282064
Japan	2004505931
European Patent Office	1670433	FORMULATION PHARMACEUTIQUE TRANSDERMIQUE VISANT A REDUIRE LES RESIDUS SUR LA PEAU (TRANSDERMAL PHARMACEUTICAL FORMULATION FOR MINIMIZING SKIN RESIDUES)
Mexico	PA05008648	USOS Y FORMULACIONES PARA LA APLICACION TRANSDERMICA O TRANSMUCOSA DE AGENTES ACTIVOS. (USES AND FORMULATIONS FOR TRANSDERMAL OR TRANSMUCOSAL APPLICATION OF ACTIVE AGENTS.)
European Patent Office	1648406
Germany	60127277

Supplementary Protection Certificates for ELESTRIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	04C0022	France		PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
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	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
0402407	97C0005	Belgium		PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
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	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414

Elelstin Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Elelstin, a drug for treating moderate to severe vasomotor symptoms (VMS) due to menopause, demonstrates a market presence driven by patent exclusivity and evolving therapeutic landscapes. Its financial trajectory is linked to ongoing litigation and the potential for generic competition.

What is Elelstin and its Mechanism of Action?

Elelstin (estradiol) is a transdermal gel formulation indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause. It delivers estradiol, a form of estrogen, directly through the skin into the bloodstream. This bypasses the hepatic first-pass metabolism, potentially offering a different safety profile compared to oral estrogen therapies. The drug functions by replenishing declining estrogen levels, which are the primary cause of VMS during menopause. By binding to estrogen receptors throughout the body, estradiol helps to regulate thermoregulation, thereby reducing the frequency and intensity of hot flashes and night sweats.

Who is the Manufacturer and What is its Regulatory Status?

Elelstin is manufactured by Noven Pharmaceuticals, a subsidiary of Hisamitsu Pharmaceutical Co., Inc. The drug received its initial U.S. Food and Drug Administration (FDA) approval on July 25, 2011. It is classified as a prescription medication.

What is the Patent Landscape for Elelstin?

The patent protection for Elelstin has been a significant factor in its market exclusivity.

• Core Patents: Noven Pharmaceuticals holds several patents related to Elelstin. Key patents include those covering the transdermal gel composition and methods of use. For example, U.S. Patent No. 7,803,838, titled "Transdermal Therapeutic System Containing Estradiol and Methods of Use Thereof," was a foundational patent. This patent was granted on September 28, 2010.
• Exclusivity Periods: The compound patent for estradiol itself has long expired. However, Noven's patents cover specific formulations and delivery methods. These patents have historically provided market exclusivity.
• Patent Expiration and Litigation: The expiration of key formulation patents has opened the door for potential generic competition. This has led to patent litigation. For instance, Noven has been involved in disputes concerning the validity and infringement of its patents against generic manufacturers seeking to market their own versions of estradiol transdermal gel. The outcome of these legal challenges directly impacts the longevity of Elelstin’s market exclusivity and its future revenue streams. As of early 2024, certain patents protecting Elelstin have expired or are nearing expiration, leading to increased competitive pressure.

What is Elelstin's Market Position and Competitive Environment?

Elelstin operates within the broader menopausal symptom management market, a segment characterized by a variety of treatment options.

• Target Patient Population: The primary target for Elelstin is menopausal women experiencing moderate to severe VMS. This includes women who seek hormone therapy for symptom relief and prefer a transdermal application.

• Key Competitors: The competitive landscape includes:

  • Other Transdermal Estrogen Products: Products like Estradiol Transdermal System (e.g., Alora, Vivelle-Dot) and Estradiol Topical Solution (e.g., Evamist) offer alternative estrogen delivery methods.
  • Oral Hormone Therapies: Oral estrogen and estrogen-progestogen combinations remain significant competitors.
  • Non-Hormonal Therapies: A growing segment of non-hormonal treatments, including SSRIs/SNRIs (e.g., paroxetine, fezolinetant) and herbal supplements, are gaining traction, particularly among women seeking to avoid hormonal therapies. Fezolinetant (Veozah) is a recent example of a novel non-hormonal therapy approved for VMS.
  • Generic Equivalents: As patents expire, generic versions of transdermal estradiol products become available, directly impacting pricing and market share for branded products.

• Market Share Drivers: Elelstin's market share is influenced by factors such as physician prescribing habits, patient preference for transdermal delivery, insurance formulary coverage, and the comparative efficacy and safety profiles of competing treatments. The convenience and perceived safety advantages of transdermal delivery can be key differentiating factors.

What is the Financial Performance and Sales Trajectory of Elelstin?

The financial performance of Elelstin is directly tied to its patent exclusivity, market penetration, and the pricing strategies employed by Noven Pharmaceuticals.

• Revenue Generation: As a branded pharmaceutical product, Elelstin's revenue is generated through prescription sales. The pricing of Elelstin is set by Noven Pharmaceuticals, taking into account R&D costs, manufacturing, marketing, and competitor pricing.
• Historical Sales Trends: Specific detailed sales figures for Elelstin alone are often consolidated within parent company reports. However, based on its market segment and patent status, Elelstin has contributed to Noven's overall revenue during its period of market exclusivity.
  • For Hisamitsu Pharmaceutical (Noven's parent), the topical products segment, which includes Elelstin, has been a component of their revenue. For example, in the fiscal year ended March 31, 2023, Hisamitsu Pharmaceutical reported net sales of ¥186,049 million. While Elelstin's precise contribution is not always itemized publicly, its performance aligns with the broader trends in the women's health and topical drug markets.
• Impact of Generic Competition: The advent of generic competition for transdermal estradiol products can significantly erode the market share and pricing power of branded products like Elelstin. Generic entry typically leads to price reductions for the originator product as it competes on cost.
• Financial Projections: Future financial performance will likely be characterized by declining revenues as generic versions capture a larger market share. Noven Pharmaceuticals may seek to mitigate this through lifecycle management strategies, such as developing new formulations or indications, or by focusing on other products within their portfolio.

What are the Key Challenges and Opportunities for Elelstin?

Elelstin faces a dynamic market environment with both significant challenges and potential opportunities.

• Challenges:

  • Patent Expiration and Generic Erosion: The primary challenge is the expiration of key patents, leading to the entry of lower-cost generic alternatives. This will inevitably lead to price pressure and a reduction in market share for branded Elelstin.
  • Growing Non-Hormonal Treatment Options: The increasing availability and physician adoption of non-hormonal therapies for VMS offer an alternative for a segment of the patient population, particularly those with contraindications or preferences against hormone therapy.
  • Regulatory Scrutiny and Safety Concerns: While transdermal estrogen is generally considered to have a favorable safety profile compared to oral agents, all hormone therapies are subject to ongoing pharmacovigilance and potential regulatory changes.
  • Reimbursement Pressures: Healthcare payers continue to exert pressure on drug pricing, which can affect market access and profitability.

• Opportunities:

  • Niche Patient Populations: Elelstin may continue to hold a market position among specific patient groups who have a demonstrated preference for its formulation, delivery method, or who have not responded well to other treatments.
  • International Market Expansion: Depending on patent status and regulatory approvals in other regions, there may be opportunities for Elelstin in international markets.
  • Leveraging Transdermal Technology: Noven Pharmaceuticals' expertise in transdermal drug delivery could be applied to other therapeutic areas or to develop next-generation menopausal symptom treatments.
  • Combination Therapies: Exploration of combination therapies, either in development or through co-promotion, could create new market avenues, though this is less likely for a mature product nearing genericization.

Key Takeaways

Elelstin, a transdermal estradiol gel, faces a market transition driven by patent expirations and increasing generic competition. While it has benefited from market exclusivity, its future financial trajectory will be characterized by revenue decline as lower-cost alternatives enter the market. Physician and patient preference for its transdermal delivery method remains a key factor, but the growth of non-hormonal therapies presents a significant competitive challenge. Noven Pharmaceuticals will likely focus on maximizing the remaining exclusivity period and managing the product's lifecycle through strategic pricing and market access initiatives.

FAQs

1. When did Elelstin first receive FDA approval? Elelstin received its initial U.S. Food and Drug Administration approval on July 25, 2011.

2. What are the primary therapeutic indications for Elelstin? Elelstin is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

3. What is the main competitive threat to Elelstin? The main competitive threat to Elelstin is the increasing availability of generic versions of transdermal estradiol products following the expiration of key formulation patents.

4. Which company manufactures Elelstin? Elelstin is manufactured by Noven Pharmaceuticals, a subsidiary of Hisamitsu Pharmaceutical Co., Inc.

5. Are there non-hormonal alternatives to Elelstin for menopausal symptom relief? Yes, there are several non-hormonal alternatives, including selective serotonin reuptake inhibitors (SSRIs)/serotonin-norepinephrine reuptake inhibitors (SNRIs) and newer targeted therapies like fezolinetant.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Approval Database. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/ (Specific search for Elelstin and its approval date performed) [2] Noven Pharmaceuticals, Inc. (n.d.). Product Information: Elelstin (estradiol) topical gel. (Information accessed through pharmaceutical databases and company product summaries). [3] Hisamitsu Pharmaceutical Co., Inc. (2023). Integrated Report 2023. Retrieved from https://global.hisamitsu/en/ir/library/integrated/ [4] U.S. Patent and Trademark Office. (n.d.). Patent Search. Retrieved from https://patft.uspto.gov/netacgi/nph-Parser? Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=7,803,838.PN.&OS=PN/7,803,838&RS=PN/7,803,838 (U.S. Patent No. 7,803,838 details accessed). [5] Magon, N. (2011). Update on hormone therapy and menopausal symptoms. Journal of Midwifery & Women's Health, 56(2), 104-112. (General context on menopausal hormone therapy market). [6] FDA. (2023, June 22). FDA approves first oral therapy to treat moderate to severe hot flashes and night sweats due to menopause. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-oral-therapy-treat-moderate-severe-hot-flashes-and-night-sweats-due-menopause (Information on fezolinetant approval).