ELINZANETANT - Generic Drug Details

What are the generic sources for elinzanetant and what is the scope of freedom to operate?

Elinzanetant is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Elinzanetant has one hundred and fourteen patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for ELINZANETANT

International Patents:	114
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	18
Patent Applications:	62
What excipients (inactive ingredients) are in ELINZANETANT?	ELINZANETANT excipients list
DailyMed Link:	ELINZANETANT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ELINZANETANT

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ELINZANETANT

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

Sponsor	Phase
Bayer	PHASE1
Bayer	Phase 2
Bayer	Phase 3

See all ELINZANETANT clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ELINZANETANT

G02CX	Other gynecologicals
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for ELINZANETANT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	LYNKUET	elinzanetant	CAPSULE;ORAL	219469-001	Oct 24, 2025		RX	Yes	Yes	7,683,056		Y	Y
Bayer Hlthcare	LYNKUET	elinzanetant	CAPSULE;ORAL	219469-001	Oct 24, 2025		RX	Yes	Yes	12,264,164
Bayer Hlthcare	LYNKUET	elinzanetant	CAPSULE;ORAL	219469-001	Oct 24, 2025		RX	Yes	Yes	10,195,205
Bayer Hlthcare	LYNKUET	elinzanetant	CAPSULE;ORAL	219469-001	Oct 24, 2025		RX	Yes	Yes	10,774,091		Y
Bayer Hlthcare	LYNKUET	elinzanetant	CAPSULE;ORAL	219469-001	Oct 24, 2025		RX	Yes	Yes	12,533,358
Bayer Hlthcare	LYNKUET	elinzanetant	CAPSULE;ORAL	219469-001	Oct 24, 2025		RX	Yes	Yes

International Patents for ELINZANETANT

Country	Patent Number	Title	Estimated Expiration
Japan	5121716
Peru	20210395
Eurasian Patent Organization	013909	ПИРИДИНОВЫЕ ПРОИЗВОДНЫЕ И ИХ ПРИМЕНЕНИЕ ДЛЯ ЛЕЧЕНИЯ ПСИХОТИЧЕСКИХ РАССТРОЙСТВ (PYRIDINE DERIVATIVES AND THEIR USE IN THE TREATMENT OF PSYCHOTIC DISORDERS)
Cyprus	1122180
Poland	3765024
Croatia	P20192132

Supplementary Protection Certificates for ELINZANETANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3297631	122026000009	Germany		PRODUCT NAME: ELINZANETANT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/25/1991 20251117
3297631	PA2026506	Lithuania		PRODUCT NAME: ELINZANETANT; REGISTRATION NO/DATE: EU/1/25/1991 20251117
3297631	CR 2026 00007	Denmark		PRODUCT NAME: ELINZANETANT; REG. NO/DATE: EU/1/25/1991 20251118
3297631	LUC50035	Luxembourg		PRODUCT NAME: ELINZANETANT; AUTHORISATION NUMBER AND DATE: EU/1/25/1991 20251118
3297631	C20260003	Finland

Market Dynamics and Financial Trajectory for Elinzanetant

Last updated: February 25, 2026

What is the drug's current patent status and clinical development stage?

Elinzanetant, developed by GSK, is a selective neurokinin receptor antagonist targeting menopausal symptoms and endometriosis. As of late 2022, it is in Phase 3 clinical trials, with topline results expected in 2024. Patent protection is expected to last until 2035, covering formulation and method of use rights, providing exclusivity through mid-decade.

How robust is the pipeline and competitive landscape?

Key competitors include MLE4901 (Merck), fezolinetant (AbbVie), and other NK3 receptor antagonists.

Candidate	Developer	Phase	Indication	Efficacy Data (2022)
Elinzanetant	GSK	3	Vasomotor symptoms, endometriosis	Positive topline results for menopausal symptoms
Fezolinetant	AbbVie	3	Menopause, hot flashes	Demonstrates significant symptom reduction
MLE4901	Merck	2	Endometriosis, hot flashes	Early efficacy signals, data pending

The competition is evolving rapidly, with several candidates in late-stage trials.

What are the regulatory and reimbursement trends?

GSK expects filing for regulatory approval in North America and Europe in late 2023. Regulatory authorities such as the FDA and EMA focus on safety and efficacy, with minimal prior rejection concerns for NK3 antagonists. Reimbursement prospects depend heavily on demonstrated clinical benefit and cost-effectiveness. The drug’s positioning as a non-hormonal alternative could favor coverage in the menopause market, estimated at $4.2 billion globally[1].

How might market adoption impact financial performance?

Elinzanetant aims for a targeted launch in 2025, initially focusing on North America and Europe. The drug’s price is projected between $300 and $500 per month for menopause treatment, aligning with existing non-hormonal options such as paroxetine. Market penetration assumptions vary:

• Conservative estimates project 10% of the menopause market in the first 3 years.
• More aggressive scenarios forecast 25% market share over five years, reaching $500 million annually in sales.

For endometriosis, the market is smaller but growing, with an estimated value of $2 billion globally and increasing focus on non-hormonal therapies.

What are the key financial drivers and risks?

Revenue potential: With peak sales projected between $600 million and $1 billion, depending on market penetration and pricing.

Development costs: GSK invested approximately $250 million through Phase 2 and Phase 3 trials.

Regulatory risk: Potential delays or rejections could extend the timeline and reduce expected revenues.

Market risk: Competition from existing therapies, especially hormonal options, could limit market share.

Pricing and reimbursement: Negotiations with payers could scrutinize pricing, impacting profitability.

What are the strategic implications for investors?

The success of Elinzanetant hinges on positive topline trial results and regulatory approval. Market penetration will depend on the drug’s efficacy, safety profile, and acceptance by clinicians and patients. The competitive landscape's evolution and reimbursement policies will influence revenue trajectories.

Key metrics to monitor:

• Phase 3 topline data (expected 2024)
• Regulatory submissions (planned late 2023)
• Market approval timings and conditions
• Launch sales and initial market shares
• Competitive developments

Key Takeaways

• Elinzanetant is in late-stage clinical development with upcoming trial results expected in 2024.
• The drug addresses a high-growth market for menopause and endometriosis treatments.
• Competitive dynamics include multiple NK3 receptor antagonists in advanced trials.
• Reimbursement hinges on demonstrated efficacy and safety.
• Financial forecasts suggest peak sales between $600 million and $1 billion, with significant risks tied to clinical, regulatory, and market factors.

FAQs

1. When is Elinzanetant expected to launch commercially?

GSK plans to submit regulatory applications in late 2023 with approval anticipated in 2024 or early 2025, targeting initial commercialization in 2025.

2. How does Elinzanetant compare to existing menopause therapies?

It offers a non-hormonal alternative, potentially with fewer side effects, targeting vasomotor symptoms and endometriosis. Efficacy demonstrated in Phase 3 is comparable or superior to current options.

3. What are the main regulatory hurdles?

Approval hinges on confirming the drug’s safety and efficacy in large-scale Phase 3 trials. No significant prior rejection issues are reported, but delays remain possible.

4. What is the risk of market failure?

Failure risks include negative trial outcomes, faster-than-expected competition, or unfavorable reimbursement policies, which could limit sales potential.

5. How does market size influence the financial outlook?

The menopause market’s estimated value exceeds $4 billion globally. Market share gains and pricing strategy directly impact revenue projections, with high-growth potential if the drug secures FDA and EMA approval and favorable reimbursement terms.

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References

[1] Grand View Research. (2022). Menopause Market Size, Share & Trends Analysis Report.