SYMBRAVO Drug Patent Profile

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

Symbravo is a drug marketed by Axsome and is included in one NDA. There are seventy-four patents protecting this drug.

This drug has one hundred and ninety-six patent family members in thirty-two countries.

The generic ingredient in SYMBRAVO is meloxicam; rizatriptan benzoate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the meloxicam; rizatriptan benzoate profile page.

DrugPatentWatch^® Generic Entry Outlook for Symbravo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 30, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SYMBRAVO

International Patents:	196
US Patents:	74
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	SYMBRAVO at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW PRODUCT

NDA:

215431

Dosage:

TABLET;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.

Pharmacology for SYMBRAVO

Drug Class	Nonsteroidal Anti-inflammatory Drug Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of Action	Cyclooxygenase Inhibitors Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

US Patents and Regulatory Information for SYMBRAVO

SYMBRAVO is protected by seventy-four US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PRODUCT.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes

International Patents for SYMBRAVO

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20200117055	멜록시캄을 포함하는 약학 조성물 (PHARMACEUTICAL COMPOSITIONS COMPRISING MELOXICAM)
South Korea	20190122659	멜록시캄을 포함하는 약학적 조성물
Japan	2024502041	メロキシカムを含む医薬組成物
China	113144218	包含美洛昔康的药物组合物 (PHARMACEUTICAL COMPOSITIONS COMPRISING MELOXICAM)

SYMBRAVO Market Analysis and Financial Projection

Axsome Therapeutics' SYMBRAVO (meloxicam and rizatriptan) has emerged as a pivotal player in the migraine treatment market following its FDA approval in January 2025. The drug’s multi-mechanistic approach, combining rapid absorption technology with proven migraine relief mechanisms, positions it to address unmet needs in acute migraine care. Here’s an analysis of its market dynamics and financial trajectory:

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Market Dynamics

Regulatory and Clinical Foundations

• SYMBRAVO earned FDA approval based on robust Phase 3 trials (MOMENTUM, INTERCEPT, MOVEMENT), demonstrating rapid pain relief within 2 hours, sustained efficacy up to 48 hours, and superiority over placebo and standalone rizatriptan [1][4][6].
• Recent EMERGE Phase 3 trial results (February 2025) validated SYMBRAVO’s efficacy in patients with inadequate response to oral CGRP inhibitors, expanding its addressable market to include treatment-resistant cases[11][13].

Competitive Landscape

• Target Market: SYMBRAVO enters a $6.16B global migraine treatment market (2025 estimate), projected to grow at a 6.84–9.1% CAGR through 2035[10][12]. Key competitors include triptans, CGRP inhibitors, and NSAIDs.
• Differentiation: SYMBRAVO’s rapid-action MoSEIC™ technology and dual-mechanism (meloxicam + rizatriptan) offer advantages in speed and sustained relief, particularly for patients with mild-to-severe migraines and those unresponsive to CGRP therapies[6][13].

Commercial Strategy

• Launch Plans: Commercial availability expected by mid-2025, with initial focus on high-volume headache centers[9]. Pricing remains undisclosed, but analysts highlight the need for competitive positioning against generics like rizatriptan[8].
• Peak Sales Projections: Axsome forecasts $500M–$1B in U.S. peak sales, though Mizuho analysts project a conservative $341M by 2035[8]. Success hinges on targeting the estimated 40M U.S. migraine sufferers, particularly the ~40% with inadequate treatment response[6][10].

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Financial Trajectory

Current Financial Health

• Revenue Growth: Axsome reported $385.7M in 2024 net product revenue (+88% YoY), driven by Auvelity ($291M in 2024 sales) and Sunosi. SYMBRAVO is poised to augment this growth[3][7].
• Profitability Challenges: Despite strong gross margins (91%), R&D and SG&A expenses drove a $287.2M net loss in 2024. Cash reserves of $315.4M are expected to sustain operations until cash flow positivity[3][7].

Investment and Analyst Sentiment

• Stock Performance: SYMBRAVO’s approval spurred a 25% stock price surge in early 2025, with analysts raising price targets (e.g., Truist: $190, H.C. Wainwright: $190)[9][13].
• Strategic Pipeline: Beyond SYMBRAVO, Axsome’s AXS-05 (Alzheimer’s agitation) and AXS-12 (narcolepsy)—both nearing regulatory submission—could diversify revenue streams[3][8].

Risks and Opportunities

• Execution Risks: SYMBRAVO’s commercial success depends on overcoming generic competition and demonstrating cost-effectiveness. Early adoption rates and payer coverage will be critical[8][9].
• Market Expansion: Success in the EMERGE trial cohort (CGRP-resistant patients) could carve a $1B+ niche market, aligning with Axsome’s long-term revenue goals[11][13].

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Key Takeaways

1. SYMBRAVO’s differentiation in speed and efficacy positions it to disrupt the migraine market, particularly for treatment-resistant patients.
2. Axsome’s strong revenue growth (88% YoY in 2024) and cash reserves provide runway for SYMBRAVO’s launch but require disciplined cost management.
3. Analyst optimism (price targets up to $190) reflects confidence in SYMBRAVO’s $500M–$1B peak sales potential, though execution risks persist[9][13].

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“Symbravo can provide rapid and long-lasting freedom from migraine pain... a much welcomed advancement for clinicians and our patients.” — Dr. Richard B. Lipton, Montefiore Headache Center [6]

SYMBRAVO’s trajectory will likely define Axsome’s path to profitability, with 2025–2026 serving as pivotal years for commercial execution and pipeline maturation.

References

1. https://www.timothysykes.com/news/axsome-therapeutics-inc-axsm-news-2025_02_10/
2. https://stockstotrade.com/news/axsome-therapeutics-inc-axsm-news-2025_02_10/
3. https://www.stocktitan.net/news/AXSM/axsome-therapeutics-reports-fourth-quarter-and-full-year-2024-elpa6cy8wf36.html
4. https://markets.businessinsider.com/news/stocks/axsome-therapeutics-announces-fda-approval-of-symbravo-1034291596
5. https://www.stocktitan.net/news/AXSM/axsome-therapeutics-reports-fourth-quarter-and-full-year-2023-urtoed5myd99.html
6. https://www.pharmexec.com/view/fda-approves-axsome-therapeutics-symbravo-migraine-with-without-aura
7. https://www.timothysykes.com/news/axsome-therapeutics-inc-axsm-news-2025_02_10-2/
8. https://www.fiercepharma.com/pharma/axsome-secures-hard-fought-fda-nod-rapid-acting-migraine-drug-symbravo
9. https://www.investing.com/news/analyst-ratings/truist-raises-axsome-therapeutics-stock-target-to-190-on-symbravo-approval-93CH-3845952
10. https://www.datainsightsmarket.com/reports/migraine-treatment-market-19910
11. https://financialpost.com/globe-newswire/axsome-therapeutics-announces-symbravo-meloxicam-and-rizatriptan-achieves-primary-endpoint-in-the-emerge-phase-3-trial-in-migraine-patients-experiencing-inadequate-response-to-oral-cgrp-inhibi
12. https://www.metatechinsights.com/industry-insights/migraine-treatment-market-2102
13. https://www.thepharmaletter.com/axsome-posts-positive-results-with-symbravo-in-migraine

Last updated: 2025-03-18