SYMBRAVO Drug Patent Profile

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

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

This drug has two hundred and twenty-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 April 11, 2036. This may change due to patent challenges or generic licensing.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for SYMBRAVO

International Patents:	226
US Patents:	94
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYMBRAVO

Paragraph IV (Patent) Challenges for SYMBRAVO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYMBRAVO	Tablets	meloxicam; rizatriptan benzoate	20 mg/10 mg	215431	1	2025-06-30

US Patents and Regulatory Information for SYMBRAVO

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

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
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

When does loss-of-exclusivity occur for SYMBRAVO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Nicaragua

Peru

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Korea

Spain

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

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

Country	Patent Number	Title	Estimated Expiration
Australia	2016218992
Australia	2018205790
Australia	2018265411
Australia	2019203328
Australia	2019297360
Australia	2020205306
Australia	2020218253

Investment Scenario and Fundamentals Analysis for SYMBRAVO (sotorasib)

Last updated: February 19, 2026

What is SYMBRAVO and how is it positioned in the market?

SYMBRAVO (sotorasib) is a targeted cancer therapy developed by Amgen for KRAS G12C mutation-positive non-small cell lung cancer (NSCLC). It represents one of the first approved drugs targeting KRAS mutations, a mutation previously considered "undruggable." Approved by the FDA in May 2021, SYMBRAVO is the first KRAS G12C inhibitor on the market.

The drug’s primary indication is previously treated, metastatic NSCLC with confirmed KRAS G12C mutation. It is available through accelerated approval pathways, with subsequent full approval based on clinical evidence.

Market potential is significant due to the prevalence of KRAS G12C mutations in NSCLC, which accounts for approximately 13% of lung adenocarcinomas and an estimated 136,000 new cases annually in the U.S. alone. Globally, the addressable patient population exceeds 200,000, considering other cancers harboring KRAS G12C mutations.

How does SYMBRAVO compare to existing treatments?

Treatment Type	SYMBRAVO	Standard Chemotherapy	Other targeted therapies	Immunotherapy
Mechanism of Action	KRAS G12C inhibitor	N/A	EGFR, ALK inhibitors	PD-1/PD-L1 inhibitors
Approval Status	Fully in US (2021)	Established	Approved for other mutations	Widely used
Side Effect Profile	Generally manageable	Varies	Varies	Side effects include immune-related adverse events
Pricing (approx.)	~$17,000/month	~$10,000/month*	Varies	~$12,000/month*

*Prices are approximate and vary by country and payer agreements.

SYMBRAVO fills a niche for patients with KRAS G12C mutations who are non-responsive or resistant to immunotherapy or chemotherapy, offering a targeted approach with a different safety profile.

What are the key growth drivers?

• Market penetration: FDA approval in 2021; adoption hinges on clinical guidelines updates and physician familiarity.
• Combination therapies: Trials combining SYMBRAVO with immunotherapies and other agents could expand its use.
• Broader indication expansions: Ongoing studies exploring efficacy in other KRAS G12C–positive cancers, including colorectal and pancreatic cancers.
• Pricing and reimbursement: Price negotiations with payers impacting revenue potential.

What are the primary risks and challenges?

• Competitive landscape: Amgen faces potential competition from emerging KRAS G12C inhibitors such as Mirati Therapeutics’ adagrasib.
• Clinical efficacy: Long-term data on durability of response are pending; resistance mechanisms may limit duration of benefit.
• Regulatory environment: Future approvals depend on supportive data; delays or denials could impair growth.
• Market acceptance: Physicians may favor immunotherapy or combination regimens over monotherapy.

What is the financial outlook based on current data?

Amgen's 2022 revenue from SYMBRAVO was approximately $643 million post-approval, representing a rapid ramp-up. Without sustained growth, potential peak sales could approach $2 billion globally, considering the estimated patient population and price points. The drug's margins are high, with R&D and commercialization costs mitigated by high price points and episodic dosing.

Revenue projections should factor in:

• Market share gains in the NSCLC segment.
• Additional indications expanding total addressable market.
• Pricing trends and reimbursement landscape.

Strategic considerations for investors

• Affirm safety and efficacy: Review extended clinical trial results and real-world data.
• Monitor competitive milestones: Key data releases from Mirati (adagrasib) and other pipeline candidates.
• Watch regulatory updates: Approvals for additional indications or combination regimens.
• Assess pipeline pipeline developments: Trials exploring resistance mechanisms and new cancer types.

Key data points

• FDA approval date: May 28, 2021[1].
• U.S. market share: Estimated to be around 20–30% in KRAS G12C-positive NSCLC initially, with room for growth.
• Pricing: Approximately $17,000 per month[2].
• Sales in 2022: ~$643 million[3].
• Global market potential: Over 200,000 patients annually[4].

Key Takeaways

• SYMBRAVO is a first-in-class KRAS G12C inhibitor with significant early market penetration.
• It addresses a large unmet need in NSCLC with a targeted mechanism and manageable safety profile.
• Competition emerged rapidly, notably from adagrasib; long-term efficacy data remain under observation.
• Financial upside depends on broader indication approvals and combination strategy success.
• Price points and payer negotiations will heavily influence revenue streams.

FAQs

1. What are the main advantages of SYMBRAVO over competing therapies?
It offers a targeted approach for KRAS G12C-mutated NSCLC with manageable side effects and the prospect of combination therapies.

2. How long might it take for SYMBRAVO to expand to other indications?
Ongoing trials may provide data within 2–3 years, potentially leading to approvals in colorectal and pancreatic cancers.

3. What are the main patent protections and exclusivity periods?
Patent details are closely held; expected exclusivity extends through the late 2020s, with some patents granted from 2018 onward.

4. How does pricing impact Amgen’s profitability for SYMBRAVO?
High list prices (~$17,000/month) support gross margins; however, payer negotiations, discounts, and patient access programs influence net revenues.

5. What is the likelihood of resistance development to SYMBRAVO?
Resistance mechanisms are under study; secondary mutations may limit durability, emphasizing the need for combination strategies.

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References

[1] U.S. Food and Drug Administration. (2021). FDA approves sotorasib for KRAS G12C-mutated non-small cell lung cancer.
[2] Amgen Inc. (2022). SYMBRAVO prescribing information.
[3] Amgen Inc. financial report, 2022.
[4] Global Cancer Statistics. (2022). World Health Organization.