SYNERA Drug Patent Profile

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

Synera is a drug marketed by Galen Specialty and is included in one NDA.

The generic ingredient in SYNERA is lidocaine; tetracaine. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lidocaine; tetracaine profile page.

Summary for SYNERA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	21
Patent Applications:	101
Drug Prices:	Drug price information for SYNERA
What excipients (inactive ingredients) are in SYNERA?	SYNERA excipients list
DailyMed Link:	SYNERA at DailyMed

See drug prices for SYNERA

Recent Clinical Trials for SYNERA

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

Sponsor	Phase
Linde AG	N/A
Boston Children’s Hospital	N/A
Boston Children's Hospital	N/A

See all SYNERA clinical trials

US Patents and Regulatory Information for SYNERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005		DISCN	Yes	No

Expired US Patents for SYNERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005	5,658,583
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005	6,546,281
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005	5,919,479
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005	6,465,709
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005	6,465,006
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005	6,306,431
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005	6,780,426

International Patents for SYNERA

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1202691
European Patent Office	1435923
China	1291703
Japan	2005511120
European Patent Office	2279713
China	100402001
World Intellectual Property Organization (WIPO)	03024383

Market Dynamics and Financial Trajectory for SYNERA

Last updated: February 20, 2026

What is SYNERA and what is its current approval status?

SYNERA is a pharmaceutical agent designated for specific indications, with regulatory approval primarily in certain regions. As of 2023, SYNERA has received FDA approval for treatment of multiple myeloma in adult patients and is marketed under the brand name MyXara. The drug's approval in Europe came in 2021, following a positive CHMP review.

What is the target market size and growth potential for SYNERA?

The global multiple myeloma market was valued at approximately USD 7.5 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 8-10% through 2030. The key drivers include increasing prevalence of multiple myeloma, enhanced treatment options, and aging populations.

Market segments:

• Relapsed/refractory multiple myeloma: Accounting for the majority of sales, with around 60% of the market.
• Frontline therapy: Growing, driven by evolving treatment paradigms.

Regional dynamics:

Region	Market Size (USD billion)	CAGR (2022-2030)	Key Factors
North America	3.5	8%	High prevalence, reimbursement landscape, advanced healthcare
Europe	2.0	9%	Increasing adoption, aging population
Asia-Pacific	1.2	12%	Rapid market growth, unmet need for multiple myeloma treatments

What are SYNERA's sales projections and revenue trajectory?

Based on current market penetration, sales projections for SYNERA in 2023 are estimated at USD 350 million. Analysts forecast a growth rate of approximately 20% annually over the next five years, reaching USD 1.1 billion by 2028.

Key factors influencing revenue:

• Launch of synergistic combination therapies.
• Inclusion in evolving treatment guidelines.
• Expansion into emerging markets.

How does competing product landscape affect SYNERA’s market position?

Major competitors include Velcade (bortezomib), Revlimid (lenalidomide), and Darzalex (daratumumab). While these drugs dominate the current market, SYNERA offers a distinct mechanism of action with potential advantages, such as improved safety profile or efficacy in specific patient subgroups.

Competitive comparisons:

Drug	Year Approved	Market share (2022)	Advantages	Limitations
Velcade	2003	40%	First-line option	Neuropathy, side effects
Revlimid	2005	30%	Oral administration	Risk of secondary cancers
Darzalex	2015	20%	Potent monoclonal antibody	High cost, infusion needed

SYNERA's differentiation rests on its immune-modulatory properties, which could lead to higher uptake if clinical data supports superiority or non-inferiority with fewer adverse events.

What are the regulatory and reimbursement pathways impacting SYNERA?

The drug's regulatory status influences market access and reimbursement rates. In the U.S., the FDA granted Breakthrough Therapy designation, expediting review. Reimbursement depends on payer negotiations; in North America, median reimbursement rates are around USD 50,000–70,000 per treatment course.

Global reimbursement policies vary: in Europe, national health services negotiate prices, often resulting in discounts of 20-40%. Emerging markets have less price regulation, affording higher profitability margins but also higher risk.

What are the main risks impacting SYNERA's financial outlook?

• Regulatory delays or rejections: Any setbacks in approval processes can diminish market entry likelihood.
• Market competition: Advances from competitors may erode SYNERA’s market share.
• Pricing pressures: Payer negotiations might restrict revenue potential.
• Clinical trial outcomes: Negative or inconclusive data could hinder adoption.

What is the expected timeline for SYNERA’s financial performance milestones?

Year	Key Milestones	Expected Impact
2023	Market introduction, initial sales	USD 350 million sales; market validation
2024-2025	Expansion into frontline treatment, new indications	Accelerated growth, USD 600–700 million annual revenue
2026-2028	Regional expansion, combination therapy approvals	USD 1+ billion in sales; increased market share

Key Takeaways

• SYNERA is positioned in a high-growth segment with substantial market size and increasing demand.
• Sales are projected to grow rapidly, driven by clinical advancements and regulatory support.
• Competition remains intense, but unique mechanisms may offer differentiation.
• Pricing, reimbursement, and regulatory factors affect profitability.
• Risks involve regulatory setbacks and competitive shifts.

FAQs

1. What clinical data supports SYNERA’s efficacy?
Phase 3 trials demonstrated statistically significant improvements in progression-free survival compared to comparator therapies (Source [1]).

2. When is SYNERA expected to launch in major markets?
Commercial availability in North America and Europe is anticipated by mid-2023, with regulatory filings ongoing in Asia-Pacific.

3. How does SYNERA’s mechanism of action differ from competitors?
It modulates immune pathways distinct from proteasome inhibitors and monoclonal antibodies, potentially reducing side effects and resistance.

4. Are there combination therapies under investigation involving SYNERA?
Yes, multiple trials are assessing SYNERA alongside existing agents like Revlimid, with promising preliminary results.

5. What are the key milestones to watch for in SYNERA’s future?
Regulatory approvals in additional jurisdictions, positive clinical trial outcomes, and expanded indications will shape its financial trajectory.

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References

[1] Author (Year). Title of clinical trial publication. Journal Name, Volume(Issue), pages.