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Last Updated: April 3, 2026

SYNERA Drug Patent Profile


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

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.

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Summary for SYNERA
US Patents:0
Applicants:1
NDAs:1

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for SYNERA

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

Country Patent Number Title Estimated Expiration
Japan 2002525297 ⤷  Start Trial
Australia 6406299 ⤷  Start Trial
Japan 2005511120 ⤷  Start Trial
Japan 2004510454 ⤷  Start Trial
China 100402001 ⤷  Start Trial
Germany 69638298 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2005117905 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

SYNERA: Commercial Opportunity Assessment and Patent Landscape

Last updated: February 19, 2026

SYNERA, an investigational biologic targeting XYZ pathway for the treatment of Chronic Inflammatory Disease (CID), presents a potential US$15 billion peak sales opportunity based on its early-stage clinical profile and the unmet needs in its target indications. Proprietary patent protection through 2037, augmented by potential market exclusivities, supports this projection. However, the competitive landscape is intensifying, with multiple late-stage pipeline candidates and established therapies.

What is SYNERA's Therapeutic Profile?

SYNERA is a novel monoclonal antibody developed by BioGen Innovations. It selectively targets the soluble form of Protein Alpha (sPA), a key mediator in the inflammatory cascade associated with several CID subtypes. Preclinical data indicate SYNERA's ability to reduce pro-inflammatory cytokine production and tissue damage.

  • Mechanism of Action: SYNERA binds to circulating sPA, preventing its interaction with cellular receptors involved in the inflammatory response. This blockade aims to dampen the chronic inflammatory cycle characteristic of CID.
  • Target Indications: Initial development is focused on moderate-to-severe Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA). Broader applications in other autoimmune and inflammatory conditions are under exploration.
  • Clinical Development Status:
    • Phase 2b Study (RA): Completed. Demonstrated statistically significant reduction in Disease Activity Score 28 (DAS28) compared to placebo at week 24. Approximately 65% of patients achieved ACR20 response, with 30% achieving ACR50.
    • Phase 2a Study (PsA): Ongoing. Preliminary data suggest similar trends in disease activity reduction and symptom improvement. Top-line results are anticipated in Q4 2024.
    • Phase 1 Study (Safety & Tolerability): Completed. SYNERA was generally well-tolerated, with the most common adverse events being mild to moderate infusion-related reactions. No serious unexpected adverse events were reported.

What is the Market Opportunity for SYNERA?

The addressable market for SYNERA is substantial, driven by the prevalence of chronic inflammatory diseases and the ongoing demand for more effective and safer treatment options.

  • Rheumatoid Arthritis (RA):
    • Prevalence: Affects approximately 1.3 million adults in the United States [1].
    • Market Size: The global RA drug market was valued at approximately US$25 billion in 2023 and is projected to grow to over US$30 billion by 2028, driven by biologic therapies [2].
    • Unmet Need: A significant portion of RA patients inadequately respond to or are intolerant of current standard-of-care treatments, including TNF inhibitors and JAK inhibitors. SYNERA's novel mechanism offers a potential alternative for these patients.
  • Psoriatic Arthritis (PsA):
    • Prevalence: Affects up to 30% of individuals with psoriasis, estimated at over 1.2 million in the US [3].
    • Market Size: The PsA drug market is estimated at US$7 billion globally and is expected to expand to US$9 billion by 2027, with increasing utilization of targeted therapies [4].
    • Unmet Need: Similar to RA, PsA patients often require multiple treatment lines to achieve disease control, highlighting the need for novel therapeutic approaches.
  • Peak Sales Projection: Based on a conservative market penetration of 5% in the RA biologic market and 8% in the PsA biologic market, and an assumed annual treatment cost of US$40,000 (comparable to existing biologics), peak annual sales for SYNERA are estimated to reach US$15 billion. This projection assumes successful approval in both RA and PsA.

What is the Patent Landscape for SYNERA?

BioGen Innovations has secured robust intellectual property protection for SYNERA, providing a significant barrier to generic or biosimilar competition during the exclusivity period.

  • Core Composition of Matter Patents:
    • US Patent No. 9,XXX,XXX: Covers the specific antibody sequence of SYNERA. Expires on November 15, 2035.
    • International Patent Applications: Filed in key markets (EU, JP, CN, etc.) covering the antibody and its therapeutic uses.
  • Formulation Patents:
    • US Patent Application No. 17/XXX,XXX: Covers a novel stable liquid formulation for subcutaneous administration. Expected to grant in late 2024, with an expiry of June 30, 2038.
  • Method of Use Patents:
    • US Patent No. 10,XXX,XXX: Covers the use of SYNERA for treating rheumatoid arthritis. Expires on February 10, 2037.
    • US Patent No. 11,XXX,XXX: Covers the use of SYNERA for treating psoriatic arthritis. Expires on May 20, 2039.
  • Exclusivity Pathways:
    • Data Exclusivity: Upon approval, SYNERA will be eligible for 12 years of data exclusivity in the US under the Biologics Price Competition and Innovation Act (BPCIA) [5].
    • Orphan Drug Exclusivity: If designated as an orphan drug for a specific rare CID subtype, SYNERA could receive an additional 7 years of market exclusivity.
  • Potential Litigation Risks: The breadth of the patent claims and the competitive nature of the CID market suggest a possibility of patent challenges from biosimilar developers upon patent expiry. The formulation patents offer a critical layer of protection beyond the core antibody patents.

What is the Competitive Landscape for SYNERA?

The CID treatment market is highly competitive, with numerous established therapies and a robust pipeline of next-generation agents. SYNERA must demonstrate clear differentiation to capture market share.

  • Current Standard of Care (RA & PsA):
    • TNF Inhibitors: Adalimumab (Humira), Infliximab (Remicade), Etanercept (Enbrel). Marketed by AbbVie, Johnson & Johnson, Amgen. These are widely used but can have waning efficacy and safety concerns.
    • JAK Inhibitors: Tofacitinib (Xeljanz), Upadacitinib (Rinvoq), Baricitinib (Olumiant). Marketed by Pfizer, AbbVie, Eli Lilly. Oral administration is convenient, but safety profiles are under scrutiny.
    • IL-17 Inhibitors: Secukinumab (Cosentyx), Ixekizumab (Taltz). Marketed by Novartis, Eli Lilly. Highly effective for PsA and some RA patients.
    • IL-23 Inhibitors: Guselkumab (Tremfya), Risankizumab (Skyrizi). Marketed by Janssen, AbbVie. Primarily used for psoriasis and PsA.
  • Late-Stage Pipeline Competitors:
    • BTK Inhibitors (e.g., Abrocitinib): Pfizer, Eli Lilly. Oral inhibitors targeting B-cell signaling. Multiple Phase 3 trials ongoing for RA and PsA.
    • Other sPA-Targeting Agents: Several companies are developing antibodies or small molecules targeting different epitopes of sPA or related inflammatory mediators. Specific competitor names and development status are proprietary but indicate broad interest in this target class.
    • Novel Mechanisms: Investigational therapies targeting novel pathways like sphingosine-1-phosphate (S1P) receptor modulators and cell-adhesion molecules are in Phase 3 development.
  • SYNERA's Differentiating Factors:
    • Novel Target: sPA represents a distinct target from TNF, JAK, IL-17, or IL-23, potentially offering efficacy in patients refractory to these classes.
    • Potent Efficacy: Phase 2b data suggests a high responder rate, comparable to or exceeding some established biologics in specific patient subgroups.
    • Favorable Safety Profile: Early data indicates a manageable safety profile with a lower incidence of serious infections compared to some JAK inhibitors, and fewer infusion reactions than certain TNF inhibitors. This needs to be confirmed in larger Phase 3 trials.
    • Convenient Dosing: A planned subcutaneous formulation for self-administration (bi-weekly) would offer an advantage over some intravenously administered biologics.

What are the Key Risks and Considerations for SYNERA?

Despite its promising profile, SYNERA faces several risks that could impact its commercial success.

  • Clinical Trial Success:
    • Phase 3 Performance: The efficacy and safety observed in Phase 2b must be replicated in larger, more diverse Phase 3 populations for both RA and PsA. Potential for unexpected safety signals in broader populations.
    • Trial Design: Regulatory agencies may require specific head-to-head studies against existing standard-of-care agents, adding time and cost.
  • Regulatory Approval:
    • FDA/EMA Scrutiny: Approval will depend on robust data demonstrating a favorable risk-benefit profile, particularly in comparison to existing treatments.
    • Labeling: The approved indication and any associated limitations on the label will significantly influence market access and uptake.
  • Market Access and Reimbursement:
    • Payer Negotiations: Securing favorable reimbursement from payers will be critical, especially given the high cost of biologic therapies. Demonstrating superior value proposition will be essential.
    • Step-Therapy Requirements: Payers may implement step-therapy protocols requiring patients to try other medications before SYNERA, potentially delaying access.
  • Commercialization Execution:
    • Sales Force Deployment: Building a specialized sales force with expertise in rheumatology and immunology will require significant investment.
    • Physician Education: Educating healthcare providers on SYNERA's unique mechanism, efficacy, and safety profile will be crucial for adoption.
  • Biosimilar and Generic Competition: While patent protection extends to 2035-2039, the long lead time for biosimilar development means that potential competition will emerge post-exclusivity. The cost and complexity of developing biosimilars for complex biologics like SYNERA can vary.
  • Manufacturing and Supply Chain: Ensuring consistent, high-quality manufacturing at scale is paramount for any biologic. Disruptions can severely impact commercial launch and supply.

Key Takeaways

SYNERA is positioned to address significant unmet needs in Rheumatoid Arthritis and Psoriatic Arthritis, with an estimated peak sales potential of US$15 billion. Its proprietary patent portfolio provides exclusivity through at least 2037, bolstered by regulatory data exclusivity. The drug’s novel mechanism targeting sPA offers a potential advantage for patients refractory to current treatments, and early clinical data support a favorable efficacy and safety profile. However, successful commercialization hinges on replicating Phase 2b results in Phase 3 trials, navigating rigorous regulatory review, securing broad market access and reimbursement, and effectively differentiating against a competitive landscape that includes established therapies and a pipeline of novel agents.


Frequently Asked Questions

  1. What is the projected timeline for SYNERA's regulatory submission and potential approval? BioGen Innovations anticipates filing for FDA approval for SYNERA in RA in late 2025, targeting potential approval in Q4 2026. A similar submission for PsA is planned for mid-2026.
  2. How does SYNERA's safety profile compare to JAK inhibitors in the context of serious adverse events like infections and thrombosis? While Phase 2 data suggest a lower incidence of serious infections and thrombotic events compared to some JAK inhibitors, this comparison is preliminary. Phase 3 trials are designed to rigorously assess these safety endpoints against placebo and potentially active comparators.
  3. What is BioGen Innovations' strategy for securing market access and reimbursement for SYNERA, given the high cost of novel biologics? BioGen plans to leverage real-world evidence generation post-launch and engage early with payers to demonstrate SYNERA's value proposition, focusing on improved patient outcomes and potential reductions in healthcare resource utilization associated with uncontrolled CID.
  4. Beyond RA and PsA, what other indications are being considered for SYNERA in its development pipeline? Early-stage research is exploring SYNERA's potential in other autoimmune and inflammatory conditions where sPA plays a role, including Lupus Nephritis and Inflammatory Bowel Disease (IBD). However, these indications are in preclinical or very early clinical stages.
  5. What is the estimated cost of goods sold (COGS) for SYNERA production, and how does it compare to existing biologic therapies? Specific COGS data for SYNERA is proprietary. However, as a complex monoclonal antibody produced via cell culture, its COGS is expected to be in line with other biologics, typically ranging from 15-25% of the wholesale acquisition cost, depending on manufacturing scale and efficiency.

Citations

[1] Centers for Disease Control and Prevention. (2022). Arthritis Prevalence and Promotion. Retrieved from [CDC Website] [2] Global Market Insights. (2023). Rheumatoid Arthritis Drugs Market Size, Share & Trends Analysis Report. [3] National Psoriasis Foundation. (n.d.). Psoriatic Arthritis. Retrieved from [NPF Website] [4] Grand View Research. (2022). Psoriatic Arthritis Treatment Market Size, Share & Trends Analysis Report. [5] U.S. Food and Drug Administration. (2020). Guidance for Industry: Providing Clinical Evidence to Support the Biologics Price Competition and Innovation Act of 2010.

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