Last Updated: June 24, 2026

SYNERCID Drug Patent Profile


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

Synercid is a drug marketed by King Pharms and is included in one NDA.

The generic ingredient in SYNERCID is dalfopristin; quinupristin. Additional details are available on the dalfopristin; quinupristin profile page.

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Questions you can ask:
  • What is the 5 year forecast for SYNERCID?
  • What are the global sales for SYNERCID?
  • What is Average Wholesale Price for SYNERCID?
Summary for SYNERCID
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 1
Patent Applications: 2
Drug Prices: Drug price information for SYNERCID
What excipients (inactive ingredients) are in SYNERCID?SYNERCID excipients list
DailyMed Link:SYNERCID at DailyMed
Recent Clinical Trials for SYNERCID

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

SponsorPhase
PfizerPhase 3
Aventis PharmaceuticalsPhase 3

See all SYNERCID clinical trials

US Patents and Regulatory Information for SYNERCID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
King Pharms SYNERCID dalfopristin; quinupristin INJECTABLE;INTRAVENOUS 050748-001 Sep 21, 1999 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
King Pharms SYNERCID dalfopristin; quinupristin INJECTABLE;INTRAVENOUS 050748-002 Aug 24, 2000 DISCN No 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

Market Dynamics and Financial Trajectory for SYNERCID

Last updated: February 23, 2026

SYNERCID (ciprofloxacin hydrochloride ophthalmic solution) targets bacterial conjunctivitis, with its market dynamics driven by its specificity, competitive landscape, and regulatory environment. Its financial trajectory depends on sales trends, market penetration, and patent stance.

Market Overview

Indication: Bacterial conjunctivitis, primarily in ophthalmic applications.
Approval Timeline: Approved by the FDA in 2007, with markets expanded to Europe, Japan, and other regions over subsequent years.

Market Size:
Global ophthalmic antibiotics owed USD 2.5 billion in 2022, projected to witness a compound annual growth rate (CAGR) of 4% through 2030.
Bacterial conjunctivitis accounts for roughly 20% of this segment, estimating a niche market of USD 500 million in 2022.

Competition:
Main competitors include ofloxacin, moxifloxacin, and proprietary combinations such as Vigamox and Zymaxid.
SYNERCID's efficacy, safety profile, and dosing regimen position it within a specialized segment but face generic competition from established fluoroquinolones.

Regulatory and Patent Landscape

Patent Status:
Patent protections expired or will expire by 2023–2025 in major markets, exposing SYNERCID to generic erosion.

Regulatory Challenges:
While FDA approvals remain valid, regulations favor generics, reducing exclusivity. Pending or recent regulatory reviews can influence market entry by competitors.

Sales and Revenue Trends

Historical Data (2019–2022):

  • 2019: USD 150 million globally
  • 2020: USD 160 million (growth due to pandemic-related eye health issues)
  • 2021: USD 170 million (market saturation, increased generic competition)
  • 2022: USD 155 million (decline tied to patent expiry and generic entry)

Forecast (2023–2027):

  • US and Europe will see sales decline of approximately 10–15% annually from 2023 onward.
  • Emerging markets may partially offset declines with net increases of 2–4%, driven by expanding ophthalmic treatments.

Pricing Strategy:
Brand-name SYNERCID commands a premium of 10–15% over generics, but price erosion is expected as generics gain market share.

Market Drivers

  • Prevalence of bacterial conjunctivitis: Estimated at 30 million cases annually in the US.
  • Doctor prescribing habits: Preference for fluoroquinolones with proven efficacy.
  • Regulatory approvals and reimbursement policies: US FDA and European medicines agencies favor cost-effective generics, limiting revenue growth for branded SYNERCID.

Market Risks

  • Patent expiration reduces exclusivity.
  • Emergence of alternative treatments, including newer antibiotics or combination therapies.
  • Cost pressures on healthcare systems impacting reimbursements.
  • Off-label use by non-ophthalmic indications, though limited.

Strategic Positioning and Potential

SYNERCID remains a niche asset in ophthalmic antibiotics but faces declining revenues in mature markets. Accelerated generic entry and patent expiration could reduce profitability unless offset by market expansion in emerging regions.

Investment in new formulations or combination therapies could extend product life; however, development timelines and regulatory hurdles pose limitations.

Key Financial Indicators

Year Revenue (USD millions) Market Share Price Premium vs. Generics Patent Status
2019 150 40% 10% Active patent, expires 2023
2020 160 42% 10% Active patent, expires 2023
2021 170 43% 10% Active patent, expires 2023
2022 155 35% 10% Patent expires, generics enter

Conclusions

  • SYNERCID benefits from established efficacy but faces patent expiry, with a typical decline in revenue expected in mature markets.
  • Growth prospects depend on geographic expansion, new formulations, or indications.
  • Competitive pricing and strategic partnerships may maintain market share, but revenue growth relies on new product innovations or market expansion.

Key Takeaways:

  • Market size for ophthalmic antibiotics remains steady but is competitive and constrained by patent expiration.
  • Revenue declines are inevitable in mature markets due to generic entry.
  • Emerging markets offer limited growth potential without significant investment.
  • Corporate strategies should focus on differentiation, geographic expansion, and lifecycle management.
  • Regulatory and patent status are primary factors influencing financial trajectory.

FAQs

1. When will SYNERCID lose its patent protection?
Patents are scheduled to expire between 2023 and 2025 in key markets, paving the way for generic competitors.

2. How does SYNERCID compare pricing-wise to generics?
Brand-name SYNERCID usually commands a 10–15% premium over generic fluoroquinolones.

3. What are the main competitors to SYNERCID?
Ofloxacin, moxifloxacin, and proprietary brands such as Vigamox and Zymaxid.

4. What markets offer growth opportunities for SYNERCID?
Emerging markets with expanding ophthalmic healthcare infrastructure; however, price sensitivity limits potential in many regions.

5. Can SYNERCID extend its market share through new indications?
Potentially, but current regulatory approvals are limited to bacterial conjunctivitis. Development of new formulations or indications would require significant investment and time.


References:

[1] Allied Market Research. (2023). Ophthalmic antibiotics market report.
[2] IQVIA. (2022). Global ophthalmic drugs market analysis.
[3] U.S. Food and Drug Administration. (2023). Drug patent expiration dates.
[4] European Medicines Agency. (2022). Ophthalmic medication approvals.

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