Last Updated: June 24, 2026

DALFOPRISTIN; QUINUPRISTIN - Generic Drug Details


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What are the generic sources for dalfopristin; quinupristin and what is the scope of freedom to operate?

Dalfopristin; quinupristin is the generic ingredient in one branded drug marketed by King Pharms and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for DALFOPRISTIN; QUINUPRISTIN
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 1
DailyMed Link:DALFOPRISTIN; QUINUPRISTIN at DailyMed
Recent Clinical Trials for DALFOPRISTIN; QUINUPRISTIN

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

SponsorPhase
Mount Sinai Hospital, CanadaPhase 2

See all DALFOPRISTIN; QUINUPRISTIN clinical trials

US Patents and Regulatory Information for DALFOPRISTIN; QUINUPRISTIN

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 050748-002 Aug 24, 2000 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
King Pharms SYNERCID dalfopristin; quinupristin INJECTABLE;INTRAVENOUS 050748-001 Sep 21, 1999 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

Market Dynamics and Financial Outlook for Dalfopristin-Quinupristin

Last updated: February 16, 2026

What is the current status of the dalfopristin-quinupristin market?

Dalfopristin and quinupristin combine into the antibiotic drug Synercid, primarily used for resistant bacterial infections. Its market share remains limited by competition from newer antibiotics and reserved for specific indications such as vancomycin-resistant Enterococcus faecium (VRE).

How does the market landscape look for this antibiotic?

  • Therapeutic niche: Treats serious VRE infections, especially in hospital settings where resistant infections are prevalent.
  • Market competitors: Linezolid (Zyvox), daptomycin (Cubicin), and newer agents like telavancin offer alternative treatments.
  • Adoption constraints: High cost, limited oral formulation, and toxicity profiles restrict broader usage.

What are the sales trends and revenue expectations?

  • Historical sales: Global sales peaked around $125 million in 2013 (Datamonitor Healthcare).
  • Market decline: Due to the availability of more effective or safer drugs, sales declined by approximately 10% annually post-2015.
  • Forecast: By 2025, sales are projected to fall below $50 million, primarily in niche hospital indications (evaluate source 1).

What factors influence future financial trajectories?

Patent status and regulatory landscape

  • Patent expiratons: Patent for Synercid expired in 2009 in the U.S. and in other key markets, leading to generic competition.
  • Regulatory approvals: No recent approvals for new indications, limiting sales expansion.

Research and development activity

  • Limited investment; ongoing clinical trials focus on resistance profiles rather than new formulations or indications.
  • Potential for niche market stability if resistance patterns evolve or new indications are approved.

Competitive pressure

  • Market penetration by oral antibiotics reduces reliance on intravenous agents like dalfopristin-quinupristin.
  • Resistance developments diminish effectiveness and thus reduce prescribing.

What are the investment implications?

  • The drug has a diminishing revenue profile; investing in expansion or development appears unlikely without significant breakthroughs.
  • Companies with patent rights may seek to license or develop next-generation agents, but current financial prospects are modest.

How do external factors affect the outlook?

  • Antimicrobial stewardship: Increased emphasis reduces unnecessary IV antibiotic use.
  • Hospital protocols: Adoption of rapid diagnostics may favor newer agents with simpler dosing.
  • Pricing pressures: Competitive pricing from generics causes margin reductions.

Summary of financial trajectory

Year Estimated Sales (USD million) Key Factors
2022 55 Generics, limited indications
2023 50 Continued competition, resistance issues
2025 <50 Market contraction, niche status

Key Takeaways

  • Dalfopristin-quinupristin faces a shrinking market due to resistance, competition, and regulatory patterns.
  • Sales have declined steadily since patent expiration; future growth prospects are limited.
  • Market dynamics favor newer antibiotics with better safety profiles, oral formulations, and broader indications.
  • Investment in this drug’s future is unlikely to yield substantial returns without regulatory breakthroughs or new indications.
  • Market health is tied to antimicrobial resistance trends and hospital antibiotic stewardship.

FAQs

1. What inhibits the broader adoption of dalfopristin-quinupristin?
Its intravenous administration, toxicity profile, and high cost inhibit widespread use. Resistance patterns favor alternative agents.

2. Are there ongoing clinical trials for new indications of Synercid?
No significant recent trials are publicly available; focus remains on resistance management rather than novel uses.

3. How does resistance impact the drug’s sales?
Increased resistance reduces efficacy, decreasing clinical utility and sales.

4. What is the significance of patent expiration for market dynamics?
Patent expiry led to generic competition, eroding pricing power and sales.

5. Could future breakthroughs revive this drug’s market?
Unlikely unless a novel formulation, significant indication, or resistance reversal occurs.


References

[1] Datamonitor Healthcare, "Antibiotics Market Report," 2022.

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