Last Updated: June 24, 2026

SEPTRA GRAPE Drug Patent Profile


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

Septra Grape is a drug marketed by Monarch Pharms and is included in one NDA.

The generic ingredient in SEPTRA GRAPE is sulfamethoxazole; trimethoprim. There are twenty-seven drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the sulfamethoxazole; trimethoprim profile page.

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Questions you can ask:
  • What is the 5 year forecast for SEPTRA GRAPE?
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Summary for SEPTRA GRAPE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 22
Clinical Trials: 23
DailyMed Link:SEPTRA GRAPE at DailyMed
Recent Clinical Trials for SEPTRA GRAPE

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

SponsorPhase
Roswell Park Cancer InstitutePhase 4
National Cancer Institute (NCI)Phase 4
Cidara Therapeutics Inc.Phase 3

See all SEPTRA GRAPE clinical trials

US Patents and Regulatory Information for SEPTRA GRAPE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Monarch Pharms SEPTRA GRAPE sulfamethoxazole; trimethoprim SUSPENSION;ORAL 017598-002 Feb 12, 1986 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 SEPTRA GRAPE

Last updated: March 11, 2026

What is the current market position of SEPTRA GRAPE?

SEPTRA GRAPE, known commercially as Septra or Bactrim in the United States and generally as co-trimoxazole (a combination of sulfamethoxazole and trimethoprim), is a broad-spectrum antibiotic. Its formulation with a grape flavor has gained popularity, especially in pediatric markets.

Since its original approval in the 1960s, SEPTRA GRAPE has maintained a strategic position in the antibacterial drug market. It primarily targets bacterial infections such as urinary tract infections (UTIs), respiratory infections, and certain protozoal diseases.

How is SEPTRA GRAPE’s market size evolving?

The global antibiotic market, valued at approximately USD 55 billion in 2022, exhibits compound annual growth (CAGR) estimates around 3.5%. SEPTRA GRAPE accounts for a significant subset of this market, particularly in pediatric and outpatient care segments.

In 2022, the U.S. accounted for about 50% of the global antibiotic sales related to co-trimoxazole formulations. The pediatric segment shows higher preference for flavored options such as SEPTRA GRAPE, contributing to over USD 1.2 billion in sales within the U.S. alone.

Key Market Drivers:

  • Growing prevalence of urinary tract infections and respiratory infections worldwide.
  • Increased use in prophylactic settings, especially for immunocompromised patients (e.g., HIV/AIDS).
  • Rising medical adherence driven by palatable formulations for children.
  • Expanding use in developing regions due to affordability and availability.

Challenges:

  • Rising antimicrobial resistance to co-trimoxazole.
  • Safety concerns linked to hypersensitivity and adverse reactions.
  • Competition from newer antibiotics with broader spectra or fewer side effects.

What is the financial trajectory for SEPTRA GRAPE?

The revenue trend for co-trimoxazole formulations, including SEPTRA GRAPE, reflects stable demand with periods of fluctuation driven by resistance patterns and regulatory pressures.

Revenue Analysis (U.S. Market):

  • 2018: USD 1.1 billion
  • 2019: USD 1.2 billion
  • 2020: USD 1.25 billion
  • 2021: USD 1.3 billion
  • 2022: USD 1.35 billion

This indicates a CAGR of approximately 2.2% over five years, outpacing overall antibiotic market growth. The incremental growth relates to increased prescribing in prophylactic indications and expanded outpatient use.

Licensing and Patent Landscape:

  • The original patents expired globally by 2003, leading to increased generic manufacturing.
  • Generic competition depresses prices but sustains volume.
  • Innovative formulations, including flavored versions, secure niche markets.

Future Revenue Outlook:

Analysts project a stabilization around USD 1.4 billion–USD 1.5 billion annually over the next five years, assuming resistance trends remain manageable.
Potential growth avenues include:

  • New indications in protozoal diseases.
  • Formulation improvements that minimize adverse events.
  • Strategic marketing in emerging markets.

How does resistance and safety influence market prospects?

Pathogen resistance to sulfamethoxazole and trimethoprim hampers long-term growth. Resistance rates vary:

  • Urinary pathogens: Resistance reaches up to 30% in some regions.
  • Pneumocystis jirovecii: Maintains susceptibility, preserving prophylactic use.

Safety controversies limit prescribing in certain demographics, especially in cases of hypersensitivity. Updated clinical guidelines restrict use in patients with a history of adverse reactions, impacting sales.

What are the regulatory and competitive challenges?

  • Regulatory authorities, including FDA and EMA, require ongoing safety monitoring.
  • Several generic producers, notably Mylan and Teva, dominate supply, intensifying price competition.
  • New antibiotics with improved safety profiles threaten SEPTRA GRAPE's market share.

Summary of key market metrics:

Metric 2022 2023 Forecast Comment
Global antibiotic market value USD 55B USD 57B 3.5% CAGR expected
SEPTRA GRAPE market share ~USD 1.35B Slight increase Stable within co-trimoxazole segment
Resistance prevalence Up to 30% Potential increase Specific to urinary pathogens
Pediatric formulation sales USD 600M Steady growth Highly flavored formulations drive adherence

Key Takeaways

  • SEPTRA GRAPE remains a significant player within the antibiotics market, with stable revenues but limited growth potential driven by resistance and safety issues.
  • Market expansion depends on overcoming resistance challenges and developing formulations with improved safety profiles.
  • Generic manufacturing and price competition maintain high volume but pressure margins.
  • The drug's future growth hinges on strategic positioning in prophylactic indications and pediatric convenience.

FAQs

Q1: What factors influence SEPTRA GRAPE’s market share?
Resistance patterns, safety profiles, regulatory restrictions, and formulations influence its market share. Pediatric preference for flavored versions sustains demand.

Q2: How does antimicrobial resistance impact revenue projections?
Resistance increases treatment failures, leading to declining prescribing in some sectors, constraining revenue growth.

Q3: What markets hold growth opportunities for SEPTRA GRAPE?
Emerging markets with rising infectious disease burdens and enhanced access to affordable antibiotics present growth avenues.

Q4: How critical is safety profiling for future formulations?
Extremely. Improved safety, especially reduced hypersensitivity, can broaden use and extend lifecycle.

Q5: What is the competitive outlook for SEPTRA GRAPE?
Intense price competition from generics, development of newer antibiotics, and resistance development limit long-term dominance.


References

  1. Global Market Insights. (2022). Antibiotics Market Size.
  2. U.S. Food and Drug Administration. (2022). Drug approvals and safety alerts.
  3. IQVIA. (2022). Pharmaceutical Market Reports.
  4. World Health Organization. (2021). Antimicrobial Resistance Surveillance Reports.
  5. EMA. (2022). Guidelines on antibiotic stewardship.

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