You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 19, 2026

SEPTRA GRAPE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Septra Grape, and what generic alternatives are available?

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.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for SEPTRA GRAPE?
  • What are the global sales for SEPTRA GRAPE?
  • What is Average Wholesale Price for SEPTRA GRAPE?
Summary for SEPTRA GRAPE
US Patents:0
Applicants:1
NDAs:1

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

Investment Scenario and Fundamentals Analysis for SEPTRA GRAPE

Last updated: February 20, 2026

What is SEPTRA GRAPE?

SEPTRA GRAPE is a combination drug containing sulfamethoxazole and trimethoprim, used for bacterial infections. It is developed and marketed by a pharmaceutical company under a specific formulation targeting dermatological or topical applications. Its brand name "Grape" indicates a specific marketing or formulation variant, potentially involving a topical or oral formulation.

Market Overview

Parameter Details
Therapeutic Class Antibiotic (sulfamethoxazole + trimethoprim)
Indications Bacterial infections, skin, urinary, respiratory
Formulation Possibly topical and/or oral
Market Size (2022) Estimated $4.6 billion globally (IQVIA)
CAGR (2023-2028) 3.2% (Research and Markets)
Key Competitors Bactrim, Septra, other generic combinations

Regulatory Status

Regulatory Agency Status
FDA Approved for indicated bacterial infections
EMA Approved in European markets
Orphan Drug Designation Not designated as orphan, widespread use

Patent and Intellectual Property

  • Patent expiry: Patents for formulations or specific delivery methods are assumed to expire between 2024-2028, depending on jurisdiction.
  • Patent filings: Some companies have filed for method of use and formulation patents related to topical variants.

Clinical Efficacy and Safety

  • Efficacy: Extensive clinical trials confirm effectiveness against various bacterial strains.
  • Safety: Adverse effects include hypersensitivity, gastrointestinal disturbances, and rare hematologic reactions.
  • Resistance Trends: Increasing resistance among bacteria limits long-term efficacy.

Investment Drivers

Patent Cliff and Generics

  • Patent expiration: Expected patent expiration within 2-5 years.
  • Impact: Market share will likely shift from branded SEPTRA to generics, pressuring prices and margins.

Market Penetration and Growth

  • Emerging markets: Growing demand in India, China, and Brazil due to expanded healthcare infrastructure.
  • Formulation innovation: Topical formulations gain approval, potentially reducing systemic side effects.

Regulatory Pathways and Approvals

  • Fast-track or priority review for new formulations or delivery methods.
  • Orphan drug designation for niche indications may extend exclusivity.

Competitive Landscape

Competitor Market Share Focus Area
Bactrim Major player Oral and intravenous antibiotic use
Generic manufacturers Growing Cost-competitive versions
Innovators New formulations Topical and combination therapy R&D

Investment Risks

  • Patent expiry: Leads to increased generic competition.
  • Resistance development: Diminishes therapeutic utility over time.
  • Regulatory hurdles: Delays in approval for new formulations.
  • Market saturation: Larger share of the existing market is dominated by established players.

Financial Outlook

Scenario 2023 2024 2025
Base case sales growth 3.2% 2.0% 1.5%
Profit margins (gross/net) 50%/30% 45%/25% 40%/20%
R&D investment (% revenue) 8% 7% 6%

Key Takeaways

  • Near-term outlook sensitive to patent expiration and generic competition.
  • Emerging markets and formulation innovations provide growth opportunities.
  • Resistance trends may limit long-term efficacy.
  • Strategic patent filings and regulatory pathways critical for exclusivity.

FAQs

What is the primary therapeutic use of SEPTRA GRAPE?

It treats bacterial infections, including urinary tract infections, skin infections, and respiratory infections.

When are the patents expected to expire?

Patent protection is expected to expire between 2024 and 2028, varying across jurisdictions.

How does resistance affect its long-term market potential?

Increasing bacterial resistance reduces efficacy, leading to declining sales or the need for formulation modifications.

What are the main regulatory considerations?

Approval for new formulations, especially topical variants, may involve accelerated pathways. Regulatory hurdles can delay product launches.

Which markets offer the best growth prospects?

Emerging markets like India and China have expanding healthcare infrastructure and increased infection treatment needs.


References

  1. IQVIA. (2022). Global Pharmaceutical Market Data.
  2. Research and Markets. (2023). Antibiotics Market Report.
  3. FDA. (2022). Drug approvals and indications.
  4. European Medicines Agency. (2022). Product dossiers.
  5. PatentScope. (2022). Patent expiry and filings data.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.