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Last Updated: April 22, 2025

TRIMETH/SULFA Drug Patent Profile


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Which patents cover Trimeth/sulfa, and what generic alternatives are available?

Trimeth/sulfa is a drug marketed by Alpharma Us Pharms and Naska and is included in three NDAs.

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

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Summary for TRIMETH/SULFA
US Patents:0
Applicants:2
NDAs:3
Raw Ingredient (Bulk) Api Vendors:162
DailyMed Link:TRIMETH/SULFA at DailyMed
Drug patent expirations by year for TRIMETH/SULFA

US Patents and Regulatory Information for TRIMETH/SULFA

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Alpharma Us Pharms TRIMETH/SULFA sulfamethoxazole; trimethoprim SUSPENSION;ORAL 072289-001 May 23, 1988 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Alpharma Us Pharms TRIMETH/SULFA sulfamethoxazole; trimethoprim SUSPENSION;ORAL 072398-001 May 23, 1988 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Naska TRIMETH/SULFA sulfamethoxazole; trimethoprim SUSPENSION;ORAL 072399-001 May 23, 1988 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 3 of 3 entries

Market Dynamics and Financial Trajectory of Trimethoprim/Sulfamethoxazole

Introduction

Trimethoprim/sulfamethoxazole (TMP/SMX), commonly known as co-trimoxazole, is a widely used antimicrobial combination that has been a cornerstone in the treatment of various bacterial infections for decades. This article delves into the market dynamics and financial trajectory of this drug, highlighting its usage, market trends, and financial projections.

Mechanism of Action and Clinical Use

TMP/SMX works by inhibiting two successive steps in the bacterial biosynthesis of nucleic acids and proteins, making it a potent bactericidal agent. This synergistic effect is crucial in treating infections such as urinary tract infections, middle ear infections, bronchitis, and more[1][2][5].

Global Market Presence

Manufacturing and Distribution

TMP/SMX is formulated and distributed by numerous pharmaceutical companies worldwide. In 2000, it was reported that sulfamethoxazole was formulated by 194 companies in India, 41 in Brazil, and several others in various countries, indicating a widespread manufacturing base[4].

Market Share of Generic Medicines

Given that TMP/SMX is a generic medicine, it falls under the category of drugs that dominate the global pharmaceutical market. Generic medicines account for a significant portion of the global supply, with India, Brazil, and South Africa having market shares of 97%, 84%, and 70% respectively[3].

Financial Trajectory

Global Market Value of Generic Medicines

The global market for generic medicines, which includes TMP/SMX, has seen substantial growth. In 2022, the market value was estimated at USD 311.8 billion and is projected to reach USD 442.3 billion by 2027, growing at a compound annual growth rate (CAGR) of 7.24%[3].

Regional Market Growth

In regions like Latin America and the Middle East and Africa, the market value for generic medicines is also on the rise. For Latin America, the value is projected to increase from USD 37.1 billion in 2022 to USD 50.7 billion by 2027, while for the Middle East and Africa, it is expected to rise from USD 31 billion to USD 42.7 billion during the same period[3].

Cost Affordability and Accessibility

Economic Impact

TMP/SMX is highly cost-affordable, making it accessible to a wide range of patients, especially in low- and middle-income countries (LMICs). The affordability of this drug contributes significantly to its widespread use and market dominance[1].

Role in Public Health

The cost-effectiveness of TMP/SMX makes it a crucial component in public health initiatives, particularly in treating common infections that are prevalent in resource-limited settings. This affordability helps in reducing healthcare costs and improving health outcomes globally.

Challenges and Considerations

Resistance and Side Effects

Despite its widespread use, TMP/SMX faces challenges such as the development of drug-resistant bacteria and potential side effects. Prescribing this medication without a proven or strongly suspected bacterial infection can contribute to the development of drug resistance[5].

Contraindications and Precautions

TMP/SMX has several contraindications, including known hypersensitivity to either drug, pregnancy, liver parenchymal damage, hematological disorders, and renal insufficiency. These factors must be carefully considered by healthcare providers to ensure safe and effective treatment[1].

Geriatric and Pediatric Use

Geriatric Considerations

Elderly patients may experience more severe side effects due to age-related kidney or liver problems and potential folate deficiencies. However, studies have not demonstrated geriatric-specific problems that would limit the usefulness of TMP/SMX in this population[2].

Pediatric Use

In pediatric patients, especially neonates less than 6 weeks old, TMP/SMX is contraindicated due to the risk of kernicterus and other adverse effects. For older children, the drug can be used under careful medical supervision[1].

Market Trends and Projections

Growing Demand

The demand for TMP/SMX is expected to continue growing due to its effectiveness in treating a wide range of bacterial infections. The rise in chronic diseases and the need for cost-effective treatments further drive this demand.

Competition from New Antibiotics

While TMP/SMX remains a staple, the development of new antibiotics and the increasing concern over antibiotic resistance may impact its market share in the future. However, its established position and affordability are likely to maintain its relevance.

Key Takeaways

  • Market Dominance: TMP/SMX is a widely used generic medicine with a significant market presence globally.
  • Financial Growth: The global market for generic medicines, including TMP/SMX, is projected to grow substantially by 2027.
  • Cost Affordability: The drug's affordability makes it accessible and crucial in public health initiatives.
  • Challenges: Despite its benefits, TMP/SMX faces challenges such as drug resistance and side effects.
  • Geriatric and Pediatric Use: Careful consideration is needed when prescribing TMP/SMX to elderly and pediatric patients.

FAQs

Q: What is the mechanism of action of trimethoprim/sulfamethoxazole?

A: TMP/SMX works by inhibiting two successive steps in the bacterial biosynthesis of nucleic acids and proteins, making it a bactericidal agent[1][5].

Q: Why is trimethoprim/sulfamethoxazole contraindicated in pregnancy?

A: TMP/SMX is contraindicated in pregnancy due to the inhibition of folate synthesis, which can lead to congenital abnormalities[1].

Q: How does the global market for generic medicines impact the financial trajectory of TMP/SMX?

A: The growing global market for generic medicines, projected to reach USD 442.3 billion by 2027, significantly influences the financial trajectory of TMP/SMX, ensuring its continued market presence and financial growth[3].

Q: What are the potential side effects of trimethoprim/sulfamethoxazole in elderly patients?

A: Elderly patients are more likely to experience severe side effects such as skin rash, increased potassium levels, and problems with blood clotting or the immune system[2].

Q: Can trimethoprim/sulfamethoxazole be used during breastfeeding?

A: Studies suggest that TMP/SMX poses minimal risk to the infant when used during breastfeeding[2].

Sources

  1. Trimethoprim Sulfamethoxazole - StatPearls - NCBI Bookshelf
  2. Sulfamethoxazole and trimethoprim (oral route) - Mayo Clinic
  3. Generic & Biosimilar Medicines Programme 2023 - Access to Medicine Foundation
  4. SULFAMETHOXAZOLE 1. Exposure Data - IARC Publications
  5. Sulfamethoxazole and trimethoprim tablets USP 400 / 80 mg

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