Viewing data from:

BACTRIM

NDA

SULFAMETHOXAZOLE; TRIMETHOPRIM | N017377 | SUN PHARMACEUTICAL INDUSTRIES INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Lannett Holdings, Inc. - Citizen Petition FDA-2010-P-0170 · 6 docket documents Lannett Holdings, Inc. submitted a suitability petition under Section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare sulfamethoxazole and trimethoprim powder suitable for submission in an ANADA, proposing to substitute sulfamethoxazole for sulfadiazine in the r	Other	2010-03-29	Partially Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

100 trials from ClinicalTrials.gov — 3 recruiting, 2 active, 69 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis NCT03919435	Phase 1/2	Active	University of Pennsylvania	8	2019-03-27 → 2027-12-30
Prophylactic Antibiotics or Placebo After Hypospadias Repair NCT02096159	N/A	Active	Ann & Robert H Lurie Children's Hospital of Chicago	93	2014-03 → 2025-08
A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration NCT03178149	Phase 1	Recruiting	Astellas Institute for Regenerative Medicine	42	2018-07-13 → 2026-06-30
Effects of Treatments on Atopic Dermatitis NCT01631617	Phase 2	Recruiting	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	130	2012-09-18 → 2027-01-01
Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions NCT03014687	Phase 4	Recruiting	St. Joseph's Hospital and Medical Center, Phoenix	116	2017-07-01 → 2019-07
Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy.NCT03228108	Phase 4	Completed	Radboud University Medical Center	1,538	2018-04-03 → 2021-09-26
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)NCT01599806	Phase 3	Completed	Pfizer	641	2012-10 → 2014-08
Antibiotic Use Following Distal and Mid-shaft Hypospadias Repair NCT02593903	N/A	Completed	Medical College of Wisconsin	67	2014-03-04 → 2018-04
Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites NCT00000826	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	48	— → 1999-05
Vancomycin Or Trimethoprim/Sulfamethoxazole for Methicillin-resistant Staphylococcus Aureus Osteomyelitis NCT00324922	Phase 3	Completed	University of Washington	2	2006-05-01 → 2007-05-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Bactrim (2024)

Total Spending

$2K

Total Claims

Beneficiaries

Avg Cost/Unit

$1.17

Spending Trend

$4K(2019)→$2K(2020)→$2K(2021)→$2K(2023)→$2K(2024)

YoY Change:-12.6%

5yr CAGR:-4.2%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Feb 25, 2025	SUPPL -85	View Letter (PDF)
Jun 25, 2024	SUPPL -84	View Letter (PDF)
May 4, 2021	SUPPL -83	View Letter (PDF)
Jul 29, 2020	SUPPL -80	View Letter (PDF)
Jul 17, 2014	SUPPL -74	View Letter (PDF)
Jul 15, 2013	SUPPL -68	View Letter (PDF)
Jul 15, 2013	SUPPL -73	View Letter (PDF)
Aug 31, 2012	SUPPL -71	View Letter (PDF)
Jul 29, 2010	SUPPL -67	View Letter (PDF)
Jul 2, 2010	SUPPL -66	View Letter (PDF)
Jun 7, 2007	SUPPL -63	View Letter (PDF)
Feb 12, 2003	SUPPL -57	View Letter (PDF)
Oct 17, 2002	SUPPL -58	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 400MG;80MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 800MG;160MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982