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TRIMETHOPRIM

NDA

TRIMETHOPRIM | N018679 | DR REDDYS LABORATORIES SA

1 strength0 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

119 trials from ClinicalTrials.gov — 4 recruiting, 3 active, 83 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
Study of Subretinally Injected ATSN-101 Administered in Patients With Leber Congenital Amaurosis Caused by Biallelic Mutations in GUCY2D NCT03920007	Phase 1/2	Active	Atsena Therapeutics Inc.	15	2019-09-12 → 2027-05-19
TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis NCT03919435	Phase 1/2	Active	University of Pennsylvania	8	2019-03-27 → 2027-12-30
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
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
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
[18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects NCT04263792	Phase 1	Recruiting	University of Pennsylvania	20	2020-02-07 → 2027-01
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

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$1.23

per ea

Lowest NADAC/Unit

$1.23

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
75907004301TRIMETHOPRIM 100 MG TABLET	$1.23	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$45.58

Highest Price

$45.58

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
75907-0043-01TRIMETHOPRIM 100MG TAB	$45.58	FSS	Dr. Reddys Laboratories	09/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain8 active DMFs24 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVTRIMETHOPRIM USP

DMF 28721977

SOUTHWEST SYNTHETIC PHARMACEUTICAL CORP LTDTRIMETHOPRIM USP

DMF 67951987

SHANDONG XINHUA PHARMACEUTICAL CO LTDTRIMETHOPRIM USP

DMF 131441998

INVENTAA INDUSTRIES PRIVATE LTDTRIMETHOPRIM USP

DMF 155062001

SHOUGUANG FUKANG PHARMACEUTICAL CO LTDTRIMETHOPRIM

DMF 251952011

IPCA LABORATORIES LTDTRIMETHOPRIM USP

DMF 256622012

SHANDONG RONGYUAN PHARMACEUTICAL CO LTDTRIMETHOPRIM

DMF 278802014

ANDHRA ORGANICS LTDTRIMETHOPRIM USP

DMF 329932018

ISTITUTO CHEMICOTHERAPICO ITALIANOInactiveTRIMETHOPRIM BULK, BP 1973

DMF 31471978

ACIC LTDInactiveTRIMETHOPRIM

DMF 34681979

DINAMITE DIPHARMA SPAInactiveTRIMETHOPRIM BP 73

DMF 35021978

FABBRICA ITALIANA SINTETICI SPAInactiveTRIMETHOPRIM USP, BULK FORM

DMF 42051981

SIGMA F AND D DIV LTDInactiveTRIMETHOPRIM

DMF 47261982

LUDWIG HEUMANN AND CO GMBHInactiveTRIMETHOPRIM

DMF 47551983

MEDIMPEX NORTH AMERICA INCInactiveTRIMETHOPRIM

DMF 48761983

NORTH EAST SIXTH PHARMACEUTICAL FACTORYInactiveTRIMETHOPRIM USP BULK

DMF 57811985

JAGSONPAL PHARMACEUTICALS PRIVATE LTDInactiveTRIMETHOPRIM

DMF 57861985

NAPP CHEMICALS INCInactiveTRIMETHOPRIM USP

DMF 58151985

DAEWOONG CHEMICAL CO LTDInactiveTRIMETHOPRIM

DMF 60171985

FABBRICA ITALIANA SINTETICI SPAInactiveTRIMETHOPRIM AF (ANILINE FREE)

DMF 62231985

MOEHS SA DIV SANOFInactiveTRIMETHOPRIM

DMF 68801987

CADILA LABORATORIES PVT LTDInactiveTRIMETHOPRIM

DMF 71951987

GUANGDONG PHARMACEUTICAL FACTORYInactiveTRIMETHOPRIM AND SULFAMETHOXAZOLE

DMF 72771988

BOMBAY DRUG HOUSE LTDInactiveTRIMETHOPRIM

DMF 76771988

OREX PHARMA PVT LTDInactiveTRIMETHOPRIM

DMF 78751989

IPCA LABORATORIES LTDInactiveTRIMETHOPRIM USP

DMF 85451990

BURROUGHS WELLCOME INDIA LTDInactiveTRIMETHOPRIM BULK DRUG PRODUCT

DMF 92401991

STANDARD ORGANICS LTDInactiveTRIMETHOPRIM USP (NON-STERILE BULK)

DMF 119341996

WYCKOFF CHEMICAL CO INCInactiveTRIMETHOPRIM

DMF 127341997

HALCYON LABS PRIVATE LTDInactiveTRIMETHOPRIM USP

DMF 128161998

SIFAVITOR SRLInactiveTRIMETHOPRIM

DMF 155102001

ALPHA DRUG INDIA LTDInactiveTRIMETHOPRIM

DMF 159842002

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 15, 2016	SUPPL -44	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 30, 1982

No patent or exclusivity listings for this strength.