Last Updated: November 9, 2026

DIRITHROMYCIN - Generic Drug Details

Name: DIRITHROMYCIN Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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What are the generic drug sources for dirithromycin and what is the scope of freedom to operate?

Dirithromycin is the generic ingredient in one branded drug marketed by Lilly Res Labs and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for DIRITHROMYCIN

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	5
DailyMed Link:	DIRITHROMYCIN at DailyMed

Recent Clinical Trials for DIRITHROMYCIN

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

Sponsor	Phase
Abdi Ibrahim Ilac San. ve Tic A.S.	Phase 1
Pharmaceutical Research Unit, Jordan	Phase 1
University of Louisville	Early Phase 1

See all DIRITHROMYCIN clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DIRITHROMYCIN

J01FA	Macrolides
J01F	MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for DIRITHROMYCIN

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly Res Labs	DYNABAC	dirithromycin	TABLET, DELAYED RELEASE;ORAL	050678-001	Jun 19, 1995		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

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