PYRAZINAMIDE - Generic Drug Details

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

Pyrazinamide is the generic ingredient in one branded drug marketed by Hikma, Macleods Pharms Ltd, and Novitium Pharma, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for pyrazinamide. Eight suppliers are listed for this compound.

Summary for PYRAZINAMIDE

US Patents:	0
Tradenames:	1
Applicants:	3
NDAs:	3
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	152
Clinical Trials:	125
Patent Applications:	7,081
Drug Prices:	Drug price trends for PYRAZINAMIDE
What excipients (inactive ingredients) are in PYRAZINAMIDE?	PYRAZINAMIDE excipients list
DailyMed Link:	PYRAZINAMIDE at DailyMed

See drug prices for PYRAZINAMIDE

Recent Clinical Trials for PYRAZINAMIDE

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

Sponsor	Phase
Madras Medical College	Phase 3
All India Institute of Medical Sciences, Jodhpur	Phase 3
Rural Development Trust Hospital	Phase 3

See all PYRAZINAMIDE clinical trials

Pharmacology for PYRAZINAMIDE

Drug Class	Antimycobacterial

Medical Subject Heading (MeSH) Categories for PYRAZINAMIDE

Antitubercular Agents

Anatomical Therapeutic Chemical (ATC) Classes for PYRAZINAMIDE

J04AK	Other drugs for treatment of tuberculosis
J04A	DRUGS FOR TREATMENT OF TUBERCULOSIS
J04	ANTIMYCOBACTERIALS
J	Antiinfectives for systemic use

US Patents and Regulatory Information for PYRAZINAMIDE

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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
Macleods Pharms Ltd	PYRAZINAMIDE	pyrazinamide	TABLET;ORAL	212541-001	Jul 27, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novitium Pharma	PYRAZINAMIDE	pyrazinamide	TABLET;ORAL	080157-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	PYRAZINAMIDE	pyrazinamide	TABLET;ORAL	081319-001	Jun 30, 1992	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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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