ALLOPURINOL SODIUM - Generic Drug Details

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

Allopurinol sodium is the generic ingredient in two branded drugs marketed by Gland Pharma Ltd, Hikma, and Mylan, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound.

Summary for ALLOPURINOL SODIUM

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	10
Patent Applications:	28
What excipients (inactive ingredients) are in ALLOPURINOL SODIUM?	ALLOPURINOL SODIUM excipients list
DailyMed Link:	ALLOPURINOL SODIUM at DailyMed

Recent Clinical Trials for ALLOPURINOL SODIUM

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

Sponsor	Phase
University of Bari	Phase 4
Fondazione Schena	Phase 4
University of Colorado Denver School of Medicine Barbara Davis Center	Phase 4

See all ALLOPURINOL SODIUM clinical trials

Pharmacology for ALLOPURINOL SODIUM

Drug Class	Xanthine Oxidase Inhibitor
Mechanism of Action	Xanthine Oxidase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ALLOPURINOL SODIUM

M04AA	Preparations inhibiting uric acid production
M04A	ANTIGOUT PREPARATIONS
M04	ANTIGOUT PREPARATIONS
M	Musculo-skeletal system

US Patents and Regulatory Information for ALLOPURINOL SODIUM

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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
Hikma	ALLOPURINOL SODIUM	allopurinol sodium	INJECTABLE;INJECTION	076870-001	Aug 26, 2004	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	ALOPRIM	allopurinol sodium	INJECTABLE;INJECTION	020298-001	May 17, 1996	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gland Pharma Ltd	ALLOPURINOL SODIUM	allopurinol sodium	INJECTABLE;INJECTION	212363-001	Jan 26, 2022	AP	RX	No	No	⤷ 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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