ALLOPURINOL - Generic Drug Details

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What are the generic sources for allopurinol and what is the scope of patent protection?

Allopurinol is the generic ingredient in six branded drugs marketed by Accord Hlthcare, Aiping Pharm Inc, Chartwell, Endo Operations, Harman Finochem, Hetero Labs Ltd V, Indoco, Ipca Labs Ltd, Lupin Ltd, Mutual Pharm, Mylan, Northstar Hlthcare, Puracap Pharm, Purepac Pharm, Sandoz, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Unichem, Watson Labs, Zydus Pharms, Abbott, Dr Reddys La, Casper Pharma Llc, Gland Pharma Ltd, Hikma, and Ironwood Pharms Inc, and is included in thirty-six NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for allopurinol. Forty-three suppliers are listed for this compound.

Summary for ALLOPURINOL

US Patents:	9
Tradenames:	6
Applicants:	27
NDAs:	36
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	274
Clinical Trials:	222
Patent Applications:	7,833
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ALLOPURINOL
Drug Sales Revenues:	Drug sales revenues for ALLOPURINOL
What excipients (inactive ingredients) are in ALLOPURINOL?	ALLOPURINOL excipients list
DailyMed Link:	ALLOPURINOL at DailyMed

See drug prices for ALLOPURINOL

Drug Sales Revenue Trends for ALLOPURINOL

See drug sales revenues for ALLOPURINOL

Recent Clinical Trials for ALLOPURINOL

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

Sponsor	Phase
Urica Therapeutics Inc.	Phase 1/Phase 2
Eli Lilly and Company	Phase 2
Dana-Farber Cancer Institute	Phase 2

See all ALLOPURINOL clinical trials

Pharmacology for ALLOPURINOL

Drug Class	Xanthine Oxidase Inhibitor
Mechanism of Action	Xanthine Oxidase Inhibitors

Medical Subject Heading (MeSH) Categories for ALLOPURINOL

Antimetabolites
Enzyme Inhibitors
Free Radical Scavengers
Gout Suppressants

Anatomical Therapeutic Chemical (ATC) Classes for ALLOPURINOL

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

US Patents and Regulatory Information for ALLOPURINOL

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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
Gland Pharma Ltd	ALLOPURINOL SODIUM	allopurinol sodium	INJECTABLE;INJECTION	212363-001	Jan 26, 2022	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Accord Hlthcare	ALLOPURINOL	allopurinol	TABLET;ORAL	203154-002	May 6, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Superpharm	ALLOPURINOL	allopurinol	TABLET;ORAL	070950-001	Nov 30, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Industries	ALLOPURINOL	allopurinol	TABLET;ORAL	071450-001	Jan 9, 1987	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ALLOPURINOL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbott	LOPURIN	allopurinol	TABLET;ORAL	018297-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Casper Pharma Llc	ZYLOPRIM	allopurinol	TABLET;ORAL	016084-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Casper Pharma Llc	ZYLOPRIM	allopurinol	TABLET;ORAL	016084-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Abbott	LOPURIN	allopurinol	TABLET;ORAL	018297-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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