Last Updated: August 2, 2026

ARTHROTEC Drug Patent Profile

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Which patents cover Arthrotec, and when can generic versions of Arthrotec launch?

Arthrotec is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in ARTHROTEC is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Arthrotec

A generic version of ARTHROTEC was approved as diclofenac sodium; misoprostol by ACTAVIS LABS FL INC on July 9^th, 2012.

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Summary for ARTHROTEC

US Patents:	0
Applicants:	1
NDAs:	1

Paragraph IV (Patent) Challenges for ARTHROTEC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ARTHROTEC	Delayed-release Tablets	diclofenac sodium; misoprostol	50 mg/0.2 mg	020607	1	2009-06-29
ARTHROTEC	Delayed-release Tablets	diclofenac sodium; misoprostol	75 mg/0.2 mg	020607	1	2008-11-28

US Patents and Regulatory Information for ARTHROTEC

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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
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-001	Dec 24, 1997	AB	RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-002	Dec 24, 1997	AB	RX	Yes	Yes	⤷ 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

International Patents for ARTHROTEC

See the table below for patents covering ARTHROTEC around the world.

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Country	Patent Number	Title	Estimated Expiration
Austria	121625		⤷ Start Trial
Australia	7876491		⤷ Start Trial
Canada	2082944	COMPOSITIONS PHARMACEUTIQUES (PHARMACEUTICAL COMPOSITIONS)	⤷ Start Trial
Germany	69109286		⤷ Start Trial
Denmark	0527887		⤷ Start Trial
European Patent Office	0527887	COMPOSITION PHARMACEUTIQUE. (PHARMACEUTICAL COMPOSITION.)	⤷ Start Trial
Spain	2071312		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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