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Last Updated: March 18, 2024

ARTHROTEC Drug Patent Profile


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When do Arthrotec patents expire, 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.

Drug patent expirations by year for ARTHROTEC
Drug Prices for ARTHROTEC

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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

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-002 Dec 24, 1997 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ARTHROTEC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-001 Dec 24, 1997 ⤷  Try a Trial ⤷  Try a Trial
Pfizer ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-002 Dec 24, 1997 ⤷  Try a Trial ⤷  Try a Trial
Pfizer ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-002 Dec 24, 1997 ⤷  Try a Trial ⤷  Try a Trial
Pfizer ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-002 Dec 24, 1997 ⤷  Try a Trial ⤷  Try a Trial
Pfizer ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-001 Dec 24, 1997 ⤷  Try a Trial ⤷  Try a Trial
Pfizer ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-001 Dec 24, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ARTHROTEC

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

Country Patent Number Title Estimated Expiration
Portugal 97562 PROCESSO PARA A PREPARACAO DE UMA COMPOSICAO FARMACEUTICA CONTENDO UM NUCLEO DE DICLOFENAC OU DE PIROXICAMO E UM REVESTIMENTO DE COBERTURA DE UMA PROSTAGLANDINA ⤷  Try a Trial
Greece 3015939 ⤷  Try a Trial
Ireland 911486 ⤷  Try a Trial
South Africa 9103353 ⤷  Try a Trial
European Patent Office 0527887 COMPOSITION PHARMACEUTIQUE. (PHARMACEUTICAL COMPOSITION.) ⤷  Try a Trial
New Zealand 238024 PHARMACEUTICAL COMPOSITIONS COMPRISING A CORE OF DICLOFENAC OR PIROXICAM AND A MANTLE COATING OF A PROSTAGLANDIN ⤷  Try a Trial
Canada 2082944 COMPOSITIONS PHARMACEUTIQUES (PHARMACEUTICAL COMPOSITIONS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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