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Last Updated: October 31, 2020

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SITAVIG Drug Profile

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When do Sitavig patents expire, and when can generic versions of Sitavig launch?

Sitavig is a drug marketed by Epi Hlth and is included in one NDA. There are three patents protecting this drug.

This drug has forty-six patent family members in twenty-nine countries.

The generic ingredient in SITAVIG is acyclovir. There are fifty-six drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the acyclovir profile page.

US ANDA Litigation and Generic Entry Outlook for Sitavig

A generic version of SITAVIG was approved as acyclovir by TEVA on April 22nd, 1997.

  Start Trial

US Patents and Regulatory Information for SITAVIG

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Epi Hlth SITAVIG acyclovir TABLET;BUCCAL 203791-001 Apr 12, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Epi Hlth SITAVIG acyclovir TABLET;BUCCAL 203791-001 Apr 12, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Epi Hlth SITAVIG acyclovir TABLET;BUCCAL 203791-001 Apr 12, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for SITAVIG

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0809498 10C0038 France   Start Trial PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
0809498 SPC/GB10/012 United Kingdom   Start Trial PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
Baxter
Express Scripts
Colorcon
Mallinckrodt

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