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Last Updated: June 10, 2023

SITAVIG Drug Patent 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. Seventy suppliers are listed for this compound. Additional details are available on the acyclovir profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Sitavig

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

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US Patents and Regulatory Information for SITAVIG

SITAVIG is protected by three US patents.

Patents protecting SITAVIG

Mucoadhesive buccal tablets for the treatment of orofacial herpes
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HERPES LABIALIS

Mucosal bioadhesive slow release carrier for delivering active principles
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HERPES LABIALIS

Mucosal bioadhesive slow release carrier for delivering active principles
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HERPES LABIALIS

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Epi Hlth SITAVIG acyclovir TABLET;BUCCAL 203791-001 Apr 12, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Epi Hlth SITAVIG acyclovir TABLET;BUCCAL 203791-001 Apr 12, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

International Patents for SITAVIG

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

Country Patent Number Title Estimated Expiration
Croatia P20181103 ⤷  Try a Trial
Australia 2007231029 Mucosal bioadhesive slow release carrier for delivering active principles ⤷  Try a Trial
European Patent Office 1837020 Vehicule bioadhesif pour les muqueuses pour delivrer lentement des principes actifs (Mucosal bioadhesive slow release carrier for delivering active principles) ⤷  Try a Trial
Serbia 57430 MUKOADHEZIVNE BUKALNE TABLETE ZA LEČENJE OROFACIJALNOG HERPESA (MUCOADHESIVE BUCCAL TABLETS FOR THE TREATMENT OF OROFACIAL HERPES) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SITAVIG

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0809498 10C0038 France ⤷  Try a 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 ⤷  Try a 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

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.