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. Sixty-two 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.
Summary for SITAVIG
International Patents: | 46 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 168 |
Clinical Trials: | 1 |
Patent Applications: | 4,058 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for SITAVIG |
What excipients (inactive ingredients) are in SITAVIG? | SITAVIG excipients list |
DailyMed Link: | SITAVIG at DailyMed |



Recent Clinical Trials for SITAVIG
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bayer | Phase 3 |
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HERPES LABIALIS
Mucosal bioadhesive slow release carrier for delivering active principles
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HERPES LABIALIS
Mucosal bioadhesive slow release carrier for delivering active principles
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Epi Hlth | SITAVIG | acyclovir | TABLET;BUCCAL | 203791-001 | Apr 12, 2013 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Epi Hlth | SITAVIG | acyclovir | TABLET;BUCCAL | 203791-001 | Apr 12, 2013 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>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 |
---|---|---|---|
Russian Federation | 2008139869 | БИОАДГЕЗИВНЫЙ НОСИТЕЛЬ С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ ДЛЯ СЛИЗИСТЫХ ОБОЛОЧЕК, ПРЕДНАЗНАЧЕННЫХ ДЛЯ ДОСТАВКИ АКТИВНЫХ КОМПОНЕНТОВ | See Plans and Pricing |
Argentina | 060085 | VEHICULO BIOADHESIVO DE LIBERACION LENTA EN MUCOSAS PARA ADMINISTRAR PRINCIPIOS ACTIVOS | See Plans and Pricing |
Serbia | 57430 | MUKOADHEZIVNE BUKALNE TABLETE ZA LEČENJE OROFACIJALNOG HERPESA (MUCOADHESIVE BUCCAL TABLETS FOR THE TREATMENT OF OROFACIAL HERPES) | See Plans and Pricing |
Japan | 5242548 | See Plans and Pricing | |
Cyprus | 1109723 | See Plans and Pricing | |
Canada | 2647123 | VECTEUR MUQUEUX BIOADHESIF A LIBERATION LENTE POUR LA DELIVRANCE DE PRINCIPES ACTIFS (MUCOSAL BIOADHESIVE SLOW RELEASE CARRIER FOR DELIVERING ACTIVE PRINCIPLES) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SITAVIG
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0809498 | SPC/GB10/012 | United Kingdom | See Plans and Pricing | PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112 |
0809498 | 10C0038 | France | See Plans and Pricing | PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |