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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.
Summary for SITAVIG
| International Patents: | 46 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 153 |
| Patent Applications: | 4,927 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SITAVIG |
| DailyMed Link: | SITAVIG at DailyMed |
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 |
International Patents for SITAVIG
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2013513575 | Start Trial |
| Russian Federation | 2420267 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2007110778 | Start Trial |
| Austria | 446743 | Start Trial |
| South Korea | 20090010958 | Start Trial |
| Poland | 2509586 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
