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VIRAMUNE XR Drug Profile
» See Plans and Pricing
When do Viramune Xr patents expire, and when can generic versions of Viramune Xr launch?
Viramune Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has thirty-three patent family members in twenty-eight countries.
The generic ingredient in VIRAMUNE XR is nevirapine. There are twenty drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the nevirapine profile page.
US ANDA Litigation and Generic Entry Outlook for Viramune Xr
A generic version of VIRAMUNE XR was approved as nevirapine by AUROBINDO on May 22nd, 2012.
Summary for VIRAMUNE XR
| International Patents: | 33 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 108 |
| Clinical Trials: | 34 |
| Patent Applications: | 5,731 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VIRAMUNE XR |
| DailyMed Link: | VIRAMUNE XR at DailyMed |
Paragraph IV (Patent) Challenges for VIRAMUNE XR
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VIRAMUNE XR | TABLET, EXTENDED RELEASE;ORAL | nevirapine | 201152 | 2013-06-21 |
US Patents and Regulatory Information for VIRAMUNE XR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | VIRAMUNE XR | nevirapine | TABLET, EXTENDED RELEASE;ORAL | 201152-002 | Nov 8, 2012 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Boehringer Ingelheim | VIRAMUNE XR | nevirapine | TABLET, EXTENDED RELEASE;ORAL | 201152-001 | Mar 25, 2011 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start 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 VIRAMUNE XR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | VIRAMUNE XR | nevirapine | TABLET, EXTENDED RELEASE;ORAL | 201152-001 | Mar 25, 2011 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VIRAMUNE XR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 69007891 | Start Trial |
| Hong Kong | 1011025 | Start Trial |
| Brazil | PI0811732 | Start Trial |
| Spain | 2574836 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VIRAMUNE XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0429987 | 99C0021 | Belgium | Start Trial | PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION NO/DATE: CH 54393 19971223 |
| 0429987 | 990022 | Netherlands | Start Trial | 990022, 20101116, EXPIRES: 20121222 |
| 0429987 | 99C0019 | France | Start Trial | PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGUSTRATION: CH/LI 54 393 19971223 |
| 0429987 | C990022 | Netherlands | Start Trial | PRODUCT NAME: NEVIRAPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION: CH 54393 19971223 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
