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VIRAMUNE XR Drug Profile
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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. Eleven suppliers are listed for this compound. Additional details are available on the nevirapine profile page.
DrugPatentWatch® 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 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 120 |
| Clinical Trials: | 34 |
| Patent Applications: | 4,172 |
| 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 | Get Started Free | Get Started Free | Get Started Free | |||
| Boehringer Ingelheim | VIRAMUNE XR | nevirapine | TABLET, EXTENDED RELEASE;ORAL | 201152-001 | Mar 25, 2011 | AB | RX | Yes | Yes | Get Started Free | Get Started Free | Get Started Free | |||
| >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 | Get Started Free | Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VIRAMUNE XR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | H03115283 | Get Started Free |
| Ireland | 65247 | Get Started Free |
| Norway | 175478 | Get Started Free |
| Denmark | 0429987 | Get Started Free |
| Denmark | 0410148 | Get Started Free |
| Uruguay | 31128 | Get Started Free |
| Denmark | 0393529 | Get Started Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VIRAMUNE XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0429987 | C990022 | Netherlands | Get Started Free | 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 |
| 0429987 | 9990018-5 9991018-4 | Sweden | Get Started Free | PRODUCT NAME: 5,11-DIHYDRO-6H-DIPYRIDO3,2-B:2,3-E1,4DIAZEPINER OCH DERAS ANVAENDNING VID PREVENTION ELLER BEHANDLING AV HIV-INFEKTION; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRTION: LI 54393 19971223 |
| 0429987 | 990022 | Netherlands | Get Started Free | 990022, 20101116, EXPIRES: 20121222 |
| 0429987 | 99C0021 | Belgium | Get Started Free | PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION NO/DATE: CH 54393 19971223 |
| 0429987 | 99C0019 | France | Get Started Free | PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGUSTRATION: CH/LI 54 393 19971223 |
| 0429987 | SPC/GB99/020 | United Kingdom | Get Started Free | PRODUCT NAME: NEVIRAPINE = 11-CYCLOPROPYL-5,11-DIHYDRO-4-METHYL-6H-DIPYRIDO(3,2-B:2',3'-E)(1,4)DIAZEPIN-6-ONE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTERED: CH 54393 19971223; UK EU/1/97/055/001 19980205 |
| 0429987 | 18/1999 | Austria | Get Started Free | PRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
