VIRAMUNE Drug Patent Profile
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When do Viramune patents expire, and when can generic versions of Viramune launch?
Viramune is a drug marketed by Boehringer Ingelheim and is included in three NDAs. There is one patent protecting this drug.
The generic ingredient in VIRAMUNE is nevirapine. There are twenty drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the nevirapine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Viramune
A generic version of VIRAMUNE was approved as nevirapine by AUROBINDO on May 22nd, 2012.
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Questions you can ask:
- What is the 5 year forecast for VIRAMUNE?
- What are the global sales for VIRAMUNE?
- What is Average Wholesale Price for VIRAMUNE?
Summary for VIRAMUNE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 142 |
Clinical Trials: | 42 |
Patent Applications: | 4,789 |
Drug Prices: | Drug price information for VIRAMUNE |
What excipients (inactive ingredients) are in VIRAMUNE? | VIRAMUNE excipients list |
DailyMed Link: | VIRAMUNE at DailyMed |
Recent Clinical Trials for VIRAMUNE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Columbia University | Phase 4 |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 4 |
University of Witwatersrand, South Africa | Phase 4 |
Pharmacology for VIRAMUNE
US Patents and Regulatory Information for VIRAMUNE
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 | nevirapine | SUSPENSION;ORAL | 020933-001 | Sep 11, 1998 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Boehringer Ingelheim | VIRAMUNE XR | nevirapine | TABLET, EXTENDED RELEASE;ORAL | 201152-001 | Mar 25, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Boehringer Ingelheim | VIRAMUNE | nevirapine | TABLET;ORAL | 020636-001 | Jun 21, 1996 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | VIRAMUNE | nevirapine | SUSPENSION;ORAL | 020933-001 | Sep 11, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | VIRAMUNE | nevirapine | TABLET;ORAL | 020636-001 | Jun 21, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for VIRAMUNE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim International GmbH | Viramune | nevirapine | EMEA/H/C/000183 Tablets and oral suspensionViramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adults, adolescents, and children of any age.Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing.50- and 100-mg prolonged-release tabletsViramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adolescents and children three years and above and able to swallow tablets.Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used.Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing.400-mg prolonged-release tabletsViramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adults, adolescents and children three years and above and able to swallow tablets.Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used.Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing. |
Authorised | no | no | no | 1998-02-04 | |
Teva B.V. | Nevirapine Teva | nevirapine | EMEA/H/C/001119 Nevirapine Teva is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV 1 infected adults, adolescents, and children of any age.Most of the experience with nevirapine is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after nevirapine should be based on clinical experience and resistance testing. |
Withdrawn | yes | no | no | 2009-11-30 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for VIRAMUNE
See the table below for patents covering VIRAMUNE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 630251 | ⤷ Sign Up | |
Russian Federation | 2040527 | DERIVATIVES OF DIPYRIDO-DIAZEPINE AND THEIR HYDRATES SHOWING BIOLOGICAL ACTIVITY | ⤷ Sign Up |
Finland | 94529 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VIRAMUNE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0429987 | 99C0021 | Belgium | ⤷ Sign Up | PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION NO/DATE: CH 54393 19971223 |
0429987 | SPC/GB99/020 | United Kingdom | ⤷ Sign Up | 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 | C990022 | Netherlands | ⤷ Sign Up | 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 |