VIRAMUNE XR Drug Patent 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-two patent family members in twenty-seven countries.
The generic ingredient in VIRAMUNE XR 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 Xr
A generic version of VIRAMUNE XR was approved as nevirapine by AUROBINDO on May 22nd, 2012.
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Questions you can ask:
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Summary for VIRAMUNE XR
International Patents: | 32 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 142 |
Clinical Trials: | 42 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for VIRAMUNE XR |
DailyMed Link: | VIRAMUNE XR at DailyMed |
![VIRAMUNE XR drug patent expirations Drug patent expirations by year for VIRAMUNE XR](/p/graph/s/t/VIRAMUNE_XR-patent-expirations.png)
![Drug Prices for VIRAMUNE XR](/p/graph/drug-price/VIRAMUNE+XR.png)
Recent Clinical Trials for VIRAMUNE XR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 4 |
University of Witwatersrand, South Africa | Phase 4 |
National Institutes of Health (NIH) | Phase 4 |
Paragraph IV (Patent) Challenges for VIRAMUNE XR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
VIRAMUNE XR | Extended-release Tablets | nevirapine | 400 mg | 201152 | 3 | 2013-06-21 |
US Patents and Regulatory Information for VIRAMUNE XR
VIRAMUNE XR is protected by one US patents.
Patents protecting VIRAMUNE XR
Extended release formulation of nevirapine
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV-1 BY ONCE DAILY ADMINISTRATION
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 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Boehringer Ingelheim | VIRAMUNE XR | nevirapine | TABLET, EXTENDED RELEASE;ORAL | 201152-001 | Mar 25, 2011 | AB | RX | Yes | Yes | ⤷ 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 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 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for VIRAMUNE XR
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 XR
See the table below for patents covering VIRAMUNE XR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 5417662 | ⤷ Sign Up | |
Ireland | 904141 | ⤷ Sign Up | |
Hungary | E028598 | ⤷ Sign Up | |
New Zealand | 234261 | DIAZEPIN-6-ONE AND -THIONE DERIVATIVES, PREPARATION AND PHARMACEUTICAL COMPOSITIONS THEREOF | ⤷ Sign Up |
European Patent Office | 0429987 | 5,11-Dihydro-6H-dipyrido[3,2-b:2'3'-e] [1,4]diazépines et leur utilisation pour prévenir ou traiter l'infection par le VIH (5,11-Dihydro-6H-dipyrido[3,2-b:2',3'-e] [1,4]diazepines and their use in the prevention or treatment of HIV infection) | ⤷ Sign Up |
New Zealand | 236105 | 6H-DIPYRIDO[3,2-B:2',3'-E][1,4] DIAZAPIN-6-ONE (AND THIONE) DERIVATIVE, PREPARATION AND PHARMACEUTICAL COMPOSITIONS THEREOF | ⤷ Sign Up |
South Africa | 9009246 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VIRAMUNE XR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0429987 | 9990018-5 9991018-4 | Sweden | ⤷ Sign Up | 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 | 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 |
0429987 | 18/1999 | Austria | ⤷ Sign Up | PRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205 |
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 | 990022 | Netherlands | ⤷ Sign Up | 990022, 20101116, EXPIRES: 20121222 |
0429987 | 99C0019 | France | ⤷ Sign Up | PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGUSTRATION: CH/LI 54 393 19971223 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |