NEVIRAPINE - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for nevirapine and what is the scope of freedom to operate?
Nevirapine
is the generic ingredient in three branded drugs marketed by Aurobindo, Cipla, Boehringer Ingelheim, Alvogen, Apotex, Aurobindo Pharma, Macleods Pharms Ltd, Mylan, Sandoz, Tech Organized, Apotex Inc, Hetero Labs Ltd Iii, Micro Labs Ltd, Mylan Labs, Mylan Pharms Inc, Prinston Inc, and Strides Pharma, and is included in twenty-six NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Nevirapine has thirty-two patent family members in twenty-seven countries.
There are twenty drug master file entries for nevirapine. Eight suppliers are listed for this compound. There are six tentative approvals for this compound.
Summary for NEVIRAPINE
International Patents: | 32 |
US Patents: | 1 |
Tradenames: | 3 |
Applicants: | 17 |
NDAs: | 26 |
Drug Master File Entries: | 20 |
Finished Product Suppliers / Packagers: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 142 |
Clinical Trials: | 220 |
Patent Applications: | 6,836 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for NEVIRAPINE |
What excipients (inactive ingredients) are in NEVIRAPINE? | NEVIRAPINE excipients list |
DailyMed Link: | NEVIRAPINE at DailyMed |
Recent Clinical Trials for NEVIRAPINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
The Aurum Institute NPC | Phase 1/Phase 2 |
Johns Hopkins University | Phase 1/Phase 2 |
Jean-Pierre Routy | N/A |
Generic filers with tentative approvals for NEVIRAPINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 50MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 200MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 200MG | TABLET; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for NEVIRAPINE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
NEVIRAPINE | Injection | nevirapine | 5 mg/vial | 203411 | 1 | 2016-12-21 |
VIRAMUNE XR | Extended-release Tablets | nevirapine | 400 mg | 201152 | 3 | 2013-06-21 |
US Patents and Regulatory Information for NEVIRAPINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Macleods Pharms Ltd | NEVIRAPINE | nevirapine | TABLET;ORAL | 090688-001 | Jan 14, 2019 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Strides Pharma | NEVIRAPINE | nevirapine | TABLET;ORAL | 078195-001 | May 22, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Tech Organized | NEVIRAPINE | nevirapine | TABLET, EXTENDED RELEASE;ORAL | 207467-002 | Jul 31, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Alvogen | NEVIRAPINE | nevirapine | TABLET, EXTENDED RELEASE;ORAL | 204621-001 | Jul 10, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hetero Labs Ltd Iii | NEVIRAPINE | nevirapine | TABLET;ORAL | 078584-001 | May 22, 2012 | AB | RX | No | 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 NEVIRAPINE
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 |
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 NEVIRAPINE
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 NEVIRAPINE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Ukraine | 97971 | ПРЕПАРАТ НЕВИРАПИНА ПРОЛОНГИРОВАННОГО ВЫСВОБОЖДЕНИЯ;ПРЕПАРАТ НЕВІРАПІНУ ПРОЛОНГОВАНОГО ВИВІЛЬНЕННЯ (EXTENDED RELEASE FORMULATION OF NEVIRAPINE) | ⤷ Sign Up |
South Korea | 101017862 | ⤷ Sign Up | |
Peru | 20090371 | FORMULACION DE NEVIRAPINA DE LIBERACION PROLONGADA | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2008154234 | ⤷ Sign Up | |
European Patent Office | 2155169 | FORMULATION À LIBÉRATION PROLONGÉE DE NÉVIRAPINE (EXTENDED RELEASE FORMULATION OF NEVIRAPINE) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NEVIRAPINE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0429987 | 18/1999 | Austria | ⤷ Sign Up | PRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: 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 | 99C0019 | France | ⤷ Sign Up | 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 | ⤷ 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 | 99C0021 | Belgium | ⤷ Sign Up | PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION NO/DATE: CH 54393 19971223 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.