Nevirapine - Generic Drug Details
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What are the generic 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: | 7,060 |
| 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 |
|---|---|
| Johns Hopkins University | Phase 1/Phase 2 |
| The Aurum Institute NPC | Phase 1/Phase 2 |
| Jean-Pierre Routy | N/A |
Generic filers with tentative approvals for NEVIRAPINE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try a Trial | ⤷ Try a Trial | 50MG | TABLET; ORAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 200MG | TABLET; ORAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo | NEVIRAPINE | nevirapine | TABLET;ORAL | 077521-001 | May 22, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sandoz | NEVIRAPINE | nevirapine | TABLET, EXTENDED RELEASE;ORAL | 203411-001 | Apr 3, 2014 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Prinston Inc | NEVIRAPINE | nevirapine | TABLET;ORAL | 078644-001 | May 22, 2012 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Tech Organized | NEVIRAPINE | nevirapine | TABLET;ORAL | 203176-001 | May 22, 2012 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan Pharms Inc | NEVIRAPINE | nevirapine | TABLET;ORAL | 202523-001 | May 22, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Cipla | NEVIRAPINE | nevirapine | SUSPENSION;ORAL | 207684-001 | Aug 3, 2017 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Alvogen | NEVIRAPINE | nevirapine | TABLET, EXTENDED RELEASE;ORAL | 204621-002 | Nov 9, 2015 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 nevirapine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | VIRAMUNE | nevirapine | TABLET;ORAL | 020636-001 | Jun 21, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | VIRAMUNE | nevirapine | SUSPENSION;ORAL | 020933-001 | Sep 11, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | VIRAMUNE XR | nevirapine | TABLET, EXTENDED RELEASE;ORAL | 201152-001 | Mar 25, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| Hungary | E028598 | ⤷ Try a Trial | |
| Eurasian Patent Organization | 200900958 | ПРЕПАРАТ НЕВИРАПИНА ПРОЛОНГИРОВАННОГО ВЫСВОБОЖДЕНИЯ | ⤷ Try a Trial |
| New Zealand | 578664 | EXTENDED RELEASE FORMULATION OF NEVIRAPINE | ⤷ Try a Trial |
| Ukraine | 97971 | ПРЕПАРАТ НЕВИРАПИНА ПРОЛОНГИРОВАННОГО ВЫСВОБОЖДЕНИЯ;ПРЕПАРАТ НЕВІРАПІНУ ПРОЛОНГОВАНОГО ВИВІЛЬНЕННЯ (EXTENDED RELEASE FORMULATION OF NEVIRAPINE) | ⤷ Try a Trial |
| Uruguay | 31128 | FORMULACION DE NEVIRAPINA DE LIBERACION PROLONGADA | ⤷ Try a Trial |
| Peru | 20131035 | FORMULACION DE NEVIRAPINA DE LIBERACION PROLONGADA | ⤷ Try a Trial |
| Mexico | 2009007764 | FORMULACION DE NEVIRAPINA DE LIBERACION PROLONGADA. (EXTENDED RELEASE FORMULATION OF NEVIRAPINE.) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for nevirapine
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0429987 | C990022 | Netherlands | ⤷ Try a 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 |
| 0429987 | 99C0021 | Belgium | ⤷ Try a Trial | PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION NO/DATE: CH 54393 19971223 |
| 0429987 | 18/1999 | Austria | ⤷ Try a Trial | PRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205 |
| 0429987 | SPC/GB99/020 | United Kingdom | ⤷ Try a Trial | 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 | 99C0019 | France | ⤷ Try a Trial | 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 |
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