Nevirapine Patent Expiration

Nevirapine is Used for managing HIV-1 infection through once-daily administration. It was first introduced by Boehringer Ingelheim Pharmaceuticals Inc in its drug Viramune on Jun 21, 1996. Another drug containing Nevirapine is Viramune Xr. 17 different companies have introduced drugs containing Nevirapine.


Nevirapine Patents

Given below is the list of patents protecting Nevirapine, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Viramune Xr US8460704 Extended release formulation of nevirapine Mar 12, 2029 Boehringer Ingelheim



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Nevirapine's patents.

Given below is the list recent legal activities going on the following patents of Nevirapine.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 21 Sep, 2020 US8460704
Post Issue Communication - Certificate of Correction 05 Feb, 2015 US8460704
Email Notification 13 Sep, 2014 US8460704
Mail-Record a Petition Decision of Granted for Patent Term Adjustment after Allowance 10 Sep, 2014 US8460704
Record a Petition Decision of Granted for Patent Term Adjustment after Allowance 09 Sep, 2014 US8460704
Adjustment of PTA Calculation by PTO 05 Sep, 2014 US8460704
Petition Entered 14 Jun, 2013 US8460704
Recordation of Patent Grant Mailed 11 Jun, 2013 US8460704
Patent Issue Date Used in PTA Calculation 11 Jun, 2013 US8460704
Email Notification 23 May, 2013 US8460704


Nevirapine's Family Patents

Family Patents

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Nevirapine Generic API Manufacturers

Several generic applications have been filed for Nevirapine. The first generic version for Nevirapine was by Cipla Ltd and was approved on May 22, 2012. And the latest generic version is by Macleods Pharmaceuticals Ltd and was approved on Jan 14, 2019.

Given below is the list of companies who have filed for Nevirapine generic, along with the locations of their manufacturing plants worldwide.


1. ALVOGEN

Alvogen Inc has filed for 2 different strengths of generic version for Nevirapine. Given below are the details of the strengths of this generic introduced by Alvogen.

Strength Dosage Form Availability Application Pathway TE code Launch Date
400MG

tablet, extended release Discontinued ORAL N/A Jul 10, 2015
100MG

tablet, extended release Discontinued ORAL N/A Nov 9, 2015


Manufacturing Plant Locations
New

Alvogen's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Alvogen as present at those locations.

Country City Firm Name
United States
Morristown Alvogen, Inc





2. APOTEX

Apotex Inc has filed for 1 generic for Nevirapine. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
400MG

tablet, extended release Discontinued ORAL N/A Apr 3, 2014


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Winnipeg Apotex Fermentation Inc.
Etobicoke Apotex, Inc.
Toronto Apotex Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.
Brantford Apotex Pharmachem Inc.
India
Bengaluru Apotex Research Private Limited
Bangalore Apotex Pharmachem India Pvt Ltd.
Bangalore Apotex Research Private Limited - Bioequivalence Centre





3. APOTEX INC

Apotex Inc has filed for 1 generic for Nevirapine. Given below are the details of the strengths of this generic introduced by Apotex Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Discontinued ORAL N/A May 22, 2012


Manufacturing Plant Locations
New

Apotex Inc's manufacturing plants are situated in 1 country - Canada. Given below are the details of these plant locations as well as the firm names of Apotex Inc as present at those locations.

Country City Firm Name
Canada
Richmond Hill Apotex Inc.
Toronto Apotex Inc.
North York Apotex Inc.





4. AUROBINDO

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Nevirapine. Given below are the details of the strengths of this generic introduced by Aurobindo.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Prescription ORAL AB May 22, 2012
50MG/5ML

(reference standard)

suspension Prescription ORAL AA May 22, 2012


Manufacturing Plant Locations
New

Aurobindo's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo as present at those locations.

Country City Firm Name
India
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
Sangareddy Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





5. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Nevirapine. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG

tablet, extended release Discontinued ORAL N/A Nov 23, 2016
400MG

tablet, extended release Discontinued ORAL N/A Feb 28, 2017


Manufacturing Plant Locations
New

Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.

Country City Firm Name
India
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
Sangareddy Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





6. CIPLA

Cipla Ltd has filed for 3 different strengths of generic version for Nevirapine. Given below are the details of the strengths of this generic introduced by Cipla.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Prescription ORAL AB May 22, 2012
400MG

tablet, extended release Discontinued ORAL N/A Oct 15, 2015
50MG/5ML

suspension Prescription ORAL AA Aug 3, 2017


Manufacturing Plant Locations
New

Cipla's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Cipla as present at those locations.

Country City Firm Name
India
Bangalore Cipla Ltd.
Vasco Da Gama Cipla Limited
Kurkumbh Village, Dist. Pune Cipla, Ltd.
Pithampur, District Dhar Cipla Limited
Bengaluru Cipla Limited
Raigad Cipla Limited
Mumbai Cipla Limited





7. HETERO LABS LTD III

Hetero Labs Ltd Unit Iii has filed for 1 generic for Nevirapine. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Prescription ORAL AB May 22, 2012





8. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Nevirapine. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
400MG

(reference standard)

tablet, extended release Prescription ORAL AB Oct 6, 2017
200MG

(reference standard)

tablet Prescription ORAL AB Jan 14, 2019





9. MICRO LABS LTD

Micro Labs Ltd has filed for 1 generic for Nevirapine. Given below are the details of the strengths of this generic introduced by Micro Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Prescription ORAL AB May 22, 2012





10. MYLAN

Mylan Pharmaceuticals Inc has filed for 1 generic for Nevirapine. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
400MG

tablet, extended release Prescription ORAL AB Oct 27, 2014


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
San Carlos Mylan Pharmaceuticals Inc.
Saint Albans Mylan Technologies, Inc.
Morgantown Mylan Specialty, L.P.
Greensboro Mylan Pharmaceuticals Inc
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Rockford Mylan Institutional, Inc.
India
Anekal Taluk, Bangalore Mylan Laboratories Limited
Sinnar Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Hyderabad Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Pithampur, District Dhar Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





11. MYLAN PHARMS INC

Mylan Pharmaceuticals Inc has filed for 1 generic for Nevirapine. Given below are the details of the strengths of this generic introduced by Mylan Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Prescription ORAL AB May 22, 2012





12. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 2 different strengths of generic version for Nevirapine. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Discontinued ORAL N/A May 22, 2012
100MG

tablet, extended release Discontinued ORAL N/A Nov 9, 2015





13. PRINSTON INC

Prinston Pharmaceutical Inc has filed for 1 generic for Nevirapine. Given below are the details of the strengths of this generic introduced by Prinston Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Discontinued ORAL N/A May 22, 2012





14. SANDOZ

Sandoz Inc has filed for 1 generic for Nevirapine. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
400MG

tablet, extended release Prescription ORAL AB Apr 3, 2014


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Langkampfen Sandoz GmbH
Kundl Sandoz GmbH
United States
Princeton Sandoz Inc
East Hanover Sandoz Incorporated
Spain
Palafolls Sandoz Industrial Products, S.A.
Les Franqueses Del Valles Sandoz Industrial Products S.A.
India
Navi Mumbai Sandoz Private Limited





15. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 1 generic for Nevirapine. Given below are the details of the strengths of this generic introduced by Strides Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Prescription ORAL AB May 22, 2012


Manufacturing Plant Locations
New

Strides Pharma's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Strides Pharma as present at those locations.

Country City Firm Name
United States
Chestnut Ridge Strides Pharma, Inc.
East Brunswick Strides Pharma Inc.
India
Bangalore Strides Pharma Science Limited
Puducherry Strides Pharma Science Limited





16. TECH ORGANIZED

Technology Organized Llc has filed for 3 different strengths of generic version for Nevirapine. Given below are the details of the strengths of this generic introduced by Tech Organized.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Discontinued ORAL N/A May 22, 2012
100MG

tablet, extended release Discontinued ORAL N/A Jul 31, 2017
400MG

tablet, extended release Discontinued ORAL N/A Jul 31, 2017