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Modafinil Patent Expiration

Modafinil is Used for treating excessive daytime sleepiness associated with narcolepsy. It was first introduced by Nuvo Pharmaceuticals (Ireland) Dac in its drug Provigil on Dec 24, 1998. 10 different companies have introduced drugs containing Modafinil.


Modafinil Patents

Given below is the list of patents protecting Modafinil, 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
Provigil US7297346

(Pediatric)

 Pharmaceutical formulations of modafinil May 29, 2024

(Expired)

 Nuvo Pharms
Provigil US7297346 Pharmaceutical formulations of modafinil Nov 29, 2023

(Expired)

 Nuvo Pharms
Provigil USRE37516

(Pediatric)

 Acetamide derivative having defined particle size Apr 06, 2015

(Expired)

 Nuvo Pharms
Provigil USRE37516 Acetamide derivative having defined particle size Oct 06, 2014

(Expired)

 Nuvo Pharms



Modafinil's Family Patents

Family Patents

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Modafinil Generic API Manufacturers

Several generic applications have been filed for Modafinil. The first generic version for Modafinil was by Natco Pharma Ltd and was approved on Jul 16, 2012. And the latest generic version is by Cadila Healthcare Ltd and was approved on Sep 14, 2017.

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


1. ALEMBIC

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

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

tablet Prescription ORAL AB Oct 18, 2012
200MG

tablet Prescription ORAL AB Oct 18, 2012


Manufacturing Plant Locations
New

Alembic'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 Alembic as present at those locations.

Country City Firm Name
India
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals, Ltd
Vadodara Alembic Pharmaceuticals Ltd
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Panelav Alembic Pharmaceuticals Limited





2. APOTEX

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

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

tablet Prescription ORAL AB Feb 3, 2014
100MG

tablet Prescription ORAL AB Feb 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
Etobicoke Apotex, Inc.
Winnipeg Apotex Fermentation Inc.
Brantford Apotex Pharmachem Inc.
Toronto Apotex Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.
India
Bangalore Apotex Pharmachem India Pvt Ltd.
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bengaluru Apotex Research Private Limited





3. APPCO

Appco Pharma Llc has filed for 2 different strengths of generic version for Modafinil. Given below are the details of the strengths of this generic introduced by Appco.

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

tablet Prescription ORAL AB Aug 16, 2017
200MG

tablet Prescription ORAL AB Aug 16, 2017


Manufacturing Plant Locations
New

Appco'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 Appco as present at those locations.

Country City Firm Name
United States
Somerset Appco Pharma, LLC
Piscataway Appco Pharma LLC





4. AUROBINDO PHARMA LTD

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

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

tablet Prescription ORAL AB Sep 27, 2012
200MG

tablet Prescription ORAL AB Sep 27, 2012


Manufacturing Plant Locations
New

Aurobindo Pharma Ltd'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 Aurobindo Pharma Ltd as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd





5. CADILA

Cadila Healthcare Ltd has filed for 2 different strengths of generic version for Modafinil. Given below are the details of the strengths of this generic introduced by Cadila.

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

tablet Prescription ORAL AB Sep 14, 2017
200MG

tablet Prescription ORAL AB Sep 14, 2017


Manufacturing Plant Locations
New

Cadila'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 Cadila as present at those locations.

Country City Firm Name
United States
Pennington Cadila Healthcare Limited
India
Ankleshwar Cadila Pharmaceuticals Limited
Ahmedabad Cadila Pharmaceuticals Limited





6. HIKMA PHARMS

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

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

tablet Discontinued ORAL N/A Sep 26, 2012
200MG

tablet Discontinued ORAL N/A Sep 26, 2012





7. NATCO PHARMA

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

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

tablet Discontinued ORAL N/A Jul 16, 2012
200MG

tablet Discontinued ORAL N/A Jul 16, 2012


Manufacturing Plant Locations
New

Natco Pharma'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 Natco Pharma as present at those locations.

Country City Firm Name
India
Paravada Natco Pharma Limited
Hyderabad Natco Pharma Limited
Hyderabad NATCO PHARMA LTD
Rangareddy NATCO Pharma Limited
Chennai NATCO Pharma Limited Chemical Division Chennai
Rangareddy District Natco Pharma Ltd. - Chemical Division





8. ORBION PHARMS

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

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

tablet Prescription ORAL AB Sep 26, 2012
200MG

tablet Prescription ORAL AB Sep 26, 2012





9. WATSON LABS INC

Watson Laboratories Inc has filed for 2 different strengths of generic version for Modafinil. Given below are the details of the strengths of this generic introduced by Watson Labs Inc.

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

tablet Prescription ORAL AB Nov 1, 2012
100MG

tablet Prescription ORAL AB Nov 1, 2012