Albuterol Sulfate Patent Expiration

Albuterol Sulfate was first introduced by Schering Corp Sub Schering Plough Corp in its drug Proventil on May 7, 1982. Other drugs containing Albuterol Sulfate are Proair Hfa, Ventolin Rotacaps, Proair Respiclick, Ventolin, Proventil-Hfa, Volmax, Ventolin Hfa, Accuneb, Proair Digihaler. 51 different companies have introduced drugs containing Albuterol Sulfate.


Albuterol Sulfate Patents

Given below is the list of patents protecting Albuterol Sulfate, 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
Proair Digihaler US11266796 Inhalation device with integrated electronics Feb 22, 2041 Teva Branded Pharm
Proair Digihaler US11173259 Drug delivery device with electronics and power management Jul 06, 2040 Teva Branded Pharm
Proair Digihaler US11464923 Inhaler system Jun 19, 2040 Teva Branded Pharm
Proair Digihaler US11439777 Drug delivery device with electronics May 24, 2040 Teva Branded Pharm
Proair Digihaler US11344685 Drug delivery device with electronics Sep 26, 2039 Teva Branded Pharm
Proair Digihaler US11000653 Inhaler Dec 18, 2038 Teva Branded Pharm
Proair Digihaler US11357935 Drug delivery device with electronics Sep 24, 2038 Teva Branded Pharm
Proair Digihaler US11351317 Drug delivery device with electronics Feb 10, 2038 Teva Branded Pharm
Proair Digihaler US10569034 Compliance monitoring module for a breath-actuated inhaler Aug 16, 2036 Teva Branded Pharm
Proair Digihaler US10918816 Compliance monitoring module for a breath-actuated inhaler Dec 14, 2035 Teva Branded Pharm
Proair Digihaler US9782550 Compliance monitoring module for a breath-actuated inhaler Aug 28, 2035 Teva Branded Pharm
Proair Digihaler US9782551 Compliance monitoring module for a breath-actuated inhaler Aug 28, 2035 Teva Branded Pharm
Proair Respiclick US9782550 Compliance monitoring module for a breath-actuated inhaler Aug 28, 2035 Teva Branded Pharm
Proair Respiclick US9782551 Compliance monitoring module for a breath-actuated inhaler Aug 28, 2035 Teva Branded Pharm
Proair Digihaler US8978966 Dose counters for inhalers, inhalers and methods of assembly thereof Jan 13, 2032 Teva Branded Pharm
Proair Respiclick US8978966 Dose counters for inhalers, inhalers and methods of assembly thereof Jan 13, 2032 Teva Branded Pharm
Proair Digihaler US10561808 Dose counter for inhaler having an anti-reverse rotation actuator Jan 01, 2032 Teva Branded Pharm
Proair Hfa US10561808 Dose counter for inhaler having an anti-reverse rotation actuator Jan 01, 2032 Teva Branded Pharm
Proair Respiclick US10561808 Dose counter for inhaler having an anti-reverse rotation actuator Jan 01, 2032 Teva Branded Pharm
Proair Digihaler US9216260 Dose counters for inhalers, inhalers and methods of assembly thereof Jun 28, 2031 Teva Branded Pharm
Proair Respiclick US9216260 Dose counters for inhalers, inhalers and methods of assembly thereof Jun 28, 2031 Teva Branded Pharm
Proair Digihaler US10022510 Dose counters for inhalers, inhalers and methods of assembly thereof May 18, 2031 Teva Branded Pharm
Proair Digihaler US10124131 Dose counter for inhaler having an anti-reverse rotation actuator May 18, 2031 Teva Branded Pharm
Proair Digihaler US9731087 Dose counter for inhaler having a bore and shaft arrangement May 18, 2031 Teva Branded Pharm
Proair Hfa US10022509 Dose counter for inhaler having a bore and shaft arrangement May 18, 2031 Teva Branded Pharm
Proair Hfa US10022510 Dose counters for inhalers, inhalers and methods of assembly thereof May 18, 2031 Teva Branded Pharm
Proair Hfa US10086156 Dose counter for inhaler and method for counting doses May 18, 2031 Teva Branded Pharm
Proair Hfa US10695512 Dose counter for inhaler having an anti-reverse rotation actuator May 18, 2031 Teva Branded Pharm
Proair Hfa US11395889 Dose counter for inhaler having an anti-reverse rotation actuator May 18, 2031 Teva Branded Pharm
Proair Hfa US9463289 Dose counters for inhalers, inhalers and methods of assembly thereof May 18, 2031 Teva Branded Pharm
Proair Hfa US9808587 Dose counter for inhaler having an anti-reverse rotation actuator May 18, 2031 Teva Branded Pharm
Proair Respiclick US10022510 Dose counters for inhalers, inhalers and methods of assembly thereof May 18, 2031 Teva Branded Pharm
Proair Respiclick US10124131 Dose counter for inhaler having an anti-reverse rotation actuator May 18, 2031 Teva Branded Pharm
Proair Respiclick US9731087 Dose counter for inhaler having a bore and shaft arrangement May 18, 2031 Teva Branded Pharm
Proair Hfa US8132712 Metered-dose inhaler Sep 07, 2028 Teva Branded Pharm
Proair Digihaler US8651103 Dry powder inhalation apparatus Mar 26, 2028 Teva Branded Pharm
Proair Respiclick US8651103 Dry powder inhalation apparatus Mar 26, 2028 Teva Branded Pharm
Ventolin Hfa US7500444

(Pediatric)

Actuation indicator for a dispensing device Jul 04, 2025 Glaxosmithkline
Proair Digihaler US10765820 Dry powder inhalation apparatus May 19, 2025 Teva Branded Pharm
Proair Digihaler US9463288 Dry powder inhalation apparatus May 19, 2025 Teva Branded Pharm
Proair Respiclick US10765820 Dry powder inhalation apparatus May 19, 2025 Teva Branded Pharm
Proair Respiclick US9463288 Dry powder inhalation apparatus May 19, 2025 Teva Branded Pharm
Ventolin Hfa US7500444 Actuation indicator for a dispensing device Jan 04, 2025 Glaxosmithkline
Ventolin Hfa US7832351

(Pediatric)

Actuation indicator for a dispensing device Dec 19, 2023

(Expired)

Glaxosmithkline
Proair Hfa US7105152 Suspension aerosol formulations Sep 12, 2023

(Expired)

Teva Branded Pharm
Ventolin Hfa US7832351 Actuation indicator for a dispensing device Jun 19, 2023

(Expired)

Glaxosmithkline
Proair Digihaler US7540282 Reservoir pressure system for medicament inhaler May 06, 2023

(Expired)

Teva Branded Pharm
Proair Respiclick US7540282 Reservoir pressure system for medicament inhaler May 06, 2023

(Expired)

Teva Branded Pharm
Accuneb US6702997 Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma Dec 28, 2021

(Expired)

Norvium Bioscience
Ventolin Hfa US6743413

(Pediatric)

Suspension aerosol formulations Dec 01, 2021

(Expired)

Glaxosmithkline
Proair Digihaler US6701917 Dose counter for medicament inhaler Jun 23, 2021

(Expired)

Teva Branded Pharm
Proair Digihaler US6718972 Dose metering system for medicament inhaler Jun 23, 2021

(Expired)

Teva Branded Pharm
Proair Digihaler US6748947 De-agglomerator for breath-actuated dry powder inhaler Jun 23, 2021

(Expired)

Teva Branded Pharm
Proair Digihaler US6871646 De-agglomerator for breath-actuated dry powder inhaler Jun 23, 2021

(Expired)

Teva Branded Pharm
Proair Digihaler US8006690 Reservoir pressure system for medicament inhaler Jun 23, 2021

(Expired)

Teva Branded Pharm
Proair Respiclick US6701917 Dose counter for medicament inhaler Jun 23, 2021

(Expired)

Teva Branded Pharm
Proair Respiclick US6718972 Dose metering system for medicament inhaler Jun 23, 2021

(Expired)

Teva Branded Pharm
Proair Respiclick US6748947 De-agglomerator for breath-actuated dry powder inhaler Jun 23, 2021

(Expired)

Teva Branded Pharm
Proair Respiclick US6871646 De-agglomerator for breath-actuated dry powder inhaler Jun 23, 2021

(Expired)

Teva Branded Pharm
Proair Respiclick US8006690 Reservoir pressure system for medicament inhaler Jun 23, 2021

(Expired)

Teva Branded Pharm
Ventolin Hfa US6743413 Suspension aerosol formulations Jun 01, 2021

(Expired)

Glaxosmithkline
Ventolin Hfa US9861771 Device housing for an aerosol container Oct 11, 2020

(Expired)

Glaxosmithkline
Ventolin Hfa US7350676

(Pediatric)

Valve for aerosol container Feb 24, 2019

(Expired)

Glaxosmithkline
Ventolin Hfa US6431168

(Pediatric)

Dispenser with doses′ counter Dec 08, 2018

(Expired)

Glaxosmithkline
Ventolin Hfa US7107986

(Pediatric)

Dispenser with doses' counter Dec 06, 2018

(Expired)

Glaxosmithkline
Ventolin Hfa US7350676 Valve for aerosol container Aug 24, 2018

(Expired)

Glaxosmithkline
Ventolin Hfa US6161724

(Pediatric)

Indicating device Jul 16, 2018

(Expired)

Glaxosmithkline
Ventolin Hfa US6435372

(Pediatric)

Delivery system for a medicament and method for the assembly thereof Jul 16, 2018

(Expired)

Glaxosmithkline
Ventolin Hfa US6938796

(Pediatric)

Indicating device Jul 16, 2018

(Expired)

Glaxosmithkline
Ventolin Hfa US6997349

(Pediatric)

Indicating device Jul 16, 2018

(Expired)

Glaxosmithkline
Ventolin Hfa US7143908

(Pediatric)

Indicating device Jul 16, 2018

(Expired)

Glaxosmithkline
Ventolin Hfa US6170717

(Pediatric)

Valve for aerosol container Jun 23, 2018

(Expired)

Glaxosmithkline
Ventolin Hfa US6315173

(Pediatric)

Valve for aerosol container Jun 23, 2018

(Expired)

Glaxosmithkline
Ventolin Hfa US6510969

(Pediatric)

Valve for aerosol container Jun 23, 2018

(Expired)

Glaxosmithkline
Ventolin Hfa US6966467

(Pediatric)

Valve for aerosol container Jun 23, 2018

(Expired)

Glaxosmithkline
Ventolin Hfa US6431168 Dispenser with doses′ counter Jun 08, 2018

(Expired)

Glaxosmithkline
Ventolin Hfa US7107986 Dispenser with doses' counter Jun 08, 2018

(Expired)

Glaxosmithkline
Ventolin Hfa US6161724 Indicating device Jan 16, 2018

(Expired)

Glaxosmithkline
Ventolin Hfa US6435372 Delivery system for a medicament and method for the assembly thereof Jan 16, 2018

(Expired)

Glaxosmithkline
Ventolin Hfa US6938796 Indicating device Jan 16, 2018

(Expired)

Glaxosmithkline
Ventolin Hfa US6997349 Indicating device Jan 16, 2018

(Expired)

Glaxosmithkline
Ventolin Hfa US7143908 Indicating device Jan 16, 2018

(Expired)

Glaxosmithkline
Ventolin Hfa US6170717 Valve for aerosol container Dec 23, 2017

(Expired)

Glaxosmithkline
Ventolin Hfa US6315173 Valve for aerosol container Dec 23, 2017

(Expired)

Glaxosmithkline
Ventolin Hfa US6510969 Valve for aerosol container Dec 23, 2017

(Expired)

Glaxosmithkline
Ventolin Hfa US6966467 Valve for aerosol container Dec 23, 2017

(Expired)

Glaxosmithkline
Proair Hfa US6446627 Inhaler dose counter Dec 18, 2017

(Expired)

Teva Branded Pharm
Proair Respiclick US6446627 Inhaler dose counter Dec 18, 2017

(Expired)

Teva Branded Pharm
Ventolin Hfa US6558651

(Pediatric)

Aerosols containing annealed particulate salbutamol and tetrafluoroethane Jun 19, 2017

(Expired)

Glaxosmithkline
Proair Hfa US7566445 Medicinal aerosols and methods of delivery thereof Jun 04, 2017

(Expired)

Teva Branded Pharm
Proair Hfa US8834849 Medicinal aerosols and methods of delivery thereof Jun 04, 2017

(Expired)

Teva Branded Pharm
Proventil-hfa US6006745 Device for delivering an aerosol Dec 28, 2016

(Expired)

Kindeva
Ventolin Hfa US6558651 Aerosols containing annealed particulate salbutamol and tetrafluoroethane Dec 19, 2016

(Expired)

Glaxosmithkline
Proventil-hfa US5775321 Seal configuration for aerosol canister Jul 07, 2015

(Expired)

Kindeva
Ventolin Hfa US6596260

(Pediatric)

Aerosol container and a method for storage and administration of a predetermined amount of a pharmaceutically active aerosol Feb 10, 2015

(Expired)

Glaxosmithkline
Ventolin Hfa US6596260 Aerosol container and a method for storage and administration of a predetermined amount of a pharmaceutically active aerosol Aug 10, 2014

(Expired)

Glaxosmithkline
Proair Hfa US5605674 Medicinal aerosol formulations Feb 25, 2014

(Expired)

Teva Branded Pharm
Proventil-hfa US5605674 Medicinal aerosol formulations Feb 25, 2014

(Expired)

Kindeva



Albuterol Sulfate's Family Patents

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List

Albuterol Sulfate Generic API Manufacturers

Several generic applications have been filed for Albuterol Sulfate. The first generic version for Albuterol Sulfate was by Sandoz Inc and was approved on Dec 5, 1989. And the latest generic version is by Armstrong Pharmaceuticals Inc and was approved on May 21, 2024.

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


1. ACTAVIS MID ATLANTIC

Actavis Mid Atlantic Llc has filed for 2 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Actavis Mid Atlantic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.083% BASE

solution Discontinued INHALATION N/A Sep 26, 1995
EQ 2MG BASE/5ML

syrup Discontinued ORAL N/A Mar 30, 1999





2. AIZANT

Aizant Drug Research Solutions Private Ltd has filed for 2 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Aizant.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE

tablet Prescription ORAL BX Mar 15, 2019
EQ 4MG BASE

tablet Prescription ORAL BX Mar 15, 2019


Manufacturing Plant Locations
New

Aizant'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 Aizant as present at those locations.

Country City Firm Name
India
Hyderabad Aizant Drug Research Solutions Private Ltd.
Hyderabad Aizant Drug Research Solutions Pvt Ltd., Clinical Pharmacology Unit-II





3. AM THERAP

American Therapeutics Inc has filed for 2 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Am Therap.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE

tablet Discontinued ORAL N/A Dec 5, 1989
EQ 4MG BASE

tablet Discontinued ORAL N/A Dec 5, 1989





4. AMNEAL PHARMS

Amneal Pharmaceuticals has filed for 1 generic for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Amneal Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE/5ML

syrup Prescription ORAL AA May 12, 2010





5. AMNEAL PHARMS CO

Amneal Pharmaceuticals Co Gmbh has filed for 2 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Amneal Pharms Co.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE

tablet Prescription ORAL AB May 21, 2018
EQ 2MG BASE

tablet Prescription ORAL AB May 21, 2018





6. APOTEX INC

Apotex Inc has filed for 4 different strengths of generic version for Albuterol Sulfate. 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
EQ 0.5% BASE

solution Discontinued INHALATION N/A Apr 1, 2003
EQ 0.083% BASE

solution Discontinued INHALATION N/A Feb 2, 2007
EQ 0.021% BASE

solution Discontinued INHALATION N/A Apr 5, 2010
EQ 0.042% BASE

solution Discontinued INHALATION N/A Apr 5, 2010


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.





7. ARMSTRONG PHARMS

Armstrong Pharmaceuticals Inc has filed for 1 generic for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Armstrong Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.09MG BASE/INH

aerosol, metered Prescription INHALATION AB2 May 21, 2024





8. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Albuterol Sulfate. 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
EQ 2MG BASE

tablet Discontinued ORAL N/A May 14, 2020
EQ 4MG BASE

tablet Discontinued ORAL N/A May 14, 2020


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





9. BAUSCH

Bausch Health Us Llc has filed for 2 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Bausch.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5% BASE

solution Discontinued INHALATION N/A Jun 18, 1998
EQ 0.083% BASE

solution Discontinued INHALATION N/A Mar 29, 2000


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Bridgewater Bausch Health Companies, Inc.
Rancho Cucamonga Bausch and Lomb, Incorporated
Irvine Bausch and Lomb, Incorporated
Saint Louis Bausch & Lomb Inc
Wilmington Bausch & Lomb Incorporated
Rochester Bausch & Lomb Incorporated
Manchester Bausch & Lomb, Inc.
Lancaster Bausch & Lomb Incorporated
Petaluma Bausch Health Americas, Inc.
Rochester Bausch Health Americas, Inc.
Woodruff Bausch & Lomb Inc
Greenville Bausch & Lomb Incorporated
Bridgewater Bausch and Lomb, Inc
Canada
Laval Bausch Health Companies Inc.
Steinbach Bausch Health Companies Inc.





10. CHARTWELL MOLECULAR

Chartwell Molecular Holdings Llc has filed for 1 generic for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Chartwell Molecular.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE/5ML

syrup Prescription ORAL AA Dec 27, 2006





11. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 3 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE

tablet Discontinued ORAL N/A Dec 5, 1989
EQ 4MG BASE

tablet Discontinued ORAL N/A Dec 5, 1989
EQ 2MG BASE/5ML

syrup Prescription ORAL AA Jun 26, 2007





12. CIPLA

Cipla Ltd has filed for 1 generic for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Cipla.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.09MG BASE/INH

aerosol, metered Prescription INHALATION AB1 Apr 8, 2020


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





13. COPLEY PHARM

Copley Pharmaceutical Inc has filed for 4 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Copley Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE

tablet Discontinued ORAL N/A Nov 22, 1991
EQ 2MG BASE

tablet Discontinued ORAL N/A Nov 22, 1991
EQ 0.5% BASE

solution Discontinued INHALATION N/A Nov 27, 1991
EQ 0.083% BASE

solution Discontinued INHALATION N/A May 28, 1993





14. COSETTE

Cosette Pharmaceuticals Inc has filed for 1 generic for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Cosette.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE/5ML

syrup Prescription ORAL AA Sep 25, 1995


Manufacturing Plant Locations
New

Cosette'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 Cosette as present at those locations.

Country City Firm Name
United States
South Plainfield Cosette Pharmaceuticals, Inc.
Lincolnton Cosette Pharmaceuticals NC Laboratories, LLC





15. DASH PHARMS NATCO

Dash Pharmaceuticals Llc A Fully Owned Sub Of Natco Pharma Ltd has filed for 2 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Dash Pharms Natco.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE

tablet Prescription ORAL AB Jan 17, 1991
EQ 4MG BASE

(reference standard)

tablet Prescription ORAL AB Jan 17, 1991





16. DAVA PHARMS INC

Dava Pharmaceuticals Inc has filed for 1 generic for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Dava Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE

tablet Discontinued ORAL N/A Dec 20, 1989





17. EPIC PHARMA LLC

Epic Pharma Llc has filed for 1 generic for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Epic Pharma Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.083% BASE

solution Discontinued INHALATION N/A Feb 9, 1999





18. HIBROW HLTHCARE

Hibrow Healthcare Private Ltd has filed for 2 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Hibrow Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE

tablet Discontinued ORAL N/A Oct 8, 2020
EQ 2MG BASE

tablet Discontinued ORAL N/A Oct 8, 2020





19. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE/5ML

syrup Discontinued ORAL N/A Jan 30, 1998


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Dayton Hikma Injectables USA Inc
Cherry Hill Hikma Pharmaceuticals USA Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Eatontown Hikma Pharmaceuticals USA, Inc.
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





20. LANDELA PHARM

Landela Pharmaceutical has filed for 1 generic for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Landela Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.083% BASE

solution Discontinued INHALATION N/A Apr 4, 2006





21. LEXENPHARM

Lexenpharm Suzhou Ltd has filed for 2 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Lexenpharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.021% BASE

solution Prescription INHALATION AN May 3, 2024
EQ 0.042% BASE

solution Prescription INHALATION AN May 3, 2024





22. LUOXIN AUROVITAS

Luoxin Aurovitas Pharma Chengdu Co Ltd has filed for 3 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Luoxin Aurovitas.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.083% BASE

solution Prescription INHALATION AN Oct 17, 2017
EQ 0.042% BASE

solution Prescription INHALATION AN Apr 20, 2020
EQ 0.021% BASE

solution Prescription INHALATION AN Apr 20, 2020





23. LUPIN

Lupin Inc has filed for 1 generic for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Lupin.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.09MG BASE/INH

aerosol, metered Prescription INHALATION AB2 Aug 24, 2020


Manufacturing Plant Locations
New

Lupin'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 Lupin as present at those locations.

Country City Firm Name
India
Anakapalli District Lupin Manufacturing Solutions Limited
Mumbai Lupin Limited
Pirangut Lupin Limited
Pithampur Lupin Limited
Mandideep Lupin Limited
Nagpur Lupin Limited
Pithampur Lupin Limited (Unit 1)
Dabhasa LUPIN MANUFACTURING SOLUTIONS LIMITED
Aurangabad Lupin Ltd.
Vasco Da Gama Lupin Limited
Mandideep Lupin Limited (Unit II)
Navi Mumbai LUPIN LIMITED
Tarapur, Thane Lupin Limited
Pune Lupin Bioresearch Center
United States
Baltimore Lupin Pharmaceuticals Inc.
Coral Springs Lupin Research Inc





24. MOVA

Mova Pharmaceuticals Corp has filed for 1 generic for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Mova.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE/5ML

syrup Discontinued ORAL N/A Sep 30, 1994





25. NEPHRON

Nephron Pharmaceuticals Corp has filed for 4 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Nephron.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.083% BASE

(reference standard)

solution Prescription INHALATION AN Sep 17, 1997
EQ 0.5% BASE

(reference standard)

solution Prescription INHALATION AN Jun 26, 2001
EQ 0.042% BASE

(reference standard)

solution Prescription INHALATION AN Jun 28, 2004
EQ 0.021% BASE

solution Prescription INHALATION AN Mar 31, 2010


Manufacturing Plant Locations
New

Nephron'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 Nephron as present at those locations.

Country City Firm Name
United States
Mountain Home Nephron Pharmaceuticals
West Columbia Nephron Sc Inc
West Columbia Nephron Sterile Compounding Center LLC
Murray Nephron Pharmaceuticals





26. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 1 generic for Albuterol Sulfate. 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
EQ 0.083% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

solution Discontinued INHALATION N/A Feb 21, 1992





27. PADAGIS US

Padagis Us Llc has filed for 1 generic for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Padagis Us.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.09MG BASE/INH

aerosol, metered Discontinued INHALATION N/A Feb 24, 2020


Manufacturing Plant Locations
New

Padagis Us'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 Padagis Us as present at those locations.

Country City Firm Name
United States
Minneapolis Padagis US LLC





28. PLIVA

Pliva Inc has filed for 2 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Pliva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE

tablet Discontinued ORAL N/A Dec 5, 1989
EQ 4MG BASE

tablet Discontinued ORAL N/A Dec 5, 1989


Manufacturing Plant Locations
New

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

Country City Firm Name
Croatia
Zagreb PLIVA Hrvatska d.o.o.
Brdovec Pliva Hrvatska d.o.o.
United States
East Hanover Pliva, Inc.
Czech Republic
Brno PLIVA-Lachema a.s.





29. QUAGEN

Quagen Pharmaceuticals Llc has filed for 1 generic for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Quagen.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE/5ML

syrup Prescription ORAL AA Sep 6, 2019


Manufacturing Plant Locations
New

Quagen'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 Quagen as present at those locations.

Country City Firm Name
United States
West Caldwell Quagen Pharmacuticals, LLC
West Caldwell Quagen Pharma, LLC





30. RISING

Rising Pharma Holdings Inc has filed for 3 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE

tablet Prescription ORAL AB Jun 29, 2018
EQ 8MG BASE

tablet, extended release Discontinued ORAL N/A Jan 29, 2007
EQ 2MG BASE

tablet Prescription ORAL AB Jun 29, 2018


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Rising Sun Rising Sun Veterinary Clinic
Phoenix Rising Sun Farms Inc
Livingston Risingsun Iodine Products Corp.
Saddle Brook Rising Pharmaceuticals, Inc.
Decatur Rising Pharma Holdings, Inc
East Brunswick Rising Pharma Holding, Inc.
Mount Morris Rising Creek Bakery LLC
Fort Bragg Rising Tide Sea Vegetables
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





31. RITEDOSE CORP

The Ritedose Corp has filed for 3 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Ritedose Corp.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.083% BASE

solution Prescription INHALATION AN Dec 16, 2008
EQ 0.021% BASE

(reference standard)

solution Prescription INHALATION AN Dec 28, 2021
EQ 0.042% BASE

solution Prescription INHALATION AN Dec 28, 2021





32. ROXANE

Roxane Laboratories Inc has filed for 1 generic for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Roxane.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.083% BASE

solution Discontinued INHALATION N/A Feb 13, 2001





33. SANDOZ

Sandoz Inc has filed for 2 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE

tablet Discontinued ORAL N/A Dec 5, 1989
EQ 0.09MG BASE/INH

aerosol, metered Prescription INHALATION AB1 Jun 1, 2021


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





34. SENTISS

Sentiss Ag has filed for 1 generic for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Sentiss.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5% BASE

solution Prescription INHALATION AN Jan 15, 1998


Manufacturing Plant Locations
New

Sentiss'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 Sentiss as present at those locations.

Country City Firm Name
India
District Solan Sentiss Pharma Pvt. Ltd.





35. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 3 different strengths of generic version for Albuterol Sulfate. Out of these eq 4mg base version comes by the name VOSPIRE ER, eq 8mg base version comes by the name VOSPIRE ER. 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
EQ 2MG BASE

tablet Discontinued ORAL N/A Dec 20, 1989
EQ 4MG BASE

tablet, extended release Discontinued ORAL N/A Sep 26, 2002
EQ 8MG BASE

tablet, extended release Discontinued ORAL N/A Sep 26, 2002


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





36. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 1 generic for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.083% BASE

solution Prescription INHALATION AN Jul 21, 2017


Manufacturing Plant Locations
New

Sun Pharm'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 Sun Pharm as present at those locations.

Country City Firm Name
United States
Billerica Sun Pharmaceutical Industries, Inc.
Lexington Sun Pharmaceutical Industries Inc
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
India
New Delhi Sun Pharmaceutical Industries Limited
Punjab Sun Pharmaceutical Industries, Inc.
Ahmednagar Sun Pharmaceutical Industries Limited
Dadra Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Vadodara Sun Pharmaceutical Industries Ltd.
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Vadodara Sun Pharmaceutical Industries Ltd
Bharuch Sun Pharmaceutical Industries Ltd
Baruch Sun Pharmaceutical Industries Ltd.
Halol Sun Pharmaceutical Industries Ltd.
Mohali Sun Pharmaceutical Industries Limited
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)





37. SUN PHARM INDUSTRIES

Sun Pharmaceutical Industries Inc has filed for 2 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Sun Pharm Industries.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE

tablet Prescription ORAL AB Dec 5, 1989
EQ 2MG BASE

tablet Prescription ORAL AB Dec 5, 1989





38. TEVA

Teva Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE

tablet Discontinued ORAL N/A Jun 25, 1993
EQ 4MG BASE

tablet Discontinued ORAL N/A Jun 25, 1993
EQ 2MG BASE/5ML

(reference standard)

syrup Prescription ORAL AA Mar 30, 1992


Manufacturing Plant Locations
New

Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.

Country City Firm Name
United States
Horsham Teva Branded Pharmaceutical Products R&D
Malvern Teva Branded Pharmaceutical Products R&D, Inc.
Miami Teva Branded Pharmaceutical Products R & D, Inc.
Fort Dodge TEVA Animal Health Inc
India
Gajraula, Amroha Teva API India Private Ltd.
Bhind Teva API India Ltd- Malanpur
Canada
Stouffville Teva Canada Limited
Markham Teva Canada Limited
Scarborough Teva Canada Limited
Czech Republic
Opava Teva Czech Industries s.r.o.
Ireland
Dundalk Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona TEVA Medical Ltd.





39. TEVA PHARMS

Teva Pharmaceuticals Usa has filed for 1 generic for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Teva Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.083% BASE

solution Discontinued INHALATION N/A Nov 9, 1999





40. UCB INC

Ucb Inc has filed for 2 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Ucb Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE

tablet Discontinued ORAL N/A Sep 29, 1992
EQ 4MG BASE

tablet Discontinued ORAL N/A Sep 29, 1992





41. VIRTUS PHARM

Virtus Pharmaceutical Inc has filed for 2 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Virtus Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE

tablet Prescription ORAL AB Oct 26, 2018
EQ 4MG BASE

tablet Prescription ORAL AB Oct 26, 2018


Manufacturing Plant Locations
New

Virtus Pharm'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 Virtus Pharm as present at those locations.

Country City Firm Name
United States
Newtown VIRTUS PHARMACEUTICALS LLC.
Bristol VIRTUS PHARMACEUTICALS, LLC
Nashville VIRTUS PHARMACEUTICALS OPCO II L





42. WARNER CHILCOTT

Warner Chilcott Div Warner Lambert Co has filed for 2 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Warner Chilcott.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE

tablet Discontinued ORAL N/A Jan 9, 1990
EQ 4MG BASE

tablet Discontinued ORAL N/A Jan 9, 1990


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Rockaway Warner Chilcott US LLC
Norwich Warner Chilcott Pharmaceuticals, Inc.
Manati Warner Chilcott Company LLC
Germany
Weiterstadt Warner Chilcott Deutschland GmbH





43. WATSON LABS

Watson Laboratories Inc has filed for 5 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Watson Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE

tablet Discontinued ORAL N/A Aug 28, 1991
EQ 4MG BASE

tablet Discontinued ORAL N/A Aug 28, 1991
EQ 2MG BASE/5ML

syrup Discontinued ORAL N/A Apr 29, 1993
EQ 0.042% BASE

solution Discontinued INHALATION N/A Sep 25, 2007
EQ 0.021% BASE

solution Discontinued INHALATION N/A Sep 25, 2007





44. WATSON LABS INC

Watson Laboratories Inc has filed for 1 generic for Albuterol Sulfate. 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
EQ 0.083% BASE

solution Discontinued INHALATION N/A Nov 24, 2003





45. WOCKHARDT EU OPERATN

Wockhardt Eu Operations Swiss Ag has filed for 1 generic for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Wockhardt Eu Operatn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.083% BASE

solution Discontinued INHALATION N/A Nov 22, 1999





46. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Albuterol Sulfate. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE

tablet Prescription ORAL AB Oct 22, 2020
EQ 4MG BASE

tablet Prescription ORAL AB Oct 22, 2020





Albuterol Sulfate News

Teva Unsuccessful in Inhaler Patent Lawsuit Against Amneal, Required to Modify Orange Book Entry

12 Jun, 2024

See More