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Acetaminophen Patent Expiration

Acetaminophen was first introduced by Johnson And Johnson Consumer Inc Mcneil Consumer Healthcare Div in its drug Tylenol on Approved Prior to Jan 1, 1982. Other drugs containing Acetaminophen are Injectapap, Infants' Feverall, Neopap, Ofirmev, Acephen, Acetaminophen. 30 different companies have introduced drugs containing Acetaminophen.


Acetaminophen Patents

Given below is the list of patents protecting Acetaminophen, 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
Ofirmev US9399012

(Pediatric)

 Reduced dose intravenous acetaminophen Mar 11, 2032 Mallinckrodt Hosp
Ofirmev US9399012 Reduced dose intravenous acetaminophen Sep 11, 2031 Mallinckrodt Hosp
Acetaminophen US8741959 Paracetamol for parenteral administration Apr 19, 2030 Fresenius Kabi Usa
Ofirmev US9610265

(Pediatric)

 Reduced dose intravenous acetaminophen May 13, 2029 Mallinckrodt Hosp
Ofirmev US9987238

(Pediatric)

 Reduced dose intravenous acetaminophen May 13, 2029 Mallinckrodt Hosp
Ofirmev US10383834 Reduced dose intravenous acetaminophen Nov 13, 2028 Mallinckrodt Hosp
Ofirmev US9610265 Reduced dose intravenous acetaminophen Nov 13, 2028 Mallinckrodt Hosp
Ofirmev US9987238 Reduced dose intravenous acetaminophen Nov 13, 2028 Mallinckrodt Hosp
Ofirmev US6992218

(Pediatric)

 Method for obtaining aqueous formulations of oxidation-sensitive active principles Dec 06, 2021

(Expired)

 Mallinckrodt Hosp
Ofirmev US6992218 Method for obtaining aqueous formulations of oxidation-sensitive active principles Jun 06, 2021

(Expired)

 Mallinckrodt Hosp
Ofirmev US6028222

(Pediatric)

 Stable liquid paracetamol compositions, and method for preparing same Feb 05, 2018

(Expired)

 Mallinckrodt Hosp
Ofirmev US6028222 Stable liquid paracetamol compositions, and method for preparing same Aug 05, 2017

(Expired)

 Mallinckrodt Hosp



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 Acetaminophen's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 03 Dec, 2021 US8741959
Payment of Maintenance Fee, 4th Year, Large Entity 23 Nov, 2017 US8741959
Patent Issue Date Used in PTA Calculation
Critical
 03 Jun, 2014 US8741959
Recordation of Patent Grant Mailed
Critical
 03 Jun, 2014 US8741959
Email Notification
Critical
 16 May, 2014 US8741959
Issue Notification Mailed
Critical
 14 May, 2014 US8741959
Dispatch to FDC 05 May, 2014 US8741959
Application Is Considered Ready for Issue
Critical
 05 May, 2014 US8741959
Issue Fee Payment Verified
Critical
 24 Apr, 2014 US8741959
Issue Fee Payment Received
Critical
 24 Apr, 2014 US8741959


Acetaminophen's Family Patents

Family Patents

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Acetaminophen Generic API Manufacturers

Several generic applications have been filed for Acetaminophen. The first generic version for Acetaminophen was by Perrigo New York Inc and was approved on Dec 1, 1986. And the latest generic version is by Gland Pharma Ltd and was approved on Apr 2, 2025.

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


1. ABLE

Able Laboratories Inc has filed for 3 different strengths of generic version for Acetaminophen. Given below are the details of the strengths of this generic introduced by Able.

Strength Dosage Form Availability Application Pathway TE code Launch Date
120MG

suppository Discontinued RECTAL N/A Feb 27, 1995
650MG

suppository Discontinued RECTAL N/A Feb 27, 1995
325MG

suppository Discontinued RECTAL N/A Feb 27, 1995


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Roseville AbleNet, Inc.
Los Angeles Able Freight Services LLC
Catano Able Sales Company, Inc.
Los Angeles ABLE INC
Mayaguez Able Sales Company
Raleigh Ablexan Corporation
Sparks Able Groupe Inc
Cincinnati Ablecare Medical Inc
Malaysia
Telok Panglima Garang Able Dairies





2. ACINO PRODS

Acino Products Llc has filed for 2 different strengths of generic version for Acetaminophen. Given below are the details of the strengths of this generic introduced by Acino Prods.

Strength Dosage Form Availability Application Pathway TE code Launch Date
120MG

suppository Discontinued RECTAL N/A May 12, 1987
650MG

suppository Discontinued RECTAL N/A May 12, 1987





3. ASPIRO

Aspiro Pharma Ltd has filed for 1 generic for Acetaminophen. Given below are the details of the strengths of this generic introduced by Aspiro.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM/100ML (10MG/ML)

solution Prescription INTRAVENOUS AP1 Jul 27, 2022


Manufacturing Plant Locations
New

Aspiro'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 Aspiro as present at those locations.

Country City Firm Name
India
Siddipet (Dist) Aspiro Pharma Limited





4. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 1 generic for Acetaminophen. 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
650MG

tablet, extended release Over the counter ORAL N/A Nov 9, 2016


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
Sangareddy Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





5. BAXTER HLTHCARE CORP

Baxter Healthcare Corp has filed for 1 generic for Acetaminophen. Given below are the details of the strengths of this generic introduced by Baxter Hlthcare Corp.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM/100ML (10MG/ML)

solution Prescription INTRAVENOUS AP1 Sep 17, 2021





6. COSETTE

Cosette Pharmaceuticals Inc has filed for 3 different strengths of generic version for Acetaminophen. All of these versions come by the name ACEPHEN. Given below are the details of the strengths of this generic introduced by Cosette.

Strength Dosage Form Availability Application Pathway TE code Launch Date
120MG

suppository Discontinued RECTAL N/A Mar 27, 1992
325MG

suppository Discontinued RECTAL N/A Mar 27, 1992
650MG

suppository Discontinued RECTAL N/A Mar 27, 1992


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
Lincolnton Cosette Pharmaceuticals NC Laboratories, LLC
South Plainfield Cosette Pharmaceuticals, Inc.





7. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 1 generic for Acetaminophen. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM/100ML (10MG/ML)

solution Prescription INTRAVENOUS AP1 Oct 21, 2020


Manufacturing Plant Locations
New

Eugia 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 Eugia Pharma as present at those locations.

Country City Firm Name
India
Riico Industrial Area EUGIA Pharma Specialities Limited
Pashamylaram Eugia Pharma Specialities Limited
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited





8. GLAND

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG/50ML (10MG/ML)

solution Prescription INTRAVENOUS AP Apr 2, 2025
1GM/100ML (10MG/ML)

solution Prescription INTRAVENOUS AP2 Apr 2, 2025


Manufacturing Plant Locations
New

Gland'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 Gland as present at those locations.

Country City Firm Name
India
Visakhapatnam Gland Pharma Limited
Hyderabad Gland Pharma Limited, Units I+II Pashamylaram Site
Malur Gland Chemicals Pvt Ltd.
Sriperumbudur Gland Chemical Private Limited
Aurangabad Gland Chemical Private Limited
Hyderabad Gland Pharma Limited
Parawada, Visakhapatnam Gland Pharma Limited





9. GRANULES

Granules India Ltd has filed for 1 generic for Acetaminophen. Given below are the details of the strengths of this generic introduced by Granules.

Strength Dosage Form Availability Application Pathway TE code Launch Date
650MG

tablet, extended release Over the counter ORAL N/A Apr 16, 2019


Manufacturing Plant Locations
New

Granules'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 Granules as present at those locations.

Country City Firm Name
United States
Manassas Granules Consumer Health Inc.
Chantilly Granules Pharmaceuticals Inc.
India
Secunderabad Granules India Limited
Parawada Mandal Granules India Limited
Visakhapatnam Granules India Limited
Medchal-Malkhajgiri District Granules India Limited
Sangareddy District Granules India Limited





10. HERITAGE PHARMA

Heritage Pharma Labs Inc has filed for 1 generic for Acetaminophen. Given below are the details of the strengths of this generic introduced by Heritage Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
650MG

tablet, extended release Over the counter ORAL N/A May 31, 2018


Manufacturing Plant Locations
New

Heritage Pharma'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 Heritage Pharma as present at those locations.

Country City Firm Name
United States
East Brunswick Heritage Pharmaceuticals Inc
East Brunswick Heritage Pharmaceuticals, Inc. DBA AVET Pharmaceutical LABS





11. HIKMA

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM/100ML (10MG/ML)

solution Prescription INTRAVENOUS AP1 Jun 13, 2016


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





12. INFORLIFE

Inforlife Sa has filed for 1 generic for Acetaminophen. Given below are the details of the strengths of this generic introduced by Inforlife.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM/100ML (10MG/ML)

solution Prescription INTRAVENOUS AP1 May 3, 2023


Manufacturing Plant Locations
New

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

Country City Firm Name
Switzerland
Campascio InfoRLife SA





13. MARKSANS PHARMA

Marksans Pharma Ltd has filed for 1 generic for Acetaminophen. Given below are the details of the strengths of this generic introduced by Marksans Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
650MG

tablet, extended release Over the counter ORAL N/A Aug 25, 2021


Manufacturing Plant Locations
New

Marksans 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 Marksans Pharma as present at those locations.

Country City Firm Name
United States
Commack Marksans Pharmaceuticals Ltd
India
Verna Marksans Pharma Limited





14. MYLAN

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM/100ML (10MG/ML)

solution Prescription INTRAVENOUS AP1 Aug 7, 2020


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





15. OHM LABS

Ohm Laboratories Inc has filed for 1 generic for Acetaminophen. Given below are the details of the strengths of this generic introduced by Ohm Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
650MG

tablet, extended release Over the counter ORAL N/A Mar 19, 2002





16. PERRIGO

L Perrigo Co has filed for 1 generic for Acetaminophen. Given below are the details of the strengths of this generic introduced by Perrigo.

Strength Dosage Form Availability Application Pathway TE code Launch Date
650MG

tablet, extended release Over the counter ORAL N/A Feb 25, 2000


Manufacturing Plant Locations
New

Perrigo'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 Perrigo as present at those locations.

Country City Firm Name
United States
Bronx Perrigo New York, Inc.
Allegan Perrigo Company PLC-Allegan Logistics Center
Martin Perrigo Company PLC
West Palm Beach Perrigo Florida, Inc
Eau Claire Perrigo Wisconsin, LLC
India
Thane Perrigo Laboratories India Pvt Ltd





17. PERRIGO NEW YORK

Perrigo New York Inc has filed for 2 different strengths of generic version for Acetaminophen. Given below are the details of the strengths of this generic introduced by Perrigo New York.

Strength Dosage Form Availability Application Pathway TE code Launch Date
650MG

suppository Over the counter RECTAL N/A Dec 1, 1986
120MG

suppository Over the counter RECTAL N/A Apr 6, 1987


Manufacturing Plant Locations
New

Perrigo New York'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 Perrigo New York as present at those locations.

Country City Firm Name
United States
Bronx Perrigo New York, Inc.





18. SANDOZ

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM/100ML (10MG/ML)

(reference standard)

solution Prescription INTRAVENOUS AP1 Mar 22, 2016


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





19. SUN PHARM INDS LTD

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
650MG

tablet, extended release Discontinued ORAL N/A Dec 14, 2011





20. WOCKHARDT BIO AG

Wockhardt Bio Ag has filed for 1 generic for Acetaminophen. Given below are the details of the strengths of this generic introduced by Wockhardt Bio Ag.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM/100ML (10MG/ML)

solution Prescription INTRAVENOUS AP1 Apr 18, 2023





21. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Acetaminophen. 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
1GM/100ML (10MG/ML)

solution Discontinued INTRAVENOUS N/A Oct 25, 2022