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, Acetaminophen, Neopap, Ofirmev, Acephen, Infants' Feverall. 28 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
Acetaminophen US8741959 Paracetamol for parenteral administration Apr 19, 2030 Fresenius Kabi Usa
Ofirmev US10383834 Reduced dose intravenous acetaminophen Nov 13, 2028 Mallinckrodt Hosp
Ofirmev US6028222 Stable liquid paracetamol compositions, and method for preparing same Aug 05, 2017

(Expired)

Mallinckrodt Hosp
Ofirmev US6028222

(Pediatric)

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

(Expired)

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

(Expired)

Mallinckrodt Hosp
Ofirmev US6992218

(Pediatric)

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

(Expired)

Mallinckrodt Hosp
Ofirmev US9399012 Reduced dose intravenous acetaminophen Sep 11, 2031 Mallinckrodt Hosp
Ofirmev US9399012

(Pediatric)

Reduced dose intravenous acetaminophen Mar 11, 2032 Mallinckrodt Hosp
Ofirmev US9610265 Reduced dose intravenous acetaminophen Nov 13, 2028 Mallinckrodt Hosp
Ofirmev US9610265

(Pediatric)

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

(Pediatric)

Reduced dose intravenous acetaminophen May 13, 2029 Mallinckrodt Hosp


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Acetaminophen Generics

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 Inforlife Sa and was approved on May 3, 2023.

Given below is the list of companies who have filed for Acetaminophen generic.


1. 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 AP Apr 18, 2023


2. 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 AP Aug 7, 2020


3. 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


4. 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


5. 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
650MG suppository Discontinued RECTAL N/A Feb 27, 1995
120MG suppository Discontinued RECTAL N/A Feb 27, 1995
325MG suppository Discontinued RECTAL N/A Feb 27, 1995


6. 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 AP May 3, 2023


7. 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


8. 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


9. 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 Over the counter ORAL N/A Dec 14, 2011


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


11. 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 AP Mar 22, 2016


12. 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


13. 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


14. 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 AP Sep 17, 2021


15. 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 AP Jun 13, 2016


16. 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


17. 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 AP Oct 21, 2020


18. 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 AP Jul 27, 2022


19. 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


20. 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