Acetylcysteine Patent Expiration
Acetylcysteine is Used for treating acetaminophen overdose with acetylcysteine solutions to provide a reduction in side effects for human patients. It was first introduced by Apothecon Inc Div Bristol Myers Squibb
Acetylcysteine Patents
Given below is the list of patents protecting Acetylcysteine, 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 |
|---|---|---|---|---|
| Acetadote | US8148356 | Acetylcysteine composition and uses therefor | May 21, 2026 | Cumberland Pharms |
| Acetadote | US8399445 | Acetylcysteine composition and uses thereof | Aug 24, 2025 | Cumberland Pharms |
| Acetadote | US8653061 | Acetylcysteine composition and uses thereof | Aug 24, 2025 | Cumberland Pharms |
| Acetadote | US8722738 | Acetycysteine compositions and methods of use thereof | Apr 06, 2032 | Cumberland Pharms |
| Acetadote | US8952065 | Acetylcysteine composition and uses thereof | Feb 10, 2035 | Cumberland Pharms |
| Acetadote | US9327028 | Acetylcysteine compositions and methods of use thereof | Jul 21, 2031 | Cumberland Pharms |
| Cetylev | US8747894 | Effervescent compositions containing N-acetylcysteine | May 08, 2032 | Arbor Pharms Llc |
| Cetylev | US9427421 | Effervescent compositions containing N-acetylcysteine | May 08, 2032 | Arbor Pharms Llc |
| Cetylev | US9561204 | Effervescent compositions containing N-acetylcysteine | May 08, 2032 | Arbor Pharms Llc |
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Acetylcysteine Generics
Several generic applications have been filed for Acetylcysteine. The first generic version for Acetylcysteine was by Dey Lp and was approved on Oct 14, 1986. And the latest generic version is by Somerset Therapeutics Llc and was approved on Jun 7, 2024.
Given below is the list of companies who have filed for Acetylcysteine generic.
1. RISING
Rising Pharma Holdings Inc has filed for 1 generic for Acetylcysteine. Given below are the details of the strengths of this generic introduced by Rising.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 6GM/30ML (200MG/ML) | injectable | Discontinued | INTRAVENOUS | N/A | Jun 19, 2015 |
2. ROXANE
Roxane Laboratories Inc has filed for 2 different strengths of generic version for Acetylcysteine. Given below are the details of the strengths of this generic introduced by Roxane.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10% | solution | Discontinued | INHALATION, ORAL | N/A | Sep 30, 1992 |
| 20% | solution | Discontinued | INHALATION, ORAL | N/A | Sep 30, 1992 |
3. STERISCIENCE
Steriscience Pte Ltd has filed for 1 generic for Acetylcysteine. Given below are the details of the strengths of this generic introduced by Steriscience.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 6GM/30ML (200MG/ML) | injectable | Prescription | INTRAVENOUS | AP | Apr 19, 2023 |
4. HOSPIRA
Hospira Inc has filed for 2 different strengths of generic version for Acetylcysteine. Given below are the details of the strengths of this generic introduced by Hospira.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 20% | solution | Prescription | INHALATION, ORAL | AN | Aug 30, 1994 |
| 10% | solution | Prescription | INHALATION, ORAL | AN | Aug 30, 1994 |
5. AM REGENT
American Regent Inc has filed for 2 different strengths of generic version for Acetylcysteine. Given below are the details of the strengths of this generic introduced by Am Regent.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 20%
(reference standard) | solution | Prescription | INHALATION, ORAL | AN | Jul 28, 1995 |
| 10%
(reference standard) | solution | Prescription | INHALATION, ORAL | AN | Jul 28, 1995 |
6. DEY
Dey Lp has filed for 2 different strengths of generic version for Acetylcysteine. Out of these 10% version comes by the name MUCOSIL-10, 20% version comes by the name MUCOSIL-20. Given below are the details of the strengths of this generic introduced by Dey.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10% | solution | Discontinued | INHALATION, ORAL | N/A | Oct 14, 1986 |
| 20% | solution | Discontinued | INHALATION, ORAL | N/A | Oct 14, 1986 |
7. EXELA PHARMA
Exela Pharma Sciences Llc has filed for 2 different strengths of generic version for Acetylcysteine. Given below are the details of the strengths of this generic introduced by Exela Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 6GM/30ML (200MG/ML) | injectable | Discontinued | INTRAVENOUS | N/A | Apr 15, 2021 |
| 20% | solution | Discontinued | INHALATION, ORAL | N/A | Nov 1, 2023 |
8. INDOCO
Indoco Remedies Ltd has filed for 1 generic for Acetylcysteine. Given below are the details of the strengths of this generic introduced by Indoco.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 6GM/30ML (200MG/ML) | injectable | Prescription | INTRAVENOUS | AP | Feb 23, 2022 |
9. ALVOGEN
Alvogen Inc has filed for 2 different strengths of generic version for Acetylcysteine. Given below are the details of the strengths of this generic introduced by Alvogen.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 20% | solution | Prescription | INHALATION, ORAL | AN | Jun 21, 2012 |
| 10% | solution | Prescription | INHALATION, ORAL | AN | Feb 11, 2014 |
10. EUGIA PHARMA
Eugia Pharma Specialities Ltd has filed for 1 generic for Acetylcysteine. 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 |
|---|---|---|---|---|---|
| 6GM/30ML (200MG/ML) | injectable | Prescription | INTRAVENOUS | AP | Feb 29, 2016 |
11. SOMERSET THERAPS LLC
Somerset Therapeutics Llc has filed for 1 generic for Acetylcysteine. Given below are the details of the strengths of this generic introduced by Somerset Theraps Llc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 6GM/30ML (200MG/ML) | injectable | Prescription | INTRAVENOUS | AP | Jun 7, 2024 |
12. FRESENIUS KABI USA
Fresenius Kabi Usa Llc has filed for 1 generic for Acetylcysteine. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 6GM/30ML (200MG/ML) | injectable | Prescription | INTRAVENOUS | AP | Nov 7, 2012 |
13. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Acetylcysteine. 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 |
|---|---|---|---|---|---|
| 6GM/30ML (200MG/ML) | injectable | Prescription | INTRAVENOUS | AP | Jul 20, 2018 |
14. SAGENT PHARMS INC
Sagent Pharmaceuticals Inc has filed for 1 generic for Acetylcysteine. Given below are the details of the strengths of this generic introduced by Sagent Pharms Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 6GM/30ML (200MG/ML) | injectable | Prescription | INTRAVENOUS | AP | Oct 31, 2017 |
15. ASPEN
Aspen Pharma Usa Inc has filed for 1 generic for Acetylcysteine. Given below are the details of the strengths of this generic introduced by Aspen.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 6GM/30ML (200MG/ML) | injectable | Prescription | INTRAVENOUS | AP | Feb 3, 2022 |