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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 in its drug Mucomyst on Approved Prior to Jan 1, 1982. Other drugs containing Acetylcysteine are Acetadote, Cetylev. 18 different companies have introduced drugs containing Acetylcysteine.


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 US8952065 Acetylcysteine composition and uses thereof Feb 10, 2035 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
Acetadote US8722738 Acetycysteine compositions and methods of use thereof Apr 06, 2032 Cumberland Pharms
Acetadote US9327028 Acetylcysteine compositions and methods of use thereof Jul 21, 2031 Cumberland Pharms
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



Acetylcysteine's Family Patents

Family Patents

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Acetylcysteine Generic API Manufacturers

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, along with the locations of their manufacturing plants worldwide.


1. 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


Manufacturing Plant Locations
New

Alvogen'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 Alvogen as present at those locations.

Country City Firm Name
United States
Morristown Alvogen, Inc





2. 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





3. 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


Manufacturing Plant Locations
New

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

Country City Firm Name
China
Jingzhou DEYAN AQUATIC PRODUCTS & FOOD CO., LTD
United States
Plainwell DeYoung Pork, Inc.
Moss Landing Deyerle Brothers Seafood Inc, dba Sea Harvest
Czech Republic
Hronov Deymed Diagnostic SRO





4. 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


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
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Riico Industrial Area EUGIA Pharma Specialities Limited
Pashamylaram Eugia Pharma Specialities Limited





5. 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


Manufacturing Plant Locations
New

Exela 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 Exela Pharma as present at those locations.

Country City Firm Name
United States
Lenoir Exela Pharma Sciences LLC





6. 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


Manufacturing Plant Locations
New

Fresenius Kabi Usa'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 Fresenius Kabi Usa as present at those locations.

Country City Firm Name
United States
Melrose Park Fresenius Kabi USA LLC
Grand Island Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA, LLC
Lake Zurich Fresenius Kabi USA, LLC
Bensenville Fresenius Kabi USA LLC (FK USA)
Skokie Fresenius Kabi USA LLC
North Andover Fresenius Kabi USA, LLC
Wilson Fresenius Kabi USA, LLC





7. GLENMARK PHARMS INC

Glenmark Pharmaceuticals Inc Usa has filed for 1 generic for Acetylcysteine. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6GM/30ML (200MG/ML)

injectable Prescription INTRAVENOUS AP Feb 3, 2022





8. 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


Manufacturing Plant Locations
New

Hospira's manufacturing plants are situated in 3 countries - Australia, United States, Dominican Republic (the). Given below are the details of these plant locations as well as the firm names of Hospira as present at those locations.

Country City Firm Name
Australia
Mulgrave Hospira Australia Pty Ltd.
United States
Pleasant Prairie Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Clayton Hospira, Inc.
Morgan Hill Hospira Inc
Rocky Mount Hospira, Inc.
Lake Forest Hospira Inc
Mcpherson Hospira, Inc., A Pfizer Company
Dominican Republic (the)
Haina, San Cristobal Hospira, Ltd.





9. 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


Manufacturing Plant Locations
New

Indoco'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 Indoco as present at those locations.

Country City Firm Name
India
Verna Indoco Remedies Limited (Plant I)
Taluka Khalapur, District Raigad Indoco Remedies Limited
Verna Indoco Remedies Limited
Navi Mumbai Indoco Remedies Limited





10. 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


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





11. 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





12. 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





13. 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





14. STERISCIENCE SPECLTS

Steriscience Specialities Pte Ltd has filed for 1 generic for Acetylcysteine. Given below are the details of the strengths of this generic introduced by Steriscience Speclts.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6GM/30ML (200MG/ML)

injectable Prescription INTRAVENOUS AP Apr 19, 2023





15. 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