Methotrexate Sodium Patent Expiration

Methotrexate Sodium is Used for treating acute lymphoblastic leukemia and juvenile rheumatoid arthritis. It was first introduced by Strides Pharma Global Pte Ltd in its drug Methotrexate Sodium on Approved Prior to Jan 1, 1982. Other drugs containing Methotrexate Sodium are Methotrexate Preservative Free, Methotrexate Sodium Preservative Free, Methotrexate Lpf, Xatmep. 30 different companies have introduced drugs containing Methotrexate Sodium.


Methotrexate Sodium Patents

Given below is the list of patents protecting Methotrexate Sodium, 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
Xatmep US10231927 Methotrexate composition Jan 02, 2033 Azurity
Xatmep US10610485 Methotrexate composition Jan 02, 2033 Azurity
Xatmep US11116724 Methotrexate composition Jan 02, 2033 Azurity
Xatmep US11969503 Methotrexate composition Jan 02, 2033 Azurity
Xatmep US9259427 Methotrexate composition Jan 02, 2033 Azurity
Xatmep US9855215 Methotrexate composition Jan 02, 2033 Azurity



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 Methotrexate Sodium's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 12 Sep, 2023 US10610485
Payment of Maintenance Fee, 4th Year, Large Entity 05 Aug, 2022 US10231927
Patent Issue Date Used in PTA Calculation 14 Sep, 2021 US11116724
Recordation of Patent Grant Mailed 14 Sep, 2021 US11116724
Email Notification 26 Aug, 2021 US11116724
Issue Notification Mailed 25 Aug, 2021 US11116724
Dispatch to FDC 16 Aug, 2021 US11116724
Application Is Considered Ready for Issue 16 Aug, 2021 US11116724
Issue Fee Payment Received 10 Aug, 2021 US11116724
Issue Fee Payment Verified 10 Aug, 2021 US11116724


Methotrexate Sodium's Family Patents

Family Patents

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Methotrexate Sodium Generic API Manufacturers

Several generic applications have been filed for Methotrexate Sodium. The first generic version for Methotrexate Sodium was by Bristol Laboratories Inc Div Bristol Myers Co and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Alembic Pharmaceuticals Ltd and was approved on Jun 3, 2024.

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


1. ABIC

Abic Ltd has filed for 4 different strengths of generic version for Methotrexate Sodium. All of these versions come by the name ABITREXATE. Given below are the details of the strengths of this generic introduced by Abic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 25MG BASE/ML

injectable Discontinued INJECTION N/A Mar 10, 1987
EQ 50MG BASE/VIAL

injectable Discontinued INJECTION N/A Jul 17, 1987
EQ 250MG BASE/VIAL

injectable Discontinued INJECTION N/A Jul 17, 1987
EQ 100MG BASE/VIAL

injectable Discontinued INJECTION N/A Jul 17, 1987


Manufacturing Plant Locations
New

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

Country City Firm Name
Canada
Montreal Abich Inc
Israel
Netanya Abic Ltd.





2. ABRAXIS PHARM

Abraxis Pharmaceutical Products has filed for 5 different strengths of generic version for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Abraxis Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 20MG BASE/VIAL

injectable Discontinued INJECTION N/A Oct 11, 1985
EQ 50MG BASE/VIAL

injectable Discontinued INJECTION N/A Oct 11, 1985
EQ 100MG BASE/VIAL

injectable Discontinued INJECTION N/A Oct 11, 1985
EQ 25MG BASE/ML

injectable Discontinued INJECTION N/A Jun 13, 1986
EQ 2.5MG BASE/ML

injectable Discontinued INJECTION N/A Jun 13, 1986





3. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 4 different strengths of generic version for Methotrexate Sodium. Out of these eq 250mg base/10ml (eq 25mg base/ml) version comes by the name METHOTREXATE SODIUM PRESERVATIVE FREE, eq 50mg base/2ml (eq 25mg base/ml) version comes by the name METHOTREXATE SODIUM PRESERVATIVE FREE, eq 1gm base/40ml (eq 25mg base/ml) version comes by the name METHOTREXATE SODIUM PRESERVATIVE FREE. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)

(reference standard)

injectable Prescription INJECTION AP Apr 30, 2007
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)

(reference standard)

injectable Prescription INJECTION AP Apr 30, 2007
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

(reference standard)

injectable Prescription INJECTION AP Apr 30, 2007
EQ 2.5MG BASE

tablet Prescription ORAL AB Jan 24, 2020





4. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 1 generic for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2.5MG BASE

tablet Prescription ORAL AB Jun 3, 2024


Manufacturing Plant Locations
New

Alembic'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 Alembic as present at those locations.

Country City Firm Name
India
Vadodara Alembic Pharmaceuticals Ltd
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals, Ltd
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)





5. AMNEAL PHARMS

Amneal Pharmaceuticals Of New York Llc has filed for 1 generic for Methotrexate Sodium. 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 2.5MG BASE

tablet Discontinued ORAL N/A Dec 22, 2017





6. BARR

Barr Laboratories Inc has filed for 5 different strengths of generic version for Methotrexate Sodium. Out of these eq 7.5mg base version comes by the name TREXALL, eq 5mg base version comes by the name TREXALL, eq 10mg base version comes by the name TREXALL, eq 15mg base version comes by the name TREXALL. Given below are the details of the strengths of this generic introduced by Barr.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2.5MG BASE

tablet Prescription ORAL AB Oct 15, 1990
EQ 7.5MG BASE

tablet Prescription ORAL N/A Mar 21, 2001
EQ 5MG BASE

tablet Prescription ORAL N/A Mar 21, 2001
EQ 10MG BASE

tablet Prescription ORAL N/A Mar 21, 2001
EQ 15MG BASE

(reference standard)

tablet Prescription ORAL N/A Mar 21, 2001


Manufacturing Plant Locations
New

Barr's manufacturing plants are situated in 4 countries - Mexico, Singapore, United States, Philippines. Given below are the details of these plant locations as well as the firm names of Barr as present at those locations.

Country City Firm Name
Mexico
Aldama Barra La Coma, S. De R.L
Singapore
Singapore Barramundi Asia Pte Ltd
United States
Madison Barriques Holding Company, LLC
Buffalo Barrel and Brine Inc
Englewood Barrett E. Cowan, MD
Hereford Barrett and Crofoot Feedyard, West
Greenwood Barr Enterprises, Inc.
Lake Barrington Barrington Ventures, Ltd
Arecibo Barreto Dairy, Inc.
Live Oak Barrington Dairy Farm
Brainerd Barrett Ag Service, Inc.
Commerce Barreras Meat Co
Barrett Barrett Farm Supply, Inc.
Lee Barrington Coffee Roasting Company, Inc.
Belvidere Barred Woods, LLC
Paso Robles Barreto Cellars
Somerset Barrett Distribution Centers Inc
Franklin Barrett Distribution Centers, Inc.
Forest Barr Laboratories Inc.
Memphis Barrett Distribution Centers
Machipongo Barrier Island Seafood
Swartz Creek Barrett Donut Mixes, Inc..
Curtis Bay Barrett Distribution Center
Newton Barrett Technology, LLC
Dillon Barretts Minerals Inc
Davie Barrier Technologies LLC
Montezuma Barrington Dairies
Hereford Barrett and Crofoot, LLP
Harrison Barrington Chemical Corporation
Randolph Barrett Farm
Philippines
Bulacan Barrio Fiesta Manufacturing Corporation





7. BRISTOL

Bristol Laboratories Inc Div Bristol Myers Co has filed for 4 different strengths of generic version for Methotrexate Sodium. All of these versions come by the name MEXATE. Given below are the details of the strengths of this generic introduced by Bristol.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 250MG BASE/VIAL

injectable Discontinued INJECTION N/A Approved Prior to Jan 1, 1982
EQ 100MG BASE/VIAL

injectable Discontinued INJECTION N/A Approved Prior to Jan 1, 1982
EQ 50MG BASE/VIAL

injectable Discontinued INJECTION N/A Approved Prior to Jan 1, 1982
EQ 20MG BASE/VIAL

injectable Discontinued INJECTION N/A Approved Prior to Jan 1, 1982


Manufacturing Plant Locations
New

Bristol's manufacturing plants are situated in 4 countries - United States, Ireland, Mexico, United Kingdom. Given below are the details of these plant locations as well as the firm names of Bristol as present at those locations.

Country City Firm Name
United States
Princeton Bristol-Myers Squibb Company
Manati Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company
Princeton Bristol Myers Squibb
Wallingford Bristol-Myers Squibb Company
Catano Bristol Myers Squibb Pr
Boothbay Harbor Bristol Lobster Sales Inc.
Plainsboro Bristol Myers Squibb Company
Madison Bristol-Myers Squibb Company
Mayaguez Bristol Myers Squibb Caribbean Company
Louisville Bristol Commissary
Devens Bristol-Myers Squibb Company
Humacao Bristol-Myers Squibb Manufacturing Company Unlimited Company
New Brunswick Bristol-Myers Squibb Company
Portland Bristol Seafood, LLC
Mayaguez Bristol-Myers Squibb Manufacturing Company
Ireland
Mulhuddart, Dublin 15 Bristol-Myers Squibb Cruiserath Biologics
Mexico
Mexico D.F. Bristol - Myers Squibb De Mexico, S. De R.L. De C.V.
United Kingdom
Wirral Bristol-Myers Squibb Pharmaceuticals Limited





8. BRISTOL MYERS

Bristol Myers Co has filed for 1 generic for Methotrexate Sodium. This eq 25mg base/ml version comes by the name MEXATE-AQ. Given below are the details of the strengths of this generic introduced by Bristol Myers.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 25MG BASE/ML

injectable Discontinued INJECTION N/A Feb 14, 1985


Manufacturing Plant Locations
New

Bristol Myers'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 Bristol Myers as present at those locations.

Country City Firm Name
United States
Princeton Bristol Myers Squibb
Catano Bristol Myers Squibb Pr
Plainsboro Bristol Myers Squibb Company
Mayaguez Bristol Myers Squibb Caribbean Company





9. BRISTOL MYERS SQUIBB

Bristol Myers Squibb has filed for 1 generic for Methotrexate Sodium. This eq 25mg base/ml version comes by the name MEXATE-AQ PRESERVED. Given below are the details of the strengths of this generic introduced by Bristol Myers Squibb.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 25MG BASE/ML

injectable Discontinued INJECTION N/A Apr 14, 1989


Manufacturing Plant Locations
New

Bristol Myers Squibb'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 Bristol Myers Squibb as present at those locations.

Country City Firm Name
United States
Princeton Bristol Myers Squibb
Catano Bristol Myers Squibb Pr
Plainsboro Bristol Myers Squibb Company
Mayaguez Bristol Myers Squibb Caribbean Company





10. DAITO

Daito Pharmaceutical Co Ltd has filed for 1 generic for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Daito.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2.5MG BASE

tablet Prescription ORAL AB Aug 7, 2023


Manufacturing Plant Locations
New

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

Country City Firm Name
Japan
Toyama Daito Pharmaceutical Co., Ltd.
Bizen Daito Kasei Kogyo Co., Ltd.
Fukaya Daitoh Shokken Co. Ltd.





11. DURAMED PHARMS BARR

Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc has filed for 1 generic for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Duramed Pharms Barr.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2.5MG BASE

tablet Discontinued ORAL N/A Jun 17, 1999





12. ELITE LABS INC

Elite Laboratories Inc has filed for 1 generic for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Elite Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2.5MG BASE

tablet Prescription ORAL AB May 16, 2024





13. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 1 generic for Methotrexate Sodium. 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
EQ 2.5MG BASE

tablet Prescription ORAL AB Jan 30, 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





14. EUGIA PHARMA SPECLTS

Eugia Pharma Specialities Ltd has filed for 4 different strengths of generic version for Methotrexate Sodium. All of these versions come by the name METHOTREXATE SODIUM PRESERVATIVE FREE. Given below are the details of the strengths of this generic introduced by Eugia Pharma Speclts.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)

injectable Discontinued INJECTION N/A Mar 29, 2012
EQ 100MG BASE/4ML (EQ 25MG BASE/ML)

injectable Discontinued INJECTION N/A Mar 29, 2012
EQ 200MG BASE/8ML (EQ 25MG BASE/ML)

injectable Discontinued INJECTION N/A Mar 29, 2012
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)

injectable Discontinued INJECTION N/A Mar 29, 2012





15. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 4 different strengths of generic version for Methotrexate Sodium. Out of these eq 25mg base/ml version comes by the name METHOTREXATE PRESERVATIVE FREE, eq 1gm base/vial version comes by the name METHOTREXATE PRESERVATIVE FREE. 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
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)

(reference standard)

injectable Prescription INJECTION AP Feb 26, 1999
EQ 25MG BASE/ML

injectable Discontinued INJECTION N/A Feb 26, 1999
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)

injectable Discontinued INJECTION N/A Feb 26, 1999
EQ 1GM BASE/VIAL

injectable Prescription INJECTION AP Feb 26, 1999


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
Bensenville Fresenius Kabi USA LLC (FK USA)
Skokie Fresenius Kabi USA LLC
North Andover Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA LLC
Melrose Park Fresenius Kabi USA, LLC
Lake Zurich Fresenius Kabi USA, LLC
Wilson Fresenius Kabi USA, LLC
Grand Island Fresenius Kabi USA, LLC





16. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 6 different strengths of generic version for Methotrexate Sodium. Out of these eq 50mg base/2ml (eq 25mg base/ml) version comes by the name METHOTREXATE SODIUM PRESERVATIVE FREE, eq 250mg base/10ml (eq 25mg base/ml) version comes by the name METHOTREXATE SODIUM PRESERVATIVE FREE, eq 1gm base/vial version comes by the name METHOTREXATE SODIUM PRESERVATIVE FREE. 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 50MG BASE/2ML (EQ 25MG BASE/ML)

(reference standard)

injectable Prescription INJECTION AP Sep 16, 1986
EQ 200MG BASE/8ML (EQ 25MG BASE/ML)

(reference standard)

injectable Prescription INJECTION N/A Sep 16, 1986
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)

injectable Prescription INJECTION AP Sep 16, 1986
EQ 100MG BASE/4ML (EQ 25MG BASE/ML)

(reference standard)

injectable Prescription INJECTION AP Sep 16, 1986
EQ 2.5MG BASE

(reference standard)

tablet Prescription ORAL AB Aug 1, 1994
EQ 1GM BASE/VIAL

(reference standard)

injectable Prescription INJECTION AP Aug 12, 2005


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





17. LOTUS PHARM CO LTD

Lotus Pharmaceutical Co Ltd Nantou Plant has filed for 1 generic for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Lotus Pharm Co Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2.5MG BASE

tablet Discontinued ORAL N/A Apr 23, 2021





18. MYLAN

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2.5MG BASE

tablet Prescription ORAL AB May 15, 1992


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





19. NORBROOK

Norbrook Laboratories Ltd has filed for 1 generic for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Norbrook.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 25MG BASE/ML

injectable Discontinued INJECTION N/A May 9, 1986


Manufacturing Plant Locations
New

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

Country City Firm Name
United Kingdom
Newry Norbrook Laboratories Limited
Ireland
Monaghan Norbrook Manufacturing Limited





20. PHARMACHEMIE BV

Pharmachemie Bv has filed for 5 different strengths of generic version for Methotrexate Sodium. All of these versions come by the name METHOTREXATE SODIUM PRESERVATIVE FREE. Given below are the details of the strengths of this generic introduced by Pharmachemie Bv.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)

injectable Prescription INJECTION AP Jan 11, 2010
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)

injectable Prescription INJECTION AP Jan 11, 2010
EQ 250MG/10ML (EQ 25MG BASE/ML)

injectable Prescription INJECTION AP Jan 11, 2010
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

injectable Prescription INJECTION AP Jan 11, 2010
EQ 100MG BASE/4ML (EQ 25MG BASE/ML)

injectable Prescription INJECTION N/A Feb 27, 2012





21. PHARMACHEMIE USA

Pharmachemie Usa Inc has filed for 1 generic for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Pharmachemie Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 25MG BASE/ML

injectable Discontinued INJECTION N/A Jul 8, 1988





22. PHARMACIA AND UPJOHN

Pharmacia And Upjohn Co has filed for 5 different strengths of generic version for Methotrexate Sodium. Out of these eq 25mg base/vial version comes by the name FOLEX, eq 100mg base/vial version comes by the name FOLEX, eq 50mg base/vial version comes by the name FOLEX, eq 250mg base/vial version comes by the name FOLEX, eq 25mg base/ml version comes by the name FOLEX PFS. Given below are the details of the strengths of this generic introduced by Pharmacia And Upjohn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 25MG BASE/VIAL

injectable Discontinued INJECTION N/A Apr 8, 1983
EQ 100MG BASE/VIAL

injectable Discontinued INJECTION N/A Apr 8, 1983
EQ 50MG BASE/VIAL

injectable Discontinued INJECTION N/A Apr 8, 1983
EQ 250MG BASE/VIAL

injectable Discontinued INJECTION N/A Oct 24, 1985
EQ 25MG BASE/ML

injectable Discontinued INJECTION N/A Aug 23, 1991





23. RISING

Rising Pharma Holdings Inc has filed for 1 generic for Methotrexate Sodium. This eq 1gm base/40ml (eq 25mg base/ml) version comes by the name METHOTREXATE SODIUM PRESERVATIVE FREE. 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 1GM BASE/40ML (EQ 25MG BASE/ML)

injectable Discontinued INJECTION N/A Mar 29, 2012


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





24. SAGENT PHARMS INC

Sagent Pharmaceuticals Inc has filed for 3 different strengths of generic version for Methotrexate Sodium. All of these versions come by the name METHOTREXATE SODIUM PRESERVATIVE FREE. 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
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)

injectable Prescription INJECTION AP Aug 9, 2018
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)

injectable Prescription INJECTION AP Aug 9, 2018
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

injectable Prescription INJECTION AP Aug 9, 2018





25. SANDOZ

Sandoz Inc has filed for 3 different strengths of generic version for Methotrexate Sodium. All of these versions come by the name METHOTREXATE SODIUM PRESERVATIVE FREE. 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 50MG BASE/2ML (EQ 25MG BASE/ML)

injectable Prescription INJECTION AP Mar 31, 2009
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

injectable Prescription INJECTION AP Mar 31, 2009
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)

injectable Prescription INJECTION AP Mar 31, 2009


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
Les Franqueses Del Valles Sandoz Industrial Products S.A.
Palafolls Sandoz Industrial Products, S.A.
India
Navi Mumbai Sandoz Private Limited





26. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 1 generic for Methotrexate Sodium. 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 2.5MG BASE

tablet Prescription ORAL AB May 21, 2015


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





27. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Methotrexate Sodium. 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 2.5MG BASE

tablet Prescription ORAL AB Jan 13, 2017