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Melphalan Hydrochloride Patent Expiration

Melphalan Hydrochloride was first introduced by Apotex Inc in its drug Alkeran on Nov 18, 1992. Other drugs containing Melphalan Hydrochloride are Hepzato, Evomela, Ivra. 19 different companies have introduced drugs containing Melphalan Hydrochloride.


Melphalan Hydrochloride Patents

Given below is the list of patents protecting Melphalan Hydrochloride, 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
Ivra US10537520 Stable liquid formulations of melphalan Jun 29, 2036 Apotex
Hepzato US9707331 Apparatus for removing chemotherapy compounds from blood Sep 17, 2034 Delcath Systems Inc
Hepzato US9314561 Filter and frame apparatus and method of use Feb 07, 2034 Delcath Systems Inc
Evomela US10040872 Alkylated cyclodextrin compositions and processes for preparing and using the same Jan 30, 2034 Acrotech Biopharma
Evomela US9493582 Alkylated cyclodextrin compositions and processes for preparing and using the same Feb 27, 2033 Acrotech Biopharma
Hepzato US10195334 Filter and frame apparatus and method of use Jan 16, 2033 Delcath Systems Inc
Hepzato US11083831 Filter and frame apparatus and method of use Dec 30, 2032 Delcath Systems Inc
Hepzato US11833286 Filter and frame apparatus and method of use Dec 30, 2032 Delcath Systems Inc
Hepzato US10098997 Apparatus for removing chemotherapy compounds from blood Nov 07, 2032 Delcath Systems Inc
Hepzato US10369264 Apparatus for removing chemotherapy compounds from blood Nov 07, 2032 Delcath Systems Inc
Hepzato US10569004 Apparatus for removing chemotherapy compounds from blood Nov 07, 2032 Delcath Systems Inc
Hepzato US11241522 Apparatus for removing chemotherapy compounds from blood Nov 07, 2032 Delcath Systems Inc
Hepzato US11633528 Apparatus for removing chemotherapy compounds from blood Nov 07, 2032 Delcath Systems Inc
Evomela US10940128 Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same Jun 14, 2030 Acrotech Biopharma
Evomela US10864183 Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same May 28, 2030 Acrotech Biopharma
Evomela US11020363 Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same May 28, 2030 Acrotech Biopharma
Evomela US8410077 Sulfoalkyl ether cyclodextrin compositions Mar 13, 2029 Acrotech Biopharma
Evomela US9200088 Sulfoalkyl ether cyclodextrin compositions Mar 13, 2029 Acrotech Biopharma



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 Melphalan Hydrochloride's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Yr, Small Entity 23 Jan, 2023 US10537520
Post Issue Communication - Certificate of Correction 31 Jan, 2020 US10537520
Recordation of Patent Grant Mailed
Critical
 21 Jan, 2020 US10537520
Patent Issue Date Used in PTA Calculation
Critical
 21 Jan, 2020 US10537520
Issue Notification Mailed
Critical
 01 Jan, 2020 US10537520
Dispatch to FDC 16 Dec, 2019 US10537520
Application Is Considered Ready for Issue
Critical
 16 Dec, 2019 US10537520
Issue Fee Payment Received
Critical
 03 Dec, 2019 US10537520
Issue Fee Payment Verified
Critical
 03 Dec, 2019 US10537520
Printer Rush- No mailing 02 Dec, 2019 US10537520


Melphalan Hydrochloride's Family Patents

Family Patents

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Melphalan Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Melphalan Hydrochloride. The first generic version for Melphalan Hydrochloride was by Mylan Institutional Llc and was approved on Jun 9, 2009. And the latest generic version is by Avet Lifesciences Private Ltd and was approved on Oct 29, 2024.

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


1. ACTAVIS LLC

Actavis Llc has filed for 1 generic for Melphalan Hydrochloride. Given below are the details of the strengths of this generic introduced by Actavis Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 50MG BASE/VIAL

powder Discontinued INTRAVENOUS N/A Mar 6, 2020


Manufacturing Plant Locations
New

Actavis Llc'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 Actavis Llc as present at those locations.

Country City Firm Name
United States
Edison Actavis LLC





2. ALMAJECT

Almaject Inc has filed for 1 generic for Melphalan Hydrochloride. Given below are the details of the strengths of this generic introduced by Almaject.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 50MG BASE/VIAL

injectable Prescription INJECTION AP May 17, 2019





3. ARTHUR GRP

Arthur Group Llc has filed for 1 generic for Melphalan Hydrochloride. Given below are the details of the strengths of this generic introduced by Arthur Grp.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 50MG BASE/VIAL

injectable Prescription INJECTION AP Sep 13, 2019





4. AVET LIFESCIENCES

Avet Lifesciences Private Ltd has filed for 1 generic for Melphalan Hydrochloride. Given below are the details of the strengths of this generic introduced by Avet Lifesciences.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 50MG BASE/VIAL

injectable Prescription INJECTION AP Oct 29, 2024





5. BPI LABS

Bpi Labs Llc has filed for 1 generic for Melphalan Hydrochloride. Given below are the details of the strengths of this generic introduced by Bpi Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 50MG BASE/VIAL

injectable Prescription INJECTION AP May 8, 2020


Manufacturing Plant Locations
New

Bpi Labs'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 Bpi Labs as present at those locations.

Country City Firm Name
United States
Evanston BPI Labs





6. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 1 generic for Melphalan Hydrochloride. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 50MG BASE/VIAL

injectable Prescription INJECTION AP Dec 8, 2017





7. ENDO OPERATIONS

Endo Operations Ltd has filed for 1 generic for Melphalan Hydrochloride. Given below are the details of the strengths of this generic introduced by Endo Operations.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 50MG BASE/VIAL

injectable Discontinued INJECTION N/A Aug 22, 2016





8. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 1 generic for Melphalan Hydrochloride. 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/VIAL

injectable Prescription INJECTION AP Dec 22, 2017


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





9. GLAND PHARMA LTD

Gland Pharma Ltd has filed for 1 generic for Melphalan Hydrochloride. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 50MG BASE/VIAL

injectable Prescription INJECTION AP May 28, 2019





10. HETERO LABS

Hetero Labs Ltd has filed for 1 generic for Melphalan Hydrochloride. Given below are the details of the strengths of this generic introduced by Hetero Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 50MG BASE/VIAL

injectable Prescription INJECTION AP May 23, 2024


Manufacturing Plant Locations
New

Hetero Labs'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 Hetero Labs as present at those locations.

Country City Firm Name
India
Visakhapatnam Hetero Labs Ltd. - Unit IX
Mahabubnagar Hetero Labs Limited (Unit V)
Sangareddy Hetero Labs Limited
Mahaboob Nagar Hetero Labs Ltd. Unit VI
Sanath Nagar Hetero Labs Ltd
Hyderabad Hetero Labs Limited - Unit III
Bodugallam Hetero Labs Limited (Unit III)





11. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Melphalan Hydrochloride. 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/VIAL

injectable Prescription INJECTION AP Oct 28, 2010


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





12. INGENUS PHARMS LLC

Ingenus Pharmaceuticals Llc has filed for 1 generic for Melphalan Hydrochloride. Given below are the details of the strengths of this generic introduced by Ingenus Pharms Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 50MG BASE/VIAL

injectable Prescription INJECTION AP Feb 18, 2020





13. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 1 generic for Melphalan Hydrochloride. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 50MG BASE/VIAL

injectable Prescription INJECTION AP May 28, 2021





14. MYLAN INSTITUTIONAL

Mylan Institutional Llc has filed for 1 generic for Melphalan Hydrochloride. Given below are the details of the strengths of this generic introduced by Mylan Institutional.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 50MG BASE/VIAL

injectable Discontinued INJECTION N/A Oct 27, 2009


Manufacturing Plant Locations
New

Mylan Institutional'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 Mylan Institutional as present at those locations.

Country City Firm Name
United States
Rockford Mylan Institutional, Inc.





15. SAGENT PHARMS INC

Sagent Pharmaceuticals Inc has filed for 1 generic for Melphalan Hydrochloride. 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/VIAL

injectable Prescription INJECTION AP Feb 28, 2017





16. USWM

Uswm Llc has filed for 1 generic for Melphalan Hydrochloride. Given below are the details of the strengths of this generic introduced by Uswm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 50MG BASE/VIAL

injectable Discontinued INJECTION N/A May 3, 2019