Fingolimod Hydrochloride Patent Expiration
Fingolimod Hydrochloride is Used for treating autoimmune diseases and multiple sclerosis, including relapsing-remitting and pediatric patients. It was first introduced by Novartis Pharmaceuticals Corp
Fingolimod Hydrochloride Patents
Given below is the list of patents protecting Fingolimod 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 |
|---|---|---|---|---|
| Gilenya |
US9592208 (Pediatric) | Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol | Sep 30, 2032 | Novartis |
| Gilenya | US9592208 | Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol | Mar 30, 2032 | Novartis |
| Gilenya | US10543179 | Dosage regimen of an S1P receptor modulator | Dec 25, 2027 | Novartis |
| Gilenya |
US9187405 (Pediatric) | S1P receptor modulators for treating relasping-remitting multiple sclerosis | Dec 25, 2027 | Novartis |
| Gilenya | US9187405 | S1P receptor modulators for treating relasping-remitting multiple sclerosis | Jun 25, 2027 | Novartis |
| Gilenya |
US8324283 (Pediatric) | Solid pharmaceutical compositions comprising a SIP receptor agonist and a sugar alcohol | Sep 29, 2026 | Novartis |
| Gilenya | US8324283 | Solid pharmaceutical compositions comprising a SIP receptor agonist and a sugar alcohol | Mar 29, 2026 | Novartis |
| Gilenya |
US5604229 (Pediatric) | 2-amino-1,3-propanediol compound and immunosuppressant |
Aug 18, 2019
(Expired) | Novartis |
| Gilenya | US5604229 | 2-amino-1,3-propanediol compound and immunosuppressant |
Feb 18, 2019
(Expired) | Novartis |
| Gilenya | US6004565 | Compositions and methods of using compositions with accelerated lymphocyte homing immunosuppressive properties |
Sep 23, 2017
(Expired) | Novartis |
| Gilenya | US5604229 | 2-amino-1,3-propanediol compound and immunosuppressant |
Feb 18, 2014
(Expired) | Novartis |
Fingolimod Hydrochloride's Family Patents
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Fingolimod Hydrochloride Generic API Manufacturers
Several generic applications have been filed for Fingolimod Hydrochloride. The first generic version for Fingolimod Hydrochloride was by Biocon Ltd and was approved on Dec 4, 2019. And the latest generic version is by Aurobindo Pharma Ltd and was approved on Feb 28, 2024.
Given below is the list of companies who have filed for Fingolimod Hydrochloride generic, along with the locations of their manufacturing plants worldwide.
1. ACCORD HLTHCARE
Accord Healthcare Inc has filed for 1 generic for Fingolimod Hydrochloride. 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 0.5MG BASE | capsule | Prescription | ORAL | AB | Oct 28, 2020 |
2. ALKEM LABS LTD
Alkem Laboratories Ltd has filed for 1 generic for Fingolimod Hydrochloride. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.5MG BASE | capsule | Prescription | ORAL | AB | Dec 30, 2020 |
3. APOTEX
Apotex Inc has filed for 1 generic for Fingolimod Hydrochloride. Given below are the details of the strengths of this generic introduced by Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.5MG BASE | capsule | Prescription | ORAL | AB | Dec 18, 2020 |
Manufacturing Plant Locations New
Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.
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| United States |
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| Canada |
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| India |
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4. AUROBINDO PHARMA LTD
Aurobindo Pharma Ltd has filed for 1 generic for Fingolimod Hydrochloride. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.5MG BASE | capsule | Prescription | ORAL | AB | Feb 28, 2024 |
Manufacturing Plant Locations New
Aurobindo Pharma Ltd'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 Aurobindo Pharma Ltd as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
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5. BIOCON LTD
Biocon Ltd has filed for 1 generic for Fingolimod Hydrochloride. Given below are the details of the strengths of this generic introduced by Biocon Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.5MG BASE | capsule | Prescription | ORAL | AB | Dec 4, 2019 |
6. BIONPHARMA
Bionpharma Inc has filed for 1 generic for Fingolimod Hydrochloride. Given below are the details of the strengths of this generic introduced by Bionpharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.5MG BASE | capsule | Prescription | ORAL | AB | May 24, 2023 |
Manufacturing Plant Locations New
Bionpharma'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 Bionpharma as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
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7. CHARTWELL RX
Chartwell Rx Sciences Llc has filed for 1 generic for Fingolimod Hydrochloride. Given below are the details of the strengths of this generic introduced by Chartwell Rx.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.5MG BASE | capsule | Discontinued | ORAL | N/A | Jun 29, 2020 |
8. DR REDDYS
Dr Reddys Laboratories Ltd has filed for 1 generic for Fingolimod 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 0.5MG BASE | capsule | Prescription | ORAL | AB | Mar 5, 2021 |
9. EZRA VENTURES
Ezra Ventures Llc has filed for 1 generic for Fingolimod Hydrochloride. Given below are the details of the strengths of this generic introduced by Ezra Ventures.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.5MG BASE | capsule | Prescription | ORAL | AB | Dec 6, 2023 |
10. GLENMARK PHARMS LTD
Glenmark Pharmaceuticals Ltd has filed for 1 generic for Fingolimod Hydrochloride. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.5MG BASE | capsule | Prescription | ORAL | AB | Jun 18, 2020 |
11. HEC PHARM CO LTD
Hec Pharm Co Ltd has filed for 1 generic for Fingolimod Hydrochloride. Given below are the details of the strengths of this generic introduced by Hec Pharm Co Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.5MG BASE | capsule | Prescription | ORAL | AB | Nov 10, 2021 |
12. HETERO LABS LTD V
Hetero Labs Ltd Unit V has filed for 1 generic for Fingolimod Hydrochloride. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.5MG BASE | capsule | Prescription | ORAL | AB | May 18, 2020 |
13. MYLAN
Mylan Pharmaceuticals Inc has filed for 1 generic for Fingolimod Hydrochloride. 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 0.5MG BASE | capsule | Prescription | ORAL | AB | Jan 19, 2021 |
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.
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| United States |
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| India |
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| Canada |
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| Ireland |
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14. PRINSTON INC
Prinston Pharmaceutical Inc has filed for 1 generic for Fingolimod Hydrochloride. Given below are the details of the strengths of this generic introduced by Prinston Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.5MG BASE | capsule | Prescription | ORAL | AB | Sep 7, 2022 |
15. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 1 generic for Fingolimod Hydrochloride. 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 0.5MG BASE | capsule | Discontinued | ORAL | N/A | Dec 4, 2019 |
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 | ||||||||||||||||||||||||||||
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| United States |
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| India |
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16. TEVA PHARMS USA
Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Fingolimod Hydrochloride. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.5MG BASE | capsule | Prescription | ORAL | AB | Jul 2, 2020 |
| EQ 0.25MG BASE | capsule | Discontinued | ORAL | N/A | Nov 12, 2021 |
17. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Fingolimod Hydrochloride. 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 0.5MG BASE | capsule | Prescription | ORAL | AB | Oct 14, 2020 |