Niacin Patent Expiration
Niacin is Used for treating hyperlipidemia by dosing once daily in the evening or at night to reduce elevated total cholesterol, LDL cholesterol, and triglyceride levels, and increase HDL cholesterol levels. It was first introduced by Medpointe Pharmaceuticals Medpointe Healthcare Inc
Niacin Patents
Given below is the list of patents protecting Niacin, 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 |
|---|---|---|---|---|
| Niaspan | US6469035 | Methods of pretreating hyperlipidemic individuals with a flush inhibiting agent prior to the start of single daily dose nicotinic acid therapy to reduce flushing provoked by nicotinic acid |
Mar 15, 2018
(Expired) | Abbvie |
| Niaspan | US6080428 | Nicotinic acid compositions for treating hyperlipidemia and related methods therefor |
May 27, 2017
(Expired) | Abbvie |
| Niaspan Titration Starter Pack | US6080428 | Nicotinic acid compositions for treating hyperlipidemia and related methods therefor |
May 27, 2017
(Expired) | Abbvie |
| Niaspan | US6818229 | Intermediate release nicotinic acid compositions for treating hyperlipidemia |
Feb 15, 2014
(Expired) | Abbvie |
| Niaspan | US6129930 | Methods and sustained release nicotinic acid compositions for treating hyperlipidemia at night |
Sep 20, 2013
(Expired) | Abbvie |
| Niaspan | US6406715 | Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique urinary metabolite profiles |
Sep 20, 2013
(Expired) | Abbvie |
| Niaspan | US6676967 | Methods for reducing flushing in individuals being treated with nicotinic acid for hyperlipidemia |
Sep 20, 2013
(Expired) | Abbvie |
| Niaspan | US6746691 | Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics |
Sep 20, 2013
(Expired) | Abbvie |
| Niaspan | US6818229 | Intermediate release nicotinic acid compositions for treating hyperlipidemia |
Sep 20, 2013
(Expired) | Abbvie |
| Niaspan | US7011848 | Hydrophobic component free sustained release nicotinic acid compositions for treating hyperlipidemia and related methods therefor |
Sep 20, 2013
(Expired) | Abbvie |
| Niaspan | US7998506 | Nicotinic acid compositions for treating hyperlipidemia and related methods therefor |
Sep 20, 2013
(Expired) | Abbvie |
| Niaspan Titration Starter Pack | US6129930 | Methods and sustained release nicotinic acid compositions for treating hyperlipidemia at night |
Sep 20, 2013
(Expired) | Abbvie |
| Niaspan Titration Starter Pack | US6406715 | Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique urinary metabolite profiles |
Sep 20, 2013
(Expired) | Abbvie |
| Niaspan Titration Starter Pack | US6746691 | Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics |
Sep 20, 2013
(Expired) | Abbvie |
| Niaspan Titration Starter Pack | US7011848 | Hydrophobic component free sustained release nicotinic acid compositions for treating hyperlipidemia and related methods therefor |
Sep 20, 2013
(Expired) | Abbvie |
Niacin's Family Patents
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Niacin Generic API Manufacturers
Several generic applications have been filed for Niacin. The first generic version for Niacin was by Impax Laboratories Inc and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Hibrow Healthcare Private Ltd and was approved on Aug 25, 2023.
Given below is the list of companies who have filed for Niacin generic, along with the locations of their manufacturing plants worldwide.
1. AMNEAL PHARMS
Amneal Pharmaceuticals has filed for 3 different strengths of generic version for Niacin. 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 |
|---|---|---|---|---|---|
| 500MG | tablet, extended release | Prescription | ORAL | AB | Jul 24, 2015 |
| 1GM | tablet, extended release | Prescription | ORAL | AB | Jul 24, 2015 |
| 750MG | tablet, extended release | Prescription | ORAL | AB | Dec 11, 2015 |
2. AUROBINDO PHARMA LTD
Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Niacin. 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 |
|---|---|---|---|---|---|
| 750MG | tablet, extended release | Prescription | ORAL | AB | Feb 1, 2018 |
| 500MG | tablet, extended release | Prescription | ORAL | AB | Feb 1, 2018 |
| 1GM | tablet, extended release | Prescription | ORAL | AB | Feb 1, 2018 |
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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3. AVONDALE PHARMS
Avondale Pharmaceuticals Llc has filed for 1 generic for Niacin. This 500mg version comes by the name NIACOR. Given below are the details of the strengths of this generic introduced by Avondale Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG
(reference standard) | tablet | Prescription | ORAL | N/A | May 3, 2000 |
4. BARR
Barr Laboratories Inc has filed for 3 different strengths of generic version for Niacin. Given below are the details of the strengths of this generic introduced by Barr.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1GM | tablet, extended release | Prescription | ORAL | AB | Apr 14, 2005 |
| 750MG | tablet, extended release | Prescription | ORAL | AB | Apr 26, 2005 |
| 500MG | tablet, extended release | Prescription | ORAL | AB | Apr 26, 2005 |
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.
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| Singapore |
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| United States |
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| Philippines |
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5. BEIJING
Beijing Sciecure Pharmaceutical Co Ltd has filed for 2 different strengths of generic version for Niacin. Given below are the details of the strengths of this generic introduced by Beijing.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet, extended release | Discontinued | ORAL | N/A | Nov 22, 2021 |
| 1GM | tablet, extended release | Discontinued | ORAL | N/A | Nov 22, 2021 |
Manufacturing Plant Locations New
Beijing's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Beijing as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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6. CHARTWELL RX
Chartwell Rx Sciences Llc has filed for 3 different strengths of generic version for Niacin. 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 |
|---|---|---|---|---|---|
| 750MG | tablet, extended release | Prescription | ORAL | AB | Mar 20, 2014 |
| 1GM | tablet, extended release | Prescription | ORAL | AB | Mar 20, 2014 |
| 500MG | tablet, extended release | Prescription | ORAL | AB | Mar 20, 2014 |
7. EVERYLIFE
Everylife has filed for 1 generic for Niacin. Given below are the details of the strengths of this generic introduced by Everylife.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Discontinued | ORAL | N/A | Approved Prior to Jan 1, 1982 |
8. HALSEY
Halsey Drug Co Inc has filed for 1 generic for Niacin. Given below are the details of the strengths of this generic introduced by Halsey.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Discontinued | ORAL | N/A | Approved Prior to Jan 1, 1982 |
Manufacturing Plant Locations New
Halsey'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 Halsey as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
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9. HIBROW HLTHCARE
Hibrow Healthcare Private Ltd has filed for 3 different strengths of generic version for Niacin. Given below are the details of the strengths of this generic introduced by Hibrow Hlthcare.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet, extended release | Prescription | ORAL | AB | Aug 25, 2023 |
| 750MG | tablet, extended release | Prescription | ORAL | AB | Aug 25, 2023 |
| 1GM | tablet, extended release | Prescription | ORAL | AB | Aug 25, 2023 |
10. HIKMA
Hikma Pharmaceuticals Llc has filed for 1 generic for Niacin. Given below are the details of the strengths of this generic introduced by Hikma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Discontinued | ORAL | N/A | Approved Prior to Jan 1, 1982 |
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 |
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| Portugal |
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| Jordan |
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11. IMPAX LABS
Impax Laboratories Inc has filed for 1 generic for Niacin. Given below are the details of the strengths of this generic introduced by Impax Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Discontinued | ORAL | N/A | Approved Prior to Jan 1, 1982 |
12. IVAX SUB TEVA PHARMS
Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa has filed for 1 generic for Niacin. Given below are the details of the strengths of this generic introduced by Ivax Sub Teva Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Discontinued | ORAL | N/A | Approved Prior to Jan 1, 1982 |
13. JUBILANT GENERICS
Jubilant Generics Ltd has filed for 3 different strengths of generic version for Niacin. Given below are the details of the strengths of this generic introduced by Jubilant Generics.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1GM | tablet, extended release | Discontinued | ORAL | N/A | May 14, 2018 |
| 500MG | tablet, extended release | Discontinued | ORAL | N/A | May 14, 2018 |
| 750MG | tablet, extended release | Discontinued | ORAL | N/A | May 14, 2018 |
Manufacturing Plant Locations New
Jubilant Generics'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 Jubilant Generics as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
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14. LANNETT CO INC
Lannett Co Inc has filed for 2 different strengths of generic version for Niacin. Given below are the details of the strengths of this generic introduced by Lannett Co Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet, extended release | Prescription | ORAL | AB | Jun 16, 2017 |
| 1GM | tablet, extended release | Prescription | ORAL | AB | Jun 16, 2017 |
15. MACLEODS PHARMS LTD
Macleods Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Niacin. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1GM | tablet, extended release | Prescription | ORAL | AB | Mar 3, 2022 |
| 500MG | tablet, extended release | Prescription | ORAL | AB | Mar 3, 2022 |
16. MK LABS
Mk Laboratories Inc has filed for 1 generic for Niacin. Given below are the details of the strengths of this generic introduced by Mk Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Discontinued | ORAL | N/A | Approved Prior to Jan 1, 1982 |
17. PUREPAC PHARM
Purepac Pharmaceutical Co has filed for 1 generic for Niacin. Given below are the details of the strengths of this generic introduced by Purepac Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Discontinued | ORAL | N/A | Approved Prior to Jan 1, 1982 |
18. RISING
Rising Pharma Holdings Inc has filed for 3 different strengths of generic version for Niacin. Given below are the details of the strengths of this generic introduced by Rising.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1GM | tablet, extended release | Discontinued | ORAL | N/A | Feb 22, 2019 |
| 750MG | tablet, extended release | Discontinued | ORAL | N/A | Feb 22, 2019 |
| 500MG | tablet, extended release | Discontinued | ORAL | N/A | Feb 22, 2019 |
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 | ||||||||||||||||||
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| United States |
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| Mexico |
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19. SANDOZ
Sandoz Inc has filed for 1 generic for Niacin. Given below are the details of the strengths of this generic introduced by Sandoz.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Discontinued | ORAL | N/A | Approved Prior to Jan 1, 1982 |
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 |
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| United States |
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| Spain |
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20. SANOFI AVENTIS US
Sanofi Aventis Us Llc has filed for 1 generic for Niacin. This 500mg version comes by the name NICOLAR. Given below are the details of the strengths of this generic introduced by Sanofi Aventis Us.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Discontinued | ORAL | N/A | Approved Prior to Jan 1, 1982 |
21. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 3 different strengths of generic version for Niacin. 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 |
|---|---|---|---|---|---|
| 500MG | tablet, extended release | Prescription | ORAL | AB | Apr 23, 2014 |
| 1GM
(reference standard) | tablet, extended release | Prescription | ORAL | AB | Apr 23, 2014 |
| 750MG
(reference standard) | tablet, extended release | Prescription | ORAL | AB | Apr 23, 2014 |
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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22. TABLICAPS
Tablicaps Inc has filed for 1 generic for Niacin. Given below are the details of the strengths of this generic introduced by Tablicaps.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Discontinued | ORAL | N/A | Approved Prior to Jan 1, 1982 |
23. WATSON LABS
Watson Laboratories Inc has filed for 1 generic for Niacin. Given below are the details of the strengths of this generic introduced by Watson Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Discontinued | ORAL | N/A | Approved Prior to Jan 1, 1982 |
24. WOCKHARDT
Wockhardt Ltd has filed for 1 generic for Niacin. Given below are the details of the strengths of this generic introduced by Wockhardt.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Discontinued | ORAL | N/A | Apr 28, 1992 |
Manufacturing Plant Locations New
Wockhardt'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 Wockhardt as present at those locations.
| Country | City | Firm Name | ||||||
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| India |
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25. YICHANG HUMANWELL
Yichang Humanwell Pharmaceutical Co Ltd has filed for 3 different strengths of generic version for Niacin. Given below are the details of the strengths of this generic introduced by Yichang Humanwell.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 750MG | tablet, extended release | Discontinued | ORAL | N/A | Jun 10, 2019 |
| 1GM | tablet, extended release | Discontinued | ORAL | N/A | Jun 10, 2019 |
| 500MG | tablet, extended release | Discontinued | ORAL | N/A | Jun 10, 2019 |
Manufacturing Plant Locations New
Yichang Humanwell's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Yichang Humanwell as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| China |
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