Niaspan is a drug owned by Abbvie Inc. It is protected by 9 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 15, 2018. Details of Niaspan's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| 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, 2018
(6 years ago) |
Expired
|
| US6080428 | Nicotinic acid compositions for treating hyperlipidemia and related methods therefor |
May, 2017
(7 years ago) |
Expired
|
| US6818229 | Intermediate release nicotinic acid compositions for treating hyperlipidemia |
Sep, 2013
(11 years ago) |
Expired
|
| US6129930 | Methods and sustained release nicotinic acid compositions for treating hyperlipidemia at night |
Sep, 2013
(11 years ago) |
Expired
|
| US7998506 | Nicotinic acid compositions for treating hyperlipidemia and related methods therefor |
Sep, 2013
(11 years ago) |
Expired
|
| US6406715 | Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique urinary metabolite profiles |
Sep, 2013
(11 years ago) |
Expired
|
| US7011848 | Hydrophobic component free sustained release nicotinic acid compositions for treating hyperlipidemia and related methods therefor |
Sep, 2013
(11 years ago) |
Expired
|
| US6746691 | Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics |
Sep, 2013
(11 years ago) |
Expired
|
| US6676967 | Methods for reducing flushing in individuals being treated with nicotinic acid for hyperlipidemia |
Sep, 2013
(11 years ago) |
Expired
|
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 Niaspan's patents.
Latest Legal Activities on Niaspan's Patents
Given below is the list of recent legal activities going on the following patents of Niaspan.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 11 Sep, 2015 | US7998506 |
| Correspondence Address Change Critical | 01 Jul, 2013 | US7998506 |
| Email Notification Critical | 07 Oct, 2011 | US7998506 |
| Change in Power of Attorney (May Include Associate POA) Critical | 07 Oct, 2011 | US7998506 |
| Patent Issue Date Used in PTA Calculation Critical | 16 Aug, 2011 | US7998506 |
| Recordation of Patent Grant Mailed Critical | 16 Aug, 2011 | US7998506 |
| Email Notification Critical | 28 Jul, 2011 | US7998506 |
| Issue Notification Mailed Critical | 27 Jul, 2011 | US7998506 |
| Application Is Considered Ready for Issue Critical | 13 Jul, 2011 | US7998506 |
| Dispatch to FDC | 13 Jul, 2011 | US7998506 |
US patents provide insights into the exclusivity only within the United States, but Niaspan is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Niaspan's family patents as well as insights into ongoing legal events on those patents.
Niaspan's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Niaspan's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 15, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Niaspan Generic API suppliers:
Niacin is the generic name for the brand Niaspan. 25 different companies have already filed for the generic of Niaspan, with Yichang Humanwell having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Niaspan's generic
How can I launch a generic of Niaspan before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Niaspan's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Niaspan's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Niaspan -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 500 mg, 750 mg and 1000 mg |
Alternative Brands for Niaspan
Niaspan which 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., has several other brand drugs in the same treatment category and using the same active ingredient (Niacin). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||
|---|---|---|---|---|---|---|
| Abbvie |
| |||||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Niacin. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Abbvie |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Niacin, Niaspan's active ingredient. Check the complete list of approved generic manufacturers for Niaspan
About Niaspan
Niaspan is a drug owned by Abbvie Inc. It 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. Niaspan uses Niacin as an active ingredient. Niaspan was launched by Abbvie in 1997.
Approval Date:
Niaspan was approved by FDA for market use on 28 July, 1997.
Active Ingredient:
Niaspan uses Niacin as the active ingredient. Check out other Drugs and Companies using Niacin ingredient
Treatment:
Niaspan 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.
Dosage:
Niaspan is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 375MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |