Niaspan Titration Starter Pack is a drug owned by Abbvie Inc. It is protected by 5 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 May 27, 2017. Details of Niaspan Titration Starter Pack'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). | |||
| US6080428 | Nicotinic acid compositions for treating hyperlipidemia and related methods therefor |
May, 2017
(7 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
|
| US6129930 | Methods and sustained release nicotinic acid compositions for treating hyperlipidemia at night |
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
|
| US6746691 | Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics |
Sep, 2013
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Niaspan Titration Starter Pack 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 Titration Starter Pack's family patents as well as insights into ongoing legal events on those patents.
Niaspan Titration Starter Pack's Family Patents
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Generic Launch
Generic Release Date:
Niaspan Titration Starter Pack's generic launch date based on the expiry of its last outstanding patent is estimated to be May 27, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Niaspan Titration Starter Pack Generic API suppliers:
Niacin is the generic name for the brand Niaspan Titration Starter Pack. 25 different companies have already filed for the generic of Niaspan Titration Starter Pack, with Yichang Humanwell having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Niaspan Titration Starter Pack's generic
How can I launch a generic of Niaspan Titration Starter Pack before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Niaspan Titration Starter Pack's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Niaspan Titration Starter Pack'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 Titration Starter Pack -
| 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 Titration Starter Pack
Niaspan Titration Starter Pack which is used for treating hyperlipidemia with once daily dosing of a nicotinic acid formulation., 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 Titration Starter Pack's active ingredient. Check the complete list of approved generic manufacturers for Niaspan Titration Starter Pack
About Niaspan Titration Starter Pack
Niaspan Titration Starter Pack is a drug owned by Abbvie Inc. It is used for treating hyperlipidemia with once daily dosing of a nicotinic acid formulation. Niaspan Titration Starter Pack uses Niacin as an active ingredient. Niaspan Titration Starter Pack was launched by Abbvie in 1997.
Approval Date:
Niaspan Titration Starter Pack was approved by FDA for market use on 28 July, 1997.
Active Ingredient:
Niaspan Titration Starter Pack uses Niacin as the active ingredient. Check out other Drugs and Companies using Niacin ingredient
Treatment:
Niaspan Titration Starter Pack is used for treating hyperlipidemia with once daily dosing of a nicotinic acid formulation.
Dosage:
Niaspan Titration Starter Pack is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 375MG;500MG;750MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |