Zemplar is a drug owned by Abbvie Inc. It is protected by 9 US drug patents filed from 2013 to 2014 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 18, 2023. Details of Zemplar'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). | |||
|
US6136799 (Pediatric) | Cosolvent formulations |
Oct, 2018
(6 years ago) |
Expired
|
|
US6361758 (Pediatric) | Cosolvent formulations |
Oct, 2018
(6 years ago) |
Expired
|
| US6136799 | Cosolvent formulations |
Apr, 2018
(6 years ago) |
Expired
|
| US6361758 | Cosolvent formulations |
Apr, 2018
(6 years ago) |
Expired
|
|
US5597815 (Pediatric) | Prevention of hyperphosphatemia in kidney disorder patients |
Jan, 2016
(8 years ago) |
Expired
|
| US5597815 | Prevention of hyperphosphatemia in kidney disorder patients |
Jul, 2015
(9 years ago) |
Expired
|
|
US5587497 (Pediatric) | 19-nor-vitamin D compounds |
Jun, 2014
(10 years ago) |
Expired
|
| US5587497 | 19-nor-vitamin D compounds |
Dec, 2013
(10 years ago) |
Expired
|
|
US5246925 (Pediatric) | 19-nor-vitamin D compounds for use in treating hyperparathyroidism |
Oct, 2012
(12 years ago) |
Expired
|
FDA has granted several exclusivities to Zemplar. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zemplar, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Zemplar.
Exclusivity Information
Zemplar holds 5 exclusivities. All of its exclusivities have expired in 2023. Details of Zemplar's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-599) | Jun 29, 2012 |
| New Patient Population(NPP) | Oct 18, 2019 |
| Orphan Drug Exclusivity(ODE) | Oct 18, 2023 |
| ODE*(ODE*) | Oct 18, 2023 |
| Orphan Drug Exclusivity(ODE-125) | Oct 18, 2023 |
US patents provide insights into the exclusivity only within the United States, but Zemplar 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 Zemplar's family patents as well as insights into ongoing legal events on those patents.
Zemplar's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zemplar's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 18, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zemplar Generic API suppliers:
Paricalcitol is the generic name for the brand Zemplar. 12 different companies have already filed for the generic of Zemplar, with Rising having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zemplar's generic
How can I launch a generic of Zemplar before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zemplar's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zemplar'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 Zemplar -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.002 mg per mL in 1 mL vial and 0.005 mg per mL in 1 mL and 2 mL vials | 28 Nov, 2008 | 1 | 27 Jul, 2011 | 08 Oct, 2018 | Eligible |
| 1 mcg and 2 mcg | 14 Oct, 2008 | 1 | 27 Sep, 2013 | 24 Jun, 2014 | Eligible |
| 4 mcg | 25 Aug, 2008 | 1 | 27 Sep, 2013 | 24 Jun, 2014 | Eligible |
About Zemplar
Zemplar is a drug owned by Abbvie Inc. It is used for managing secondary hyperparathyroidism in chronic kidney disease. Zemplar uses Paricalcitol as an active ingredient. Zemplar was launched by Abbvie in 2000.
Approval Date:
Zemplar was approved by FDA for market use on 01 February, 2000.
Active Ingredient:
Zemplar uses Paricalcitol as the active ingredient. Check out other Drugs and Companies using Paricalcitol ingredient
Treatment:
Zemplar is used for managing secondary hyperparathyroidism in chronic kidney disease.
Dosage:
Zemplar is available in the following dosage forms - solution form for intravenous use, capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.01MG/2ML (0.005MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 0.005MG/ML (0.005MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 0.002MG/ML (0.002MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 1MCG | CAPSULE | Prescription | ORAL |
| 2MCG | CAPSULE | Prescription | ORAL |
| 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | Discontinued | ORAL |