Miacalcin is a drug owned by Norvium Bioscience Llc. It is protected by 2 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 31, 2015. Details of Miacalcin'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). | |||
| US5759565 | Galenic compositions comprising calcitonin and their use |
Mar, 2015
(9 years ago) |
Expired
|
| US5733569 | Galenic compositions comprising calcitonin and their use |
Mar, 2015
(9 years ago) |
Expired
|
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Miacalcin and ongoing litigations to help you estimate the early arrival of Miacalcin generic.
Miacalcin's Litigations
Miacalcin been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 23, 1994, against patent number US5759565. The petitioner , challenged the validity of this patent, with AZRIA et al as the respondent. Click below to track the latest information on how companies are challenging Miacalcin's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US5759565 | May, 1994 |
Decision
(25 Aug, 1997) | AZRIA et al | |
US patents provide insights into the exclusivity only within the United States, but Miacalcin 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 Miacalcin's family patents as well as insights into ongoing legal events on those patents.
Miacalcin's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Miacalcin's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 31, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Miacalcin Generic API suppliers:
Calcitonin Salmon is the generic name for the brand Miacalcin. 6 different companies have already filed for the generic of Miacalcin, with Endo Operations having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Miacalcin's generic
How can I launch a generic of Miacalcin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Miacalcin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Miacalcin'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 Miacalcin -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 200 IU/spray |
Alternative Brands for Miacalcin
Miacalcin which is used for treating nasal conditions., has several other brand drugs in the same treatment category and using the same active ingredient (Calcitonin Salmon). 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 | ||
|---|---|---|---|---|
| Upsher Smith Labs |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Calcitonin Salmon, Miacalcin's active ingredient. Check the complete list of approved generic manufacturers for Miacalcin
About Miacalcin
Miacalcin is a drug owned by Norvium Bioscience Llc. It is used for treating nasal conditions. Miacalcin uses Calcitonin Salmon as an active ingredient. Miacalcin was launched by Norvium Bioscience in 1995.
Approval Date:
Miacalcin was approved by FDA for market use on 17 August, 1995.
Active Ingredient:
Miacalcin uses Calcitonin Salmon as the active ingredient. Check out other Drugs and Companies using Calcitonin Salmon ingredient
Treatment:
Miacalcin is used for treating nasal conditions.
Dosage:
Miacalcin is available in spray, metered form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED | Discontinued | NASAL |