Macrilen is a drug owned by Novo Nordisk Inc. It is protected by 2 US drug patents filed in 2018. Out of these, 1 drug patents are active and 1 has expired. Macrilen's patents have been open to challenges since 20 December, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 12, 2027. Details of Macrilen's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US6861409 | Growth hormone secretagogues |
Aug, 2022
(2 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8192719 | Methods and kits to diagnose growth hormone deficiency by oral administration of EP 1572 or EP 1573 compounds |
Oct, 2027
(2 years from now) | Active |
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 Macrilen's patents.
Latest Legal Activities on Macrilen's Patents
Given below is the list of recent legal activities going on the following patents of Macrilen.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 27 Nov, 2023 | US8192719 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 Nov, 2019 | US8192719 |
| Patent Issue Date Used in PTA Calculation Critical | 05 Jun, 2012 | US8192719 |
| Recordation of Patent Grant Mailed Critical | 05 Jun, 2012 | US8192719 |
| Filing Receipt - Corrected | 30 May, 2012 | US8192719 |
| Issue Notification Mailed Critical | 16 May, 2012 | US8192719 |
| Dispatch to FDC | 08 May, 2012 | US8192719 |
| Application Is Considered Ready for Issue Critical | 02 May, 2012 | US8192719 |
| Filing Receipt - Corrected | 01 May, 2012 | US8192719 |
| Issue Fee Payment Received Critical | 30 Apr, 2012 | US8192719 |
FDA has granted several exclusivities to Macrilen. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Macrilen, 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 Macrilen.
Exclusivity Information
Macrilen holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2024. Details of Macrilen's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 20, 2022 |
| Orphan Drug Exclusivity(ODE-170) | Dec 20, 2024 |
US patents provide insights into the exclusivity only within the United States, but Macrilen 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 Macrilen's family patents as well as insights into ongoing legal events on those patents.
Macrilen's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Macrilen's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 12, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Macrilen Generics:
There are no approved generic versions for Macrilen as of now.
About Macrilen
Macrilen is a drug owned by Novo Nordisk Inc. It is used for diagnosing adult growth hormone deficiency. Macrilen uses Macimorelin Acetate as an active ingredient. Macrilen was launched by Novo in 2017.
Approval Date:
Macrilen was approved by FDA for market use on 20 December, 2017.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Macrilen is 20 December, 2017, its NCE-1 date is estimated to be 20 December, 2021.
Active Ingredient:
Macrilen uses Macimorelin Acetate as the active ingredient. Check out other Drugs and Companies using Macimorelin Acetate ingredient
Treatment:
Macrilen is used for diagnosing adult growth hormone deficiency.
Dosage:
Macrilen is available in for solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 60MG BASE/POUCH | FOR SOLUTION | Discontinued | ORAL |