Natesto is a drug owned by Acerus Pharmaceuticals Corp. It is protected by 6 US drug patents filed from 2014 to 2025. Out of these, 2 drug patents are active and 4 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 17, 2034. Details of Natesto'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). | |||
| US11090312 | Methods of treating hypogonadism with transnasal testerosterone bio-adhesive gel formulations in male with allergic rhinitis, and methods for preventing an allergic rhinitis event |
Mar, 2034
(7 years from now) | Active |
| US11744838 | Methods Of Treating Hypogonadism With Transnasal Testosterone Bio-Adhesive Gel Formulations In Male With Allergic Rhinitis, And Methods For Preventing An Allergic Rhinitis Event |
Mar, 2034
(7 years from now) | Active |
| US8784882 | Controlled release delivery system for nasal applications and method of treatment |
Feb, 2024
(2 years ago) |
Expired
|
| US8877230 | Controlled release delivery system for nasal applications |
Feb, 2024
(2 years ago) |
Expired
|
| US8784869 | Controlled release delivery system for nasal applications and methods of treatment |
Feb, 2024
(2 years ago) |
Expired
|
| US8574622 | Controlled release delivery system for nasal applications |
Feb, 2024
(2 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 Natesto's patents.
Latest Legal Activities on Natesto's Patents
Given below is the list of recent legal activities going on the following patents of Natesto.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed | 09 Mar, 2026 | US8784869 |
| Maintenance Fee Reminder Mailed | 09 Mar, 2026 | US8784882 |
| Expire Patent | 08 Dec, 2025 | US8574622 |
| Maintenance Fee Reminder Mailed | 23 Jun, 2025 | US8574622 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 11 Jan, 2025 | US11090312 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 02 Jul, 2024 | US11090312 |
| Email Notification
Critical | 02 Jul, 2024 | US11090312 |
| Email Notification | 02 Jul, 2024 | US11744838 |
| Change in Power of Attorney (May Include Associate POA) | 02 Jul, 2024 | US11744838 |
| Patent Issue Date Used in PTA Calculation | 05 Sep, 2023 | US11744838 |
FDA has granted several exclusivities to Natesto. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Natesto, 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
Natesto.
Exclusivity Information
Natesto holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Natesto's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 28, 2017 |
US patents provide insights into the exclusivity only within the United States, but
Natesto 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 Natesto's family patents as well as insights into
ongoing legal events
on those patents.
Natesto's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Natesto:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Natesto's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 17, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Natesto Generic API suppliers:
Testosterone is the generic name for the brand Natesto. 14 different companies have already filed for the generic of Natesto, with Actavis Labs Ut Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Natesto's generic
Alternative Brands for Natesto
Natesto which is used for testosterone replacement therapy., has several other brand drugs using the same active ingredient (Testosterone). 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 | |||
|---|---|---|---|---|
| Alza |
| |||
| Antares Pharma Inc |
| |||
| Auxilium Pharms Llc |
| |||
| Azurity |
| |||
| Besins Hlthcare |
| |||
| Eli Lilly And Co |
| |||
| Endo Operations |
| |||
| Marius |
| |||
| Tolmar |
| |||
| Upsher Smith Labs |
| |||
| Verity |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Testosterone, Natesto's active ingredient. Check the complete list of approved generic manufacturers for Natesto
About Natesto
Natesto is a drug owned by Acerus Pharmaceuticals Corp. It is used for testosterone replacement therapy. Natesto uses Testosterone as an active ingredient. Natesto was launched by Acerus in 2014.
Approval Date:
Natesto was approved by FDA for market use on 28 May, 2014.
Active Ingredient:
Natesto uses Testosterone as the active ingredient. Check out other Drugs and Companies using Testosterone ingredient
Treatment:
Natesto is used for testosterone replacement therapy.
Dosage:
Natesto is available in gel, metered form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5.5MG/0.122GM ACTUATION | GEL, METERED | Prescription | NASAL |