Pyridostigmine Bromide is a drug owned by Amneal Pharmaceuticals Llc. It is protected by 9 US drug patents filed from 2024 to 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 18, 2038. Details of Pyridostigmine Bromide'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). | |||
| US12042559 | Gastroretentive dosage forms for sustained drug delivery |
Jun, 2038
(12 years from now) | Active |
| US10925833 | Extended release compositions comprising pyridostigmine |
Jun, 2038
(12 years from now) | Active |
| US11478425 | Extended release compositions comprising pyridostigmine |
Jun, 2038
(12 years from now) | Active |
| US12233166 | Extended release compositions comprising pyridostigmine |
Jun, 2038
(12 years from now) | Active |
| US10987311 | Extended release compositions comprising pyridostigmine |
Jun, 2038
(12 years from now) | Active |
| US10881617 | Extended release compositions comprising pyridostigmine |
Jun, 2038
(12 years from now) | Active |
| US11666536 | Extended release compositions comprising pyridostigmine |
Jun, 2038
(12 years from now) | Active |
| US11911515 | Extended release compositions comprising pyridostigmine |
Jun, 2038
(12 years from now) | Active |
| US11229606 | Extended release compositions comprising pyridostigmine |
Jun, 2038
(12 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 Pyridostigmine Bromide's patents.
Latest Legal Activities on Pyridostigmine Bromide's Patents
Given below is the list of recent legal activities going on the following patents of Pyridostigmine Bromide.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 25 Jul, 2025 | US11229606 |
| Email Notification | 03 Mar, 2025 | US12233166 |
| Mail O.P. Petition Decision | 03 Mar, 2025 | US12233166 |
| Mail-Petition Decision - Dismissed | 26 Feb, 2025 | US12233166 |
| Petition Decision - Dismissed | 25 Feb, 2025 | US12233166 |
| Patent eGrant Notification | 25 Feb, 2025 | US12233166 |
| Recordation of Patent Grant Mailed | 25 Feb, 2025 | US12233166 |
| Mail Patent eGrant Notification | 25 Feb, 2025 | US12233166 |
| Email Notification | 25 Feb, 2025 | US12233166 |
| Patent Issue Date Used in PTA Calculation | 25 Feb, 2025 | US12233166 |
US patents provide insights into the exclusivity only within the United States, but
Pyridostigmine Bromide 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 Pyridostigmine Bromide's family patents as well as insights into
ongoing legal events
on those patents.
Pyridostigmine Bromide's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Pyridostigmine Bromide's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 18, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pyridostigmine Bromide Generic API suppliers:
Pyridostigmine Bromide is the generic name for the brand Pyridostigmine Bromide. 12 different companies have already filed for the generic of Pyridostigmine Bromide, with Impax Labs having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Pyridostigmine Bromide's generic
About Pyridostigmine Bromide
Pyridostigmine Bromide is a drug owned by Amneal Pharmaceuticals Llc. Pyridostigmine Bromide uses Pyridostigmine Bromide as an active ingredient. Pyridostigmine Bromide was launched by Amneal in 2024.
Approval Date:
Pyridostigmine Bromide was approved by FDA for market use on 04 October, 2024.
Active Ingredient:
Pyridostigmine Bromide uses Pyridostigmine Bromide as the active ingredient. Check out other Drugs and Companies using Pyridostigmine Bromide ingredient
Dosage:
Pyridostigmine Bromide is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 105MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |