Alphagan P is a drug owned by Abbvie Inc. It is protected by 16 US drug patents filed from 2013 to 2019 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 02, 2024. Details of Alphagan P'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US5424078 (Pediatric) | Aqueous ophthalmic formulations and methods for preserving same |
Dec, 2012
(11 years ago) |
Expired
|
| US9295641 | Compositions containing alpha-2-adrenergic agonist components |
Jul, 2021
(3 years ago) |
Expired
|
| US9687443 | Compositions containing alpha-2-adrenergic agonist components |
Jul, 2021
(3 years ago) |
Expired
|
| US10307368 | Compositions containing alpha-2-adrenergic agonist components |
Jul, 2021
(3 years ago) |
Expired
|
| US6562873 | Compositions containing therapeutically active components having enhanced solubility |
Jul, 2021
(3 years ago) |
Expired
|
| US6627210 | Compositions containing α-2-adrenergic agonist components |
Jul, 2021
(3 years ago) |
Expired
|
| US6673337 | Compositions containing alpha-2-adrenergic agonist components |
Jul, 2021
(3 years ago) |
Expired
|
| US6641834 | Compositions containing alpha-2-adrenergic agonist components |
Jul, 2021
(3 years ago) |
Expired
|
|
US9687443 (Pediatric) | Compositions containing alpha-2-adrenergic agonist components |
Jan, 2022
(2 years ago) |
Expired
|
|
US6562873 (Pediatric) | Compositions containing therapeutically active components having enhanced solubility |
Jan, 2022
(2 years ago) |
Expired
|
|
US9295641 (Pediatric) | Compositions containing alpha-2-adrenergic agonist components |
Jan, 2022
(2 years ago) |
Expired
|
|
US6627210 (Pediatric) | Compositions containing α-2-adrenergic agonist components |
Jan, 2022
(2 years ago) |
Expired
|
|
US6673337 (Pediatric) | Compositions containing alpha-2-adrenergic agonist components |
Jan, 2022
(2 years ago) |
Expired
|
|
US6641834 (Pediatric) | Compositions containing alpha-2-adrenergic agonist components |
Jan, 2022
(2 years ago) |
Expired
|
| US8858961 | Compositions containing alpha-2-adrenergic agonist components |
Sep, 2023
(10 months ago) |
Expired
|
|
US8858961 (Pediatric) | Compositions containing alpha-2-adrenergic agonist components |
Mar, 2024
(4 months 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 Alphagan P's patents.
Latest Legal Activities on Alphagan P's Patents
Given below is the list of recent legal activities going on the following patents of Alphagan P.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Expire Patent | 10 Jul, 2023 | US10307368 |
| Maintenance Fee Reminder Mailed | 23 Jan, 2023 | US10307368 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Mar, 2022 | US8858961 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Dec, 2020 | US9687443 |
| Patent Issue Date Used in PTA Calculation | 04 Jun, 2019 | US10307368 |
| Recordation of Patent Grant Mailed | 04 Jun, 2019 | US10307368 |
| Email Notification | 16 May, 2019 | US10307368 |
| Issue Notification Mailed | 15 May, 2019 | US10307368 |
| Dispatch to FDC | 02 May, 2019 | US10307368 |
| Email Notification | 01 May, 2019 | US10307368 |
US patents provide insights into the exclusivity only within the United States, but Alphagan P 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 Alphagan P's family patents as well as insights into ongoing legal events on those patents.
Alphagan P's family patents
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Generic Launch
Generic Release Date:
Alphagan P's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 02, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Alphagan P Generics:
Brimonidine Tartrate is the generic name for the brand Alphagan P. 12 different companies have already filed for the generic of Alphagan P, with Sandoz having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Alphagan P's generic
How can I launch a generic of Alphagan P before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Alphagan P's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Alphagan P'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 Alphagan P -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.001 | 20 Dec, 2006 | 1 | 28 Jul, 2021 | Extinguished | |
| 0.0015 | 03 Nov, 2006 | 1 | 28 Jan, 2022 | Extinguished |
About Alphagan P
Alphagan P is a drug owned by Abbvie Inc. It is used for reducing elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Alphagan P uses Brimonidine Tartrate as an active ingredient. Alphagan P was launched by Abbvie in 2001.
Market Authorisation Date:
Alphagan P was approved by FDA for market use on 16 March, 2001.
Active Ingredient:
Alphagan P uses Brimonidine Tartrate as the active ingredient. Check out other Drugs and Companies using Brimonidine Tartrate ingredient
Treatment:
Alphagan P is used for reducing elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
Dosage:
Alphagan P is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.15% | SOLUTION/DROPS | Prescription | OPHTHALMIC |
| 0.1% | SOLUTION/DROPS | Prescription | OPHTHALMIC |