Phenylephrine Hydrochloride is a drug owned by Paragon Bioteck Inc. It is protected by 1 US drug patent filed in 2014 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 14, 2033. Details of Phenylephrine Hydrochloride'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). | |||
| US8859623 | Methods and compositions of stable phenylephrine formulations |
Nov, 2033
(9 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 Phenylephrine Hydrochloride's patents.
Latest Legal Activities on Phenylephrine Hydrochloride's Patents
Given below is the list of recent legal activities going on the following patents of Phenylephrine Hydrochloride.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 7.5 yr surcharge - late pmt w/in 6 mo, Large Entity | 03 Oct, 2022 | US8859623 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Oct, 2022 | US8859623 |
| Application Return from OIPE | 18 Jul, 2022 | US8859623 |
| Correspondence Address Change Critical | 18 Jul, 2022 | US8859623 |
| Application Return TO OIPE | 18 Jul, 2022 | US8859623 |
| Maintenance Fee Reminder Mailed Critical | 06 Jun, 2022 | US8859623 |
| Appeal to Court of Appeals | 13 Jan, 2017 | US8859623 |
| Termination or Final Written Decision | 14 Nov, 2016 | US8859623 |
| Application ready for PDX access by participating foreign offices Critical | 31 Aug, 2015 | US8859623 |
| Petition Requesting Trial | 11 May, 2015 | US8859623 |
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 Phenylephrine Hydrochloride and ongoing litigations to help you estimate the early arrival of Phenylephrine Hydrochloride generic.
Phenylephrine Hydrochloride's Litigations
Phenylephrine Hydrochloride been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 11, 2015, against patent number US8859623. The petitioner Altaire Pharmaceuticals, Inc., challenged the validity of this patent, with Paragon BioTeck, Inc. as the respondent. Click below to track the latest information on how companies are challenging Phenylephrine Hydrochloride's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8859623 | May, 2015 |
Final Written Decision
(14 Nov, 2016) | Paragon BioTeck, Inc. | Altaire Pharmaceuticals, Inc. |
US patents provide insights into the exclusivity only within the United States, but Phenylephrine Hydrochloride 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 Phenylephrine Hydrochloride's family patents as well as insights into ongoing legal events on those patents.
Phenylephrine Hydrochloride's Family Patents
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Generic Launch
Generic Release Date:
Phenylephrine Hydrochloride's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 14, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Phenylephrine Hydrochloride Generic API suppliers:
Phenylephrine Hydrochloride is the generic name for the brand Phenylephrine Hydrochloride. 16 different companies have already filed for the generic of Phenylephrine Hydrochloride, with Caplin having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Phenylephrine Hydrochloride's generic
Alternative Brands for Phenylephrine Hydrochloride
Phenylephrine Hydrochloride which is used for eye examinations., has several other brand drugs using the same active ingredient (Phenylephrine Hydrochloride). 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 | |
|---|---|---|
| Eyenovia |
| |
| Hikma |
| |
| Rayner Surgical |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Phenylephrine Hydrochloride, Phenylephrine Hydrochloride's active ingredient. Check the complete list of approved generic manufacturers for Phenylephrine Hydrochloride
About Phenylephrine Hydrochloride
Phenylephrine Hydrochloride is a drug owned by Paragon Bioteck Inc. It is used for eye examinations. Phenylephrine Hydrochloride uses Phenylephrine Hydrochloride as an active ingredient. Phenylephrine Hydrochloride was launched by Paragon Bioteck in 2013.
Approval Date:
Phenylephrine Hydrochloride was approved by FDA for market use on 21 March, 2013.
Active Ingredient:
Phenylephrine Hydrochloride uses Phenylephrine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Phenylephrine Hydrochloride ingredient
Treatment:
Phenylephrine Hydrochloride is used for eye examinations.
Dosage:
Phenylephrine Hydrochloride is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10% | SOLUTION/DROPS | Prescription | OPHTHALMIC |
| 2.5% | SOLUTION/DROPS | Prescription | OPHTHALMIC |