Orladeyo is a drug owned by Biocryst Pharmaceuticals Inc. It is protected by 8 US drug patents filed from 2021 to 2023 out of which none have expired yet. Orladeyo's patents have been open to challenges since 03 December, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 01, 2039. Details of Orladeyo'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. | |||
| US10662160 | Crystalline salts of a plasma kallikrein inhibitor |
Nov, 2039
(14 years from now) | Active |
| US10125102 | Human plasma kallikrein inhibitors |
Apr, 2035
(10 years from now) | Active |
| US10329260 | Human plasma kallikrein inhibitors |
Mar, 2035
(10 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11618733 | Crystalline salts of a plasma kallikrein inhibitor |
Nov, 2039
(14 years from now) | Active |
| US11117867 | Crystalline salts of a plasma kallikrein inhibitor |
Nov, 2039
(14 years from now) | Active |
| US11708333 | Human plasma kallikrein inhibitors |
Mar, 2035
(10 years from now) | Active |
| US11230530 | Human plasma kallikrein inhibitors |
Mar, 2035
(10 years from now) | Active |
| US10689346 | Human plasma kallikrein inhibitors |
Mar, 2035
(10 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 Orladeyo's patents.
Latest Legal Activities on Orladeyo's Patents
Given below is the list of recent legal activities going on the following patents of Orladeyo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Nov, 2023 | US10689346 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 16 Nov, 2023 | US10662160 |
| Recordation of Patent Grant Mailed Critical | 25 Jul, 2023 | US11708333 |
| Email Notification Critical | 25 Jul, 2023 | US11708333 |
| Patent Issue Date Used in PTA Calculation Critical | 25 Jul, 2023 | US11708333 |
| Patent eGrant Notification | 25 Jul, 2023 | US11708333 |
| Recordation of Patent eGrant | 25 Jul, 2023 | US11708333 |
| Mail Patent eGrant Notification | 25 Jul, 2023 | US11708333 |
| Electronic Review Critical | 25 Jul, 2023 | US11708333 |
| Email Notification Critical | 06 Jul, 2023 | US11708333 |
FDA has granted several exclusivities to Orladeyo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Orladeyo, 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 Orladeyo.
Exclusivity Information
Orladeyo holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Orladeyo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 03, 2025 |
| Orphan Drug Exclusivity(ODE-333) | Dec 03, 2027 |
US patents provide insights into the exclusivity only within the United States, but Orladeyo 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 Orladeyo's family patents as well as insights into ongoing legal events on those patents.
Orladeyo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Orladeyo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 01, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Orladeyo Generics:
There are no approved generic versions for Orladeyo as of now.
About Orladeyo
Orladeyo is a drug owned by Biocryst Pharmaceuticals Inc. It is used for preventing attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older. Orladeyo uses Berotralstat Hydrochloride as an active ingredient. Orladeyo was launched by Biocryst in 2020.
Can you believe Orladeyo received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Orladeyo was approved by FDA for market use on 03 December, 2020.
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 Orladeyo is 03 December, 2020, its NCE-1 date is estimated to be 03 December, 2024.
Active Ingredient:
Orladeyo uses Berotralstat Hydrochloride as the active ingredient. Check out other Drugs and Companies using Berotralstat Hydrochloride ingredient
Treatment:
Orladeyo is used for preventing attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older.
Dosage:
Orladeyo is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 150MG BASE | CAPSULE | Prescription | ORAL |
| EQ 110MG BASE | CAPSULE | Prescription | ORAL |