Bylvay is a drug owned by Ipsen Biopharmaceuticals Inc. It is protected by 13 US drug patents filed from 2021 to 2024. Out of these, 12 drug patents are active and 1 has expired. Bylvay's patents will be open to challenges from 20 July, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 12, 2041. Details of Bylvay'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. | |||
| US12091394 | Crystal modifications of odevixibat |
Jun, 2039
(14 years from now) | Active |
| US10975046 | Crystal modifications of odevixibat |
Jun, 2039
(14 years from now) | Active |
| US7132416 | Benzothiazepine and benzothiazepine derivatives with ileal bile acid transport (IBAT) inhibotory activity for the treatment hyperlipidaemia |
Sep, 2022
(2 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11583539 | Treating progressive familial intrahepatic cholestasis (PFIC) with IBAT inhibitors |
Nov, 2041
(16 years from now) | Active |
| US11802115 | Pharmaceutical formulation of odevixibat |
Jun, 2039
(14 years from now) | Active |
| US11801226 | Pharmaceutical formulation of odevixibat |
Jun, 2039
(14 years from now) | Active |
| US11365182 | Crystal modifications of odevixibat |
Jun, 2039
(14 years from now) | Active |
| US10487111 | IBAT inhibitors for the treatment of liver diseases |
Nov, 2031
(6 years from now) | Active |
| US10093697 | IBAT inhibitors for the treatment of liver diseases |
Nov, 2031
(6 years from now) | Active |
| US10011633 | IBAT inhibitors for the treatment of liver diseases |
Nov, 2031
(6 years from now) | Active |
| US9694018 | IBAT inhibitors for the treatment of liver disease |
Nov, 2031
(6 years from now) | Active |
| US11732006 | IBAT inhibitors for the treatment of liver diseases |
Nov, 2031
(6 years from now) | Active |
| US10981952 | IBAT inhibitors for the treatment of liver diseases |
Nov, 2031
(6 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 Bylvay's patents.
Latest Legal Activities on Bylvay's Patents
Given below is the list of recent legal activities going on the following patents of Bylvay.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 08 Mar, 2024 | US9694018 |
| Letter from FDA or Dept of Agriculture re PTE application | 07 Feb, 2024 | US9694018 |
| Letter from FDA or Dept of Agriculture re PTE application | 18 Jan, 2024 | US10011633 |
| Letter from FDA or Dept of Agriculture re PTE application | 18 Jan, 2024 | US10093697 |
| Recordation of Patent Grant Mailed Critical | 31 Oct, 2023 | US11801226 |
| Recordation of Patent eGrant | 31 Oct, 2023 | US11801226 |
| Sequence Moved to Public Database | 31 Oct, 2023 | US11801226 |
| Mail Patent eGrant Notification | 31 Oct, 2023 | US11801226 |
| Patent eGrant Notification | 31 Oct, 2023 | US11801226 |
| Email Notification Critical | 31 Oct, 2023 | US11801226 |
FDA has granted several exclusivities to Bylvay. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Bylvay, 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 Bylvay.
Exclusivity Information
Bylvay holds 4 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Bylvay's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-918) | Jun 13, 2026 |
| New Chemical Entity Exclusivity(NCE) | Jul 20, 2026 |
| Orphan Drug Exclusivity(ODE-363) | Jul 20, 2028 |
| Orphan Drug Exclusivity(ODE-436) | Jun 13, 2030 |
US patents provide insights into the exclusivity only within the United States, but Bylvay 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 Bylvay's family patents as well as insights into ongoing legal events on those patents.
Bylvay's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Bylvay's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 12, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Bylvay Generics:
There are no approved generic versions for Bylvay as of now.
About Bylvay
Bylvay is a drug owned by Ipsen Biopharmaceuticals Inc. It is used for reducing serum bile acids and treating pruritus in patients with Alagille Syndrome and Progressive Familial Intrahepatic Cholestasis. Bylvay uses Odevixibat as an active ingredient. Bylvay was launched by Ipsen in 2021.
Approval Date:
Bylvay was approved by FDA for market use on 20 July, 2021.
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 Bylvay is 20 July, 2021, its NCE-1 date is estimated to be 20 July, 2025.
Active Ingredient:
Bylvay uses Odevixibat as the active ingredient. Check out other Drugs and Companies using Odevixibat ingredient
Treatment:
Bylvay is used for reducing serum bile acids and treating pruritus in patients with Alagille Syndrome and Progressive Familial Intrahepatic Cholestasis.
Dosage:
Bylvay is available in the following dosage forms - capsule, pellets form for oral use, capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.4MG | CAPSULE | Prescription | ORAL |
| 0.6MG | CAPSULE, PELLETS | Prescription | ORAL |
| 1.2MG | CAPSULE | Prescription | ORAL |
| 0.2MG | CAPSULE, PELLETS | Prescription | ORAL |