Bylvay Patent Expiration

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.

Given below is the list of recent legal activities going on the following patents of Bylvay.

Activity Date Patent Number
Patent litigations
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 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 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

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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

Bylvay has patent protection in a total of 47 countries. It's US patent count contributes only to 16.9% of its total global patent coverage. 9 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Bylvay.

Family Patents

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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 form for oral use, capsule, pellets 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


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