Bludigo is a drug owned by Provepharm Sas. It is protected by 3 US drug patents filed from 2022 to 2023 out of which none have expired yet. Bludigo's patents will be open to challenges from 08 July, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 23, 2037. Details of Bludigo'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. | |||
| US10927258 | Process for the preparation of Indigotindisulfonate sodium (indigo carmine) |
Dec, 2037
(13 years from now) | Active |
| US11499050 | Process for the preparation of indigotindisulfonate sodium (indigo carmine) |
Dec, 2037
(13 years from now) | Active |
| US11845867 | Process for the preparation of indigotindisulfonate sodium (indigo carmine) |
Nov, 2036
(12 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 Bludigo's patents.
Latest Legal Activities on Bludigo's Patents
Given below is the list of recent legal activities going on the following patents of Bludigo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification Critical | 20 Dec, 2023 | US11845867 |
| Patent Issue Date Used in PTA Calculation Critical | 19 Dec, 2023 | US11845867 |
| Recordation of Patent eGrant | 19 Dec, 2023 | US11845867 |
| Recordation of Patent Grant Mailed Critical | 19 Dec, 2023 | US11845867 |
| Mail Patent eGrant Notification | 19 Dec, 2023 | US11845867 |
| Patent eGrant Notification | 19 Dec, 2023 | US11845867 |
| Email Notification Critical | 30 Nov, 2023 | US11845867 |
| Issue Notification Mailed Critical | 29 Nov, 2023 | US11845867 |
| Application Is Considered Ready for Issue Critical | 07 Nov, 2023 | US11845867 |
| Dispatch to FDC | 07 Nov, 2023 | US11845867 |
FDA has granted several exclusivities to Bludigo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Bludigo, 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 Bludigo.
Exclusivity Information
Bludigo holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Bludigo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 08, 2027 |
US patents provide insights into the exclusivity only within the United States, but Bludigo 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 Bludigo's family patents as well as insights into ongoing legal events on those patents.
Bludigo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Bludigo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 23, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Bludigo Generics:
There are no approved generic versions for Bludigo as of now.
About Bludigo
Bludigo is a drug owned by Provepharm Sas. Bludigo uses Indigotindisulfonate Sodium as an active ingredient. Bludigo was launched by Provepharm Sas in 2022.
Approval Date:
Bludigo was approved by FDA for market use on 08 July, 2022.
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 Bludigo is 08 July, 2022, its NCE-1 date is estimated to be 08 July, 2026.
Active Ingredient:
Bludigo uses Indigotindisulfonate Sodium as the active ingredient. Check out other Drugs and Companies using Indigotindisulfonate Sodium ingredient
Dosage:
Bludigo is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG/5ML (8MG/ML) | SOLUTION | Prescription | INTRAVENOUS |