Attruby is a drug owned by Bridgebio Pharma Inc. It is protected by 12 US drug patents filed in 2024 out of which none have expired yet. Attruby's patents will be open to challenges from 22 November, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 16, 2039. Details of Attruby'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. | |||
| US10513497 | Process for preparing AG-10, its intermediates, and salts thereof |
Feb, 2038
(12 years from now) | Active |
| US9642838 | Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions |
May, 2031
(6 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). | |||
| US11260047 | Formulations of AG10 |
Aug, 2039
(14 years from now) | Active |
| US12005043 | Formulations of AG10 |
Aug, 2039
(14 years from now) | Active |
| US12070449 | Methods of treating TTR amyloidosis using AG10 |
Mar, 2039
(14 years from now) | Active |
| US11058668 | Methods of treating TTR amyloidosis using AG10 |
Mar, 2039
(14 years from now) | Active |
| US11919865 | Processes for preparing AG-10, its intermediates, and salts thereof |
Feb, 2038
(12 years from now) | Active |
| US8877795 | Identification of stabilizers of multimeric proteins |
May, 2031
(6 years from now) | Active |
| US9913826 | Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions |
May, 2031
(6 years from now) | Active |
| US10842777 | Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions |
May, 2031
(6 years from now) | Active |
| US9169214 | Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions |
May, 2031
(6 years from now) | Active |
| US10398681 | Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions |
May, 2031
(6 years from now) | Active |
FDA has granted several exclusivities to Attruby. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Attruby, 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 Attruby.
Exclusivity Information
Attruby holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Attruby's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 22, 2029 |
| Orphan Drug Exclusivity(ODE-506) | Nov 22, 2031 |
US patents provide insights into the exclusivity only within the United States, but Attruby 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 Attruby's family patents as well as insights into ongoing legal events on those patents.
Attruby's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Attruby's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 16, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Attruby Generics:
There are no approved generic versions for Attruby as of now.
About Attruby
Attruby is a drug owned by Bridgebio Pharma Inc. Attruby uses Acoramidis Hydrochloride as an active ingredient. Attruby was launched by Bridgebio Pharma in 2024.
Approval Date:
Attruby was approved by FDA for market use on 22 November, 2024.
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 Attruby is 22 November, 2024, its NCE-1 date is estimated to be 22 November, 2028.
Active Ingredient:
Attruby uses Acoramidis Hydrochloride as the active ingredient. Check out other Drugs and Companies using Acoramidis Hydrochloride ingredient
Dosage:
Attruby is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 356MG BASE | TABLET | Prescription | ORAL |