- On February 23, 2022, Bausch reported revenue for TRULANCE® (plecanatide), which the Company acquired in 2019, exceeded $100 million during the full year of 2021.
- Orange Book Patents:
PLECANATIDE (TRULANCE) TABLET 3MG
| Product No | Patent No | Patent Expiration | Drug Substance | Drug Product | Patent Use Code | Key Claimed Elements | Submission Date |
|---|---|---|---|---|---|---|---|
| 001 | 7041786 | 01/30/2028 | DS | A peptide consisting of an amino acid sequence | 02/14/2017 | ||
| 001 | 9919024 | 09/15/2031 | U-1999 U-2230 | low moisture carrier | 04/10/2018 | ||
| 001 | 9925231 | 09/15/2031 | DP | low moisture carrier | 04/10/2018 | ||
| 001 | 9610321 | 09/15/2031 | U-1999 U-2230 | low moisture carrier | 05/01/2017 | ||
| 001 | 9616097 | 08/20/2032 | DP | low moisture carrier | 05/01/2017 | ||
| 001 | 11319346 | 03/01/2032 | DP | less than 2% by weight of topoisomers | 05/11/2022 | ||
| 001 | 10011637 | 06/05/2034 | DS | Bulk density, acetamide container etc. | 07/19/2018 | ||
| 001 | 11142549 | 06/05/2034 | DP | microcrystalline cellulose | 10/25/2021 | ||
| 001 | 11834521 | 06/05/2034 | DP | bulk density, alpha-Asp-9-plecanatide and topoisomer limits. | 12/14/2023 |
In chemistry, topoisomers are a special type of isomer, which means they are molecules with the same chemical formula and bond connectivity but differ in their spatial arrangement. However, unlike conventional isomers, topoisomers differ in their topology, which describes how their atoms are connected in 3D space without considering bond rotations. Topoisomers play a crucial role in many biological processes, particularly in DNA replication and transcription. Enzymes called topoisomerases are essential for manipulating the topology of DNA to prevent tangles and facilitate these processes.
