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Bedaquiline Fumarate Patent Expiration

Bedaquiline Fumarate is Used for treating pulmonary multi-drug resistant tuberculosis. It was first introduced by Janssen Therapeutics Div Janssen Products Lp in its drug Sirturo on Dec 28, 2012.


Bedaquiline Fumarate Patents

Given below is the list of patents protecting Bedaquiline Fumarate, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Sirturo US7498343 Mycobacterial inhibitors Dec 01, 2026 Janssen Therap
Sirturo US8546428 Fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol Mar 19, 2029 Janssen Therap


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 Bedaquiline Fumarate's patents.

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

Event Date Patent/Publication
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 17 Mar, 2021 US8546428
Payment of Maintenance Fee, 12th Year, Large Entity 21 Aug, 2020 US7498343
Patent Term Extension Certificate 04 Apr, 2017 US7498343
Notice of Final Determination -Eligible 07 Dec, 2016 US7498343
FDA Final Eligibility Letter 29 Jul, 2016 US7498343
transaction for FDA Determination of Regulatory Review Period 28 Dec, 2015 US7498343
transaction for FDA Determination of Regulatory Review Period 10 Dec, 2015 US7498343
Second letter to regulating agency to determine regulatory review period 13 Mar, 2015 US7498343
Letter from FDA or Dept of Agriculture re PTE application 27 Mar, 2014 US7498343
Initial letter Re: PTE Application to regulating agency 21 Feb, 2014 US7498343



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