Sirturo is a drug owned by Janssen Therapeutics Div Janssen Products Lp. It is protected by 2 US drug patents filed in 2020 out of which none have expired yet. Sirturo's patents have been open to challenges since 28 December, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 19, 2029. Details of Sirturo'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. | |||
| US8546428 | Fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol |
Mar, 2029
(3 years from now) | Active |
| US7498343 | Mycobacterial inhibitors |
Dec, 2026
(1 year, 30 days 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 Sirturo's patents.
Latest Legal Activities on Sirturo's Patents
Given below is the list of recent legal activities going on the following patents of Sirturo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 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
Critical | 04 Apr, 2017 | US7498343 |
| Notice of Final Determination -Eligible | 07 Dec, 2016 | US7498343 |
| FDA Final Eligibility Letter
Critical | 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 |
FDA has granted several exclusivities to Sirturo. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Sirturo, 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
Sirturo.
Exclusivity Information
Sirturo holds 8 exclusivities out of which 4 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Sirturo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 28, 2017 |
| Orphan Drug Exclusivity(ODE) | Dec 28, 2019 |
| Orphan Drug Exclusivity(ODE-38) | Dec 28, 2019 |
| New Patient Population(NPP) | Aug 09, 2022 |
| ODE*(ODE*) | Aug 09, 2026 |
| Orphan Drug Exclusivity(ODE-251) | Aug 09, 2026 |
| Orphan Drug Exclusivity(ODE-307) | May 27, 2027 |
| M(M-306) | Jun 21, 2027 |
Several oppositions have been filed on Sirturo's European patents.
EP oppositions
can significantly impact the timeline for the generic launch of drugs. If an opposition results in the
revocation or
amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an
earlier entry
of generic versions into the market. To help you estimate the potential early arrival of Sirturo's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Sirturo patents.
Sirturo's Oppositions Filed in EPO
Sirturo has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 15, 2013, by Gallafent, Antony Xavier. This opposition was filed on patent number EP07847697A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP07847697A | Feb, 2013 | Gallafent, Antony Xavier | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but
Sirturo 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 Sirturo's family patents as well as insights into
ongoing legal events
on those patents.
Sirturo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sirturo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 19, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sirturo Generics:
There are no approved generic versions for Sirturo as of now.
About Sirturo
Sirturo is a drug owned by Janssen Therapeutics Div Janssen Products Lp. It is used for treating pulmonary multi-drug resistant tuberculosis. Sirturo uses Bedaquiline Fumarate as an active ingredient. Sirturo was launched by Janssen Therap in 2020.
Approval Date:
Sirturo was approved by FDA for market use on 27 May, 2020.
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 Sirturo is 27 May, 2020, its NCE-1 date is estimated to be 28 December, 2016.
Active Ingredient:
Sirturo uses Bedaquiline Fumarate as the active ingredient. Check out other Drugs and Companies using Bedaquiline Fumarate ingredient
Treatment:
Sirturo is used for treating pulmonary multi-drug resistant tuberculosis.
Dosage:
Sirturo is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 100MG BASE | TABLET | Prescription | ORAL |
| EQ 20MG BASE | TABLET | Prescription | ORAL |