Daklinza is a drug owned by Bristol-myers Squibb Co. It is protected by 5 US drug patents filed from 2015 to 2016 out of which none have expired yet. Daklinza's patents have been open to challenges since 25 July, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 13, 2031. Details of Daklinza'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. | |||
| US8629171 | Crystalline form of methyl ((1S)-1-((25)-2-(5-(4'-(2-((25)-1((2S)-2-((methoxycarbonyl)amino)-3-methylbutanoyl)-2-pyrrolidinyl)-1H-imidazol-2-yl)-1-pyrrolidinyl)carbonyl)-2-methylpropyl)carbamate dihydrochloride salt |
Jun, 2031
(5 years from now) | Active |
| US8329159 | Hepatitis C virus inhibitors |
Jul, 2029
(3 years from now) | Active |
| US8642025 | Hepatitis C virus inhibitors |
Aug, 2027
(1 year, 9 months from now) | Active |
| US9421192 | Hepatitis C virus inhibitors |
Aug, 2027
(1 year, 9 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8900566 | Hepatitis C virus inhibitors |
Aug, 2027
(1 year, 9 months 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 Daklinza's patents.
Latest Legal Activities on Daklinza's Patents
Given below is the list of recent legal activities going on the following patents of Daklinza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent
Critical | 09 Jan, 2023 | US8900566 |
| Maintenance Fee Reminder Mailed
Critical | 25 Jul, 2022 | US8900566 |
| Expire Patent
Critical | 14 Mar, 2022 | US8642025 |
| Maintenance Fee Reminder Mailed
Critical | 27 Sep, 2021 | US8642025 |
| Expire Patent
Critical | 18 Jan, 2021 | US8329159 |
| Expire Patent
Critical | 28 Sep, 2020 | US9421192 |
| Maintenance Fee Reminder Mailed
Critical | 03 Aug, 2020 | US8329159 |
| Maintenance Fee Reminder Mailed
Critical | 13 Apr, 2020 | US9421192 |
| Patent Term Extension Certificate
Critical | 17 Dec, 2019 | US8329159 |
| Email Notification
Critical | 12 Nov, 2019 | US8329159 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets
invalidated somehow, the
generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal
pitfalls. Given
below are details of the litigation history of Daklinza and ongoing
litigations to
help you estimate the early arrival of Daklinza generic.
Daklinza's Litigations
Daklinza been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 23, 2010, against patent number US8329159. The petitioner , challenged the validity of this patent, with Makonen Belema et al as the respondent. Click below to track the latest information on how companies are challenging Daklinza's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8329159 | August, 2010 |
Decision
(31 Jan, 2011) | Makonen Belema et al | |
FDA has granted some exclusivities to Daklinza. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Daklinza,
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
Daklinza.
Exclusivity Information
Daklinza holds 5 exclusivities. All of its exclusivities have expired in 2020. Details of Daklinza's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-161) | Feb 05, 2019 |
| New Dosing Schedule(D-162) | Feb 05, 2019 |
| New Indication(I-726) | Feb 05, 2019 |
| New Indication(I-727) | Feb 05, 2019 |
| New Chemical Entity Exclusivity(NCE) | Jul 24, 2020 |
US patents provide insights into the exclusivity only within the United States, but
Daklinza 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 Daklinza's family patents as well as insights into
ongoing legal events
on those patents.
Daklinza's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Daklinza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 13, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Daklinza Generics:
There are no approved generic versions for Daklinza as of now.
About Daklinza
Daklinza is a drug owned by Bristol-Myers Squibb Co. It is used for treating hepatitis C virus infections. Daklinza uses Daclatasvir Dihydrochloride as an active ingredient. Daklinza was launched by Bristol-Myers Squibb in 2015.
Approval Date:
Daklinza was approved by FDA for market use on 24 July, 2015.
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 Daklinza is 24 July, 2015, its NCE-1 date is estimated to be 25 July, 2019.
Active Ingredient:
Daklinza uses Daclatasvir Dihydrochloride as the active ingredient. Check out other Drugs and Companies using Daclatasvir Dihydrochloride ingredient
Treatment:
Daklinza is used for treating hepatitis C virus infections.
Dosage:
Daklinza is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 60MG BASE | TABLET | Discontinued | ORAL |
| EQ 30MG BASE | TABLET | Discontinued | ORAL |
| EQ 90MG BASE | TABLET | Discontinued | ORAL |