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
(4 years from now) | Active |
| US8642025 | Hepatitis C virus inhibitors |
Aug, 2027
(2 years from now) | Active |
| US9421192 | Hepatitis C virus inhibitors |
Aug, 2027
(2 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). | |||
| US8900566 | Hepatitis C virus inhibitors |
Aug, 2027
(2 years 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 |