Symproic is a drug owned by Biodelivery Sciences International Inc. It is protected by 7 US drug patents filed from 2017 to 2025 out of which none have expired yet. Symproic's patents have been open to challenges since 23 March, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be May 13, 2033. Details of Symproic'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. | |||
| US10952968 | Preparation containing 6,7-unsaturated-7-carbamoyl morphinan derivatives |
May, 2033
(7 years from now) | Active |
| US9108975 | Crystal of 6,7-unsaturated-7-carbamoyl morphinan derivative and method for producing the same |
Nov, 2031
(5 years from now) | Active |
| USRE46365 | 6,7-unsaturated-7-carbamoyl substituted morphinan derivative |
Feb, 2031
(5 years from now) | Active |
| US8084460 | 6,7-unsaturated-7-carbamoyl substituted morphinan derivative |
Jan, 2028
(2 years from now) | Active |
| US8536192 | 6,7-unsaturated-7-carbamoyl substituted morphinan derivative |
Oct, 2026
(10 months from now) | Active |
| USRE46375 | 6,7-unsaturated-7-carbamoyl substituted morphinan derivative |
Oct, 2026
(10 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). | |||
| US12350377 | NA |
May, 2033
(7 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 Symproic's patents.
Latest Legal Activities on Symproic's Patents
Given below is the list of recent legal activities going on the following patents of Symproic.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Feb, 2023 | US9108975 |
| Patent Issue Date Used in PTA Calculation
Critical | 23 Mar, 2021 | US10952968 |
| Recordation of Patent Grant Mailed
Critical | 23 Mar, 2021 | US10952968 |
| Email Notification
Critical | 05 Mar, 2021 | US10952968 |
| Issue Notification Mailed
Critical | 03 Mar, 2021 | US10952968 |
| Email Notification
Critical | 18 Feb, 2021 | US10952968 |
| Mail Response to 312 Amendment (PTO-271)
Critical | 18 Feb, 2021 | US10952968 |
| Printer Rush- No mailing | 18 Feb, 2021 | US10952968 |
| Dispatch to FDC | 17 Feb, 2021 | US10952968 |
| Response to Amendment under Rule 312
Critical | 08 Feb, 2021 | US10952968 |
FDA has granted several exclusivities to Symproic. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Symproic, 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
Symproic.
Exclusivity Information
Symproic holds 1 exclusivities. All of its exclusivities have expired in 2022. Details of Symproic's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 23, 2022 |
US patents provide insights into the exclusivity only within the United States, but
Symproic 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 Symproic's family patents as well as insights into
ongoing legal events
on those patents.
Symproic's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Symproic's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 13, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Symproic Generics:
There are no approved generic versions for Symproic as of now.
Alternative Brands for Symproic
Symproic which is used for treating opioid-induced constipation., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
About Symproic
Symproic is a drug owned by Biodelivery Sciences International Inc. It is used for treating opioid-induced constipation. Symproic uses Naldemedine Tosylate as an active ingredient. Symproic was launched by Bdsi in 2017.
Approval Date:
Symproic was approved by FDA for market use on 23 March, 2017.
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 Symproic is 23 March, 2017, its NCE-1 date is estimated to be 23 March, 2021.
Active Ingredient:
Symproic uses Naldemedine Tosylate as the active ingredient. Check out other Drugs and Companies using Naldemedine Tosylate ingredient
Treatment:
Symproic is used for treating opioid-induced constipation.
Dosage:
Symproic is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.2MG BASE | TABLET | Prescription | ORAL |