Signifor is a drug owned by Recordati Rare Diseases Inc. It is protected by 3 US drug patents filed in 2013. Out of these, 2 drug patents are active and 1 has expired. Signifor's patents have been open to challenges since 14 December, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 14, 2026. Details of Signifor'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. | |||
| US7473761 | Somatostatin analogues |
Dec, 2026
(1 year, 7 months from now) | Active |
| US8299209 | Pharmaceutical composition comprising cyclic somatostatin analogues |
Dec, 2025
(7 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). | |||
| US6225284 | Somatostatin peptides |
Jun, 2016
(8 years ago) |
Expired
|
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 Signifor's patents.
Latest Legal Activities on Signifor's Patents
Given below is the list of recent legal activities going on the following patents of Signifor.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 30 Apr, 2024 | US8299209 |
| Court Processing Terminated | 01 Mar, 2024 | US7473761 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Jul, 2020 | US7473761 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Apr, 2020 | US8299209 |
| Case Docketed to Examiner in GAU Critical | 30 Mar, 2020 | US7473761 |
| Correspondence Address Change Critical | 12 Mar, 2020 | US8299209 |
| Change in Power of Attorney (May Include Associate POA) Critical | 12 Mar, 2020 | US8299209 |
| Patent Term Extension Certificate Critical | 24 Oct, 2017 | US7473761 |
| Case Docketed to Examiner in GAU Critical | 27 Jul, 2017 | US7473761 |
| Notice of Final Determination -Eligible | 11 Jul, 2017 | US7473761 |
FDA has granted several exclusivities to Signifor. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Signifor, 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 Signifor.
Exclusivity Information
Signifor holds 3 exclusivities. All of its exclusivities have expired in 2019. Details of Signifor's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 14, 2017 |
| Orphan Drug Exclusivity(ODE) | Dec 14, 2019 |
| Orphan Drug Exclusivity(ODE-34) | Dec 14, 2019 |
US patents provide insights into the exclusivity only within the United States, but Signifor 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 Signifor's family patents as well as insights into ongoing legal events on those patents.
Signifor's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Signifor's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 14, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Signifor Generics:
There are no approved generic versions for Signifor as of now.
About Signifor
Signifor is a drug owned by Recordati Rare Diseases Inc. Signifor uses Pasireotide Diaspartate as an active ingredient. Signifor was launched by Recordati Rare in 2012.
Can you believe Signifor received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Signifor was approved by FDA for market use on 14 December, 2012.
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 Signifor is 14 December, 2012, its NCE-1 date is estimated to be 14 December, 2016.
Active Ingredient:
Signifor uses Pasireotide Diaspartate as the active ingredient. Check out other Drugs and Companies using Pasireotide Diaspartate ingredient
Dosage:
Signifor is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML) | SOLUTION | Prescription | SUBCUTANEOUS |