Signifor Lar Kit is a drug owned by Recordati Rare Diseases Inc. It is protected by 5 US drug patents filed from 2014 to 2019. Out of these, 3 drug patents are active and 2 have expired. Signifor Lar Kit'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 May 23, 2028. Details of Signifor Lar Kit'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 |
| US6225284 | Somatostatin peptides |
Jun, 2016
(8 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9351923 | Extended-release composition comprising a somatostatin derivative in microparticles |
May, 2028
(3 years from now) | Active |
| US7759308 | Microparticles comprising somatostatin analogues |
Oct, 2026
(1 year, 5 months from now) | Active |
| US8822637 | Somatostatin analogues |
Aug, 2023
(1 year, 9 months 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 Lar Kit's patents.
Latest Legal Activities on Signifor Lar Kit's Patents
Given below is the list of recent legal activities going on the following patents of Signifor Lar Kit.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Court Processing Terminated | 01 Mar, 2024 | US7473761 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Nov, 2023 | US9351923 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Mar, 2022 | US8822637 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Jan, 2022 | US7759308 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Jul, 2020 | US7473761 |
| Change in Power of Attorney (May Include Associate POA) Critical | 04 May, 2020 | US8822637 |
| Change in Power of Attorney (May Include Associate POA) Critical | 01 May, 2020 | US9351923 |
| Filing Receipt - Corrected | 01 May, 2020 | US9351923 |
| Correspondence Address Change Critical | 29 Apr, 2020 | US8822637 |
| Correspondence Address Change Critical | 28 Apr, 2020 | US9351923 |
FDA has granted several exclusivities to Signifor Lar Kit. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Signifor Lar Kit, 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 Lar Kit.
Exclusivity Information
Signifor Lar Kit holds 6 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Signifor Lar Kit's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 14, 2017 |
| New Product(NP) | Dec 15, 2017 |
| New Indication(I-785) | Jun 29, 2021 |
| Orphan Drug Exclusivity(ODE) | Dec 15, 2021 |
| Orphan Drug Exclusivity(ODE-81) | Dec 15, 2021 |
| Orphan Drug Exclusivity(ODE-268) | Jun 29, 2025 |
US patents provide insights into the exclusivity only within the United States, but Signifor Lar Kit 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 Lar Kit's family patents as well as insights into ongoing legal events on those patents.
Signifor Lar Kit's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Signifor Lar Kit's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 23, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Signifor Lar Kit Generics:
There are no approved generic versions for Signifor Lar Kit as of now.
About Signifor Lar Kit
Signifor Lar Kit is a drug owned by Recordati Rare Diseases Inc. It is used for treating conditions related to excess growth hormone secretion, such as acromegaly. Signifor Lar Kit uses Pasireotide Pamoate as an active ingredient. Signifor Lar Kit was launched by Recordati Rare in 2018.
Can you believe Signifor Lar Kit 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 Lar Kit was approved by FDA for market use on 29 June, 2018.
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 Lar Kit is 29 June, 2018, its NCE-1 date is estimated to be 14 December, 2016.
Active Ingredient:
Signifor Lar Kit uses Pasireotide Pamoate as the active ingredient. Check out other Drugs and Companies using Pasireotide Pamoate ingredient
Treatment:
Signifor Lar Kit is used for treating conditions related to excess growth hormone secretion, such as acromegaly.
Dosage:
Signifor Lar Kit is available in for suspension form for intramuscular use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 60MG BASE/VIAL | FOR SUSPENSION | Prescription | INTRAMUSCULAR |
| EQ 10MG BASE/VIAL | FOR SUSPENSION | Prescription | INTRAMUSCULAR |
| EQ 40MG BASE/VIAL | FOR SUSPENSION | Prescription | INTRAMUSCULAR |
| EQ 20MG BASE/VIAL | FOR SUSPENSION | Prescription | INTRAMUSCULAR |
| EQ 30MG BASE/VIAL | FOR SUSPENSION | Prescription | INTRAMUSCULAR |