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Last Updated: February 12, 2025

SIGNIFOR Drug Patent Profile


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Which patents cover Signifor, and what generic alternatives are available?

Signifor is a drug marketed by Recordati Rare and is included in two NDAs. There are four patents protecting this drug.

This drug has eighty-seven patent family members in thirty-nine countries.

The generic ingredient in SIGNIFOR is pasireotide pamoate. One supplier is listed for this compound. Additional details are available on the pasireotide pamoate profile page.

DrugPatentWatch® Generic Entry Outlook for Signifor

Signifor was eligible for patent challenges on December 14, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 14, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for SIGNIFOR
International Patents:87
US Patents:2
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 8
Clinical Trials: 7
Patent Applications: 262
Drug Prices: Drug price information for SIGNIFOR
What excipients (inactive ingredients) are in SIGNIFOR?SIGNIFOR excipients list
DailyMed Link:SIGNIFOR at DailyMed
Drug patent expirations by year for SIGNIFOR
Drug Prices for SIGNIFOR

See drug prices for SIGNIFOR

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SIGNIFOR
Generic Entry Date for SIGNIFOR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SIGNIFOR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Colorado, DenverPhase 1
Hospices Civils de LyonPhase 2
Zealand University HospitalPhase 4

See all SIGNIFOR clinical trials

Pharmacology for SIGNIFOR

US Patents and Regulatory Information for SIGNIFOR

SIGNIFOR is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SIGNIFOR is ⤷  Try for Free.

This potential generic entry date is based on patent ⤷  Try for Free.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Recordati Rare SIGNIFOR pasireotide diaspartate SOLUTION;SUBCUTANEOUS 200677-001 Dec 14, 2012 RX Yes No ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-005 Jun 29, 2018 RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-003 Dec 15, 2014 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-004 Jun 29, 2018 RX Yes No ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Recordati Rare SIGNIFOR pasireotide diaspartate SOLUTION;SUBCUTANEOUS 200677-002 Dec 14, 2012 RX Yes No ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for SIGNIFOR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Recordati Rare SIGNIFOR pasireotide diaspartate SOLUTION;SUBCUTANEOUS 200677-001 Dec 14, 2012 ⤷  Try for Free ⤷  Try for Free
Recordati Rare SIGNIFOR pasireotide diaspartate SOLUTION;SUBCUTANEOUS 200677-002 Dec 14, 2012 ⤷  Try for Free ⤷  Try for Free
Recordati Rare SIGNIFOR pasireotide diaspartate SOLUTION;SUBCUTANEOUS 200677-003 Dec 14, 2012 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SIGNIFOR

See the table below for patents covering SIGNIFOR around the world.

Country Patent Number Title Estimated Expiration
Czech Republic 2003288 ⤷  Try for Free
Iceland 8247 Lyfjablanda sem felur í sér hringtengdar vaxtarhormónsandvakahliðstæður ⤷  Try for Free
European Patent Office 0835263 PEPTIDES DE SOMATOSTATINE (SOMATOSTATIN PEPTIDES) ⤷  Try for Free
Norway 331093 ⤷  Try for Free
South Africa 200509741 Pharmaceutical composition comprising cyclic smatostin analogues ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SIGNIFOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1307486 2012C/026 Belgium ⤷  Try for Free PRODUCT NAME: PASIREOTIDE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/12/753/001 20120426
1686964 92701 Luxembourg ⤷  Try for Free PRODUCT NAME: PASIREOTIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE OU UN HYDRATE QUI EN DERIVE; AUTHORISATION NUMBER AND DATE: EU/1/12/753 SIGNIFOR-PASIREOTIDE 20141121
1307486 CA 2012 00024 Denmark ⤷  Try for Free
1648934 C20120019 00062 Estonia ⤷  Try for Free PRODUCT NAME: SIGNIFOR-PASIREOTIID;REG NO/DATE: C(2012) 2910 FINAL 24.04.2012
1686964 C01686964/01 Switzerland ⤷  Try for Free PRODUCT NAME: PASIREOTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65148 25.02.2015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for SIGNIFOR

Introduction

SIGNIFOR, also known as pasireotide, is a pivotal drug in the treatment of rare endocrine disorders, particularly Cushing's disease and acromegaly. This article delves into the market dynamics and financial trajectory of SIGNIFOR, providing insights into its current market size, growth prospects, and the factors influencing its financial performance.

Market Size and Growth Prospects

The global market for SIGNIFOR drugs was estimated to be worth US$ 104.5 million in 2023. It is forecasted to reach a readjusted size of US$ 125 million by 2030, with a Compound Annual Growth Rate (CAGR) of 2.5% during the forecast period of 2024-2030[1].

Key Market Segments

By Type

The SIGNIFOR market is segmented by type, with formulations available in 0.3mg/ml, 0.6mg/ml, and 0.9mg/ml concentrations. These different formulations cater to various patient needs and treatment regimens[1][4].

By Application

The primary applications of SIGNIFOR include treatment in hospitals and pharmacies. The drug is indicated for adult patients with Cushing's disease who have had an inadequate response to surgery or for whom surgery is not an option, as well as for patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option[2][3].

By Region

The market is analyzed at global, regional, and country levels. The regional analysis helps in understanding the market's performance in different geographic areas, which is crucial for strategic planning and expansion[4].

Financial Trajectory

Revenue and Cost Analysis

The daily cost of pasireotide, the active ingredient in SIGNIFOR, is significant, with a recommended dose of 600 mcg to 900 mcg twice daily costing approximately $171 per day, or $62,427 annually[3].

Economic Analysis

The pharmacoeconomic analysis of SIGNIFOR highlights the drug's cost-effectiveness. However, the simplicity of the manufacturer's economic analysis and the lack of a control group in clinical studies complicate the assessment of its cost-effectiveness. The analysis includes scenarios where patients are assessed at three and six months, with nonresponders discontinued from treatment after these periods[3].

Competitive Landscape

Key Players

The main player in the SIGNIFOR market is Recordati Rare Diseases, which acquired the rights to the drug from Novartis Pharmaceuticals Corporation. This acquisition has significant implications for the market dynamics, as it influences the distribution, pricing, and marketing strategies[1][5].

Clinical Efficacy and Safety

Treatment Outcomes

SIGNIFOR is clinically proven to treat Cushing's disease by reducing the excess release of hormones. It has shown improvements in cortisol levels, blood pressure, body mass index, weight, and waist circumference. However, individual patient responses vary, and some studies lack a control group, making it challenging to attribute all improvements solely to the drug[5].

Adverse Events

Common adverse events associated with SIGNIFOR include high blood sugar (hyperglycemia), gallstones (cholelithiasis), nausea, headache, abdominal pain, fatigue, and asthenia. These side effects are significant and must be monitored by healthcare providers[3][5].

Market Drivers and Restraints

Drivers

  • Increasing Prevalence of Rare Endocrine Disorders: The growing incidence of Cushing's disease and acromegaly drives the demand for effective treatments like SIGNIFOR.
  • Clinical Efficacy: The drug's proven ability to reduce cortisol levels and improve symptoms of Cushing's disease is a key driver.
  • Market Expansion: Strategic acquisitions and partnerships, such as Recordati Rare Diseases acquiring the rights from Novartis, can expand the market reach[4].

Restraints

  • High Treatment Costs: The significant daily and annual costs of pasireotide can be a barrier to access for many patients.
  • Side Effects: The potential for serious adverse events, such as hyperglycemia and cholelithiasis, can impact patient compliance and overall market growth.
  • Simplistic Economic Analysis: The lack of comprehensive economic analysis complicates the assessment of the drug's cost-effectiveness[3][4].

Technological and Regulatory Trends

Regulatory Approvals

SIGNIFOR was approved by the FDA in December 2012 for the treatment of adult patients with Cushing's disease and later for acromegaly. Regulatory approvals are crucial for market expansion and acceptance[2].

Technological Advancements

The subcutaneous administration of SIGNIFOR, which is self-administered or administered by a caregiver, represents a technological advancement in the treatment of endocrine disorders. This ease of administration can improve patient compliance and quality of life[5].

Consumer Behavior and Market Attractiveness

Patient Preferences

Patients and caregivers prefer treatments that are easy to administer and have a favorable safety profile. The self-administered nature of SIGNIFOR aligns with these preferences, making it more attractive in the market[5].

Market Attractiveness

The market attractiveness of SIGNIFOR is influenced by its clinical efficacy, ease of administration, and the growing demand for treatments of rare endocrine disorders. However, the high cost and potential side effects are factors that need to be addressed to enhance market attractiveness[4].

COVID-19 Impact

The COVID-19 pandemic has had various impacts on the pharmaceutical industry, including disruptions in supply chains and changes in healthcare priorities. However, the demand for essential treatments like SIGNIFOR has remained relatively stable, as these drugs are critical for managing chronic conditions[1].

Key Takeaways

  • Market Size and Growth: The SIGNIFOR market is projected to grow from US$ 104.5 million in 2023 to US$ 125 million by 2030, with a CAGR of 2.5%.
  • Clinical Efficacy: SIGNIFOR is clinically proven to treat Cushing's disease and acromegaly by reducing hormone levels.
  • Financial Trajectory: The drug's high treatment costs and potential side effects are significant factors influencing its financial performance.
  • Market Drivers and Restraints: Increasing prevalence of rare endocrine disorders and clinical efficacy drive the market, while high costs and adverse events are restraints.
  • Technological and Regulatory Trends: Regulatory approvals and technological advancements in administration are key trends.

FAQs

What is the forecasted market size of SIGNIFOR by 2030?

The forecasted market size of SIGNIFOR by 2030 is US$ 125 million[1].

What are the primary applications of SIGNIFOR?

The primary applications of SIGNIFOR include the treatment of adult patients with Cushing's disease and acromegaly in hospitals and pharmacies[2][3].

What are the common adverse events associated with SIGNIFOR?

Common adverse events include high blood sugar (hyperglycemia), gallstones (cholelithiasis), nausea, headache, abdominal pain, fatigue, and asthenia[3][5].

Who is the main player in the SIGNIFOR market?

The main player in the SIGNIFOR market is Recordati Rare Diseases[1][5].

How is SIGNIFOR administered?

SIGNIFOR is administered subcutaneously, either self-administered or by a caregiver, twice daily[5].

Sources

  1. Valuates Reports: "Signifor Drugs - Market Size" - [Valuates Reports][1]
  2. FDA: "203255Orig1s000 - accessdata.fda.gov" - [FDA][2]
  3. CADTH Common Drug Review: "CDR Pharmacoeconomic Review Report for Signifor" - [CADTH][3]
  4. Cognitive Market Research: "Signifor Drugs Market Report 2024 (Global Edition)" - [Cognitive Market Research][4]
  5. SIGNIFOR.com: "Home | SIGNIFOR® (pasireotide)" - [SIGNIFOR.com][5]

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.