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SIGNIFOR LAR KIT Drug Patent Profile

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

Signifor Lar Kit is a drug marketed by Recordati Rare and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and thirty-five patent family members in fifty-three countries.

The generic ingredient in SIGNIFOR LAR KIT 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 Lar Kit

Signifor Lar Kit 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 May 23, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SIGNIFOR LAR KIT

International Patents:	135
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	7
DailyMed Link:	SIGNIFOR LAR KIT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SIGNIFOR LAR KIT

Constraining patent/regulatory exclusivity:

9,351,923

NDA:

203255

Dosage:

FOR SUSPENSION;INTRAMUSCULAR

^*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 LAR KIT

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

Sponsor	Phase
University of Colorado, Denver	Phase 1
Hospices Civils de Lyon	Phase 2
Zealand University Hospital	Phase 4

See all SIGNIFOR LAR KIT clinical trials

US Patents and Regulatory Information for SIGNIFOR LAR KIT

SIGNIFOR LAR KIT is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 9,351,923.

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 LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-004	Jun 29, 2018		RX	Yes	No	7,473,761		Y	Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014		RX	Yes	Yes	9,351,923		Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-001	Dec 15, 2014		RX	Yes	No	7,473,761		Y	Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-004	Jun 29, 2018		RX	Yes	No
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-005	Jun 29, 2018		RX	Yes	No
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014		RX	Yes	Yes
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-001	Dec 15, 2014		RX	Yes	No

Expired US Patents for SIGNIFOR LAR KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014	8,822,637
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-001	Dec 15, 2014	6,225,284
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014	8,822,637
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014	6,225,284
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014	6,225,284
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-001	Dec 15, 2014	8,822,637

International Patents for SIGNIFOR LAR KIT

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

Country	Patent Number	Title	Estimated Expiration
Portugal	1307486
San Marino	AP200900099	Composizione a rilascio protratto comprendente un derivato della somatostatina in microparticelle
Malaysia	147327	SOMATOSTATIN PEPTIDES
Brazil	PI0112859	análogos de somatostatina, composição farmacêutica, bem como uso dos referidos análogos
South Korea	101930588
Tunisia	2009000447	AN EXTENTED-RELEASE COMPOSITION COMPRISING A SOMATOSTATIN DERIVATIVE IN MICROPARTICLES
Slovakia	1212003	Somatostatin analogues, process for their preparation and pharmaceutical compositions comprising said analogues

Supplementary Protection Certificates for SIGNIFOR LAR KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1307486	2012/027	Ireland		PRODUCT NAME: PASIREOTIDE OR A SALT OR COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/12/753/001-EU/1/12/753/012 20120424
1307486	SPC/GB12/030	United Kingdom		PRODUCT NAME: CYCLO((4R)-4-(2-AMINOETHYLCARBAMOYLOXY)-L-PROLYL-L-PHENYLGLYCYL-D-TRYPTOPHYL-L-LYSYL-4-O-BENZYL-L-TYROSYL-L-PHENYLALANYL-)), PASIREOTIDE, OR SALTS THEREOF; REGISTERED: UK EU/1/12/753/001-012 20120424
1307486	12C0041	France		PRODUCT NAME: CYCLO((4R)-4(2-AMINOETHYLCARBAMOYLOXY)-L-PROLYL-L-PHENYLGLYCYL-D-TRYPTOPHYL-L-LYSYL-4-O-BENZYL-L-TYROSYL-L-PHENYLALANYL-) : PASIREOTIDE, OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/12/753/001 20120424
1686964	15/2015	Austria		PRODUCT NAME: PASIREOTID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/12/753/001-017 IDF DER ENTSCHEIDUNG DER KOMMISSION C (2014) 8916 20141119
1686964	197 5005-2015	Slovakia		PRODUCT NAME: PASIREOTID ALEBO JEHO FARMACEUTICKY PRIJATEL- NA SOL ALEBO AKYKOLVEK JEHO HYDRAT; REGISTRATION NO/DATE: EU/1/12/753/001 - EU/1/12/753/017 20141119
1307486	CA 2012 00024	Denmark
1686964	PA2015009	Lithuania		PRODUCT NAME: PASIREOTIDUM; REGISTRATION NO/DATE: EU/1/12/753/13 - EU/1/12/753/17 20141119

SIGNIFOR LAR KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SIGNIFOR LAR KIT

Introduction

SIGNIFOR LAR KIT, a long-acting release formulation of the somatostatin analog pasireotide, is a crucial treatment option for patients with acromegaly and Cushing’s disease. Here, we delve into the market dynamics and financial trajectory of this drug.

Regulatory Approval and Market Entry

SIGNIFOR LAR KIT received FDA approval in December 2014 for the treatment of patients with acromegaly, marking a significant milestone in the management of this rare hormonal disorder[2][3][5].

Indications and Usage

The drug is indicated for patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option, as well as for patients with Cushing’s disease where pituitary surgery is not an option or has not been curative[3][4].

Patent Protection and Generic Entry

SIGNIFOR LAR KIT is protected by three patents in the US and has 135 patent family members in 53 countries. The earliest estimated date for generic entry is May 23, 2028, although this could be influenced by various factors such as patent challenges, generic licensing, and regulatory exclusivity[1].

Clinical Efficacy and Safety

Clinical trials have demonstrated the efficacy of SIGNIFOR LAR KIT in achieving biochemical control and reducing tumor volume in patients with acromegaly and Cushing’s disease. For example, in a pivotal trial, 15.4% and 20.0% of patients treated with SIGNIFOR LAR 40 mg and 60 mg, respectively, achieved full GH and IGF-1 biochemical control at 6 months[2][5].

However, the drug is associated with significant side effects, including hyperglycemia, cholelithiasis, and hepatic adverse effects. Despite these, the overall safety profile is considered manageable, and the benefits outweigh the risks[2][4].

Market Competition

SIGNIFOR LAR KIT competes in the market with other somatostatin analogs such as octreotide LAR and lanreotide ATG. However, it has shown superior efficacy in normalizing GH and IGF-1 levels in patients who were inadequately controlled by first-generation somatostatin analogs[5].

Financial Performance and Projections

The financial performance of SIGNIFOR LAR KIT is influenced by several factors, including its market exclusivity, pricing, and the size of the patient population.

• Revenue Streams: The drug generates revenue through its prescription sales, primarily in the US and other countries where it is approved. Given its orphan drug status and the critical need it fills, it commands a premium price.
• Market Size: The market for acromegaly and Cushing’s disease treatments is relatively niche but significant due to the high unmet medical need and the lack of effective alternatives.
• Pricing and Reimbursement: The Average Wholesale Price (AWP) for SIGNIFOR LAR KIT is substantial, reflecting its value in treating rare and severe conditions. Reimbursement policies vary by country but generally support the use of this drug due to its clinical benefits[1].

Challenges and Opportunities

Challenges

• Patent Expiry: The potential for generic entry in 2028 poses a significant challenge to the drug's market exclusivity and revenue.
• Side Effects: The drug's side effect profile, particularly the risk of hyperglycemia and diabetes, requires careful patient monitoring and management.
• Regulatory Scrutiny: Continuous regulatory scrutiny and the need for ongoing safety monitoring can impact the drug's market dynamics.

Opportunities

• Expanding Indications: There is potential for expanding the indications of SIGNIFOR LAR KIT to other conditions where somatostatin analogs could be beneficial.
• Global Market Penetration: Further penetration into global markets, especially in regions with growing healthcare infrastructure, can increase revenue.
• Patient Education and Support: Initiatives to educate patients and healthcare providers about the benefits and management of SIGNIFOR LAR KIT can enhance its adoption and retention in the market.

Key Players and Market Share

Recordati Rare Diseases, Inc., and previously Novartis, have played significant roles in the development, marketing, and distribution of SIGNIFOR LAR KIT. The transfer of US marketing rights from Novartis to Recordati Rare Diseases in 2020 has ensured uninterrupted access to the drug for patients and healthcare providers[3].

Financial Projections

Given the drug's strong clinical profile and market position, financial projections indicate continued revenue growth until the potential generic entry in 2028. Here are some key financial metrics:

• Revenue Growth: SIGNIFOR LAR KIT has seen steady revenue growth since its approval, driven by its efficacy and the lack of effective alternatives.
• Market Share: It holds a significant market share in the somatostatin analog segment, particularly in the treatment of acromegaly and Cushing’s disease.
• Cost Management: The high cost of the drug is balanced by its clinical benefits, and reimbursement policies generally support its use.

"SIGNIFOR LAR can cause serious side effects such as high blood sugar levels... Patients should tell their doctor right away if they experience signs and symptoms such as excessive thirst, high urine output, increased appetite with weight loss, and tiredness."[2]

Conclusion

SIGNIFOR LAR KIT is a critical treatment option for patients with acromegaly and Cushing’s disease, offering significant clinical benefits despite its side effect profile. The drug's market dynamics are influenced by its patent protection, clinical efficacy, and the competitive landscape. As the drug approaches its potential generic entry date, managing these factors will be crucial for maintaining its market position.

Key Takeaways

• Regulatory Approval: FDA approval in 2014 for acromegaly and Cushing’s disease.
• Clinical Efficacy: Superior in normalizing GH and IGF-1 levels compared to first-generation somatostatin analogs.
• Patent Protection: Protected by three US patents with an estimated generic entry date of May 23, 2028.
• Market Competition: Competes with other somatostatin analogs but holds a significant market share.
• Financial Performance: Steady revenue growth driven by its clinical benefits and market exclusivity.

FAQs

Q: What is the primary indication for SIGNIFOR LAR KIT?

A: The primary indications are for the treatment of patients with acromegaly and Cushing’s disease for whom pituitary surgery is not an option or has not been curative.

Q: What are the common side effects of SIGNIFOR LAR KIT?

A: Common side effects include hyperglycemia, cholelithiasis, and hepatic adverse effects. Serious side effects can include high blood sugar levels and heart problems.

Q: When is the estimated generic entry date for SIGNIFOR LAR KIT?

A: The estimated generic entry date is May 23, 2028, although this can be influenced by various factors.

Q: Who are the key players involved in the marketing and distribution of SIGNIFOR LAR KIT?

A: Recordati Rare Diseases, Inc., and previously Novartis, have been the key players.

Q: How does SIGNIFOR LAR KIT compare to other somatostatin analogs in terms of efficacy?

A: SIGNIFOR LAR KIT has shown superior efficacy in normalizing GH and IGF-1 levels compared to first-generation somatostatin analogs.

Sources

1. Drug Patent Watch: "SIGNIFOR LAR KIT Drug Patent Profile"
2. Novartis: "Novartis gains FDA approval for Signifor® LAR to treat patients with acromegaly"
3. Recordati Rare Diseases: "SIGNIFOR and LAR Marketing Authorization"
4. Health Canada: "Regulatory Decision Summary for Signifor LAR"
5. FDA: "203255Orig1s000 - accessdata.fda.gov"