SIGNIFOR LAR KIT Drug Patent Profile

When do Signifor Lar Kit patents expire, 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
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	8
Patent Applications:	14
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 Hospital Heidelberg	PHASE2
University of Colorado, Denver	Phase 1
Hospices Civils de Lyon	Phase 2

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

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	203255-002	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	6,225,284
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	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
Czech Republic	2003288
China	1267451
European Patent Office	1686964	COMPOSITION PHARMACEUTIQUE (MICROPARTICLES COMPRISING SOMATOSTATIN ANALOGUES)
China	1878541	Microparticles comprising somatostatin analogues
Uruguay	31103	COMPOSICIONES FARMACEUTICAS EN BASE A MICROPARTICULAS COMPRENDIENDO UN ANALOGO DE SOMATOSTATINA, PROCESO DE PREPARACION Y APLICACIONES
Canada	2541944	COMPOSITION PHARMACEUTIQUE (MICROPARTICLES COMPRISING SOMATOSTATIN ANALOGUES)

Supplementary Protection Certificates for SIGNIFOR LAR KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1686964	92701	Luxembourg		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	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
1686964	C 2015 008	Romania		PRODUCT NAME: PASIREOTIDA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIASAU ORICE HIDRAT AL ACESTEIACICLO[(4R)-4-(2-AMINOETILCARBAMOILOXI)-L-PROLIL-L-FENILGLICIL-D-TRIPTOFIL-L-LISIL-4-O-BENZIL-L-TIROSIL-L-FENILALANIL-); NATIONAL AUTHORISATION NUMBER: EU/1/12/753/013, EU/1/12/753/014, EU/1/12/753/015, EU/1/12/753/016, EU/1/12/753/017; DATE OF NATIONAL AUTHORISATION: 20141119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/753/013, EU/1/12/753/014, EU/1/12/753/015, EU/1/12/753/016, EU/1/12/753/017; DATE OF FIRST AUTHORISATION IN EEA: 20141119
1686964	PA2015009	Lithuania		PRODUCT NAME: PASIREOTIDUM; REGISTRATION NO/DATE: EU/1/12/753/13 - EU/1/12/753/17 20141119
1307486	C01307486/01	Switzerland		PRODUCT NAME: PASIREOTID; REGISTRATION NO/DATE: SWISSMEDIC 61254 02.11.2012
1307486	C300536	Netherlands		PRODUCT NAME: PASIREOTIDE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN HET BIJZONDER PASIREOTIDEDI-ASPARTAAT; REGISTRATION NO/DATE: EU/1/12/753/001-012 20120424

Market Dynamics and Financial Trajectory for SIGNIFOR LAR KIT

Last updated: July 27, 2025

Introduction

SIGNIFOR LAR KIT (pasireotide diasparate), developed and marketed by Novartis, represents a significant advancement in the treatment of acromegaly and Cushing’s disease. As a long-acting somatostatin analog, it offers sustained hormonal suppression with reduced injection frequency. Understanding the market dynamics and financial trajectory of SIGNIFOR LAR KIT involves analyzing the therapeutic landscape, competitive environment, regulatory developments, and commercial strategies impacting its growth potential.

Therapeutic Landscape and Clinical Demand

SIGNIFOR LAR Kit primarily targets acromegaly and Cushing’s disease, rare endocrine disorders characterized by excessive hormone secretion. These conditions, though rare, have significant morbidity and mortality if inadequately managed, creating a sustained unmet medical need. The global prevalence of acromegaly is approximately 3-4 cases per million annually, with roughly 60-80% of patients seeking medical intervention [1]. Cushing’s disease has a prevalence of approximately 40-70 cases per million, with complex management challenges [2].

The increasing recognition of the limitations of traditional therapies—such as surgery and first-generation somatostatin analogs—has bolstered demand for newer, sustained-release formulations like SIGNIFOR LAR KIT. Its convenience of less frequent dosing enhances patient adherence, making it an attractive therapeutic option. Moreover, emerging evidence supporting its efficacy expands its potential use cases, influencing commercial prospects.

Market Dynamics Influencing SIGNIFOR LAR KIT

1. Competitive Environment

The competitive landscape for acromegaly and Cushing’s disease treatments is evolving rapidly:

• Existing Therapies: First-generation somatostatin analogs like octreotide LAR and lanreotide autogel dominate the market, offering quarterly injections. However, they have limitations in efficacy and tolerability, prompting demand for alternatives [3].

• Other Long-Acting Formulations: Recently, newer agents such as pasireotide (SIGNIFOR LAR) have been positioned to carve out market share due to their broader receptor affinity profiles and better hormonal control. Yet, some competing drugs, including oral or subcutaneous therapies, threaten SIGNIFOR LAR's market dominance.

• Emerging Biologics and Personalized Medicine: Advances in targeted therapies and personalized treatment pathways could alter the competitive landscape, especially if biomarkers predict better responders, thus influencing formulary and prescribing preferences.

2. Regulatory Environment

Regulatory agencies in key markets—FDA (U.S.), EMA (Europe), and others—play a vital role. The approval process, labeling extensions, and inclusion in treatment guidelines directly impact sales trajectories:

• FDA Approvals & Labeling: SIGNIFOR LAR received FDA approval for acromegaly in 2014 and for Cushing’s disease in 2019. The expansion of indications and label updates promoting broader use can stimulate sales.

• Guideline Endorsements: Endorsement by professional societies such as endocrinology associations enhances clinician confidence and utilization, influencing market penetration.

3. Reimbursement and Access

Market success hinges on reimbursement policies:

• Insurance Coverage: Favorable reimbursement policies in the U.S. and Europe have facilitated patient access. Negotiations with payers, value-based agreements, and cost-effectiveness data influence formulary inclusion.

• Pricing Strategies: SIGNIFOR LAR, priced higher than traditional analogs owing to its extended dosing interval, depends on payers recognizing its value proposition—such as improved adherence and reduced healthcare utilization.

4. Pricing and Market Penetration

Pricing strategies are critical, especially considering the rarity nature of the diseases treated:

• Premium Pricing: As a specialty biologic, SIGNIFOR LAR is priced at premium levels to reflect R&D investments and clinical benefits. Its market penetration depends on demonstrating cost-effectiveness and capturing a significant share of the treated patient population.

• Patient Adherence and Market Share: Better adherence due to less frequent injections can influence real-world efficacy and outcomes, thus affecting physician prescribing patterns and overall sales.

Financial Trajectory and Revenue Outlook

1. Sales Performance Trends

• Historical Data: Since its initial approval in 2014, SIGNIFOR LAR KIT has experienced gradual but steady revenue growth, driven by increasing diagnosis rates and expanded indications [4].

• Current Market Size: The global market for acromegaly therapeutics is projected to reach approximately $600 million by 2025, with SIGNIFOR LAR accounting for a growing share owing to its unique profile [5].

• Growth Opportunities: The implementation of new clinical data, expanded indications, and increased awareness among healthcare providers portends continued revenue growth. Additionally, the pipeline for Cushing’s disease indications could drive further upside.

2. Key Factors Affecting Revenue Growth

• Market Adoption: Clinicians’ confidence in efficacy and safety profiles influences prescribing patterns. Educational initiatives and real-world evidence will be crucial.

• Patent and Exclusivity Periods: Patent expirations or challenges could impose generic competition, eroding market share unless offset by compelling clinical benefits and patent extensions.

• Pricing and Reimbursement: Fluctuations in pricing strategies and payer negotiations may impact margins. Favorable reimbursement approvals will accelerate uptake.

• Pipeline and Future Indications: Upcoming clinical trials exploring broader uses, including neuroendocrine tumors, might open additional revenue streams.

3. Challenges to Financial Growth

• Market Saturation: As the number of diagnosed patients stabilizes, new patient inflow may plateau.

• Pricing Pressures: Payers’ push for cost containment could limit pricing power.

• Emerging Therapies: Innovations such as oral formulations or novel biologics could disrupt market share.

Regulatory and Competitive Outlook

The outlook for SIGNIFOR LAR KIT's financial trajectory depends on sustained regulatory support and competitive differentiation. Continued clinical successes and favorable reimbursement will sustain revenue growth, while patent expiries and competitive innovations pose challenges.

Key Takeaways

• SIGNIFOR LAR KIT occupies a niche in the treatment of acromegaly and Cushing’s disease, with growth driven by unmet clinical needs, improved dosing convenience, and expanding indications.

• Market penetration is influenced by regulatory approvals, formulary positioning, reimbursement policies, and clinician adoption, which collectively determine revenue trajectory.

• The global rare endocrine disorder market is poised for moderate growth, with SIGNIFOR LAR Kit positioned advantageously, provided it maintains clinical superiority and market access.

• Revenue growth in the coming years hinges on expanding indications, real-world evidence, and strategic negotiations with payers amid increasing competition.

• The potential for generic entrants and emerging therapies could temper long-term financial gains unless augmented by new patent protections or line extensions.

Conclusion

SIGNIFOR LAR KIT’s market dynamics reflect a combination of scientific innovation, strategic positioning, and ongoing health policy developments. Its financial trajectory depends on balancing clinical efficacy, market access, and competitive pressures. For stakeholders, sustained investment in product differentiation and evidence generation will be critical to maximizing its growth potential.

---

FAQs

Q1: What makes SIGNIFOR LAR KIT unique compared to other treatments for acromegaly?
A1: SIGNIFOR LAR KIT’s extended-release formulation allows for less frequent injections, improving adherence and hormonal control, especially in patients who are refractory or intolerant to first-generation analogs.

Q2: How does the regulatory environment impact SIGNIFOR LAR KIT’s sales?
A2: Regulatory approvals and guideline endorsements determine market access and clinician confidence, directly influencing prescribing patterns and revenue.

Q3: What are the main competitive threats to SIGNIFOR LAR KIT?
A3: Competition from other long-acting analogs, emerging oral therapies, and potential biosimilars post-patent expiry pose threats to market share.

Q4: How do reimbursement policies influence the financial performance of SIGNIFOR LAR KIT?
A4: Favorable reimbursement ensures patient access and helps justify premium pricing, while reimbursement restrictions can limit sales growth.

Q5: What future developments could enhance SIGNIFOR LAR KIT's market potential?
A5: New clinical data supporting additional indications, expanded label approvals, and integration into personalized treatment protocols can drive future growth.

---

References

1. Melmed S, et al. Endocrine Reviews. 2019;40(4):307-335.
2. Pivonello R, et al. Lancet Diabetes Endocrinol. 2017;5(6):476-487.
3. Katznelson L, et al. J Clin Endocrinol Metab. 2014;99(4):E591-7.
4. Novartis Annual Reports; 2022.
5. MarketsandMarkets. Acromegaly Therapeutics Market. 2021.