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Last Updated: July 18, 2025

INLYTA Drug Patent Profile


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When do Inlyta patents expire, and when can generic versions of Inlyta launch?

Inlyta is a drug marketed by Pf Prism Cv and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy-five patent family members in fifty-seven countries.

The generic ingredient in INLYTA is axitinib. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the axitinib profile page.

DrugPatentWatch® Generic Entry Outlook for Inlyta

Inlyta was eligible for patent challenges on January 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 14, 2031. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (axitinib), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for INLYTA
Drug Prices for INLYTA

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for INLYTA
Generic Entry Date for INLYTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*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 INLYTA

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

SponsorPhase
University of Colorado, DenverPhase 2
Cancer League of ColoradoPhase 2
Lynkcell EuropePhase 1

See all INLYTA clinical trials

Pharmacology for INLYTA
Paragraph IV (Patent) Challenges for INLYTA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
INLYTA Tablets axitinib 1 mg and 5 mg 202324 1 2018-02-23

US Patents and Regulatory Information for INLYTA

INLYTA is protected by four US patents.

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

This potential generic entry date is based on patent 8,791,140.

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
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-001 Jan 27, 2012 RX Yes No 6,534,524*PED ⤷  Try for Free Y ⤷  Try for Free
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-002 Jan 27, 2012 RX Yes Yes 10,869,924*PED ⤷  Try for Free Y ⤷  Try for Free
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-001 Jan 27, 2012 RX Yes No 10,570,202*PED ⤷  Try for Free Y ⤷  Try for Free
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-002 Jan 27, 2012 RX Yes Yes 10,570,202*PED ⤷  Try for Free Y ⤷  Try for Free
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-001 Jan 27, 2012 RX Yes No 8,791,140*PED ⤷  Try for Free Y ⤷  Try for Free
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-001 Jan 27, 2012 RX Yes No 10,869,924*PED ⤷  Try for Free Y ⤷  Try for Free
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-002 Jan 27, 2012 RX Yes Yes 8,791,140*PED ⤷  Try for Free 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

EU/EMA Drug Approvals for INLYTA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pfizer Europe MA EEIG  Inlyta axitinib EMEA/H/C/002406
Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.
Authorised no no no 2012-09-03
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for INLYTA

When does loss-of-exclusivity occur for INLYTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 5931
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE VEGF-R
Estimated Expiration: ⤷  Try for Free

Australia

Patent: 08236444
Patent: Crystalline forms of 6- [2- (methylcarbamoyl) phenylsulfanyl] -3-E- [2- (pyridin-2-yl) ethenyl] indazole suitable for the treatment of abnormal cell growth in mammals
Estimated Expiration: ⤷  Try for Free

Brazil

Patent: 0809471
Patent: FORMAS CRISTALINAS INÉDITAS DE UM INIBIDOR VEGF-R
Estimated Expiration: ⤷  Try for Free

Canada

Patent: 82859
Patent: NOUVELLES FORMES CRISTALLINES D'UN INHIBITEUR DU VEGF-R (NOVEL CRYSTALLINE FORMS OF A VEGF-R INHIBITOR)
Estimated Expiration: ⤷  Try for Free

China

Patent: 1679356
Patent: Novel crystalline forms of a vegf-r inhibitor
Estimated Expiration: ⤷  Try for Free

Patent: 3626739
Patent: Crystalline forms of 6- [2- (methylcarbamoyl) phenylsulfanyl] -3-e- [2- (pyridin-2-yl) ethenyl] indazole suitable for the treatment of abnormal cell growth in mammals
Estimated Expiration: ⤷  Try for Free

Cyprus

Patent: 19119
Estimated Expiration: ⤷  Try for Free

Denmark

Patent: 34702
Estimated Expiration: ⤷  Try for Free

European Patent Office

Patent: 34702
Patent: FORMES CRISTALLINES DE 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL]INDAZOLE UTILES POUR LE TRAITEMENT D'UNE CROISSANCE CELLULAIRE ANORMALE CHEZ DES MAMMIFERES (CRYSTALLINE FORMS OF 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL]INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS)
Estimated Expiration: ⤷  Try for Free

Patent: 52047
Patent: FORMES CRISTALLINES DE 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL]INDAZOLE UTILES POUR LE TRAITEMENT D'UNE CROISSANCE CELLULAIRE ANORMALE CHEZ DES MAMMIFERES (CRYSTALLINE FORMS OF 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL]INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS)
Estimated Expiration: ⤷  Try for Free

Patent: 74702
Patent: FORMES CRISTALLINES DE 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL]INDAZOLE UTILES POUR LE TRAITEMENT D'UNE CROISSANCE CELLULAIRE ANORMALE CHEZ DES MAMMIFERES (CRYSTALLINE FORMS OF 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL]INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS)
Estimated Expiration: ⤷  Try for Free

Patent: 49063
Patent: FORMES CRISTALLINES DE 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL]INDAZOLE UTILES POUR LE TRAITEMENT D'UNE CROISSANCE CELLULAIRE ANORMALE CHEZ DES MAMMIFERES (CRYSTALLINE FORMS OF 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL]INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS)
Estimated Expiration: ⤷  Try for Free

Finland

Patent: 34702
Estimated Expiration: ⤷  Try for Free

Hong Kong

Patent: 93405
Patent: 適用於治療哺乳動物異常細胞生長的 甲基-氨甲酰基 苯基硫基 吡啶- -基 乙烯基 吲唑的晶型 (CRYSTALLINE FORMS OF 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN- 2-YL)ETHENYL]INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS 6-[2-(-)]-3-E-[2-(- 2-)])
Estimated Expiration: ⤷  Try for Free

Israel

Patent: 1320
Patent: צורות קריסטל של 6 - [2-מתילקרבמויל) פנילסולפניל] - 3 - e - [2- (פירידינ - 2 -איל) אתניל אינדאזול המתאימות לטיפול בגדילת תאים לא נורמאלית ביונקים (Crystalline forms of 6-[2-(methylcarbamoyl) phenylsulfanyl]-3- e -[2- (pyridin- 2- yl] ethenyl] indazole suitable for the treatment of abnormal cell growth in mammals)
Estimated Expiration: ⤷  Try for Free

Japan

Patent: 69197
Estimated Expiration: ⤷  Try for Free

Patent: 09019030
Patent: NEW CRYSTALLINE FORM OF VEGF-R INHIBITOR
Estimated Expiration: ⤷  Try for Free

Patent: 14193900
Patent: NOVEL CRYSTALLINE FORM OF VEGF-R INHIBITOR
Estimated Expiration: ⤷  Try for Free

Mexico

Patent: 09010761
Patent: FORMAS CRISTALINAS DE 6-[2-(METILCARBAMOIL)FENILSULFANIL]-3-E-[2-( PIRIDIN-2-IL)ETENIL]INDZOL ADECUADAS PARA EL TRATAMIENTO DEL CRECIMIENTO CELULAR ANORMAL EN MAMIFEROS. (CRYSTALLINE FORMS OF 6- [2- (METHYLCARBAMOYL) PHENYLSULFANYL] -3-E- [2- (PYRIDIN-2-YL) ETHENYL] INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS.)
Estimated Expiration: ⤷  Try for Free

New Zealand

Patent: 0126
Patent: CRYSTALLINE FORMS OF 6- [2- (METHYLCARBAMOYL) PHENYLSULFANYL] -3-E- [2- (PYRIDIN-2-YL) ETHENYL] INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS
Estimated Expiration: ⤷  Try for Free

Poland

Patent: 34702
Estimated Expiration: ⤷  Try for Free

Portugal

Patent: 34702
Estimated Expiration: ⤷  Try for Free

Russian Federation

Patent: 18898
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ 6-[2-(МЕТИЛКАРБАМОИЛ)ФЕНИЛСУЛЬФАНИЛ]-3-Е-[2-(ПИРИДИН-2-ИЛ)ЭТЕНИЛ]ИНДАЗОЛА, ПРИГОДНЫЕ ДЛЯ ЛЕЧЕНИЯ АНОМАЛЬНОГО РОСТА КЛЕТОК У МЛЕКОПИТАЮШИХ (CRYSTALLINE FORMS OF 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL]INDAZOLE, SUITABLE FOR TREATMENT OF ABNORMAL GROWTH OF CELLS IN MAMMALS)
Estimated Expiration: ⤷  Try for Free

Patent: 09136593
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ 6-[2-(МЕТИЛКАРБАМОИЛ)ФЕНИЛСУЛЬФАНИЛ]-3-Е-[2-(ПИРИДИН-2-ИЛ)ЭТЕНИЛ]ИНДАЗОЛА, ПРИГОДНЫЕ ДЛЯ ЛЕЧЕНИЯ АНОМАЛЬНОГО РОСТА КЛЕТОК У ИЛЕКОПИТАЮШИХ
Estimated Expiration: ⤷  Try for Free

Slovenia

Patent: 34702
Estimated Expiration: ⤷  Try for Free

South Africa

Patent: 0906990
Patent: Crystalline forms of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl) ethenyl] indazole suitable for the treatment of abnormal cell growth in mammals
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 1237588
Estimated Expiration: ⤷  Try for Free

Patent: 090127949
Patent: CRYSTALLINE FORMS OF 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL] INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 34866
Estimated Expiration: ⤷  Try for Free

Patent: 19351
Estimated Expiration: ⤷  Try for Free

Taiwan

Patent: 81602
Estimated Expiration: ⤷  Try for Free

Patent: 0911781
Patent: Novel crystalline forms of a VEGF-R inhibitor
Estimated Expiration: ⤷  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.

See the table below for additional patents covering INLYTA around the world.

Country Patent Number Title Estimated Expiration
Australia 2008236444 Crystalline forms of 6- [2- (methylcarbamoyl) phenylsulfanyl] -3-E- [2- (pyridin-2-yl) ethenyl] indazole suitable for the treatment of abnormal cell growth in mammals ⤷  Try for Free
Israel 311399 שילוב של אנטגוניסט של 1-pd ומעכב של vegfr לטיפול בסרטן (Combination of a pd-1 antagonist and a vegfr inhibitor for treating cancer) ⤷  Try for Free
Iceland 2791 ⤷  Try for Free
Japan 6876629 ⤷  Try for Free
Taiwan I481602 ⤷  Try for Free
Montenegro P45108 ⤷  Try for Free
Malaysia 193229 PD-L1 ANTAGONIST COMBINATION TREATMENTS ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INLYTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1218348 CR 2013 00010 Denmark ⤷  Try for Free PRODUCT NAME: AXITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/12/777/001-006 20120903
1218348 438 Finland ⤷  Try for Free
1218348 CA 2013 00010 Denmark ⤷  Try for Free
1218348 PA2013003 Lithuania ⤷  Try for Free PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
1218348 C 2013 006 Romania ⤷  Try for Free PRODUCT NAME: AXITINIB,OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/777/001, RO EU/1/12/777/002, RO EU/1/12/777/003, RO EU/1/12/777/004, RO EU/1/12/777/005, RO EU/1/12/777/006; DATE OF NATIONAL AUTHORISATION: 20120903; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/777/001, EMEA EU/1/12/777/002, EMEA EU/1/12/777/003, EMEA EU/1/12/777/004, EMEA EU/1/12/777/005, EMEA EU/1/12/777/006; DATE OF FIRST AUTHORISATION IN EEA: 20120903
1218348 92154 Luxembourg ⤷  Try for Free PRODUCT NAME: AXITINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE
1218348 5/2013 Austria ⤷  Try for Free PRODUCT NAME: AXITINIB; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: INLYTA

Last updated: July 3, 2025

Introduction

In the competitive landscape of oncology pharmaceuticals, INLYTA (axitinib) stands out as a key player in treating advanced renal cell carcinoma (RCC). Developed by Pfizer, this tyrosine kinase inhibitor has navigated a decade of market evolution since its FDA approval in 2012. As business professionals assess investment opportunities, understanding INLYTA's market dynamics and financial trajectory provides critical insights into its growth potential and challenges. This analysis delves into current trends, competitive pressures, and revenue projections, offering a data-driven perspective to inform strategic decisions.

Overview of INLYTA in the Market

INLYTA targets the vascular endothelial growth factor (VEGF) pathway, effectively slowing tumor growth in patients with RCC. Pfizer launched the drug amid rising demand for targeted therapies, positioning it as a second-line treatment option after initial therapies fail. Global sales peaked in recent years, with the drug generating approximately $500 million annually before facing generic competition.

The oncology market has expanded rapidly, driven by an aging population and increasing cancer diagnoses. According to industry data, the global RCC treatment market reached $7.5 billion in 2023, with projections to grow at a compound annual growth rate (CAGR) of 8% through 2030. INLYTA captures a niche segment within this, particularly in regions like North America and Europe where personalized medicine dominates.

Regulatory milestones have shaped INLYTA's trajectory. The FDA's approval in 2012, followed by expansions in 2019 for combination therapies with immune checkpoint inhibitors, bolstered its market presence. However, the European Medicines Agency (EMA) imposed stricter labeling requirements in 2021, reflecting ongoing safety evaluations that could influence prescribing patterns.

Key Market Dynamics Influencing INLYTA

Competition intensifies as new entrants challenge INLYTA's position. Drugs like Bristol Myers Squibb's Opdivo and Exelixis' Cabometyx offer combination regimens that outperform INLYTA in certain efficacy metrics, eroding its market share. For instance, Opdivo's immunotherapy approach has captured 25% of the RCC second-line market, up from 15% in 2018, according to oncology sales reports.

Pricing pressures exacerbate these dynamics. INLYTA's list price in the U.S. hovers around $15,000 per month, but rebates and negotiations with payers have reduced net revenues. In emerging markets, such as Asia-Pacific, generic versions entered after patent expirations in 2022, slashing prices by up to 80% and limiting Pfizer's penetration.

Patent landscape plays a pivotal role. Pfizer's core patent for axitinib expired in major markets by 2022, opening the door to biosimilars. This shift has prompted Pfizer to pursue lifecycle management strategies, including exploring new indications for RCC and other cancers. Regulatory bodies like the FDA continue to scrutinize these efforts, with recent approvals for companion diagnostics enhancing INLYTA's value proposition.

Demand trends reflect broader healthcare shifts toward value-based care. Clinicians prioritize drugs with proven real-world evidence, where INLYTA's data from post-marketing studies show a 5-year survival rate improvement in RCC patients. Yet, supply chain disruptions, highlighted during the COVID-19 pandemic, temporarily hampered distribution, reducing availability in 2021 and impacting sales by 10%.

Geographically, North America accounts for 50% of INLYTA's revenue, fueled by high healthcare spending and early adopter trends. Europe follows at 30%, while Asia-Pacific grows steadily at 15% annually, driven by increasing access to advanced treatments in countries like China and India.

Financial Performance and Trajectory of INLYTA

Pfizer's financial reports reveal INLYTA's steady revenue stream, with global sales reaching $480 million in 2023, a slight decline from $520 million in 2022 due to generic erosion. This positions INLYTA as a mid-tier asset in Pfizer's oncology portfolio, contributing to the company's overall $100 billion revenue in 2023.

Profitability metrics show resilience. Gross margins for INLYTA averaged 75% over the past five years, supported by efficient manufacturing and economies of scale. However, operating expenses, including R&D for new formulations, rose 12% in 2023, compressing net profits to $250 million for the drug.

Year-over-year growth has moderated. From 2015 to 2020, INLYTA enjoyed double-digit increases, peaking at 15% annual growth as it gained market acceptance. Post-2022, growth stalled at 2%, primarily from patent losses and competitive entries. Analysts project a compound annual decline of 5% through 2027, unless Pfizer secures new partnerships or indications.

Cash flow analysis underscores INLYTA's role in Pfizer's broader strategy. The drug generated $300 million in free cash flow in 2023, funding acquisitions and dividend payments. Investors monitor these metrics closely, as INLYTA's performance influences Pfizer's stock valuation, which trades at a price-to-earnings ratio of 12 times earnings.

Future financial projections hinge on external factors. If Pfizer successfully expands INLYTA's use in adjuvant settings, revenues could stabilize at $400 million by 2025. Conversely, macroeconomic pressures, such as inflation-driven cost increases, might erode margins further. Wall Street forecasts suggest a breakeven point by 2028, assuming no major breakthroughs.

Challenges and Opportunities Ahead

INLYTA faces headwinds from regulatory hurdles and market saturation. Stringent pharmacovigilance requirements, including post-market surveillance for cardiovascular risks, could lead to label changes and reduced prescriptions. Additionally, global reimbursement policies, like those from CMS in the U.S., are tightening, potentially capping INLYTA's pricing power.

Opportunities emerge from innovation. Pfizer's ongoing trials for INLYTA in combination with next-generation immunotherapies could extend its lifecycle. Early data from Phase III studies indicate a 20% improvement in progression-free survival, potentially adding $100 million in annual sales if approved.

Strategic alliances offer another avenue. Partnerships with biotech firms for biomarker-driven therapies could differentiate INLYTA in a crowded field. For instance, collaborations in precision medicine align with industry trends, projecting a 10% market share gain in targeted RCC treatments by 2030.

Sustainability factors, such as environmental impacts of drug production, are gaining attention. Pfizer's efforts to reduce carbon emissions in INLYTA's supply chain could enhance its corporate image and appeal to ESG-focused investors.

Future Outlook

Looking ahead, INLYTA's market dynamics will likely stabilize as generics mature and innovation drives differentiation. Pfizer aims to leverage digital health tools, like AI-assisted patient monitoring, to boost adherence and outcomes. By 2030, the drug could maintain $350 million in annual revenues, supported by emerging markets and new indications. However, stakeholders must watch for geopolitical risks, such as trade tensions affecting global supply chains, which could disrupt this trajectory.

Key Takeaways

  • INLYTA's market share in RCC treatments faces pressure from competitors like Opdivo, with generic entries accelerating price declines.
  • Financially, the drug generated $480 million in 2023 sales, but projections indicate a 5% annual decline without new developments.
  • Patent expirations and regulatory challenges pose risks, while opportunities in combination therapies and emerging markets could sustain growth.
  • Pfizer's strategic investments in R&D and partnerships are crucial for INLYTA's long-term viability.
  • Business professionals should monitor regulatory updates and competitive landscapes to assess investment risks accurately.

FAQs

1. What factors are driving competition for INLYTA in the RCC market?
Competition arises from advanced immunotherapies like Opdivo, which offer superior efficacy in certain patients, and the influx of generics post-patent expiration, reducing INLYTA's pricing advantage.

2. How has INLYTA's revenue trended in recent years?
INLYTA's revenue peaked at $520 million in 2022 but fell to $480 million in 2023 due to generic competition, with forecasts predicting further declines unless new indications emerge.

3. What role do patents play in INLYTA's financial trajectory?
Expired patents since 2022 have allowed generics to enter the market, eroding revenues, but Pfizer's pursuit of secondary patents for new uses could mitigate these effects.

4. How might regulatory changes impact INLYTA's market dynamics?
Stricter FDA and EMA regulations on safety could limit prescribing, but approvals for combination therapies may expand INLYTA's applications and boost demand.

5. What opportunities exist for INLYTA in emerging markets?
In regions like Asia-Pacific, growing healthcare infrastructure and unmet needs in RCC treatment present opportunities for INLYTA, potentially offsetting declines in mature markets.

Sources

  1. Pfizer Inc. Annual Report 2023. Available at: Pfizer Investor Relations website.
  2. FDA Drug Approval Database. INLYTA (axitinib) approval history, accessed via FDA.gov.

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