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Last Updated: December 23, 2024

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inlyta Drug Patent Profile


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

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-four 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 ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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 ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-002 Jan 27, 2012 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-001 Jan 27, 2012 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-002 Jan 27, 2012 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-001 Jan 27, 2012 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>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: ⤷  Subscribe

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: ⤷  Subscribe

Brazil

Patent: 0809471
Patent: FORMAS CRISTALINAS INÉDITAS DE UM INIBIDOR VEGF-R
Estimated Expiration: ⤷  Subscribe

Canada

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

China

Patent: 1679356
Patent: Novel crystalline forms of a vegf-r inhibitor
Estimated Expiration: ⤷  Subscribe

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: ⤷  Subscribe

Cyprus

Patent: 19119
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 34702
Estimated Expiration: ⤷  Subscribe

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: ⤷  Subscribe

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: ⤷  Subscribe

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: ⤷  Subscribe

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: ⤷  Subscribe

Finland

Patent: 34702
Estimated Expiration: ⤷  Subscribe

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: ⤷  Subscribe

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: ⤷  Subscribe

Japan

Patent: 69197
Estimated Expiration: ⤷  Subscribe

Patent: 09019030
Patent: NEW CRYSTALLINE FORM OF VEGF-R INHIBITOR
Estimated Expiration: ⤷  Subscribe

Patent: 14193900
Patent: NOVEL CRYSTALLINE FORM OF VEGF-R INHIBITOR
Estimated Expiration: ⤷  Subscribe

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: ⤷  Subscribe

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: ⤷  Subscribe

Poland

Patent: 34702
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 34702
Estimated Expiration: ⤷  Subscribe

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: ⤷  Subscribe

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: ⤷  Subscribe

Slovenia

Patent: 34702
Estimated Expiration: ⤷  Subscribe

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: ⤷  Subscribe

South Korea

Patent: 1237588
Estimated Expiration: ⤷  Subscribe

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: ⤷  Subscribe

Spain

Patent: 34866
Estimated Expiration: ⤷  Subscribe

Patent: 19351
Estimated Expiration: ⤷  Subscribe

Taiwan

Patent: 81602
Estimated Expiration: ⤷  Subscribe

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

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
Costa Rica 6517 COMPUESTOS DE INDAZOLE Y COMPOSICIONES FARMACEUTICAS PARA LA INHIBICION DE LA PROTEINA CINASA Y METODOS PARA SU USO ⤷  Subscribe
Denmark 1614683 ⤷  Subscribe
Canada 3210360 ASSOCIATION D'UN ANTAGONISTE DU PD-1 ET D'UN INHIBITEUR DU VEGFR POUR TRAITER LE CANCER (COMBINATION OF A PD-1 ANTAGONIST AND A VEGFR INHIBITOR FOR TREATING CANCER) ⤷  Subscribe
New Zealand 516676 Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use ⤷  Subscribe
Spain 2296014 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for inlyta

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1218348 13C0010 France ⤷  Subscribe PRODUCT NAME: AXITINIB, ET OPTIONNELLEMENT SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/777/001 20120903
1218348 5/2013 Austria ⤷  Subscribe PRODUCT NAME: AXITINIB; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
1218348 2013C/015 Belgium ⤷  Subscribe PRODUCT NAME: AXITINIB; AUTHORISATION NUMBER AND DATE: EU/1/12/777/001 20120905
1218348 PA2013003 Lithuania ⤷  Subscribe PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
1218348 CA 2013 00010 Denmark ⤷  Subscribe
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Inlyta Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Inlyta

Introduction to Inlyta

Inlyta, with the active substance axitinib, is a tyrosine kinase inhibitor used to treat adults with advanced renal cell carcinoma (RCC), a type of kidney cancer. It works by blocking vascular endothelial growth factor (VEGF) receptors, thereby reducing the growth and spread of cancer cells and cutting off their blood supply[1].

Market Overview of Kidney Cancer Drugs

The global kidney cancer drugs market has been experiencing significant growth, driven by an increasing number of patients suffering from kidney cancer. This growth is attributed to factors such as unhealthy diets, pollution, and lifestyle changes. The market was valued at USD 2.6 billion in 2013 and was expected to reach USD 4.5 billion by 2020, growing at a CAGR of 6.6%[3].

Competitive Landscape

The kidney cancer drugs market is highly competitive and fragmented, with both established and emerging players. To stay competitive, companies are adopting strategies such as mergers, collaborations, and significant investments in research and development. The market dominance is shared among various drugs, including Inlyta, Votrient (pazopanib), Avastin (bevacizumab), Torisel (temsirolimus), and newer immunotherapies like Opdivo and Keytruda[3].

Efficacy and Clinical Performance of Inlyta

Inlyta has demonstrated efficacy in treating advanced RCC, particularly in patients who have failed previous treatments with other cancer medicines such as sunitinib or cytokines. In a key study involving 723 patients, Inlyta showed better outcomes compared to sorafenib, with patients on Inlyta living an average of 6.7 months without disease progression, compared to 4.7 months for those on sorafenib[1].

Side Effects and Safety Profile

While Inlyta is effective, it comes with a range of side effects, including diarrhea, hypertension, fatigue, dysphonia, nausea, vomiting, decreased appetite, weight loss, and palmar-plantar erythrodysaesthesia syndrome. The most common Grade 3/4 adverse reactions include hypertension, diarrhea, and fatigue. Despite these side effects, the European Medicines Agency (EMA) has concluded that the benefits of Inlyta outweigh its risks[1][5].

Financial Performance and Revenue

Inlyta is a part of Pfizer's oncology portfolio, which has seen significant financial activity. While Pfizer's overall revenues have been impacted by the decline in COVID-related products like Comirnaty and Paxlovid, the company's oncology segment has shown resilience. Excluding contributions from COVID-related products, Pfizer's revenues have grown operationally, driven in part by the performance of its oncology products, including Inlyta[2][4].

Revenue Projections and Market Impact

The global revenue for Inlyta, along with other kidney cancer drugs, has been steadily increasing. For instance, the global Inlyta market revenue was tracked from 2012 to 2020, showing a consistent growth trend. While specific recent revenue figures for Inlyta alone are not provided, the overall growth in the kidney cancer drugs market and Pfizer's operational revenue growth suggest a positive financial trajectory for Inlyta[3].

Regional Market Analysis

North America is expected to be a key region for the growth of the kidney cancer drugs market, including Inlyta, due to the increasing demand for effective treatments and the presence of well-developed healthcare infrastructure and favorable reimbursement policies[3].

Challenges and Opportunities

Despite the growth potential, the kidney cancer drugs market, including Inlyta, faces challenges such as the high cost of medications and treatment methodologies. However, the introduction of novel drugs like immunotherapies and the expansion of online sales platforms are expected to boost market growth. The market is also driven by the rising geriatric population and changes in lifestyle, which increase the incidence of kidney cancer[3].

Strategic Initiatives and Cost Savings

Pfizer, the manufacturer of Inlyta, has been implementing various strategic initiatives to optimize its operations and reduce costs. For example, the company launched a manufacturing optimization program aimed at achieving approximately $1.5 billion in cost savings by the end of 2027. These initiatives are expected to enhance the financial performance and competitiveness of Pfizer's oncology products, including Inlyta[4].

Key Takeaways

  • Efficacy: Inlyta has shown superior efficacy in treating advanced RCC compared to other treatments like sorafenib.
  • Market Growth: The global kidney cancer drugs market is growing, driven by increasing patient numbers and demand for effective treatments.
  • Financial Performance: Despite overall revenue declines due to COVID-related products, Pfizer's oncology segment, including Inlyta, has shown operational growth.
  • Challenges: High treatment costs and competitive market dynamics are key challenges.
  • Strategic Initiatives: Pfizer's cost-saving programs and strategic acquisitions are expected to enhance the financial trajectory of Inlyta.

FAQs

Q: What is Inlyta used for? A: Inlyta is used to treat adults with advanced renal cell carcinoma (RCC), a type of kidney cancer.

Q: How does Inlyta work? A: Inlyta works by blocking VEGF receptors, reducing the growth and spread of cancer cells and cutting off their blood supply.

Q: What are the common side effects of Inlyta? A: Common side effects include diarrhea, hypertension, fatigue, dysphonia, nausea, vomiting, and decreased appetite.

Q: How does Inlyta compare to other treatments? A: Inlyta has shown better outcomes compared to sorafenib in treating advanced RCC, with patients on Inlyta living longer without disease progression.

Q: What are the financial projections for Pfizer's oncology segment, including Inlyta? A: Pfizer's oncology segment is expected to grow operationally, driven by new product launches and cost-saving initiatives, despite declines in COVID-related revenues.

Cited Sources

  1. European Medicines Agency (EMA). Inlyta | European Medicines Agency (EMA).
  2. Pfizer. Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance.
  3. Transparency Market Research. Kidney Cancer Drugs Market- Global Industry Analysis 2020.
  4. Pfizer. Pfizer Reports Strong Second-Quarter 2024 Results And Raises Full-Year Guidance.
  5. Pfizer. INLYTA® (axitinib) Efficacy Measures | 2nd-Line | Safety Info.

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