Zhengda Tianqing Successfully Challenges Pfizer's Patent: On Track to Capture $8 Billion First-to-File Market
Aug 22, 2018 08:26
CST Updated
08:26
Pfizer
Pharmaceutical R&D Developer
CHIATAI TIANQING
High-quality pharmaceuticals research, production, and sales provider
【China Pharmaceutical Network Corporate News] Patents are the most direct barrier for domestic enterprises to engage in the production and sale of pharmaceuticals. The successful patent challenge by CHIATAI TIANQING means that the generic replication of this drug can be accelerated onto the agenda, potentially jeopardizing Pfizer’s $8 billion market.
Recently, the China National Intellectual Property Administration issued a “Decision on Examination of Request for Invalidation,” declaring that all of Pfizer’s core compound patents for the JAK inhibitor tofacitinib are invalid.
The First Oral Disease-Modifying Antirheumatic Drug in 10 Years
JAK inhibitors are drugs developed to target JAK kinases, primarily used for the treatment of hematologic disorders, tumors, rheumatoid arthritis, psoriasis, and other conditions.
Tofacitinib Citrate (generic name: Tofacitinib Citrate; brand name: Xeljanz) is indicated for adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to or intolerance to methotrexate. It may be used in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs). It is the first oral DMARD approved for the treatment of RA in a decade.
Data shows that Pfizer’s tofacitinib citrate has been approved for use in more than 50 countries worldwide, and the drug is also recommended by treatment guidelines from multiple international organizations, including the European Alliance of Associations for Rheumatology (EULAR), the American College of Rheumatology (ACR), and the Asia Pacific League of Associations for Rheumatology (APLAR).
On November 6, 2012, this product was first launched in the United States. Data show that its global sales exceeded $927 million in 2016. It is the first oral JAK inhibitor approved for the treatment of rheumatoid arthritis (RA).
On March 16, 2017, the China Food and Drug Administration (CFDA) officially approved the marketing application for Pfizer’s oral JAK inhibitor, tofacitinib citrate tablets, marking it as the fourth imported product to benefit from the priority review pathway in 2017.
On February 23, 2016, the extended-release formulation was approved by the FDA for marketing, becoming the first once-daily oral medication approved for the treatment of rheumatoid arthritis (RA).
Pharmaceuticals account for an RMB 8 billion market, benchmarked against the RMB 11.5 billion rheumatoid arthritis market size
According to data from Menet, Pfizer’s tofacitinib citrate has seen continuous growth in global sales over the past five years. In 2016, sales exceeded US$927 million, representing a year-on-year increase of 77.25%. In 2017, sales rose to US$1.345 billion, surpassing the US$1 billion mark. Since then, tofacitinib citrate has become one of Pfizer’s global blockbuster drugs.
Rheumatoid arthritis, as a chronic inflammatory autoimmune disease, can cause a series of symptoms including pain and swelling in the joints. Statistics show that approximately 4 million rheumatoid arthritis patients in China are suffering from this condition. However, the remission rate among patients is only 8.6%, while the disability rate is about 50.3%.
Meanwhile, data from Menet shows that in 2015, the market size for rheumatoid arthritis drugs in China’s public medical institutions—including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers—exceeded RMB 11.5 billion.
As a blockbuster drug for rheumatoid arthritis, tofacitinib citrate has significant market potential and promising prospects.
“The King of First Generics” May Secure Another Victory
As seen in the “Decision on Examination of Request for Invalidation,” all of Pfizer’s core patents—specifically the compound patents—for its JAK inhibitor tofacitinib were declared invalid, from which CHIATAI TIANQING benefited significantly.
Publicly available information shows that CHIATAI TIANQING has 16 products with annual sales exceeding RMB 100 million, among which two have surpassed RMB 1 billion in sales, accounting for half of the performance of its parent company, China Biopharmaceutical.
Among these 16 products with annual sales exceeding RMB 100 million, there are 7 for liver disease, 6 antineoplastic agents, and 2 anti-infective agents.Respiratory System MedicationsThere is one. Among the seven drugs for liver diseases, three are exclusive products of Chia Tai Tianqing Pharmaceutical Group Co., Ltd., and two of them have sales exceeding 1 billion yuan, indicating that the field of liver disease is the company's dominant area; among the six anti-tumor drugs, Decitabine for Injection, Imatinib Mesylate Capsules, and Dasatinib Tablets are all domestically first-to-market generic products, which has also established its position as the "King of First Generics."
According to data from Yaozhi.com, more than 30 pharmaceutical companies in China have filed applications for generic versions of tofacitinib, among which,Active Pharmaceutical Ingredient (API)Jiangsu Aosaite Pharmaceutical was the first to receive clinical trial approval, while CHIATAI TIANQING was the first to have its formulation product approved.
Pursuant to Article 46, Paragraph 2 of the Patent Law, if Pfizer is dissatisfied with this decision, it may file a lawsuit with the Beijing Intellectual Property Court within three months from the date of receipt of the notification.
If Pfizer does not file a lawsuit within the next three months, CHIATAI TIANQING's tofacitinib is likely to secure approval as the first generic version and enter the market ahead of schedule.
The “King of First Generics” is set to claim another victory.
Original Title: CHIATAI TIANQING Successfully Challenges Pfizer! The 8 Billion First-to-Market Generic Drug Shows Promise Compiled by: Xiao Wan
Recently, the China National Intellectual Property Administration issued a “Decision on Examination of Request for Invalidation,” declaring that all of Pfizer’s core compound patents for the JAK inhibitor tofacitinib are invalid.
The First Oral Disease-Modifying Antirheumatic Drug in 10 Years
JAK inhibitors are drugs developed to target JAK kinases, primarily used for the treatment of hematologic disorders, tumors, rheumatoid arthritis, psoriasis, and other conditions.
Tofacitinib Citrate (generic name: Tofacitinib Citrate; brand name: Xeljanz) is indicated for adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to or intolerance to methotrexate. It may be used in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs). It is the first oral DMARD approved for the treatment of RA in a decade.
Data shows that Pfizer’s tofacitinib citrate has been approved for use in more than 50 countries worldwide, and the drug is also recommended by treatment guidelines from multiple international organizations, including the European Alliance of Associations for Rheumatology (EULAR), the American College of Rheumatology (ACR), and the Asia Pacific League of Associations for Rheumatology (APLAR).
On November 6, 2012, this product was first launched in the United States. Data show that its global sales exceeded $927 million in 2016. It is the first oral JAK inhibitor approved for the treatment of rheumatoid arthritis (RA).
On March 16, 2017, the China Food and Drug Administration (CFDA) officially approved the marketing application for Pfizer’s oral JAK inhibitor, tofacitinib citrate tablets, marking it as the fourth imported product to benefit from the priority review pathway in 2017.
On February 23, 2016, the extended-release formulation was approved by the FDA for marketing, becoming the first once-daily oral medication approved for the treatment of rheumatoid arthritis (RA).
Pharmaceuticals account for an RMB 8 billion market, benchmarked against the RMB 11.5 billion rheumatoid arthritis market size
According to data from Menet, Pfizer’s tofacitinib citrate has seen continuous growth in global sales over the past five years. In 2016, sales exceeded US$927 million, representing a year-on-year increase of 77.25%. In 2017, sales rose to US$1.345 billion, surpassing the US$1 billion mark. Since then, tofacitinib citrate has become one of Pfizer’s global blockbuster drugs.
Rheumatoid arthritis, as a chronic inflammatory autoimmune disease, can cause a series of symptoms including pain and swelling in the joints. Statistics show that approximately 4 million rheumatoid arthritis patients in China are suffering from this condition. However, the remission rate among patients is only 8.6%, while the disability rate is about 50.3%.
Meanwhile, data from Menet shows that in 2015, the market size for rheumatoid arthritis drugs in China’s public medical institutions—including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers—exceeded RMB 11.5 billion.
As a blockbuster drug for rheumatoid arthritis, tofacitinib citrate has significant market potential and promising prospects.
“The King of First Generics” May Secure Another Victory
As seen in the “Decision on Examination of Request for Invalidation,” all of Pfizer’s core patents—specifically the compound patents—for its JAK inhibitor tofacitinib were declared invalid, from which CHIATAI TIANQING benefited significantly.
Publicly available information shows that CHIATAI TIANQING has 16 products with annual sales exceeding RMB 100 million, among which two have surpassed RMB 1 billion in sales, accounting for half of the performance of its parent company, China Biopharmaceutical.
Among these 16 products with annual sales exceeding RMB 100 million, there are 7 for liver disease, 6 antineoplastic agents, and 2 anti-infective agents.Respiratory System MedicationsThere is one. Among the seven drugs for liver diseases, three are exclusive products of Chia Tai Tianqing Pharmaceutical Group Co., Ltd., and two of them have sales exceeding 1 billion yuan, indicating that the field of liver disease is the company's dominant area; among the six anti-tumor drugs, Decitabine for Injection, Imatinib Mesylate Capsules, and Dasatinib Tablets are all domestically first-to-market generic products, which has also established its position as the "King of First Generics."
According to data from Yaozhi.com, more than 30 pharmaceutical companies in China have filed applications for generic versions of tofacitinib, among which,Active Pharmaceutical Ingredient (API)Jiangsu Aosaite Pharmaceutical was the first to receive clinical trial approval, while CHIATAI TIANQING was the first to have its formulation product approved.
Pursuant to Article 46, Paragraph 2 of the Patent Law, if Pfizer is dissatisfied with this decision, it may file a lawsuit with the Beijing Intellectual Property Court within three months from the date of receipt of the notification.
If Pfizer does not file a lawsuit within the next three months, CHIATAI TIANQING's tofacitinib is likely to secure approval as the first generic version and enter the market ahead of schedule.
The “King of First Generics” is set to claim another victory.
Original Title: CHIATAI TIANQING Successfully Challenges Pfizer! The 8 Billion First-to-Market Generic Drug Shows Promise Compiled by: Xiao Wan