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Last Updated: March 16, 2025

Hong Kong Company Profile


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Summary for Hong Kong
International Patents:74
US Patents:3
Tradenames:4
Ingredients:4
NDAs:5

Drugs and US Patents for Hong Kong

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Hong Kong EPTIFIBATIDE eptifibatide INJECTABLE;INJECTION 213599-002 May 9, 2024 AP RX No No ⤷  Try for Free ⤷  Try for Free
Hong Kong XENLETA lefamulin acetate SOLUTION;INTRAVENOUS 211673-001 Aug 19, 2019 RX Yes Yes 8,071,643 ⤷  Try for Free Y Y ⤷  Try for Free
Hong Kong XENLETA lefamulin acetate TABLET;ORAL 211672-001 Aug 19, 2019 RX Yes Yes 9,120,727 ⤷  Try for Free Y Y ⤷  Try for Free
Hong Kong XENLETA lefamulin acetate SOLUTION;INTRAVENOUS 211673-001 Aug 19, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free
Hong Kong XENLETA lefamulin acetate TABLET;ORAL 211672-001 Aug 19, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free
Hong Kong XENLETA lefamulin acetate TABLET;ORAL 211672-001 Aug 19, 2019 RX Yes Yes ⤷  Try for Free ⤷  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
Showing 1 to 6 of 6 entries

Expired US Patents for Hong Kong

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Hong Kong XENLETA lefamulin acetate SOLUTION;INTRAVENOUS 211673-001 Aug 19, 2019 6,753,445 ⤷  Try for Free
Hong Kong XENLETA lefamulin acetate TABLET;ORAL 211672-001 Aug 19, 2019 6,753,445 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 2 of 2 entries

Supplementary Protection Certificates for Hong Kong Drugs

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
2137143 132020000000167 Italy ⤷  Try for Free PRODUCT NAME: LEFAMULINA SUOI SALI E SOLVATI(XENLETA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1457, 20200728
2137143 54/2020 Austria ⤷  Try for Free PRODUCT NAME: LEFAMULIN, SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/20/1457 (MITTEILUNG) 20200728
2137143 780 Finland ⤷  Try for Free
2137143 LUC00178 Luxembourg ⤷  Try for Free PRODUCT NAME: LEFAMULINE, SELS ET SOLVATES DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1457 20200728
2137143 SPC/GB20/052 United Kingdom ⤷  Try for Free PRODUCT NAME: LEFAMULIN, OPTIONALLY IN THE FORM OF A SALT AND/OR SOLVATE THEREOF; REGISTERED: UK EU/1/20/1457 (NI) 20200728; UK PLGB 53672/0001 20200728; UK PLGB 53672/0002 20200728
0477295 SPC/GB99/046 United Kingdom ⤷  Try for Free PRODUCT NAME: EPTIFIBATIDE OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: CH 54054 19970227; CH 54050 19970227; UK EU/1/99/109/001 19990701; UK EU/1/99/109/002 19990701
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 6 of 6 entries
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Hong Kong – Market Position, Strengths & Strategic Insights

Hong Kong's pharmaceutical market is experiencing significant growth and transformation, driven by regulatory reforms, demographic shifts, and technological advancements. This comprehensive analysis delves into the competitive landscape of Hong Kong's pharmaceutical sector, exploring market positions, strengths, and strategic insights for industry players.

Market Overview and Growth Projections

Hong Kong's pharmaceutical market is on a trajectory of robust growth. The market is projected to reach $3 billion by 2028, with a compound annual growth rate (CAGR) of 8.1% in US dollar terms[1]. This growth is fueled by various factors, including an aging population, increasing prevalence of chronic diseases, and government initiatives to enhance healthcare infrastructure.

Key Growth Drivers

  1. Rising chronic diseases
  2. Innovative marketing strategies
  3. Introduction of new business models
  4. Upsurge in hospital-based pharmacies and wellness stores

Market Size and Projections

The Hong Kong Retail Pharmacy Market size was around US $XX billion in 2021 and is projected to reach US $XX billion by 2030, exhibiting a CAGR of XX% during the forecast period[4].

Regulatory Environment and Recent Reforms

Hong Kong has recently introduced significant regulatory reforms aimed at streamlining drug approvals and enhancing market access for pharmaceutical companies.

The New 1+ Drug Approval System

Hong Kong's new 1+ drug approval system is a game-changer for the pharmaceutical industry. This reform is designed to accelerate the registration process and reduce the time it takes to bring new medical treatments to market[3].

Key features of the 1+ system include:

  • Reduction in approval timeline from 24 months to 7 months
  • Simplified registration process requiring only one reference drug regulatory authority
  • Acceptance of U.S. FDA approved drugs
"Under the 1+ system, the approval timeline will be reduced from 24 months to just 7 months. The new framework simplifies the registration process by requiring only a registration and free-sale certificate from one of 36 reference drug regulatory authorities, including the U.S. FDA approved drugs."[3]

Direct Applications to Hospital Authority

In a major shift, the Hong Kong Hospital Authority (HA) has started accepting direct applications from pharmaceutical companies for new treatments. This change allows new drugs to move from review to launch in as little as five months, bypassing the earlier two-tier assessment process[3].

Competitive Landscape and Key Players

The Hong Kong pharmaceutical market is characterized by a mix of multinational corporations (MNCs) and local players. Key players in the market include:

  1. CVS Health
  2. Boots Walgreens
  3. Cigna
  4. Walmart
  5. Kroger
  6. Rite Aid Corp.
  7. Lloyd Pharmacy
  8. Well Pharmacy
  9. Humana Pharmacy Solutions
  10. Matsumoto Kiyoshi[4]

Market Leaders and Their Strategies

MSD (Merck & Co.)

MSD has established a strong position in Hong Kong's immuno-oncology market. Their strategy focuses on:

  • Continuous filing for new indications
  • Close collaboration with regulatory authorities
  • Bundling approvals for multiple indications[2]

AstraZeneca

AstraZeneca has identified rare diseases as a significant opportunity in Hong Kong. Their approach includes:

  • Leveraging government funding support for rare diseases
  • Exploring opportunities in the Greater Bay Area[2]

Novartis

Novartis is navigating the regulatory landscape for advanced therapy products (ATPs) in Hong Kong. Their focus is on:

  • Adapting to the separate pathway for ATP approvals
  • Obtaining necessary certificates from regulatory bodies like the U.S. FDA or EMA[2]

Market Dynamics and Trends

Public vs. Private Healthcare

Hong Kong's healthcare system is characterized by a dual-track structure, with both public and private sectors playing crucial roles. The public sector, managed by the Hospital Authority, serves over 90% of the population through 43 public hospitals and more than 70 specialist outpatient clinics[3].

Physician Dispensing vs. Retail Pharmacies

Hong Kong's pharmaceutical market is unique due to its physician-dispensing model. This system has significant implications for retail pharmacies:

  • Retail pharmacists primarily focus on over-the-counter (OTC) drugs
  • Physician dispensing remains a lucrative income source for doctors, clinics, and hospitals
  • Separation of prescribing and dispensing is unlikely due to the powerful doctors' lobby[5]

Patented Drugs vs. Generics

The market shows a clear divide between patented and generic drugs:

  • Patented hi-tech drugs, primarily imported, are expected to drive market growth
  • Generic drug prices are being forced down by the Hospital Authority's volume purchasing and prescribing policies
  • Multinational generic drug-makers dominate the generics market, alongside local firms with strict quality control[5]

Strategic Opportunities and Challenges

Opportunities

  1. Clinical Research and Development: Hong Kong's cost and epidemiological considerations make it an attractive base for clinical research and medical trials[5].

  2. Integration with Greater Bay Area: Hong Kong's integration with the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) provides significant market opportunities[6].

  3. Biotech Fundraising: Hong Kong has positioned itself as a premier destination for biotech IPOs, supported by a favorable listing regime and government financial backing[6].

  4. CEPA Benefits: The Closer Economic Partnership Arrangement (CEPA) offers zero tariffs for Hong Kong-origin products and provides flexibility for Hong Kong service suppliers in the mainland healthcare market[6].

Challenges

  1. Small Market Size: Despite its growth, Hong Kong remains a relatively small market compared to Mainland China, Taiwan, and South Korea[5].

  2. Competition from Neighboring Markets: Well-established clinical trial infrastructures and global networks in regions like Mainland China and South Korea may divert investment away from Hong Kong[1].

  3. Limited Reimbursement for Innovative Therapies: Relatively fewer innovative therapies are reimbursed in Hong Kong, posing downside risks to drugmakers[9].

Future Outlook and Strategic Recommendations

Future Outlook

  1. Establishment of Hong Kong Drug Approval Authority: The Hong Kong government plans to establish its own drug approval authority within the next 8-10 years, enhancing its autonomy in the drug registration process[3].

  2. Growth in Chronic Disease Management: The high burden of non-communicable diseases presents strong revenue-earning opportunities for both pharmaceutical and medical devices firms[5].

  3. Expansion of Primary Care System: Hong Kong's primary care system is expected to improve to address the needs of its aging population in disease prevention and management of chronic diseases[5].

Strategic Recommendations

  1. Focus on Innovative Therapies: Given the projected growth in chronic diseases, companies should prioritize the development and marketing of innovative therapies for these conditions.

  2. Leverage Regulatory Reforms: Pharmaceutical companies should take advantage of the new 1+ drug approval system to accelerate market entry for their products.

  3. Explore Rare Disease Opportunities: The strong ecosystem for orphan drugs in Hong Kong presents a unique opportunity for companies specializing in rare disease treatments.

  4. Invest in R&D and Clinical Trials: Hong Kong's position as an attractive base for clinical research should be leveraged to conduct cutting-edge R&D and clinical trials.

  5. Strengthen Partnerships: Collaborations with local institutions, academia, and medical experts can help build a more favorable ecosystem and drive scientific advancements.

Key Takeaways

  • Hong Kong's pharmaceutical market is projected to reach $3 billion by 2028, growing at a CAGR of 8.1%.
  • Recent regulatory reforms, including the 1+ drug approval system, have significantly streamlined market entry for pharmaceutical companies.
  • The market is characterized by a mix of multinational corporations and local players, with opportunities in both patented and generic drug segments.
  • Strategic opportunities lie in clinical research, integration with the Greater Bay Area, and biotech fundraising.
  • Future growth will be driven by the aging population, increasing chronic diseases, and improvements in the primary care system.
  • Companies should focus on innovative therapies, leverage regulatory reforms, and explore opportunities in rare diseases to succeed in the Hong Kong pharmaceutical market.

FAQs

  1. Q: What is the projected size of Hong Kong's pharmaceutical market by 2028? A: Hong Kong's pharmaceutical market is projected to reach $3 billion by 2028.

  2. Q: What is the new 1+ drug approval system in Hong Kong? A: The 1+ drug approval system is a regulatory reform that reduces the approval timeline from 24 months to 7 months and simplifies the registration process by requiring approval from only one reference drug regulatory authority.

  3. Q: How does the physician-dispensing model affect retail pharmacies in Hong Kong? A: The physician-dispensing model in Hong Kong limits retail pharmacies primarily to focusing on over-the-counter (OTC) drugs, as physicians typically dispense prescription medications directly.

  4. Q: What are the main opportunities for pharmaceutical companies in Hong Kong? A: Key opportunities include clinical research and development, integration with the Greater Bay Area, biotech fundraising, and leveraging CEPA benefits for market access in mainland China.

  5. Q: How is Hong Kong addressing the needs of its aging population in terms of healthcare? A: Hong Kong is working on improving its primary care system to better address disease prevention and management of chronic diseases for its aging population.

Sources cited: [1] https://healthcareasiamagazine.com/healthcare/news/hong-kong-pharmaceutical-market-be-valued-3b-2028 [2] https://pharmaboardroom.com/articles/hong-kong-local-market-insights-from-mnc-heads/ [3] https://www.trade.gov/market-intelligence/hong-kong-healthcare-drug-system [4] https://www.insights10.com/report/hong-kong-retail-pharmacy-market-analysis/ [5] https://biopharmaapac.com/news/73/282/the-changing-hong-kong-healthcare-market.html [6] https://www.incorp.asia/hong-kong/blogs/hong-kong-biotechnology-medical-healthcare-outlook/ [9] https://store.fitchsolutions.com/pharmaceuticals-healthcare/hong-kong-china-pharmaceuticals-report

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