Expiring Drug Patents Cheat Sheet
We analyse the patents covering drugs in 134 countries and quickly give you the likely loss-of-exclusivity/generic entry date

Hong Kong: These 16 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "Hong Kong: These 16 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026" DrugPatentWatch.com thinkBiotech, 2025 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
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These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents covering drugs. Many factors can influence early or late generic entry. This information is provided as a rough estimate of generic entry potential and should not be used as an independent source. The methodology is described in this blog post.

When can CAMCEVI KIT (leuprolide mesylate) generic drug versions launch?

Generic name: leuprolide mesylate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: January 18, 2026
Generic Entry Controlled by: Hong Kong Patent 1,126,975
Patent Title: PHARMACEUTICAL COMPOSITIONS WITH ENHANCED STABILITY

CAMCEVI KIT is a drug marketed by Accord. There are five patents protecting this drug.

This drug has thirty-nine patent family members in nineteen countries.

The generic ingredient in CAMCEVI KIT is leuprolide mesylate. There are twenty-two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the leuprolide mesylate profile page.

When can LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: March 31, 2026
Generic Entry Controlled by: Hong Kong Patent 1,131,331
Patent Title: OCULAR ALLERGY TREATMENTS

LASTACAFT is a drug marketed by Abbvie. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has forty-six patent family members in thirty countries. There has been litigation on patents covering LASTACAFT

See drug price trends for LASTACAFT.

The generic ingredient in LASTACAFT is alcaftadine. There are six drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the alcaftadine profile page.

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: Hong Kong Patent 1,172,549

TRADJENTA is a drug marketed by Boehringer Ingelheim. There are eleven patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has four hundred and eighty-six patent family members in forty-five countries. There has been litigation on patents covering TRADJENTA

See drug price trends for TRADJENTA.

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.

When can TRINTELLIX (vortioxetine hydrobromide) generic drug versions launch?

Generic name: vortioxetine hydrobromide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 16, 2026
Generic Entry Controlled by: Hong Kong Patent 1,134,483
Patent Title: 1- [2- (2, 4-DIMETHYLPHENYLSULFANYL)-PHENYL] PIPERAZINE AS A COMPOUND WITH COMBINED SEROTONIN REUPTAKE, 5-HT3 AND 5-HT1A ACTIVITY FOR THE TREATMENT OF COGNITIVE IMPAIRMENT

TRINTELLIX is a drug marketed by Takeda Pharms Usa. There are ten patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has two hundred and seventeen patent family members in forty-two countries. There has been litigation on patents covering TRINTELLIX

See drug price trends for TRINTELLIX.

The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the vortioxetine hydrobromide profile page.

When can EMBEDA (morphine sulfate; naltrexone hydrochloride) generic drug versions launch?

Generic name: morphine sulfate; naltrexone hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: Hong Kong Patent 1,173,980

EMBEDA is a drug marketed by Alpharma Pharms. There are nine patents protecting this drug and four Paragraph IV challenges.

This drug has seventy-four patent family members in twenty-three countries.

See drug price trends for EMBEDA.

The generic ingredient in EMBEDA is morphine sulfate; naltrexone hydrochloride. There are twenty-three drug master file entries for this API. Additional details are available on the morphine sulfate; naltrexone hydrochloride profile page.

When can XADAGO (safinamide mesylate) generic drug versions launch?

Generic name: safinamide mesylate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: Hong Kong Patent 1,130,245

XADAGO is a drug marketed by Mdd Us. There are three patents protecting this drug.

This drug has ninety-seven patent family members in thirty-one countries. There has been litigation on patents covering XADAGO

See drug price trends for XADAGO.

The generic ingredient in XADAGO is safinamide mesylate. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the safinamide mesylate profile page.

When can VAFSEO (vadadustat) generic drug versions launch?

Generic name: vadadustat
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 26, 2026
Generic Entry Controlled by: Hong Kong Patent 1,129,369
Patent Title: PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE

VAFSEO is a drug marketed by Akebia. There are thirteen patents protecting this drug.

This drug has two hundred and sixty patent family members in forty-eight countries. There has been litigation on patents covering VAFSEO

The generic ingredient in VAFSEO is vadadustat. One supplier is listed for this generic product. Additional details are available on the vadadustat profile page.

When can BYDUREON (exenatide synthetic) generic drug versions launch?

Generic name: exenatide synthetic
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Hong Kong Patent 1,127,359

BYDUREON is a drug marketed by Astrazeneca Ab. There are eleven patents protecting this drug.

This drug has three hundred and forty-six patent family members in forty-eight countries. There has been litigation on patents covering BYDUREON

See drug price trends for BYDUREON.

The generic ingredient in BYDUREON is exenatide synthetic. There are seven drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the exenatide synthetic profile page.

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Hong Kong Patent 1,127,359

FARXIGA is a drug marketed by Astrazeneca Ab. There are nineteen patents protecting this drug and one Paragraph IV challenge. Sixteen tentatively approved generics are ready to enter the market.

This drug has four hundred and fifty-one patent family members in fifty-two countries. There has been litigation on patents covering FARXIGA

See drug price trends for FARXIGA.

The generic ingredient in FARXIGA is dapagliflozin. There are twenty-six drug master file entries for this API. Five suppliers are listed for this generic product. Additional details are available on the dapagliflozin profile page.

When can QTERN (dapagliflozin; saxagliptin hydrochloride) generic drug versions launch?

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Hong Kong Patent 1,127,359

QTERN is a drug marketed by Astrazeneca Ab. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and thirteen patent family members in forty-eight countries. There has been litigation on patents covering QTERN

See drug price trends for QTERN.

The generic ingredient in QTERN is dapagliflozin; saxagliptin hydrochloride. There are twenty-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.

When can CREON (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 15, 2026
Generic Entry Controlled by: Hong Kong Patent 1,119,559
Patent Title: PANCREATIN MICROPELLET CORES SUITABLE FOR ENTERIC COATING

CREON is a drug marketed by

This drug has three hundred and thirteen patent family members in forty-eight countries.

See drug price trends for CREON.

The generic ingredient in CREON is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can ESBRIET (pirfenidone) generic drug versions launch?

Generic name: pirfenidone
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2026
Generic Entry Controlled by: Hong Kong Patent 1,117,762

ESBRIET is a drug marketed by Genentech Inc. There are twenty patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has two hundred and sixty-six patent family members in forty-six countries. There has been litigation on patents covering ESBRIET

See drug price trends for ESBRIET.

The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this API. Twenty-four suppliers are listed for this generic product. Additional details are available on the pirfenidone profile page.

When can KORSUVA (difelikefalin acetate) generic drug versions launch?

Generic name: difelikefalin acetate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2026
Generic Entry Controlled by: Hong Kong Patent 1,130,814
Patent Title: SYNTHETIC PEPTIDE AMIDES

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug.

This drug has fifty-three patent family members in twenty-seven countries. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. One supplier is listed for this generic product. Additional details are available on the difelikefalin acetate profile page.

When can XALKORI (crizotinib) generic drug versions launch?

Generic name: crizotinib
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 23, 2026
Generic Entry Controlled by: Hong Kong Patent 1,126,477

XALKORI is a drug marketed by Pf Prism Cv. There are five patents protecting this drug.

This drug has one hundred and fifty-two patent family members in forty-eight countries.

See drug price trends for XALKORI.

The generic ingredient in XALKORI is crizotinib. One supplier is listed for this generic product. Additional details are available on the crizotinib profile page.

When can BEVYXXA (betrixaban) generic drug versions launch?

Generic name: betrixaban
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: Hong Kong Patent 1,134,031

BEVYXXA is a drug marketed by Portola Pharms Inc. There are five patents protecting this drug.

This drug has sixty-seven patent family members in twenty-six countries. There has been litigation on patents covering BEVYXXA

See drug price trends for BEVYXXA.

The generic ingredient in BEVYXXA is betrixaban. Additional details are available on the betrixaban profile page.

When can VYKAT XR (diazoxide choline) generic drug versions launch?

Generic name: diazoxide choline
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 20, 2026
Generic Entry Controlled by: Hong Kong Patent 1,117,078
Patent Title: SALTS OF POTASSIUM ATP CHANNEL OPENERS AND USES THEREOF

VYKAT XR is a drug marketed by Soleno Therap. There are six patents protecting this drug.

This drug has seventy-eight patent family members in twenty-two countries.

The generic ingredient in VYKAT XR is diazoxide choline. There are five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the diazoxide choline profile page.

Last updated: December 27, 2025

Executive Summary

Hong Kong presents a unique pharmaceutical landscape characterized by a small population (~7.4 million [1]) and a highly developed healthcare system. Its pharmaceutical market includes both branded and generic medicines, influenced heavily by regional dynamics, historical policies, and international trade agreements. The city-state functions as a significant gateway for pharmaceutical companies targeting Asian markets, necessitating an understanding of local regulations, market drivers, and regulatory opportunities.

Key insights include:

The market size for pharmaceuticals in Hong Kong was valued at approximately HKD 8.3 billion (USD 1.07 billion) in 2022, with a compound annual growth rate (CAGR) of around 3.2% over five years [2].
The generic drug sector is expanding, driven by cost-containment policies, though branded drugs maintain a significant market share.
Regulatory agencies, primarily the Hong Kong Department of Health's Drug Office, are aligned with international standards but possess distinct policies affecting drug registration and marketing.
The regulatory environment offers opportunities for innovative therapies through fast-track approvals but also poses challenges due to stringent requirements and competition.
Key challenges involve navigating patent protections, registration timelines, and the need for local manufacturing or registration variations.

Market Overview: Size, Key Players, and Trends

Aspect	Details
Market size (2022)	HKD 8.3 billion (~USD 1.07 billion) [2]
Growth rate (2017-2022)	3.2% CAGR [2]
Market segmentation	Branded medicines (~55%), Generics (~35%), Biologics (~10%)
Major players	Novartis, Pfizer, Sanofi, local companies (e.g., Chi-Med)
Regulatory focus	Safety, efficacy, cost-effectiveness, innovation
Key market drivers	Aging population, rising chronic disease prevalence, government initiatives

Market Dynamics and Drivers

Aging Population: As of 2022, adults ≥65 years account for approximately 15% of the population, escalating demand for chronic illness management medicines [3].
Policy Initiatives: Inclusion of more drugs in the Hospital Authority formulary and broader acceptance of generic substitution support market growth.
Regional Influence: Hong Kong acts as a regional hub for pharmaceutical exports, especially for Mainland China, due to its regulatory stability and international alignment.

Market Trends Analysis

Trend	Implication
Rising generic acceptance	Cost savings and increased market share for generics
Biologics and biosimilars	Entry into high-value, complex therapeutic segments
Digital health integration	Opportunities for telepharmacy, E-health platforms
Regulatory modernization	Streamlined approval processes; acceleration of innovative medicine entry

Regulatory Environment: Opportunities and Challenges

Overview of Hong Kong Pharmaceutical Regulations

Hong Kong's pharmaceutical regulations are overseen by the Department of Health (DH), primarily through the Drug Office. The framework aligns with International Conference on Harmonisation (ICH) guidelines [4], but with specific regional provisions.

Key regulatory aspects:

Drug registration: Requires submission of data substantiating safety, efficacy, and quality; the process often takes 6 to 12 months [5].
Approval pathways: Standard, expedited pathways for innovative medicines, especially those aligned with Hong Kong Priority Review programs.
Generic drugs: Must demonstrate bioequivalence; approved via an abridged process based on reference products.
Pricing regulation: Limited direct price controls but reliance on hospital formularies and procurement processes.

Opportunities in Regulatory Framework

Opportunity	Description
Fast-track approvals	For innovative and essential medicines, especially biologics
Recognition of foreign data	Enables faster registration for internationally approved drugs
Biosimilar guideline development	Open pathways for entry of biosimilars
Digital submissions	E-platforms ease registration procedures

Top Regulatory Challenges

Challenge	Impact
Stringent data requirements	Extended approval timelines; high upfront costs
Patent protection and exclusivity	Difficult entry for generics during patent terms
Limited local manufacturing options	Dependence on imports; potential supply chain disruptions
Variations in regional standards	Need for local adaptation of documentation and clinical data

Market Access Strategies for Branded and Generic Drugs

For Branded Drugs

Emphasize international clinical trial data for faster approval.
Leverage premium pricing by demonstrating innovation and clinical benefits.
Engage early with regulators to access fast-track pathways.

For Generics

Obtain bioequivalence studies aligned with ICH standards.
Utilize patent cliff opportunities to introduce cost-effective alternatives.
Build relationships with public sector procurement organizations like the Hospital Authority.

Regional Regulatory Opportunities and Alignment

Hong Kong's regulatory standards often serve as a benchmark for neighboring regions such as Mainland China and Macau, offering a strategic entry point. The Mutual Recognition Agreements (MRAs) between Hong Kong and China facilitate faster registration procedures for specific drug classes [6].

Key Regional Initiatives

Initiative	Description
Hong Kong-Mainland MRA (2015)	Streamlined registration process for certain medicines
Asia-Pacific Economic Cooperation (APEC)	Enhances regulatory cooperation and data sharing
ICH membership	Facilitates convergence in registration standards

Comparison: Hong Kong Drug Market with Regional Peers

Aspect	Hong Kong	Singapore	Macau
Market size (2022)	HKD 8.3B (~USD 1.07B)	SGD ~2.3B (~USD 1.7B)	MOP 1.5B (~USD 0.19B)
Regulatory agency	Department of Health (Drug Office)	Health Sciences Authority (HSA)	Municipal Health Bureau
Market growth (2017–2022)	3.2% CAGR	2.8% CAGR	2.5% CAGR
Pathway for generics	Abridged bioequivalence pathway	Bioequivalence studies required	Similar pathway, shorter timelines
Challenges	Patent barriers, import dependence	Regulatory complexity, price controls	Smaller market, limited options

Key Challenges and Mitigation Strategies

Challenge	Mitigation Strategy
Patent protections and expiry	Early pipeline planning; patent analysis; licensing strategies
Registration delays	Engagement with regulators; early submission; use of fast-track options
Product registration variations	Regional harmonization; local clinical data generation
Supply chain risks	Diversify sources; establish local partnerships

FAQs

1. How does the patent landscape affect generic drug entry in Hong Kong?
Patents can hinder generic entry during the patent life unless licenses are obtained or patent challenges succeed. Understanding patent expiry timelines is critical for market entry planning.

2. What are the registration timelines for innovative drugs versus generics?
Innovative drugs may require 9-12 months; generics with bioequivalence data can register within 6 months, especially if aligned with existing approvals elsewhere.

3. Are biologics or biosimilars regulated differently?
Yes. Biosimilars require comparability studies, and Hong Kong has been developing specific guidelines, possibly aligning with FDA and EMA standards.

4. How significant is the role of pricing regulation in market entry?
While direct price controls are limited, hospital procurement policies influence pricing strategies, especially in the public healthcare sector.

5. Can foreign companies leverage Hong Kong’s regulations to expand into mainland China?
Yes. The mutual recognition agreements and regulatory convergence strategies enable smoother registration processes. Hong Kong registration can serve as a pathway into China.

Key Takeaways

Hong Kong’s pharmaceutical market offers a stable, high-quality regulatory environment with growth opportunities, particularly within the generic and biosimilar sectors.
Entry strategies should leverage recognition of foreign clinical data, fast-track approval pathways, and regional cooperation frameworks.
Challenges include patent protections, registration timelines, and supply chain dependencies, manageable through proactive planning.
Regional initiatives and harmonization efforts aid companies aiming for broader Asian market access, positioning Hong Kong as a strategic hub.
Developing a nuanced understanding of local policies, approval pathways, and market dynamics is essential for sustainable market penetration.

References

[1] Census and Statistics Department, Hong Kong SAR, 2022 Population Data.
[2] IQVIA, "Hong Kong Pharmaceutical Market Report," 2022.
[3] Hong Kong Hospital Authority, Population Demographics, 2022.
[4] International Conference on Harmonisation (ICH), Guidelines, 2021.
[5] Hong Kong Department of Health, Drug Registration Procedures, 2022.
[6] Hong Kong-China Mutual Recognition Agreement, 2015.

This analysis aggregates current data to inform strategic planning, regulatory considerations, and market development for pharmaceutical stakeholders interested in Hong Kong.