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Last Updated: April 18, 2025

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Malaysia: These 10 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "Malaysia: These 10 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 XCOPRI (cenobamate) generic drug versions launch?

Generic name: cenobamate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 22, 2025
Generic Entry Controlled by: Malaysia Patent 148,589
Patent Title: NEUROTHERAPEUTIC AZOLE COMPOUNDS

Drug Price Trends for XCOPRI
XCOPRI is a drug marketed by Sk Life. There are two patents protecting this drug.

This drug has twenty-six patent family members in twenty countries.

See drug price trends for XCOPRI.

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

When can OLYSIO (simeprevir sodium) generic drug versions launch?

Generic name: simeprevir sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 29, 2025
Generic Entry Controlled by: Malaysia Patent 144,217
Patent Title: MACROCYLIC INHIBITORS OF HEPATITIS C VIRUS

OLYSIO is a drug marketed by Janssen Prods. There are nine patents protecting this drug.

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

See drug price trends for OLYSIO.

The generic ingredient in OLYSIO is simeprevir sodium. There is one drug master file entry for this API. Additional details are available on the simeprevir sodium profile page.

When can ENTRESTO SPRINKLE (sacubitril; valsartan) generic drug versions launch?

Generic name: sacubitril; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 09, 2025
Generic Entry Controlled by: Malaysia Patent 145,462
Patent Title: PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR

ENTRESTO SPRINKLE is a drug marketed by Novartis. There are four patents protecting this drug.

This drug has one hundred and twenty-eight patent family members in forty countries. There has been litigation on patents covering ENTRESTO SPRINKLE

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this API. Nine suppliers are listed for this generic product. Additional details are available on the sacubitril; valsartan profile page.

When can KOSELUGO (selumetinib sulfate) generic drug versions launch?

Generic name: selumetinib sulfate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 21, 2025
Generic Entry Controlled by: Malaysia Patent 157,733
Patent Title: NOVEL HYDROGEN SULFATE SALT

KOSELUGO is a drug marketed by Astrazeneca. There are six patents protecting this drug.

This drug has one hundred and ninety-eight patent family members in forty-four countries.

See drug price trends for KOSELUGO.

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

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: Malaysia Patent 166,063
Patent Title: INTRAVENOUS ANTIVIRAL TREATMENTS

RAPIVAB is a drug marketed by Biocryst. There are two patents protecting this drug.

This drug has forty-two patent family members in fourteen countries.

See drug price trends for RAPIVAB.

The generic ingredient in RAPIVAB is peramivir. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the peramivir profile page.

When can PRESTALIA (amlodipine besylate; perindopril arginine) generic drug versions launch?

Generic name: amlodipine besylate; perindopril arginine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 28, 2026
Generic Entry Controlled by: Malaysia Patent 151,035
Patent Title: ? CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, A PROCESS FOR ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT

PRESTALIA is a drug marketed by Adhera. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty patent family members in twenty-seven countries. There has been litigation on patents covering PRESTALIA

The generic ingredient in PRESTALIA is amlodipine besylate; perindopril arginine. There are fifty drug master file entries for this API. Additional details are available on the amlodipine besylate; perindopril arginine 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: Malaysia Patent 153,669
Patent Title: OCULAR ALLERGY TREATMENTS FIELD OF THE INVENTION

Drug Price Trends for LASTACAFT
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: Malaysia Patent 146,969
Patent Title: DPP IV INHIBITOR FORMULATIONS

Drug Price Trends for TRADJENTA
TRADJENTA is a drug marketed by Boehringer Ingelheim. There are ten patents protecting this drug and one Paragraph IV challenge. Six tentatively approved generics are ready to enter the market.

This drug has four hundred and sixty-two 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 TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: Malaysia Patent 148,496
Patent Title: DPP IV INHIBITOR FORMULATIONS

Drug Price Trends for TRADJENTA
TRADJENTA is a drug marketed by Boehringer Ingelheim. There are ten patents protecting this drug and one Paragraph IV challenge. Six tentatively approved generics are ready to enter the market.

This drug has four hundred and sixty-two 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 FARYDAK (panobinostat lactate) generic drug versions launch?

Generic name: panobinostat lactate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 12, 2026
Generic Entry Controlled by: Malaysia Patent 149,337
Patent Title: POLYMORPHS OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2-PROPENAMIDE

FARYDAK is a drug marketed by Secura. There are two patents protecting this drug.

This drug has sixty-eight patent family members in forty countries. There has been litigation on patents covering FARYDAK

See drug price trends for FARYDAK.

The generic ingredient in FARYDAK is panobinostat lactate. There is one drug master file entry for this API. Additional details are available on the panobinostat lactate 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: Malaysia Patent 150,448
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 PAIN OR RESIDUAL SYMPTOMS IN DEPRESSION RELATING TO SLEEP AND COGNITION

Drug Price Trends for TRINTELLIX
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 sixteen 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 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: Malaysia Patent 150,647
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

Drug Price Trends for TRINTELLIX
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 sixteen 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.

Market Analysis and Financial Projection

Malaysia's pharmaceutical sector is undergoing significant transformation, with the generic drug market expanding rapidly due to demographic shifts and policy support, while branded drugs face challenges from patent expirations and regulatory complexities. The interplay between these segments creates a dynamic landscape shaped by healthcare demands, regulatory evolution, and market competition.

Branded vs. Generic Drug Markets

Market Composition & Growth

  • Generics: Valued at USD 1.29 billion in 2023, the sector is projected to grow at a 7.2% CAGR, reaching USD 1.97 billion by 2028[12]. Key drivers include:
    • Aging population (14.5% over 65 by 2040)[12] requiring long-term, affordable treatments.
    • Rising chronic diseases (hypertension, diabetes, cancer)[12][16], driving 41.5% of prescription sales[11].
    • Government initiatives like the Medication Substitution Policy (2021), enabling pharmacists to replace branded drugs with generics[12][2].
  • Branded Drugs: Once dominant (67% market share a decade ago), they now account for 45% of prescription sales[9]. Challenges include:
    • Patent expirations and competition from imported generics (CAGR 8.2% for imports)[9].
    • Regulatory hurdles, with approvals often delayed beyond 12 months[5].
Aspect Branded Drugs Generic Drugs
Price 30–80% higher than generics[18] Up to 90% cheaper[14]
Market Access Slowed by patent clustering and IP disputes[9] Supported by government procurement[3][9]
Quality Perception Higher trust among prescribers[17] Skepticism toward local manufacturers[17]

Regulatory Landscape

The National Pharmaceutical Regulatory Agency (NPRA) oversees safety, efficacy, and quality standards for both segments[4][6].

Key Policies & Frameworks

  • Generics:
    • Abbreviated registration pathways for bioequivalent drugs[4].
    • Mandatory bioequivalence testing (BE) since 2019, though limited testing centers delay launches[16].
  • Branded Drugs:
    • Strict clinical trial requirements for novel therapies[4].
    • Weak IP protections (e.g., inadequate data exclusivity)[5], deterring innovation.

Opportunities in Regulation

  • ASEAN Harmonization: Streamlined regional approvals through shared technical documents[4].
  • Digital Systems: NPRA’s Quest 3+ platform accelerates application reviews[4].

Regulatory Challenges

  • Lengthy Approvals: 12–24 months for novel drugs, misaligned with procurement cycles[5].
  • Biased Procurement: Preferential treatment for locally manufactured products[9].
  • Compliance Costs: Post-market surveillance and GMP adherence strain smaller firms[4][5].

Market Challenges and Strategic Opportunities

For Generics:

  • Barriers: Dominance of Indian/Chinese imports[3], limited BE testing capacity[16], and low R&D investment by local firms[9].
  • Opportunities: Expanding halal pharmaceuticals (USD 130 billion global market by 2030)[9] and partnerships with multinationals (e.g., Sanofi-Aventis and Hovid Bhd)[9].

For Branded Drugs:

  • Barriers: Patent evergreening tactics[9] and weak IP enforcement[5], limiting ROI on innovation.
  • Opportunities: Biosimilars and biologic therapies favored under NPRA’s expedited pathways[4].

Future Outlook

Malaysia’s pharmaceutical market will hinge on resolving regulatory bottlenecks (e.g., faster approvals, IP reforms) and leveraging ASEAN integration. Generics are poised to dominate public healthcare due to cost pressures, while branded drugs may focus on niche biologics and strategic partnerships. Stakeholders recommend:

  • Investing in BE testing infrastructure to boost local generic production[16].
  • Adopting digital pharmacovigilance tools to streamline compliance[4].
  • Aligning patent laws with global standards to attract R&D investment[5][9].

"Malaysia’s regulatory framework is evolving, but harmonizing regional standards and modernizing IP laws will be critical to unlocking growth." – Industry Analyst[5]

References

  1. https://www.insights10.com/report/malaysia-pharmaceutical-market-analysis/
  2. https://www.techsciresearch.com/report/malaysia-generic-drugs-market/15504.html
  3. https://credevo.com/articles/2021/04/15/generic-drug-registration-process-in-malaysia/
  4. https://resource.ddregpharma.com/blogs/understanding-the-pharmaceutical-regulatory-landscape-of-malaysia/
  5. https://www.fitchsolutions.com/bmi/pharmaceuticals/malaysias-new-procurement-process-will-benefit-pharmaceutical-sector-despite-regulatory-challenges-21-11-2024
  6. https://www.freyrsolutions.com/what-is-the-national-pharmaceutical-regulatory-agency-npra-in-malaysia
  7. https://mursmedic.com/shaping-the-future-of-pharma-in-malaysia-emerging-trends-innovations-and-regulatory-dynamics/
  8. https://www.haiasiapacific.org/wp-content/uploads/2014/11/Malaysian-generic-pharmaceutical-industries.pdf
  9. https://www.sganalytics.com/blog/pharmaceutical-market-and-companies-in-malaysia/
  10. https://credevo.com/articles/2024/02/25/generic-drug-market-in-the-asia-pacific-region-regulations-challenges/
  11. https://citeseerx.ist.psu.edu/document?repid=rep1&%3Btype=pdf&%3Bdoi=f4a3717a2530193652d4eb682acf78fdb07bccf4
  12. https://www.researchandmarkets.com/reports/5893633/malaysia-generic-drugs-market-competition
  13. https://www.marketdataforecast.com/market-reports/asia-pacific-generic-drugs-market
  14. https://www.doc2us.com/branded-vs-generic-medicines-are-they-the-same
  15. https://baipharm.chemlinked.com/new-webinar/malaysia-pharmaceutical-regulatory-pathway
  16. https://pmc.ncbi.nlm.nih.gov/articles/PMC10457461/
  17. https://gabionline.net/generics/research/Attitudes-towards-prescribing-generics-in-Malaysia
  18. https://japsonline.com/admin/php/uploads/257_pdf.pdf

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