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

Chile: These 18 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027

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Preferred citation:
Friedman, Yali, "Chile: These 18 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027" DrugPatentWatch.com thinkBiotech, 2026 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 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: Chile Patent 2,007,001,689

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: Chile Patent 2,011,001,610
Patent Title: Proceso de preparacion de 1-[2-(2,4-dimetilfenilsulfanil)-fenil]piperazina (div. sol. 1758-07).

TRINTELLIX is a drug marketed by Takeda Pharms Usa. There are ten patents protecting this drug and one Paragraph IV challenge. Three 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 EXFORGE HCT (amlodipine besylate; hydrochlorothiazide; valsartan) generic drug versions launch?

Generic name: amlodipine besylate; hydrochlorothiazide; valsartan
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2026
Generic Entry Controlled by: Chile Patent 2,007,001,870

EXFORGE HCT is a drug marketed by Novartis.

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

See drug price trends for EXFORGE HCT.

The generic ingredient in EXFORGE HCT is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this API. Five suppliers are listed for this generic product. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan 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: Chile Patent 2,007,001,915

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

This drug has three hundred and seven 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: Chile Patent 2,007,001,915

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

This drug has four hundred and twenty-five 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. Twenty-two 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: Chile Patent 2,007,001,915

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

This drug has two hundred and fifty-six 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 DAKLINZA (daclatasvir dihydrochloride) generic drug versions launch?

Generic name: daclatasvir dihydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 11, 2026
Generic Entry Controlled by: Chile Patent 2,007,002,327

DAKLINZA is a drug marketed by Bristol-myers Squibb. There are five patents protecting this drug.

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

See drug price trends for DAKLINZA.

The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are five drug master file entries for this API. Additional details are available on the daclatasvir dihydrochloride profile page.

When can BRILINTA (ticagrelor) generic drug versions launch?

Generic name: ticagrelor
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 21, 2026
Generic Entry Controlled by: Chile Patent 2,007,002,421

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

This drug has sixty-two patent family members in thirty-five countries. There has been litigation on patents covering BRILINTA

See drug price trends for BRILINTA.

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

When can OPSUMIT (macitentan) generic drug versions launch?

Generic name: macitentan
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 29, 2026
Generic Entry Controlled by: Chile Patent 2,007,002,494

OPSUMIT is a drug marketed by Actelion. There are five patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has one hundred and one patent family members in thirty-five countries. There has been litigation on patents covering OPSUMIT

See drug price trends for OPSUMIT.

The generic ingredient in OPSUMIT is macitentan. There are ten drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the macitentan profile page.

When can SIRTURO (bedaquiline fumarate) generic drug versions launch?

Generic name: bedaquiline fumarate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2026
Generic Entry Controlled by: Chile Patent 2,007,003,472

SIRTURO is a drug marketed by Janssen Therap. There are two patents protecting this drug.

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

See drug price trends for SIRTURO.

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

When can ZYKADIA (ceritinib) generic drug versions launch?

Generic name: ceritinib
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: Chile Patent 2,007,003,552

ZYKADIA is a drug marketed by Novartis. There are eight patents protecting this drug.

This drug has three hundred and twenty-two patent family members in fifty-six countries.

See drug price trends for ZYKADIA.

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

When can ZYKADIA (ceritinib) generic drug versions launch?

Generic name: ceritinib
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: Chile Patent 2,011,001,863

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

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Chile Patent 2,008,000,517

PANCREAZE is a drug marketed by

This drug has three hundred and twenty-two patent family members in fifty-six countries.

See drug price trends for PANCREAZE.

The generic ingredient in PANCREAZE 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 ZENPEP (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Chile Patent 2,008,000,517

ZENPEP is a drug marketed by

This drug has three hundred and twenty-two patent family members in fifty-six countries.

See drug price trends for ZENPEP.

The generic ingredient in ZENPEP 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 VARUBI (rolapitant hydrochloride) generic drug versions launch?

Generic name: rolapitant hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: March 22, 2027
Generic Entry Controlled by: Chile Patent 2,008,000,819
Patent Title: COMPOSICION FARMACEUTICA EN POLVO QUE COMPRENDE UN GRANULADO QUE COMPRENDE AL MENOS UNA SAL CRISTALINA DE (5S,8S)-8-[{(1R)-(3,5-BIS-(TRIFLUOROMETIL)FENIL)-ETOXI}-8-FENIL-1,7-DIAZA-SPIRO[4.5]DECAN-2-ONA; GRANULADO Y COMPRIMIDO; Y USO PARA EL TRATAMIEN

VARUBI is a drug marketed by Tersera. There are eight patents protecting this drug.

This drug has one hundred and fifty-eight patent family members in thirty-five countries.

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

When can EDARBI (azilsartan kamedoxomil) generic drug versions launch?

Generic name: azilsartan kamedoxomil
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: March 28, 2027
Generic Entry Controlled by: Chile Patent 2,008,000,868
Patent Title: COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UN COMPUESTO DERIVADO DE BENZIMIDAZOL Y UN AGENTE DE CONTROL DE PH; METODO DE ESTABILIZACION Y DE MEJORAMIENTO DE LA DISOLUCION; USO DE UN AGENTE DE CONTROL DE PH.

EDARBI is a drug marketed by Azurity. There is one patent protecting this drug.

This drug has twenty-one patent family members in seventeen countries. There has been litigation on patents covering EDARBI

See drug price trends for EDARBI.

The generic ingredient in EDARBI is azilsartan kamedoxomil. There are six drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the azilsartan kamedoxomil profile page.

When can KYBELLA (deoxycholic acid) generic drug versions launch?

Generic name: deoxycholic acid
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2027
Generic Entry Controlled by: Chile Patent 2,008,001,783
Patent Title: Acido desoxicolico (dca); composicion farmaceutica que lo comprende; procedimiento de preparacion de acido desoxicolico; compuestos intermediarios, utiles en la preparacion de un medicamento para remover depositos de grasa.

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

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

The generic ingredient in KYBELLA is deoxycholic acid. There are thirty-three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the deoxycholic acid profile page.

When can TEKTURNA HCT (aliskiren hemifumarate; hydrochlorothiazide) generic drug versions launch?

Generic name: aliskiren hemifumarate; hydrochlorothiazide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 22, 2027
Generic Entry Controlled by: Chile Patent 2,007,001,837

TEKTURNA HCT is a drug marketed by Noden Pharma. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in twenty-five countries. There has been litigation on patents covering TEKTURNA HCT

See drug price trends for TEKTURNA HCT.

The generic ingredient in TEKTURNA HCT is aliskiren hemifumarate; hydrochlorothiazide. There are four drug master file entries for this API. Additional details are available on the aliskiren hemifumarate; hydrochlorothiazide profile page.

When can OJEMDA (tovorafenib) generic drug versions launch?

Generic name: tovorafenib
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 29, 2027
Generic Entry Controlled by: Chile Patent 2,008,001,933

OJEMDA is a drug marketed by Day One Biopharms. There are two patents protecting this drug.

This drug has fifty patent family members in twenty-seven countries.

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

Last updated: December 28, 2025

Executive Summary

Chile's pharmaceutical market exhibits steady growth, driven by an aging population, increasing healthcare expenditure, and government initiatives to improve public health. Both branded and generic drugs play vital roles, with a marked shift toward generics due to cost containment policies. The regulatory landscape is evolving, creating opportunities for market entrants but also posing challenges related to registration processes, intellectual property (IP) rights, and pricing regulations. Navigating these dynamics is essential for stakeholders aiming to expand or optimize their presence within Chile.

Market Overview: Size, Growth, and Composition

Market Size and Growth (2022-2027 Projection)

Parameter	2022 (USD billion)	CAGR (2022-2027)	Notes
Total pharmaceutical market	3.2	4.5%	Driven by demographic shifts and healthcare expansion
Branded pharmaceuticals	1.8	3%	Predominant in specialized and innovative segments
Generic pharmaceuticals	1.4	6%	Gaining share due to policy measures

Source: IMS Health, 2022; Market Research Future, 2022

Market Breakdown

Segment	Market Share (2022)	Key Drivers
Branded drugs	56%	Innovation, patent protections, physician preferences
Generic drugs	44%	Cost-efficiency, government policies, increasing awareness

Key Market Trends

Increase in generic drug uptake driven by government policies.
Rising public and private healthcare expenditure.
Expansion of biosimilars and over-the-counter (OTC) segments.
Consolidation among local and multinational manufacturers.

Regulatory Framework in Chile: Overview and Key Policies

Primary Regulatory Bodies

Authority	Responsibilities	Effective Date
ISP (Instituto de Salud Pública)	Drug registration, quality control, pharmacovigilance	2003 (regulatory reform)
Ministerio de Salud	Overall health policy, pricing, and reimbursement policies	Ongoing
Superintendencia de Salud	Market oversight, maintaining standards	Ongoing

Key Laws and Regulations

Regulation/Policy	Focus	Date	Impact
Law No. 19,137 (2006)	Food and medicines regulation	2006	Streamlined registration, quality standards
Decree No. 146 (2014)	Simplification of drug registration process	2014	Reduced approval timelines
Pricing Policy (2015)	Price regulation, reference to international prices	2015	Caps on manufacturer and pharmacy margins
Official Guidelines on Generics	Promotion of bioequivalence and substitution	2016	Increased generics market share

Registration Process

Step	Duration	Requirements
Submission of dossier	30-60 days	Data on quality, efficacy, safety, manufacturing
Review and approval	90-180 days	Validation, inspection, good manufacturing practices (GMP) compliance
Post-approval pharmacovigilance	Ongoing	Adverse event reporting, updates

Average approval time: ~6 months, shorter for generics with bioequivalence studies.

Opportunities in the Chilean Market

For Branded Drugs

Opportunities	Strategic Actions
Innovative therapies & biologics	Enter via licensing, partnerships, or direct investment
Disease-specific niches (oncology, rare diseases)	Develop or acquire new medicines aligned with unmet needs
Digital health integration	Leverage telemedicine and e-health platforms

For Generic Drugs

Opportunities	Strategic Actions
Increasing acceptance and substitution	Promote bioequivalence and expand distribution networks
Government incentivization	Engage with procurement agencies following policies to favor generics
Local manufacturing potential	Invest in manufacturing facilities to reduce import dependence

Regulatory Opportunities

Streamlined registration pathways for biosimilars.
Incentives for local manufacturing under national health plans.
Participation in pharmacovigilance data systems to influence future policies.

Challenges Facing Stakeholders

Regulatory Hurdles

Challenge	Description	Implication
Long and complex approval process	Bureaucracy and detailed dossier requirements	Delays market entry, increased costs
Intellectual property (IP) issues	Limited patent protections for some innovative drugs	Risk of generic competition, patent challenges
Price controls and reimbursement policies	Strict pricing regulations and reimbursement caps	Reduced margins, incentivizing cost-effective generics

Market and Competitive Challenges

Challenge	Description	Impact
Pricing pressure	Government controls on drug prices	Margin squeeze on branded and premium-priced drugs
Market saturation and fragmentation	Growing number of local and international players	Intense price and marketing competition
Supply chain disruptions	Due to global logistics issues and local regulatory constraints	Potential shortages and increased costs

Operational and Policy Risks

Risk	Description	Consequence
Policy shifts and reforms	Changes in pricing, registration, or reimbursement policies	Market unpredictability and strategic planning challenges
Currency fluctuations	Impact on import costs for raw materials and finished drugs	Profit margin pressures

Comparative Analysis: Branded vs. Generic Market in Chile

Aspect	Branded Drugs	Generic Drugs
Market Share	56% (2022)	44%
Price Policy	Less regulated, premium pricing	Subject to strict price caps
Innovation & R&D	High, focus on novel therapies	Low, reliance on bioequivalence
Patent Protection	Generally protected, yet some challenges	No patent, reliant on bioequivalence
Market Entry Barriers	Higher due to innovation requirement	Lower, easier with bioequivalence registration
Reimbursement & Coverage	Favorable for innovative drugs	Strong push to promote generics

Figure 1: Market composition and growth prospects

Regulatory Comparison: Chile vs. Latin American Region

Criterion	Chile	Regional (e.g., Brazil, Argentina)	Notes
Registration Timelines	6 months (~average)	8-12 months	Chile streamlined for generics
Regulatory Stringency	Moderate	High (Brazil), Moderate (Argentina)	Emphasis on bioequivalence and quality
IP & Patent Policies	IP protections align with WHO standards	Varies, some countries have weaker IP protections	Affects innovation incentives
Price Regulation	Price caps, reference pricing	Price regulation varies regionally	Affects profitability for manufacturers

Future Outlook and Strategic Recommendations

Market Growth Drivers

Continued aging population and chronic disease prevalence.
Digital health and telemedicine adoption.
Policy shifts favoring generics and biosimilars.

Risks to Monitor

Regulatory policy changes impacting drug pricing.
International trade dynamics affecting supply chains.
Patent disputes and market exclusivity periods.

Recommendations for Stakeholders

Strategy	Action Items
Engage with regulators early	Participate in public consultations, understand approval pathways
Invest in bioequivalence and biosimilars	Align products with regulatory guidelines to expedite approval
Local manufacturing and partnerships	Reduce import dependency, benefit from government incentives
Monitor policy changes proactively	Stay abreast of legislative reforms impacting pricing and registration
Promote pharmacovigilance and transparency	Build trust, meet regulatory requirements, facilitate market access

Key Takeaways

Market growth in Chile is steady, with a significant shift toward generic drug utilization driven by government policies and cost considerations.
Regulatory environment favors streamlined processes for generics and biosimilars but requires adherence to quality, safety, and efficacy standards.
Opportunities abound for innovative drugs in niche markets and biosimilars, especially via partnerships and local manufacturing.
Challenges include regulatory complexity, price controls, patent limitations, and market competition, necessitating strategic planning.
Successful market participation hinges on timely registration, compliance, local engagement, and understanding evolving policies.

FAQs

Q1: How does Chile's drug registration process compare to other Latin American countries?
Chile offers a relatively efficient registration process (~6 months), especially for generics with bioequivalence data, compared to Brazil (up to 12 months), making it an attractive entry point for new products.

Q2: What are the key regulatory hurdles for biosimilar entry in Chile?
Regulations require comprehensive comparability studies and pharmacovigilance plans, with ongoing guidance to ensure biological equivalence and safety, aligning with WHO and U.S. FDA standards.

Q3: How do Chile's pharmaceutical price controls impact market profitability?
Price caps and reference pricing policies suppress margins, especially for branded and innovative drugs, incentivizing the scaling of cost-effective generics and biosimilars.

Q4: Are there incentives for local manufacturing of generics?
Yes, government programs incentivize local production through reduced tariffs, tax benefits, and preferential procurement, especially under national health strategies to improve medication access.

Q5: What role does electronic health record integration play in market expansion?
Digital health initiatives facilitate prescribing, substitution, and pharmacovigilance, improving access and adherence, thereby expanding the market for pharmaceuticals aligned with national digital health policies.

References

IMS Health, 2022. “Latin America Pharmaceutical Market Overview.”
Market Research Future, 2022. “Chile Pharmaceuticals Market Analysis and Trends.”
Chilean Ministry of Health, 2016. “Official Guidelines on Generic Drugs.”
Chilean Law No. 19,137, 2006. “Regulations for Food and Drugs.”
World Health Organization, 2021. “Pharmaceutical Policies in Latin America.”

Conclusion

Chile's pharmaceutical sector offers promising opportunities, particularly for generics and biosimilars, amid a supportive yet evolving regulatory landscape. Stakeholders must navigate registration complexities, pricing policies, and market competition proactively. By aligning product development and strategic partnerships with regulatory trends and public health priorities, companies can capitalize on Chile's growing healthcare needs, ensuring sustainable growth and compliance.