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

Guatemala: These 7 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "Guatemala: These 7 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 BOSULIF (bosutinib monohydrate) generic drug versions launch?

Generic name: bosutinib monohydrate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 01, 2025
Generic Entry Controlled by: Guatemala Patent 200,600,282
Patent Title: FORMAS CRISTALINAS DE 4-[(2,4-DICLORO-5-METOXIFENIL)-AMINO]-6-METOXI-7-[3-(4-METIL-1-PIPERAZINIL)-PROPOXI]-3-QUINOLINCARBONITRILO Y METODOS PARA PREPARACION DE LAS MISMAS.

BOSULIF is a drug marketed by Pf Prism Cv. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has eighty-one patent family members in thirty countries. There has been litigation on patents covering BOSULIF

See drug price trends for BOSULIF.

The generic ingredient in BOSULIF is bosutinib monohydrate. There are five drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the bosutinib monohydrate 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: Guatemala Patent 200,600,339
Patent Title: INHIBIDORES MACROCICLICOS DEL VIRUS DE LA HEPATITIS C

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 LYRICA CR (pregabalin) generic drug versions launch?

Generic name: pregabalin
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 02, 2025
Generic Entry Controlled by: Guatemala Patent 200,600,474
Patent Title: COMPOSICIONES FARMACEUTICAS SOLIDAS QUE CONTIENEN PREGABALINA

LYRICA CR is a drug marketed by Upjohn. There are three patents protecting this drug and four Paragraph IV challenges. Six tentatively approved generics are ready to enter the market.

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

See drug price trends for LYRICA CR.

The generic ingredient in LYRICA CR is pregabalin. There are forty-one drug master file entries for this API. Fifty-five suppliers are listed for this generic product. Additional details are available on the pregabalin 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: Guatemala Patent 200,700,055
Patent Title: COMBINACIONES FARMACEUTICAS DE UN ANTAGONISTA DEL RECEPTOR DE ANGIOTENSINA Y UN INHIBIDOR DE ENDOPEPTIDASA NEUTRAL (NEP).

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 AMYVID (florbetapir f-18) generic drug versions launch?

Generic name: florbetapir f-18
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: March 30, 2026
Generic Entry Controlled by: Guatemala Patent 200,800,201
Patent Title: DERIVADOS DE ESTIRILPIRIDINA Y SUS USOS PARA UNION A PLACAS AMILOIDES Y OBTENCIÓN DE IMAGENES DE LAS MISMAS.

AMYVID is a drug marketed by Avid Radiopharms Inc. There are two patents protecting this drug.

This drug has fifty-one patent family members in thirty-three countries.

The generic ingredient in AMYVID is florbetapir f-18. One supplier is listed for this generic product. Additional details are available on the florbetapir f-18 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: Guatemala Patent 200,800,280
Patent Title: POLIMORFO DE N-HIDROXI-3-[4-[[[2-(2-METIL-1H-INDOL-3-IL)ETIL]AMINO]METIL]FENIL]-2E-2-PROPENAMIDA

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

Generic name: aliskiren hemifumarate; hydrochlorothiazide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 23, 2026
Generic Entry Controlled by: Guatemala Patent 200,800,297
Patent Title: FORMULACIONES GALENICAS DE ALISQUIRENO E HIDROCLOROTIAZIDA

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.

Guatemala's pharmaceutical market has shown resilience with a rebound to $78.755 million in 2023 (+4.48% YoY)[1], driven by post-pandemic recovery and a growing middle class. However, systemic challenges in regulation, intellectual property (IP) frameworks, and market dynamics create a complex landscape for branded and generic drugs.

Market Dynamics

Branded Drugs Domination:

Aggressive Marketing: Branded generics account for most prescriptions, leveraging heavy promotion to maintain premium pricing[2][8].
IP Protections: Patent laws extend exclusivity beyond international norms—e.g., Sanofi’s Lantus insulin remains protected in Guatemala despite U.S. patent expiry[8][12].

Generic Drug Challenges:

Low Trust: 5.2% of drug samples failed quality tests in 2012[12], and physicians avoid prescribing generics due to safety concerns[2][8].
Regulatory Delays: Data exclusivity laws under CAFTA block generic entry for 5–15 years, even for drugs not marketed locally[9][16]. For example, clopidogrel (Plavix) generics were revoked post-CAFTA[16].

Regulatory Landscape

Key Agencies:

DIGEMID: Struggles with outdated manufacturing standards and limited monitoring capacity[12].
SECCATID: Coordinates narcotics control but faces corruption risks[5][10].

Critical Regulations:

Data Exclusivity: Prioritizes originator drug monopolies, delaying affordable access[9][16].
Narcotics Control: Overly restrictive opioid rules hinder pain management, forcing clinicians to bypass regulations[4].
Import Dependency: 70% of drugs are imported, exposing the market to external shortages[2][8].

Opportunities for Growth

Local Manufacturing: Reducing import reliance could lower costs and improve supply chain stability[1][7].
Regional Harmonization: AMLAC’s proposed regulatory alignment may streamline approvals and boost generic competition[6].
Upcoming Patent Expirations: Drugs like panobinostat (FARYDAK) and simeprevir (OLYSIO) face patent cliffs in 2025–2026, creating entry points for generics if exclusivity barriers are addressed[15].
Digital Health Integration: Post-pandemic telehealth adoption could expand rural access[1].

Persistent Challenges

Quality Control: Only 36% of pharmacists trust domestically produced generics[8], exacerbated by scandals like the 2014 IGSS procurement fraud[12].
Prescription Practices: Lack of mandatory International Nonproprietary Name (INN) usage perpetuates branded preferences[2][8].
Organized Crime: Drug trafficking networks (worth double Guatemala’s GDP) corrupt institutions and destabilize markets[5][11].

Strategic Recommendations

Enforce INN Prescribing: Mandate generic names in prescriptions to weaken branded dominance[8][12].
Modernize IP Laws: Align data exclusivity with WHO guidelines to prevent artificial monopolies[9][16].
Strengthen AMLAC Collaboration: Adopt regional standards for bioequivalence testing and post-market surveillance[6][13].

Highlight: "Destroying [illegal firearms] can reduce violent crime in Guatemala, but there are plenty more swords to turn into ploughshares" – Antonio Maria Costa, UNODC[5].

Future Outlook:
While regulatory reforms and AMLAC integration offer pathways to affordability, success hinges on curbing corruption and rebuilding trust in generics. Prioritizing local production and adopting risk-based pharmacovigilance could position Guatemala as a regional leader in equitable drug access[3][6][7].

References

https://www.reportlinker.com/dataset/ef07f717e12babc94f00ad4517d485321e9b7bfc
https://gabionline.net/generics/research/Perceptions-of-generic-drugs-in-Latin-America-a-Guatemalan-case-study
https://www.ijdra.com/index.php/journal/article/view/676
https://www.hrw.org/report/2017/05/17/punishing-patient/ensuring-access-pain-treatment-guatemala
https://www.unodc.org/unodc/en/frontpage/2010/March/unodc-assists-guatemala-to-fight-organized-crime.html
https://www.drugpatentwatch.com/blog/regulatory-challenges-in-the-latin-american-generic-drug-market/
https://store.fitchsolutions.com/guatemala-pharmaceuticals-report
https://gabi-journal.net/to-prescribe-generics-is-to-play-with-the-life-of-the-patient-misconceptions-of-generics-in-guatemala.html
http://www.cptech.org/ip/health/trade/cafta/msf022005.html
https://www.oas.org/ext/en/security/mem/moduleid/7398/id/827/lang/1/controller/item/action/download
https://www.fatf-gafi.org/content/dam/fatf-gafi/mer/GAFILAT-CFATF%20Mutual%20Evaluation%20Report%20of%20Guatemala%20-%202016.pdf.coredownload.inline.pdf
https://www.springermedizin.de/perceptions-and-utilization-of-generic-medicines-in-guatemala-a-/11998446
https://www.oas.org/ext/en/security/mem/moduleid/7398/id/615/lang/1/controller/item/action/download
https://www.regdesk.co/drcpfa-guidance-on-importation-regulatory-overview/
https://www.drugpatentwatch.com/p/generic-entry-opportunity-date/Guatemala
https://cpath.org/sitebuildercontent/sitebuilderfiles/GuateCpathhaonline8-25-09.pdf