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Last Updated: May 23, 2025

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

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Brazil: These 40 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "Brazil: These 40 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 LATUDA (lurasidone hydrochloride) generic drug versions launch?

Generic name: lurasidone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 26, 2025
Generic Entry Controlled by: Brazil Patent 122,020,005,056

Drug Price Trends for LATUDA
LATUDA is a drug marketed by Sunovion Pharms Inc. There are seven patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

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

See drug price trends for LATUDA.

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

When can LATUDA (lurasidone hydrochloride) generic drug versions launch?

Generic name: lurasidone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 26, 2025
Generic Entry Controlled by: Brazil Patent PI0611409
Patent Title: preparação oral e método de granulação de uma mistura em pó

Drug Price Trends for LATUDA
LATUDA is a drug marketed by Sunovion Pharms Inc. There are seven patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

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

See drug price trends for LATUDA.

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

When can VICTRELIS (boceprevir) generic drug versions launch?

Generic name: boceprevir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 02, 2025
Generic Entry Controlled by: Brazil Patent PI0610737
Patent Title: formulações farmacêuticas e métodos de tratamento usando as mesmas

VICTRELIS is a drug marketed by Merck Sharp Dohme. There are two patents protecting this drug.

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

The generic ingredient in VICTRELIS is boceprevir. Additional details are available on the boceprevir profile page.

When can OMONTYS (peginesatide acetate) generic drug versions launch?

Generic name: peginesatide acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 03, 2025
Generic Entry Controlled by: Brazil Patent PI0613233
Patent Title: composto para tratar um paciente tendo um distúrbio

OMONTYS is a drug marketed by Takeda Pharms Usa. There are two patents protecting this drug.

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

The generic ingredient in OMONTYS is peginesatide acetate. Additional details are available on the peginesatide acetate profile page.

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: Brazil Patent PI0613574
Patent Title: forma cristalina isolada de um composto, método para preparar um composto, e, composição farmacêutica

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 DUEXIS (famotidine; ibuprofen) generic drug versions launch?

Generic name: famotidine; ibuprofen
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 18, 2025
Generic Entry Controlled by: Brazil Patent PI0714937
Patent Title: forma de dosagem unitÁria oral, e, uso de uma forma de dosagem unitÁria

Drug Price Trends for DUEXIS
DUEXIS is a drug marketed by Horizon. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-five patent family members in fifteen countries. There has been litigation on patents covering DUEXIS

See drug price trends for DUEXIS.

The generic ingredient in DUEXIS is famotidine; ibuprofen. There are eighteen drug master file entries for this API. Eleven suppliers are listed for this generic product. Additional details are available on the famotidine; ibuprofen profile page.

When can APTIOM (eslicarbazepine acetate) generic drug versions launch?

Generic name: eslicarbazepine acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 29, 2025
Generic Entry Controlled by: Brazil Patent PI0615970
Patent Title: processo para preparar (s) (+)-10,11-dihidro-10-hidróxi-5h-dibenz/b,f/azepina-5-ca rboxamida, processo para preparar (s)-(-)-10-acetoxi-10,11-dihidro-5h-dibenz/b,f/azepina-5- carboxamida e processo para preparar (r)-(+)-10-acetoxi-10,11-dihidro-5h-dibenz/b,f/azepina-5- carboxamida

Drug Price Trends for APTIOM
APTIOM is a drug marketed by Sumitomo Pharma Am. There are eleven patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has one hundred patent family members in twenty-six countries. There has been litigation on patents covering APTIOM

See drug price trends for APTIOM.

The generic ingredient in APTIOM is eslicarbazepine acetate. There are twelve drug master file entries for this API. Seven suppliers are listed for this generic product. Additional details are available on the eslicarbazepine acetate 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: Brazil Patent PI0614654
Patent Title: inibidores macrocìclicos de vìrus de hepatite 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 EPSOLAY (benzoyl peroxide) generic drug versions launch?

Generic name: benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 02, 2025
Generic Entry Controlled by: Brazil Patent PI0614143
Patent Title: processo para revestir um material particulado insolével em Água, sàlido, com um àxido metÁlico, material particulado revestido, composiÇço, mÉtodo para o tratamento de uma condiÇço superficial em um induvÍduo, e, uso de material particulado revestido

Drug Price Trends for EPSOLAY
EPSOLAY is a drug marketed by Galderma Labs Lp. There are eleven patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has forty-five patent family members in thirteen countries.

See drug price trends for EPSOLAY.

The generic ingredient in EPSOLAY is benzoyl peroxide. There are seventeen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the benzoyl peroxide 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, 2025
Generic Entry Controlled by: Brazil Patent PI0614411
Patent Title: núcleos de micropéletes de pancreatina adequados para revestimento entérico

CREON is a drug marketed by

This drug has forty-five patent family members in thirteen countries. There has been litigation on patents covering CREON

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 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, 2025
Generic Entry Controlled by: Brazil Patent PI0614545
Patent Title: composições farmacêuticas de liberação controlada para fármacos instáveis em ácido

CREON is a drug marketed by

This drug has forty-five patent family members in thirteen countries. There has been litigation on patents covering CREON

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, 2025
Generic Entry Controlled by: Brazil Patent PI0616324
Patent Title: formulaÇço de cÁpsula de pirfenidona e excipientes farmaceuticamente aceitÁveis

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-four 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-three suppliers are listed for this generic product. Additional details are available on the pirfenidone 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: Brazil Patent PI0618211
Patent Title: composição farmacêutica contendo pregabalina e uso do referido composto

Drug Price Trends for LYRICA CR
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-three 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: Brazil Patent 122,013,025,375
Patent Title: compostos orgânicos, seus métodos de preparo e uso, bem como composições farmacêuticas

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 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: Brazil Patent PI0605921
Patent Title: compostos orgánicos

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 AXUMIN (fluciclovine f-18) generic drug versions launch?

Generic name: fluciclovine f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 29, 2025
Generic Entry Controlled by: Brazil Patent PI0619213
Patent Title: composto precursor de composto orgánico marcado com haloênio radioativo

AXUMIN is a drug marketed by Blue Earth. There are eight patents protecting this drug.

This drug has thirty patent family members in sixteen countries.

The generic ingredient in AXUMIN is fluciclovine f-18. One supplier is listed for this generic product. Additional details are available on the fluciclovine f-18 profile page.

When can XALKORI (crizotinib) generic drug versions launch?

Generic name: crizotinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2025
Generic Entry Controlled by: Brazil Patent PI0619420
Patent Title: bases livres de polimorfos de um inibidor de c-met/hgfr, bem como uso das mesmas, composição farmacêutica, cápsula e uso da mesma

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 BUNAVAIL (buprenorphine hydrochloride; naloxone hydrochloride) generic drug versions launch?

Generic name: buprenorphine hydrochloride; naloxone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 13, 2025
Generic Entry Controlled by: Brazil Patent PI0619806
Patent Title: dispositivo para fornecimento de fármacos transmucosal resistente ao abuso

Drug Price Trends for BUNAVAIL
BUNAVAIL is a drug marketed by Bdsi. There are four patents protecting this drug and two Paragraph IV challenges. Two tentatively approved generics are ready to enter the market.

This drug has eighty-three patent family members in twenty-six countries. There has been litigation on patents covering BUNAVAIL

See drug price trends for BUNAVAIL.

The generic ingredient in BUNAVAIL is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this API. Twenty-three suppliers are listed for this generic product. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

When can PICATO (ingenol mebutate) generic drug versions launch?

Generic name: ingenol mebutate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 16, 2025
Generic Entry Controlled by: Brazil Patent PI0619919
Patent Title: composições terapêuticas

Drug Price Trends for PICATO
PICATO is a drug marketed by Leo Labs. There are twelve patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has thirty-five patent family members in twenty-one countries. There has been litigation on patents covering PICATO

See drug price trends for PICATO.

The generic ingredient in PICATO is ingenol mebutate. There are three drug master file entries for this API. Additional details are available on the ingenol mebutate 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: Brazil Patent PI0620091
Patent Title: sal hidrogenossulafato, método para preparo e uso do mesmo

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 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: Brazil Patent PI0706558
Patent Title: composições farmacêuticas com estabilidade aperfeiçoada

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 AMITIZA (lubiprostone) generic drug versions launch?

Generic name: lubiprostone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 24, 2026
Generic Entry Controlled by: Brazil Patent PI0707334
Patent Title: formulação de cápsula de gelatila mole e método para estabilização de um composto 15-cetoprostaglandina

Drug Price Trends for AMITIZA
AMITIZA is a drug marketed by Sucampo Pharma Llc. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has forty-nine patent family members in nineteen countries. There has been litigation on patents covering AMITIZA

See drug price trends for AMITIZA.

The generic ingredient in AMITIZA is lubiprostone. There are ten drug master file entries for this API. Nineteen suppliers are listed for this generic product. Additional details are available on the lubiprostone 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: Brazil Patent PI0621552
Patent Title: tratamentos antivirais intramusculares

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 RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: Brazil Patent PI0707769
Patent Title: tratamentos antivirais intravenosos

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: Brazil Patent PI0708278
Patent Title: forma cristalina alfa do sal arginina do perindopril, o respectivo processo de preparação, e as composições farmacêuticas que a contêm

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 DYANAVEL XR (amphetamine) generic drug versions launch?

Generic name: amphetamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 16, 2026
Generic Entry Controlled by: Brazil Patent PI0709606
Patent Title: formulações de liberação modificada contendo complexos fármaco-resina de troca iÈnica

Drug Price Trends for DYANAVEL XR
DYANAVEL XR is a drug marketed by Tris Pharma Inc. There are ten patents protecting this drug.

This drug has twenty-one patent family members in fourteen countries. There has been litigation on patents covering DYANAVEL XR

See drug price trends for DYANAVEL XR.

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

When can TUZISTRA XR (chlorpheniramine polistirex; codeine polistirex) generic drug versions launch?

Generic name: chlorpheniramine polistirex; codeine polistirex
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 16, 2026
Generic Entry Controlled by: Brazil Patent PI0709606
Patent Title: formulações de liberação modificada contendo complexos fármaco-resina de troca iÈnica

TUZISTRA XR is a drug marketed by Tris Pharma Inc. There are two patents protecting this drug.

This drug has twenty-one patent family members in fourteen countries. There has been litigation on patents covering TUZISTRA XR

See drug price trends for TUZISTRA XR.

The generic ingredient in TUZISTRA XR is chlorpheniramine polistirex; codeine polistirex. There are twenty-nine drug master file entries for this API. Additional details are available on the chlorpheniramine polistirex; codeine polistirex 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: Brazil Patent PI0710225
Patent Title: derivados de estirilpiridina e sua utilização para ligar e visualizar placas amilóides

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 LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 31, 2026
Generic Entry Controlled by: Brazil Patent PI0710085
Patent Title: tratamentos de alergia ocular

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: Brazil Patent PI0711179
Patent Title: composição farmacêutica contendo composto inibidor de dpp iv e processo para a sua preparação

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: Brazil Patent PI0722388
Patent Title: Forma de dosagem oral farmacêutica preparada com uma composição farmacêutica compreendendo composto inibidor de dpp iv

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: Brazil Patent PI0712993
Patent Title: polimorfos de n-hidróxi-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 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: Brazil Patent 122,020,011,899
Patent Title: processos para a preparação de 1-[2-(2,4-dimetil-fenilsulfanil)-fenil]-piperazina e para a fabricação do sal de adição de ácido bromídrico correspondente

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: Brazil Patent 122,020,011,920
Patent Title: composto, composição farmacêutica, método para tratar uma doença, uso de um composto, e processos para a preparação de um composto, e para a fabricação de um composto

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: Brazil Patent PI0713425
Patent Title: composto, composição farmacêutica, método para tratar uma doença, uso de um composto, e processos para a preparação de um composto, e para a fabricação de um composto

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: Brazil Patent PI0808941
Patent Title: MÉTODO PARA O TRATAMENTO DE DOR OU SINTOMAS RESIDUAIS EM DEPRESSÃO, USO DE UM COMPOSTO, E, COMPOSTO

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 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: Brazil Patent PI0714039
Patent Title: COMPOSIÇÃO FARMACÊUTICA

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: Brazil Patent PI0712936
Patent Title: processo para a produção de 2-[4-(3- e 2-fluorbenziloxi)benzila-mino]propanamidas

Drug Price Trends for XADAGO
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 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: Brazil Patent PI0713338
Patent Title: formulaÇÕes galÊnicas de compostos orgÂnicos

Drug Price Trends for TEKTURNA HCT
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 VAFSEO (vadadustat) generic drug versions launch?

Generic name: vadadustat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 26, 2026
Generic Entry Controlled by: Brazil Patent PI0713350
Patent Title: inibidores de prolil hidroxilase e métodos de utilização

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

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

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 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: Brazil Patent PI0713785
Patent Title: formas de dosagem sólidas de valsartana, amlodipina e hidroclorotiazida e métodos de fabricação das mesmas

Drug Price Trends for EXFORGE HCT
EXFORGE HCT is a drug marketed by Novartis.

This drug has two hundred and forty patent family members in forty-eight 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: Brazil Patent 122,017,015,106
Patent Title: estrutura de cristal de formula 1b e composição farmacêutica

Drug Price Trends for BYDUREON
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 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: Brazil Patent 122,017,021,516
Patent Title: processo de preparação de uma estrutura de cristal de solvato de (s)-propileno glicol de fórmula ia

Drug Price Trends for BYDUREON
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 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: Brazil Patent PI0713544
Patent Title: solvatos cristalinos complexos de derivados de (1s)-1,5-anidro-1-c-(3-((fenil) metil)fenil)-d-glucitol com aminoÁcidos como inibidores de sglt2 para o tratamento de diabetes

Drug Price Trends for BYDUREON
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: Brazil Patent 122,017,015,106
Patent Title: estrutura de cristal de formula 1b e composição farmacêutica

Drug Price Trends for FARXIGA
FARXIGA is a drug marketed by Astrazeneca Ab. There are eighteen patents protecting this drug and one Paragraph IV challenge. Twelve tentatively approved generics are ready to enter the market.

This drug has four hundred and forty-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 FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Brazil Patent 122,017,021,516
Patent Title: processo de preparação de uma estrutura de cristal de solvato de (s)-propileno glicol de fórmula ia

Drug Price Trends for FARXIGA
FARXIGA is a drug marketed by Astrazeneca Ab. There are eighteen patents protecting this drug and one Paragraph IV challenge. Twelve tentatively approved generics are ready to enter the market.

This drug has four hundred and forty-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 FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Brazil Patent PI0713544
Patent Title: solvatos cristalinos complexos de derivados de (1s)-1,5-anidro-1-c-(3-((fenil) metil)fenil)-d-glucitol com aminoÁcidos como inibidores de sglt2 para o tratamento de diabetes

Drug Price Trends for FARXIGA
FARXIGA is a drug marketed by Astrazeneca Ab. There are eighteen patents protecting this drug and one Paragraph IV challenge. Twelve tentatively approved generics are ready to enter the market.

This drug has four hundred and forty-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: Brazil Patent 122,017,015,106
Patent Title: estrutura de cristal de formula 1b e composição farmacêutica

Drug Price Trends for QTERN
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 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: Brazil Patent 122,017,021,516
Patent Title: processo de preparação de uma estrutura de cristal de solvato de (s)-propileno glicol de fórmula ia

Drug Price Trends for QTERN
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 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: Brazil Patent PI0713544
Patent Title: solvatos cristalinos complexos de derivados de (1s)-1,5-anidro-1-c-(3-((fenil) metil)fenil)-d-glucitol com aminoÁcidos como inibidores de sglt2 para o tratamento de diabetes

Drug Price Trends for QTERN
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 BYFAVO (remimazolam besylate) generic drug versions launch?

Generic name: remimazolam besylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 10, 2026
Generic Entry Controlled by: Brazil Patent PI0714886
Patent Title: sais de benzodiazepina de aÇço rÁpida e suas formas polimàrficas

BYFAVO is a drug marketed by Acacia. There are eleven patents protecting this drug.

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

See drug price trends for BYFAVO.

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

When can EPIDUO (adapalene; benzoyl peroxide) generic drug versions launch?

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 13, 2026
Generic Entry Controlled by: Brazil Patent PI0713182
Patent Title: usos de adapaleno de um de seus sais farmaceuticamente aceitáveis, kit e produto

Drug Price Trends for EPIDUO
EPIDUO is a drug marketed by Galderma Labs Lp and Galderma LabsThere are four patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-eight patent family members in twenty-five countries. There has been litigation on patents covering EPIDUO

See drug price trends for EPIDUO.

The generic ingredient in EPIDUO is adapalene; benzoyl peroxide. There are twelve drug master file entries for this API. Thirteen suppliers are listed for this generic product. Additional details are available on the adapalene; benzoyl peroxide profile page.

When can EPIDUO FORTE (adapalene; benzoyl peroxide) generic drug versions launch?

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 13, 2026
Generic Entry Controlled by: Brazil Patent PI0713182
Patent Title: usos de adapaleno de um de seus sais farmaceuticamente aceitáveis, kit e produto

Drug Price Trends for EPIDUO FORTE
EPIDUO FORTE is a drug marketed by Galderma Labs.

This drug has sixty-eight patent family members in twenty-five countries. There has been litigation on patents covering EPIDUO FORTE

See drug price trends for EPIDUO FORTE.

The generic ingredient in EPIDUO FORTE is adapalene; benzoyl peroxide. There are twelve drug master file entries for this API. Thirteen suppliers are listed for this generic product. Additional details are available on the adapalene; benzoyl peroxide profile page.

When can RASUVO (methotrexate) generic drug versions launch?

Generic name: methotrexate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 21, 2026
Generic Entry Controlled by: Brazil Patent PI0715433
Patent Title: soluÇÕes concentradas de metotrexato

Drug Price Trends for RASUVO
RASUVO is a drug marketed by Medexus. There is one patent protecting this drug.

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

See drug price trends for RASUVO.

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

Market Analysis and Financial Projection

The Brazilian pharmaceutical market presents a dynamic landscape with distinct opportunities and challenges for both branded and generic drug sectors, shaped by regulatory reforms, market dynamics, and public health priorities. Here's an assessment:


Market Overview

  • Branded Drugs: Dominated by international players like Novartis and Sanofi, branded drugs account for ~50% of market share but face pressure from generics due to patent expiries and cost-containment policies[1][6].
  • Generic Drugs: Introduced in 1999 via Law 9.787, generics now represent the fastest-growing segment, reaching USD 22.4 billion in 2024 and projected to hit USD 39.3 billion by 2033 (6.43% CAGR)[8][12]. They hold ~30% of the market, driven by affordability and government support[6][8].

Regulatory Opportunities

  1. ANVISA Modernization:

    • Streamlined reliance pathways for drug approvals, reducing duplication by leveraging approvals from trusted agencies (e.g., FDA, EMA)[3].
    • Faster approval timelines and adoption of international standards (e.g., ICH guidelines) to attract global investment[13].
  2. Skinny Label Proposals:

    • ANVISA is revising regulations to allow generics to omit patented therapeutic indications on labels, potentially accelerating market entry for non-infringing uses[10][14]. This could resolve conflicts between patent protection and generic accessibility.
  3. Local Manufacturing Incentives:

    • Government programs like Productive Development Partnerships (PDPs) aim to reduce import dependency by incentivizing domestic production of generics and biosimilars[9][13]. Example: Sanofi’s USD 210 million investment in distribution infrastructure[9].
  4. Patent Expiries:

    • BRL 2 billion worth of branded drugs will lose patent protection by 2029, creating opportunities for generic substitution[8][12].

Regulatory Challenges

  1. Regulatory Data Protection (RDP) Debate:

    • Proposals to implement RDP for pharmaceuticals could delay generic entry by protecting clinical data exclusivity. Critics argue this risks limiting affordable access, especially for public health systems like SUS[4].
  2. Complex Approval Processes:

    • ANVISA’s stringent bioequivalence requirements and bureaucratic delays hinder market entry. For instance, post-approval label changes for generics require alignment with reference drugs, complicating skinny label implementation[10][14].
  3. Counterfeit Drugs:

    • Counterfeits account for ~20% of the market, undermining trust in generics and necessitating stricter enforcement[9].
  4. Perception Issues:

    • Persistent skepticism about generic drug quality among providers and patients, despite ANVISA’s bioequivalence mandates[2][9].

Market Drivers

  • Aging Population: Over 15% of Brazilians will be 65+ by 2030, increasing demand for chronic disease treatments[1][8].
  • Universal Health System (SUS): Mandates generic substitution in public healthcare, covering 75% of the population[1][5].
  • Cost Containment: Generics are ~40% cheaper than branded drugs, aligning with government efforts to reduce healthcare spending[2][6].

Competitive Landscape

  • Domestic Generics Leaders: Aché, EMS Pharma, and Eurofarma control ~60% of the generics market, focusing on volume-driven strategies[1][8].
  • Global Players: Pfizer and Bayer compete in branded drugs while investing in local manufacturing to navigate price controls[6][11].

Future Outlook

  • Biosimilars and Complex Generics: Emerging focus on oncology and diabetes biosimilars, requiring advanced R&D capabilities[2][13].
  • Digital Health Integration: Telemedicine expansion post-COVID-19 enhances distribution channels and patient engagement[13].
  • Regulatory Harmonization: ANVISA’s alignment with global standards could improve Brazil’s position in multinational clinical trials[11][13].

"ANVISA’s reliance pathways and skinny label reforms could save generics manufacturers 12–18 months in approval timelines, significantly boosting market penetration" [3][14].


Key Takeaways:

  • Generics will dominate growth due to cost pressures and policy support, but regulatory clarity on RDP and skinny labels is critical.
  • Branded drugs require innovation and local partnerships to offset pricing pressures.
  • ANVISA’s modernization efforts and anti-counterfeit measures are pivotal for market stability.

References

  1. https://www.kenresearch.com/industry-reports/brazil-pharmaceuticals-market
  2. https://markwideresearch.com/brazil-generic-drug-market/
  3. https://globalforum.diaglobal.org/issue/september-2023/how-brazilian-regulator-anvisa-is-paving-its-way-to-become-a-global-reference-agency/
  4. https://ipwatchdog.com/2024/06/05/brazilian-congress-debates-regulatory-data-protection-pharmaceutical-products/id=177486/
  5. https://www.ijdra.com/index.php/journal/article/view/201
  6. https://www.biopharmadive.com/news/spotlight-globalization-brazil-drug-development-pfizer/508217/
  7. https://www.insights10.com/report/brazil-pharmaceutical-market-analysis/
  8. https://www.globenewswire.com/news-release/2025/02/25/3031891/28124/en/Insights-Into-Brazil-s-Generic-Drug-Market-2025-2033-Drug-Patent-Expiries-Lower-Costs-Government-Support-and-Increasing-Consumer-Confidence-Driving-Growth-at-6-43-CAGR.html
  9. https://pharmexcil.com/uploads/countryreports/Brazil-_Regulatory_Market_Profile.pdf
  10. https://gabionline.net/policies-legislation/anvisa-s-decision-on-skinny-labels-for-generics-pending
  11. https://www.pharmaceutical-technology.com/features/lulas-progress-plan-for-brazil-a-year-on/
  12. https://www.globenewswire.com/news-release/2025/02/25/3031891/0/en/Insights-Into-Brazil-s-Generic-Drug-Market-2025-2033-Drug-Patent-Expiries-Lower-Costs-Government-Support-and-Increasing-Consumer-Confidence-Driving-Growth-at-6-43-CAGR.html
  13. https://scigeniq.com/unlocking-growth-in-brazils-pharma-market-opportunities-and-strategies-for-the-next-decade/
  14. https://www.lickslegal.com/articles/skinny-label-in-brazil-drug-authority-seeking-to-implement-new-regulations
Last updated: 2025-03-19

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.