Novo Nordisk’s semaglutide patent expired in Brazil on March 20, 2026. [4] ANVISA approved the first semaglutide pen from a local company 67 days later, on May 26, 2026. [6][7] The 67-day gap is our calculation from those two dates. By July 29, 2026, ANVISA had approved five more semaglutide pens. [8]
This article follows that event and the legal rules behind it. It also looks at the patents, biosimilars and price rules that shape what comes next for brand and generic makers in Brazil. We separate documented facts from our own calculations and mark each calculation as analysis.
The Short Answer
Brazil has no patent term extension. A pharmaceutical patent lasts 20 years from the filing date, and slow examination at the patent office (INPI) removes years of real protection. [1][4] The semaglutide case shows this effect clearly. Novo Nordisk filed in 2006, won the patent in 2019, and saw it expire in March 2026. [4]
The Supreme Federal Court (STF) removed the 10-year minimum term from grant in 2021, and applied that ruling to pharmaceutical patents in force. [2][3]
The Superior Court of Justice (STJ) refused to give Novo Nordisk extra term in December 2025. [4][5]
Brazil has no patent linkage and gives no data exclusivity to human medicines. [17][11]
Brand makers now compete on trademarks, formulation patents, supply deals and price. Copy makers compete on registration speed.
What the Data Shows: Seven Citable Findings
Each finding below stands alone. The sections that follow give the source and the working.
Semaglutide took about 13 years from patent filing to patent grant in Brazil, and the patent expired on March 20, 2026. [4]
ANVISA approved Ozivy (EMS) 67 days after expiry. The company filed its registration request in 2023. [7] The 67 days is our calculation.
Between May 26 and July 29, 2026, ANVISA approved six semaglutide pens. NeoFeed reports that none of the five approved on July 29 will be made in Brazil. [8]
Mattos Filho estimates that ADI 5529 affected 3,435 pharmaceutical patents, which is 11.2% of the patents then in force under the removed provision. [2] Our division implies about 30,700 patents in force under that provision in total. This is analysis, not a reported figure.
Reported pendency for pharmaceutical patents ranges from 5 years (INPI) to 6.8 years (Dannemann Siemsen data for Interfarma) to 9.15 years (USTR). [10] The three figures measure different things.
ANVISA’s database held 81 biosimilar approval records through 2025, with 10 new products in 2024 and 16 in 2025. [18] The 2025 count is 60% higher than the 2024 count (our calculation).
CMED set the 2026 maximum price adjustment at 3.81%, 2.47% or 1.13%, depending on the product’s competition level. [22]
Methodology: How We Built the Numbers
What data did we analyze, and over what period?
We used public sources dated from 2006 to October 2026. We prefer court summaries, regulator notices and official statistics. Where we could not reach a primary document, we used law-firm notes and trade press and name the source in the text. We did not use any paid database output for the figures in this article.
How did we make the calculations?
We calculated day counts with Python’s datetime module. We calculated percentages from the two source figures named in each case. We did not mix figures from different sources in one ratio unless the text says so. Each derived figure carries the words “our calculation” or “analysis”.
What are the limits of this analysis?
Brazil has no public equivalent of the US Orange Book, so we cannot list every patent for each drug from one official source. Press reports give some expiry dates as derived values (filing date plus 20 years). We flag those dates where they appear. We did not verify Brazilian patent numbers for any drug in this article, so we give none.
Where does DrugPatentWatch fit?
DrugPatentWatch is a commercial database of drug patent and exclusivity records. Analysts use tools of this kind to cross-check expiry dates against the national patent office. Our Mounjaro section shows why that check matters: public reports give two different expiry years for the same product. Readers who need patent-level detail should check INPI records and a patent database before they make a launch or investment decision.
How Does Brazil’s Patent System Work for Medicines?
Definition: what is the patent term in Brazil?
An invention patent in Brazil lasts 20 years from the filing date. A utility model lasts 15 years from filing. [1] Brazil does not add extra term for regulatory delay or examination delay. [4]
What did ADI 5529 change?
ADI 5529 removed a rule that had guaranteed a minimum term after grant. Before the ruling, the sole paragraph of Article 40 of Law 9,279/1996 gave 10 years from grant for inventions and 7 years for utility models. [4][1] The STF declared that paragraph unconstitutional. [1]
What was the vote, and what did the court limit?
The STF voted 9 to 2 on the merits on May 6, 2021. [2] The plenary finished the modulation of effects on May 12, 2021. [2][3] The court made the ruling effective from the publication of the minutes. Patents already granted under the paragraph kept their term, with two exceptions. [2][3]
The first exception covers patents challenged in lawsuits filed by April 7, 2021. The second exception covers patents for pharmaceutical products and processes, and for health equipment and materials. [2] For this second group, the ruling applies backward in time. [3]
How many pharmaceutical patents lost time?
Mattos Filho estimated that 3,435 pharmaceutical patents were affected. That figure equals 11.2% of the patents in force under the removed provision. [2] If both numbers are correct, the total pool was about 30,700 patents (3,435 divided by 0.112). This total is our analysis. The firm did not report it.
Yes, before the final ruling. In April 2021, EMS asked a Brazilian court to suspend Bayer’s rivaroxaban (Xarelto) patent and to annul it. [27] EMS said Bayer’s 20-year period ended on December 11, 2020. Bayer replied that Justice Toffoli’s provisional ruling did not apply to patents already granted. [27] The article does not report a final decision, and we found no later source for the outcome. We use it here as an example of how fast generic makers moved after the court’s preliminary ruling.
Why did ANVISA prior consent end?
Law 14,195, published in August 2021, repealed Article 229-C of the Industrial Property Law. [1] That article had required ANVISA consent before INPI could grant pharmaceutical product and process patents. [1] After the repeal, INPI alone examines and grants these applications. [1]
Does Brazil have patent linkage or data exclusivity?
Patent linkage
Brazil has no patent linkage system. ANVISA can approve a generic or biosimilar without checking Brazilian patents. [17] An approval does not give the right to launch before patent expiry. [18]
Test data protection
Brazil protects regulatory test data for veterinary products, fertilizers and agrochemicals under Law 10,603/2002. It does not protect test data for human medicines. [17] The USTR 2026 Special 301 report asks for this protection. [11] Brazil’s Senate has held hearings on a bill to extend it. [17]
The Bolar exemption
Article 43(VII) of the Industrial Property Law lets a company do the work needed for a marketing application before patent expiry. [17] Ricci Propriedade Intelectual notes that Law 10,196/2001 added this item and that it does not allow stockpiling, distribution or sale. [4] The exemption allows pre-expiry work of this kind. EMS filed its semaglutide registration request in 2023, before the patent expired. [7]
Why Is the INPI Backlog the Central Variable in Brazil’s Patent Cliff?
The patent term starts at filing. Every year INPI spends on examination is a year taken from the owner’s period of sale. Since 2021 the court-made safety net of a 10-year minimum from grant is gone, so examination time now decides real exclusivity. [4]
How long does INPI take to examine a pharmaceutical patent?
Three sources give three answers. Each measures a different thing.
Source
Metric
Value
Period
Ref.
Dannemann Siemsen data, compiled for Interfarma
Average time from filing to first decision, pharma
The metrics differ in three ways. First, “first decision” is not “grant”. Second, the USTR figure counts only patents that INPI granted, which leaves out applications that wait or fail. Third, INPI gives a 2026 average, and it may include faster recent cases. We cannot reconcile them from public data, and we do not average them.
The backlog counts also vary. The European Commission IP Helpdesk reported an INPI patent backlog of 15,134 applications in October 2022 and 1,052 in March 2025. [26] The same helpdesk article does not define the category it counted. Interfarma’s data show that pending pharmaceutical applications have grown by more than 3,000 per year since 2022. [10] Those two statements cannot describe the same pool. Researchers who cite INPI backlog numbers should name the category they use.
The decision count also changed. Dannemann Siemsen data show 2.7 thousand grants in 2021 and 1.4 thousand decisions in 2025. [10] Grants and decisions are different units, so we do not calculate a ratio.
Can Brazilian courts add patent term for INPI delay?
Not at the highest level so far. In December 2025 the STJ Fourth Panel unanimously refused Novo Nordisk’s request to extend the semaglutide term. [4][5] The report states the reasoning this way: Brazilian courts may not create compensation for administrative delay without express statutory authority. [5] The court also noted that Brazilian law gives damages for use of an invention between application publication and grant. [5]
How many term-adjustment lawsuits exist?
Chambers reports that by the end of 2025 more than 70 lawsuits sought compensation for term lost to INPI delay. [14] Courts granted many preliminary injunctions and later revoked them. Some lasted more than two years. [14] First-instance merits decisions mostly denied the claims, and two favorable decisions came in 2025. [14]
What does bill PL 5.810/2025 propose?
The bill would adjust patent terms when INPI delay is not the owner’s fault. Industry supports it. [10] Dannemann Siemsen partner Gustavo de Freitas Morais said a patent-term adjustment bill arrives “em boa hora” (at a good time). [10]
Average time to grant biopharmaceutical patents in Brazil, January 2020 to November 2025: 9.15 years. Source: USTR 2026 Special 301 report, as reported by Diário do Comércio on May 2, 2026. [11]
Semaglutide Patent Timeline in Brazil: From 2006 Filing to 2026 Expiry
Date
Event
Ref.
March 2006
Novo Nordisk files the semaglutide application at INPI
The patent expired on March 20, 2026. [4] The rule is 20 years from filing, and the application date was in March 2006. [4][15]
How much exclusivity did Novo Nordisk really get?
Ricci Propriedade Intelectual puts the effective period after grant at about 7 years. [4] That figure is consistent with the dates above: a grant in 2019 to March 2026 is between about 6 and 7 years, depending on the grant month (our check). The company asked the court for an extension to 2038. [4] Our calculation: 2038 minus 2026 is 12 years. Chambers states that the request would have delayed generic entry by more than a decade. [5]
Why did Novo Nordisk lose the extension request?
The STJ found no statutory basis for a term adjustment. [5] It refused to create one by interpretation. [5] The company argued that INPI delay harmed it. The court answered that the law already gives protection from the filing stage, including damages for unauthorized use. [5]
Does patent expiry give free access to semaglutide?
Not entirely. Ricci notes that trademarks (Ozempic, Wegovy and Rybelsus) stay protected, and that other patents may remain. It cites a protection for oral semaglutide’s absorption technology that runs to 2031. [4] We could not check that 2031 date against an INPI record. Treat it as a claim from a law firm.
Who Entered Brazil’s Semaglutide Market After the Patent Expired?
What is Ozivy, and why is it not a generic?
Ozivy is EMS’s synthetic semaglutide pen. ANVISA registered it on May 26, 2026. [7] Reuters headlined the event as a “first generic” approval. [6] Poder360 reports that ANVISA classifies Ozivy as a new medicine. [7]
Why does the classification matter?
Brazil has no generic category for biological products. A synthetic analog of a biological product therefore enters as a new medicine. [7] The route differs from the generic route that applies to small-molecule drugs. This means Ozivy needed its own efficacy, safety and quality review, and the agency calls such reviews a technical challenge worldwide. [7]
How does Ozivy differ from Ozempic in storage?
Ozivy has four presentations of semaglutide 1.34 mg/mL in a pre-filled, multi-dose disposable pen. [7] It must stay at 2 to 8 degrees Celsius before and after first use. [7] Ozempic needs refrigeration only before use and can stay up to 6 weeks at up to 30 degrees Celsius afterward. [7] That difference is a documented product difference between the two.
What happened to the approval queue?
ANVISA ordered the semaglutide reviews under Call Notice 12/2025, with GLP-1 priority rules and chronological order. [7] On May 26, five synthetic and one biological semaglutide application were still under review. [6][7] By July 29, NeoFeed reported 24 requests on the list, 11 with finished analysis and six approvals. [8] Our calculation: 13 requests remained pending (24 minus 11), and six of 11 finished analyses ended in approval, which is 55%.
Which five pens did ANVISA approve on July 29, 2026?
Mostly not. NeoFeed reports that none of the five July pens will be made in Brazil. [8] Reuters reports that EMS will make Ozivy at its plant in São Paulo state, with capacity up to 40 million pens per year. [6] Bloomberg Línea reports that EMS is investing R$1 billion in a GLP-1 plant in Hortolândia with capacity for 750,000 pens. [9] The two capacity figures differ, and the sources do not explain why. They may refer to different units of time or different plants.
How did Novo Nordisk respond before expiry?
Bloomberg Línea reports that Eurofarma partnered with Novo Nordisk to distribute second-brand semaglutide versions called Poviztra and Extensior. [9] The source reports the partnership but gives no price data for those brands.
What Happens to Prices and Revenue? Scenario Analysis for Brazil’s GLP-1 Market
How big is the GLP-1 market in Brazil?
UBS BB estimated the Brazilian GLP-1 market at about R$11 billion in 2025. It forecast about R$20 billion for 2026. [9] These are analyst estimates, and the 2026 figure is a forecast. [9]
The same report estimates fourth-quarter 2025 GLP-1 sales at about R$4 billion. It puts Eli Lilly’s Mounjaro (tirzepatide) at 57% of that quarter. [9] It says semaglutide-based products hold 43%. [9] Our calculation: 57% of R$4 billion is about R$2.3 billion, and 43% is about R$1.7 billion.
The report counts about 1 million boxes sold per month. It states that Brazilian prices for semaglutide and tirzepatide can exceed R$1,000. [9] It compares a 2.5 mg tirzepatide dose at R$294 in Paraguay with R$1,407 for Mounjaro in Brazil. [9] Our calculation: the Brazilian price is 4.8 times the Paraguayan price.
What could a generic price cut do to semaglutide revenue?
UBS BB estimates that generic semaglutide will sell for 30% to 50% less than the brand. [9] We built a simple scenario from that range and from the 43% share. This is analysis, not a forecast.
The scenario assumes that every semaglutide box reprices at once. That outcome will not occur at once, because each generic pen needs price approval first. [6] The table therefore shows a ceiling on exposure, not an expected loss. Volume growth would reduce the net effect. The source expects the market to grow, and it describes current volume as low against developed markets. [9]
Why do pharmacies want lower prices?
UBS BB reports that the gross margin on GLP-1 products in pharmacies is about 12%, with room to reach about 40% on cheaper products. [9] The report states that RD Saúde sells about 35% of GLP-1 products while holding 17% of the overall pharmaceutical market. [9] Our reading: retailers have a reason to push lower-cost versions, because the report ties a lower price to a higher margin.
Mounjaro vs. Ozempic: Two Patent Clocks in Brazil
When does the Mounjaro (tirzepatide) patent expire in Brazil?
Public reports disagree. Infomoney says June 2036. It derives that date from a June 2016 filing plus 20 years, and it cites no INPI record. [15] Futuro da Saúde refers to Lilly patents running to 2036 for Mounjaro and 2039 for Zepbound. [10] NeoFeed says the tirzepatide patent otherwise expires in 2032. [16]
We cannot resolve the conflict from public sources. The 2036 date matches the 20-year rule applied to the reported filing month. The 2032 date may refer to another patent in the family. That explanation is our guess, and the source does not say it. This conflict is the reason to check INPI records and a patent database before you plan around any single date.
What is the Mounjaro bill in the Brazilian Congress?
Deputy Mário Heringer (PDT-MG) filed a bill to declare Mounjaro and Zepbound of public interest. [16][10] Futuro da Saúde identifies it as PL 68/2026. [10] The Chamber approved urgency on February 9, 2026, one week after filing, by 337 votes to 19. [16] No date has been set to consider the merits. [16]
Has Brazil used compulsory licensing before?
Brazil has issued one compulsory license: for MSD’s efavirenz in May 2007. [10][15] A 2021 amendment allows compulsory licensing in national emergencies and public health crises. [10] Law 9,279/1996, as amended, also lets the state act in cases of public interest. [16]
How did industry respond?
Eli Lilly says the bill breaks technical standards and harms legal certainty. It cites R$760 million spent on clinical research in Brazil in 2025. [16] Interfarma and Sindusfarma warn about effects on investment and clinical research. [16] Lawyer Gustavo de Freitas Morais argues that the bill mainly aims to keep compounding pharmacies able to import active ingredients, mostly from China. [10] Critics also note that Mounjaro is not in the SUS, and that nobody has asked Conitec to review it. [16][15]
Mounjaro vs. Ozempic: how do the two products compare?
Biosimilar Launch Timeline in Brazil: How Big Is the Biologic Cliff?
How many biosimilars has ANVISA approved?
Two counts exist. The IPWatchdog analysis by Daniel Law reports 81 biosimilar approval records in ANVISA’s database through 2025. [18] The GaBI Journal reports 67 follow-on biologicals approved as of September 2025, or 66 after a withdrawal of one insulin lispro product. [19]
Why do the two counts differ?
The sources use different cut-off dates and different definitions. The GaBI count covers follow-on biologicals and biosimilars through September 2025. The Daniel Law count covers database records through year-end 2025. [18][19] We do not merge them.
What do the yearly approval numbers show?
Daniel Law counts 10 new biosimilar products in 2024 and 16 in 2025. [18] Our calculation: that is a 60% rise in one year. The same analysis describes growth from 2015 to 2018, a sharp rise in 2019 and a slowdown from 2020 to 2023. [18]
Which molecules and companies lead?
Adalimumab (reference product Humira) has 10 approved biosimilars, the most of any molecule. Trastuzumab, bevacizumab, enoxaparin sodium and rituximab follow. [18] Cancer products form the largest therapeutic group, with 26 approvals. [18]
Amgen, Samsung Bioepis and Sandoz hold 7 approvals each. Celltrion and Equilíbrio hold 6 each, and Pfizer holds 5. These six companies hold about 57% of all approvals. [19] Local holders include Fiocruz, Biomm and Libbs. [18]
What does ANVISA RDC 875/2024 change for biosimilars?
RDC 875 introduced new rules in 2024, including the use of international reference products and possible waivers of non-clinical and comparative clinical studies. [19] The GaBI article gives the publication month as June 2024, and its reference list gives May 28, 2024. We therefore state “mid-2024”. RDC 876 changed post-registration rules on June 3, 2024. [19] Law 15.087/25, signed on January 6, 2025, made December 16 the National Biosimilar Medicine Day. [19]
What are PDPs, and how do they affect biologic competition?
PDPs are Productive Development Partnerships between public laboratories and private companies. The Ministry of Health program rests on Portaria GM/MS 4.472/2024. [23] On May 29, 2025, the GECEIS plenary approved a new group of projects. [23]
The Machado Meyer note says the Ministry approved 7 PDPs, but its table lists 9 as approved. The note does not explain the gap. [23] We list five of the nine and make no count claim beyond the table.
Can Brazil’s Domestic Industry Move from Copies to Innovation?
How large is the Brazilian pharmaceutical market?
CMED and ANVISA data show revenue of about R$160.7 billion in 2024, up 12.9% from 2023. The market sold 6.07 billion packages, up 5.2%. [20] It covered 1,944 active ingredients and 232 companies. [20]
Our calculations: average revenue per package was about R$26.47 (160.7 divided by 6.07). The 12.9% growth implies 2023 revenue of about R$142.3 billion. Revenue grew faster than volume, so price and mix drove most of the gain.
How large is the generics segment?
PróGenéricos, using IQVIA data, reports 2,360,857,706 generic units sold in 2025, up 8.33% from 2024. [21] Our calculation: that implies about 2.18 billion units in 2024. The source gives no national generics share. We do not compare it with the CMED package count, because the two datasets use different bases.
What is Eurofarma doing in research?
Eurofarma reports R$712 million in R&D investment, about 350 projects, and more than 2,000 proprietary molecules protected by patent. [24] ANVISA approved cenobamate (sold as Xcopri) for drug-resistant focal epilepsy. [24] The source does not say whether the 2,000 molecules count patents or families, so we do not use it as a patent count.
Why did EMS try to buy control of Hypera in 2024?
In October 2024 EMS proposed a tender offer for up to 20% of Hypera shares at R$30 each, a 39% premium. It also proposed a merger that would give EMS 60% to 70% of the new company. [25] Hypera’s board rejected the offer unanimously three days later and called it hostile. [25] Hypera said such a deal would fit better with Eurofarma or Aché. [25]
The source reports a combined revenue of R$15.9 billion and a market share of about 20%. [25] Our check: R$15.9 billion is 9.9% of the CMED 2024 revenue figure of R$160.7 billion. The two numbers differ because the source does not say which measure it used for the 20%, and the years may differ. We do not resolve it.
Pricing Pressure: How Does CMED Cap Drug Prices in Brazil?
CMED sets maximum prices for medicines. Resolution CM-CMED No. 4, dated March 30, 2026, set the annual maximum adjustment at 3.81% for level 1, 2.47% for level 2 and 1.13% for level 3, effective March 31, 2026. [22] The source ties the levels to the latest factory price (PF) CMED published, and it gives no formula. [22] Our calculation: the gap between the highest and lowest level is 2.68 percentage points.
CMED also gates new launches. ANVISA registration does not allow sale of Ozivy until CMED approves a maximum price. [6][7] The SUS adds a second gate. Inclusion needs Conitec evaluation and approval by the Ministry of Health. [7]
Why Does US Trade Policy Matter for Brazilian Pharma Patents?
The US Trade Representative opened a Section 301 investigation into Brazil on July 15, 2025. Intellectual property protection is one of its subjects. [13] The public consultation closed on August 18, 2025. [13] We found no source that reports a final determination.
The 2026 Special 301 report keeps Brazil on the Watch List. [12][11] It criticizes the 9.15-year grant time for biopharmaceutical patents and asks for test-data protection for human medicines. [11] NeoFeed reports that critics of the Mounjaro bill see a risk of friction with the US during tariff talks. [16]
A Taxonomy of Brazil Patent-Cliff Exposure (Our Framework)
This framework is our own. It is not an industry standard. We built it from the cases above so that readers can sort products by the type of exposure they face.
Class
Definition
Example in this article
Class 1: Expired, entry under way
Main patent expired and ANVISA has approved competitors
Semaglutide: expiry March 20, 2026; six pens approved by July 29, 2026 [4][8]
Class 2: Dated but contested
Expiry date set by the 20-year rule, with a political or legal attempt to shorten it
What This Means for Brand Manufacturers, Generic Developers and Payers
What this means for brand manufacturers
Plan for the 20-year clock from filing. The STJ will not add time, and the STF ruling removed the 10-year floor from grant. [4][5] File early and use INPI priority tracks where you qualify. INPI states that priority-track applications take about seven months. [10] Build protection beyond the main compound. Ricci lists improvement patents, trademarks and trade secrets as complements. [4]
What this means for generic and biosimilar developers
Brazil has no linkage system, so ANVISA approval does not wait for patent expiry and does not clear patent risk. [17][18] File under the Bolar exemption before expiry. [17] The semaglutide queue shows that approval can take years: EMS filed in 2023 and won approval in May 2026. [7] The July approvals show that Indian and Chinese manufacturing supply most of the new pens. [8]
What this means for payers and the SUS
A registered product is not a purchased product. Conitec and the Ministry of Health decide SUS inclusion, and Conitec declined semaglutide and liraglutide in August 2025. [16] PDPs are the Ministry’s route to local supply of biologics. [23]
How Do You Check a Brazilian Drug Patent Before Planning a Launch?
Brazil has no Orange Book. A team that plans a launch must build the patent picture from several records. We suggest the steps below. They are our workflow, not an official procedure.
What steps give a reliable expiry date?
Find the INPI application number for each patent in the product family, and read the filing date. The term runs 20 years from that date for an invention patent. [1]
Check whether the patent was granted before May 2021 under the removed 10-year rule. The ADI 5529 exceptions apply backward for pharmaceutical patents. [2]
Look for related patents on salts, formulations, devices and uses. Ricci notes that an adjacent patent can outlast the main compound patent. [4]
Search court records for term-adjustment suits. Chambers reports more than 70 such suits by the end of 2025. [14]
Compare the result with a commercial patent database such as DrugPatentWatch, and record any conflict, as in the tirzepatide case above.
Which other Brazilian expiry dates did we leave out?
We did not verify Brazilian expiry dates for other drugs, such as Xarelto, Entresto or Keytruda, from primary records. The public sources we found gave no reliable dates for them. We chose to omit those dates and not to guess.
What Happens Next? Dates and Events to Watch
Thirteen semaglutide requests remained pending on July 29, 2026 (our calculation from [8]).
CMED must approve maximum prices for each new semaglutide pen before sale. [6]
The Chamber has not set a date for the merits vote on the Mounjaro bill. [16]
Congress has not passed PL 5.810/2025, the term-adjustment bill, in any source we found. [10]
About 1,000 products are expected to lose patent protection by 2030, according to Futuro da Saúde. [10] The source does not give the product list.
The reported Mounjaro expiry is 2036 or 2032, depending on the source. [15][16]
Key Takeaways
The semaglutide patent expired in Brazil on March 20, 2026, after about 13 years from filing to grant and about 7 years of protection after grant. [4]
The STJ refused to extend the term in December 2025, and Brazil has no statutory term adjustment. [4][5]
ANVISA approved Ozivy 67 days after expiry, as a new medicine and not as a generic. [7]
By July 29, 2026, six semaglutide pens were approved, and NeoFeed reports that the last five will not be made in Brazil. [8]
Reported pharmaceutical patent pendency ranges from 5 to 9.15 years, depending on source and metric. [10]
Brazil has no patent linkage and no data exclusivity for human medicines. [17][11]
ANVISA’s biosimilar approvals rose from 10 in 2024 to 16 in 2025. [18]
The Mounjaro expiry date differs across public reports, and a congressional bill seeks a compulsory license. [10][15][16]
FAQ
Can a company launch in Brazil as soon as ANVISA approves its generic or biosimilar?
No. Regulatory approval does not permit commercial launch before the relevant patents expire. [18] Brazil has no linkage system, so ANVISA does not check patents when it approves. [17]
Does Brazil have an equivalent of Paragraph IV litigation?
No. Brazil lacks a linkage system. [17] The US system adds a stay of up to 30 months and 180 days of exclusivity for a first successful generic challenger. [17] Brazil has neither mechanism in the sources we reviewed.
Does Brazil protect clinical test data for human medicines?
No. Law 10,603/2002 covers veterinary products, fertilizers and agrochemicals. [17] The USTR 2026 report asks for protection for human medicines. [11]
How often has Brazil issued a compulsory license for a drug?
Once. The license covered efavirenz in May 2007. [10]
Can patients buy a synthetic semaglutide pen yet?
Registration alone does not allow sale. Ozivy needed a CMED maximum price before sale. [6][7] We did not verify the current price or shelf status for any pen after the July 2026 approvals.
How many generic units did Brazil sell in 2025?
PróGenéricos, using IQVIA data, reports 2,360,857,706 units, up 8.33% from 2024. [21]
How much clinical research does Eli Lilly say it funded in Brazil in 2025?
Lilly cites R$760 million for 2025. [16] The company used the figure in its argument against the Mounjaro bill.
What is a PDP in Brazil?
A PDP is a Productive Development Partnership between a public laboratory and a private company. Portaria GM/MS 4.472/2024 sets the program rules. [23]
Is Brazil on the USTR Special 301 list?
Yes. Brazil stands on the 2026 Watch List. [12] Diário do Comércio reports that Brazil has appeared in the report since at least the late 1980s. [11]
Do a few companies control Brazilian biosimilar approvals?
Six companies hold about 57% of approved follow-on biologicals: Amgen, Samsung Bioepis, Sandoz, Celltrion, Equilíbrio and Pfizer. [19]
References
[1] Mattos Filho. (2021). New law revokes certain patent-related clauses in Brazil’s Industrial Property Law. Mattos Filho Advogados. https://www.mattosfilho.com.br/en/?p=59158
[10] Marin, I. (2026, May 20). Tempo de análise de patentes segue preocupando indústria farmacêutica, em meio a discussões no Congresso. Futuro da Saúde. https://futurodasaude.com.br/?p=46545
