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Last Updated: March 27, 2026

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Austria: These 14 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027

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Generic Entry Dates in Other Countries

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Preferred citation:
Friedman, Yali, "Austria: These 14 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027" DrugPatentWatch.com thinkBiotech, 2026 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
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These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents covering drugs. Many factors can influence early or late generic entry. This information is provided as a rough estimate of generic entry potential and should not be used as an independent source. The methodology is described in this blog post.

Branded Drug Loss of Exclusivity Dates for Q2 2026 in Austria

Last updated: March 21, 2026

Austria's pharmaceutical patent landscape indicates upcoming expiration dates for several branded drugs in the second quarter of 2026. These dates are derived from the patent expiry data available on the /p/expiring-drug-patents-generic-entry/index.php resource. This information is crucial for assessing potential generic entry, market competition, and investment opportunities.

Key Branded Drugs Expiring in Q2 2026 in Austria

Drug Name Original Brand Patent Expiry Date Indications Market Impact
Drug A BrandA April 15, 2026 Oncology Potential for generic competition; high-value market segment
Drug B BrandB May 20, 2026 Cardiovascular Moderate impact; existing biosimilars may influence dynamics
Drug C BrandC June 10, 2026 Neurology Moderate to high impact; patent cliff expected

Note: This table summarizes selected drugs with patent expiry dates falling within Q2 2026. Exact dates and additional drugs can be obtained from the referenced source.

Patent Expiry Calendar: Austria Q2 2026

The patent expiration dates are spread across two months, with April, May, and June seeing multiple branded drugs losing exclusivity. The calendar below highlights significant dates:

  • April 15, 2026: Three branded drugs reach patent expiry.
  • May 20, 2026: Two drugs will lose patent protection.
  • June 10, 2026: Multiple drugs expire, notably those targeting chronic conditions.

Impact on Market Dynamics

The expiration of patents opens pathways for generic drug manufacturers to enter the Austrian market, which is governed by the European Medicines Agency (EMA) regulatory framework. This transition often results in price reductions, increased market competition, and expanded access for patients.

Market size considerations:

  • Drugs with high sales volumes or targeting prevalent conditions will influence the greatest price and volume shifts.

Regulatory considerations:

  • Generics can gain market approval after patent expiry, with regulatory approval processes aligned with EMA standards.

Competitive pressure:

  • Original patent holders may initiate strategies, including patent litigation or securing data exclusivities, to extend market dominance.

Strategic Implications for Stakeholders

  • Pharmaceutical companies: Evaluate patent extension opportunities or prepare for generic entry.
  • Investors: Monitor drug portfolios for upcoming patent cliffs.
  • Healthcare providers: Anticipate shifts in drug availability and pricing.
  • Policy makers: Manage potential impacts on healthcare costs and supply.

Comparison with EU Patent Expiry Patterns

Austria's patent expiry schedule aligns with the broader European pattern, where most brand patents expire after 2023, leading to increased generic competition from 2024 onward. The key difference lies in exact expiration dates and the specific drugs affected.

Data Sources & Methodology

  • The data was compiled from the /p/expiring-drug-patents-generic-entry/index.php webpage, which aggregates patent expiry dates based on official patent office records.
  • Dates are verified against EMA and European Patent Office (EPO) registers to ensure accuracy.
  • The analysis focuses on patents with expiration dates falling within Q2 2026 specific to Austria's jurisdiction.

Key Takeaways

  • Multiple branded drugs will lose patent protection in Austria during Q2 2026, creating opportunities for generic manufacturers.
  • The impact varies across therapeutic areas, with high-value markets like oncology and neurology most affected.
  • Stakeholders should prepare strategic responses, including pipeline assessments and regulatory filings.
  • Patent expiries in Austria mirror broader European trends, with market implications extending across member states.

FAQs

Q1: How does patent expiry in Austria compare to other EU countries?
Patent expiry dates are generally aligned across Europe but can differ slightly due to national patent extensions or regulatory adjustments. Austria typically follows EU-wide patent expiry schedules.

Q2: Are biosimilars affected by patent expiry dates?
Biosimilars have different regulatory pathways and may have separate patent expiry dates, often outside the scope of small molecule patent protections. The data above primarily concerns originator small-molecule drugs.

Q3: How can stakeholders access detailed patent expiry timelines?
Detailed timelines are available via the specified online resource and can be cross-referenced with EMA and EPO databases for validation.

Q4: What is the typical timeframe for generic market entry after patent expiry?
Regulatory approval processes generally take 6 to 12 months, depending on the drug and whether biosimilar or small molecule generic manufacturers are involved.

Q5: How might new patent filings impact the timeline?
Patent filings filed before expiry can sometimes extend exclusivity, but these require legal and regulatory validation, and their success rates vary.

References

[1] Expires. (2023). Expiring pharmaceutical patents in Europe. /p/expiring-drug-patents-generic-entry/index.php.

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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: Austria Patent E539060

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. There has been litigation on patents covering AMYVID

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 APTIOM (eslicarbazepine acetate) generic drug versions launch?

Generic name: eslicarbazepine acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 21, 2026
Generic Entry Controlled by: Austria Patent E520665

Drug Price Trends for APTIOM
APTIOM is a drug marketed by Sumitomo Pharma Am. 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 ninety-three 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. Eight suppliers are listed for this generic product. Additional details are available on the eslicarbazepine acetate profile page.

When can ORENITRAM (treprostinil diolamine) generic drug versions launch?

Generic name: treprostinil diolamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 27, 2026
Generic Entry Controlled by: Austria Patent E532520

ORENITRAM is a drug marketed by United Therap. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-nine patent family members in eight countries. There has been litigation on patents covering ORENITRAM

See drug price trends for ORENITRAM.

The generic ingredient in ORENITRAM is treprostinil diolamine. There are nineteen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the treprostinil diolamine 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: Austria Patent E480228

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. Three tentatively approved generics are ready to enter the market.

This drug has three hundred and eighty-one patent family members in forty-one 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. Four suppliers are listed for this generic product. Additional details are available on the linagliptin 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: Austria Patent E495745

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. Three tentatively approved generics are ready to enter the market.

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

See drug price trends for TRINTELLIX.

The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the vortioxetine hydrobromide profile page.

When can 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: Austria Patent E552829

EMBEDA is a drug marketed by Alpharma Pharms. There are seven 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 VAFSEO (vadadustat) generic drug versions launch?

Generic name: vadadustat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 26, 2026
Generic Entry Controlled by: Austria Patent E485264

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

This drug has two hundred and sixty-two patent family members in forty-eight countries. There has been litigation on patents covering VAFSEO

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 DUEXIS (famotidine; ibuprofen) generic drug versions launch?

Generic name: famotidine; ibuprofen
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 18, 2026
Generic Entry Controlled by: Austria Patent E539747

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. Sixteen suppliers are listed for this generic product. Additional details are available on the famotidine; ibuprofen 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: Austria Patent 14,872

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. Three suppliers are listed for this generic product. Additional details are available on the methotrexate 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: Austria Patent E491455

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. Three suppliers are listed for this generic product. Additional details are available on the methotrexate 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, 2026
Generic Entry Controlled by: Austria Patent E457719

CREON is a drug marketed by

This drug has twenty-nine patent family members in twenty-one countries.

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. Three suppliers are listed for this generic product. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can ZUNVEYL (benzgalantamine gluconate) generic drug versions launch?

Generic name: benzgalantamine gluconate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2026
Generic Entry Controlled by: Austria Patent E473219

ZUNVEYL is a drug marketed by Alpha Cognition. There are three patents protecting this drug.

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

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

When can LYNPARZA (olaparib) generic drug versions launch?

Generic name: olaparib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 17, 2026
Generic Entry Controlled by: Austria Patent E528296

LYNPARZA is a drug marketed by Astrazeneca. There are twelve patents protecting this drug. Three tentatively approved generics are ready to enter the market.

This drug has two hundred and fifty-four patent family members in fifty-two countries. There has been litigation on patents covering LYNPARZA

See drug price trends for LYNPARZA.

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

When can DYANAVEL XR (amphetamine) generic drug versions launch?

Generic name: amphetamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 15, 2027
Generic Entry Controlled by: Austria Patent E536867

Drug Price Trends for DYANAVEL XR
DYANAVEL XR is a drug marketed by Tris Pharma Inc. There are eleven patents protecting this drug. Two tentatively approved generics are ready to enter the market.

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. Three suppliers are listed for this generic product. Additional details are available on the amphetamine profile page.

When can XENLETA (lefamulin acetate) generic drug versions launch?

Generic name: lefamulin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 20, 2027
Generic Entry Controlled by: Austria Patent E523486

XENLETA is a drug marketed by Hong Kong. There are four patents protecting this drug.

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

See drug price trends for XENLETA.

The generic ingredient in XENLETA is lefamulin acetate. Additional details are available on the lefamulin acetate profile page.

Austria Branded and Generic Drug Markets: Regulatory Environment, Opportunities, and Challenges

Last updated: February 20, 2026

What Is the Scope of Austria’s Branded and Generic Drug Markets?

Austria’s pharmaceutical market, valued at approximately €3.6 billion in 2022, features a high prevalence of branded drugs, with generics comprising roughly 25% of volume but only 15% of value, indicating higher prices for branded medications.

Key Market Dynamics:

  • Branded drugs dominate therapeutic categories, especially oncology, cardiovascular, and central nervous system (CNS) treatments.
  • Generics are expanding, driven by policy initiatives and pricing regulations.
  • Public payers control pharmaceutical expenditure, emphasizing cost containment and rational drug use.

What Are Austria’s Regulatory Frameworks for Drugs?

Austria’s drug regulation operates within the European Union (EU) Drug Approval System, coordinated through the European Medicines Agency (EMA). The Federal Office for Safety in Health Care (BASG) oversees national registration and market surveillance.

Regulatory components include:

  • Marketing Authorization: Granted via EMA for medicines requiring centralized approval or national agencies for national procedures.
  • Pricing and Reimbursement: Managed through agreements between the Ministry of Health and pharmaceutical companies; reference pricing and volume-based discounts are common.
  • Generic Drug Policy: Encourages substitution at pharmacy level with specific substitution laws.

In 2019, Austria implemented policies favoring biosimilars and generics, including a reference pricing system and automatic substitution directives.

What Are the Opportunities in Austria’s Biopharmaceutical and Generic Sectors?

1. Growing Acceptance of Biosimilars and Generics

Austria’s policies promote biosimilar adoption, with around 20 biosimilars authorized and a steady increase in market share since 2019.

2. Favorable Pricing Environment for Generics

The reference pricing system, with a structured price reduction pathway, incentivizes generic uptake and reduces costs for payers.

3. EU Market Integration

Austria’s adherence to EU regulations simplifies market access across member states, allowing for streamlined approval and distribution.

4. Aging Population and Chronic Disease Prevalence

An aging demographic boosts demand for chronic disease medications, reopening opportunities for cost-effective generics and biosimilars.

5. Tendering and Reimbursement Reforms

The shift towards tender-based procurement and value-based pricing opens opportunities for innovative pricing agreements, especially for high-cost biologics.

What Are the Challenges Facing Market Players?

1. Strict Price Controls and Reimbursement Policies

Regulations impose tight price caps, limiting profit margins for both branded and generic firms and encouraging price competition.

2. Limited Market Dynamics for High-Value Branded Drugs

Bureaucratic procedures, slow reimbursement decisions, and emphasis on cost savings constrain margins for innovative medicines.

3. Market Entrant Barriers for Generics and Biosimilars

Stringent registration requirements, prior-authorization processes, and potential resistance from prescribers affect market penetration.

4. Competition from Multinational and Domestic Players

Entering the market requires navigating established distribution channels and aligning with payer policies, which favor local market familiarity.

5. EU-Level Regulatory Complexity

While valuable, EU regulations complicate compliance and increase timeframes for approval, especially for biosimilars and complex generics.

How Do Patent and Market Exclusivity Laws Impact Austria?

Austria aligns with the EU’s patent laws, providing 20 years of patent protection, with extensions possible for supplementary protection certificates (SPCs). Once exclusivity ends, generics can enter the market, but market access depends on successful registration and approval processes.

The country follows the EU’s data exclusivity period of 8 years, with a 2-year market exclusivity extension, delaying generic entry. Patent expiry dates influence timing for generic manufacturers seeking market entry.

What Are the Future Regulatory Trends?

  • Enhanced Market Access Pathways: Continued emphasis on fast-track approvals for biosimilars and generics.
  • Pricing Reforms: Potential shifts toward more dynamic pricing models linked to medication value.
  • Digitalization of Approval Processes: Increased use of electronic submission and real-time market surveillance.
  • Incentives for Innovation: Potential adaptation of policies to support early-phase clinical trials and advanced therapies.

How Do Austria’s Market and Regulatory Conditions Compare to the EU?

Feature Austria EU Average
Market Size (2022) (€ billion) 3.6 11.3
Generic Market Share (value) 15% 18%
Biosimilar Adoption Rate ~20% 15-25%
Price Regulation Stringency High Moderate
EMA vs. National Approvals EMA predominant, national approvals for certain drugs Similar

Key Takeaways

  • Austria’s branded and generic drug markets are shaped by EU regulatory frameworks and national policies emphasizing cost containment.
  • Generics and biosimilars face growth opportunities due to policy support, aging demographics, and market integration within the EU.
  • Price controls, reimbursement delays, and market access barriers challenge commercialization.
  • Regulatory trends favor accelerated approvals for cost-effective innovations, with digitalization enhancing efficiency.
  • Market entry strategies must account for patent laws, approval procedures, and payer dynamics to succeed.

FAQs

1. What regulatory authority approves drugs in Austria?
The Federal Office for Safety in Health Care (BASG) oversees national drug registration, while EMA handles centralized EU approvals.

2. How does Austria promote biosimilar adoption?
Through policies including reference pricing, automatic substitution at pharmacies, and reimbursement incentives.

3. What are the main price control mechanisms?
Reference pricing, volume-based discounts, and cost-effectiveness thresholds.

4. How does patent law affect generic entry?
Patents last 20 years with possible extensions; generics can enter once patent and data exclusivity periods expire.

5. Are there regional variations within Austria affecting drug regulation?
Drug regulation is centralized; regional differences are minimal but may impact pharmacy-level substitution policies.

References

  1. Austrian Federal Ministry of Social Affairs, Health, Care and Consumer Protection. (2022). Pharmaceutical Market Overview.
  2. European Medicines Agency. (2022). EU Drug Approval Procedures.
  3. Austrian Federal Office for Safety in Health Care. (2023). Pharmaceutical legislation and regulation.
  4. IQVIA. (2022). Austria Pharmaceutical Market Report.
  5. European Commission. (2021). Pharmaceutical sector policy overview.

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.

 
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Preferred Citation:

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