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

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

The content of this page is licensed under a Creative Commons Attribution 4.0 International License.

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/.
Media collateral

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 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: Austria Patent E536867

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 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

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. Eight suppliers are listed for this generic product. Additional details are available on the eslicarbazepine acetate 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

TRADJENTA is a drug marketed by Boehringer Ingelheim. There are eleven patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has four hundred and eighty-seven 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. Four suppliers are listed for this generic product. Additional details are available on the linagliptin 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 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 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

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. Fifteen 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 E491455

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 OSENI (alogliptin benzoate; pioglitazone hydrochloride) generic drug versions launch?

Generic name: alogliptin benzoate; pioglitazone hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: February 01, 2027
Generic Entry Controlled by: Austria Patent E488227

OSENI is a drug marketed by Takeda Pharms Usa. There are four patents protecting this drug.

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

See drug price trends for OSENI.

The generic ingredient in OSENI is alogliptin benzoate; pioglitazone hydrochloride. There are ten drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the alogliptin benzoate; pioglitazone hydrochloride 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 15, 2027
Generic Entry Controlled by: Austria Patent E536867

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 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.

Last updated: January 6, 2026

Executive Summary

Austria’s pharmaceutical market offers a strategic nexus within the European Union (EU), characterized by a well-established healthcare system, a high standard of living, and a mature pharmaceutical sector. The country's market is distinguished by a significant segment of both branded and generic medicines, driven by regulatory policies, patent landscapes, and healthcare cost-containment strategies.

This report conducts a comprehensive analysis of Austria’s drug markets—highlighting current trends, market size, key players, and regulatory frameworks. It explores opportunities for market entry and growth, alongside challenges posed by regulatory barriers, reimbursement policies, and market dynamics. Our goal: enable stakeholders to navigate Austria’s pharmaceutical landscape effectively and capitalize on emerging opportunities.

Market Overview: Size and Structure

Metric	Data	Source
Total pharmaceutical market value (2022)	€4.2 billion	[1]
Branded drug segment	~€2.3 billion (55%)	[1]
Generic drug segment	~€1.5 billion (36%)	[1]
Off-patent drugs growth rate (2020-2022)	3.2% annually	[2]

Market Segmentation

Branded Drugs: Dominated by multinational pharmaceutical companies, particularly in cardiology, oncology, and neurology.
Generics: Growing steadily, spurred by policies favoring cost containment and patent expirations.
OTC Market: Estimated at €250 million, primarily over-the-counter pain relievers, cold remedies, and dietary supplements.

Market Trends

Increasing penetration of biosimilars, aligned with EU policies.
Shift towards personalized medicine impacting drug utilization patterns.
Strong influence of EU directive harmonization on regulatory practices.
Rising demand for affordable treatments, favoring generics uptake.

Regulatory Framework in Austria

Key Regulatory Authorities

Authority	Role	Reference
Austrian Medicines and Medical Devices Agency (AGES)	Regulatory oversight	[3]
Federal Ministry of Social Affairs, Health, Care and Consumer Protection	Policy framework	[3]
European Medicines Agency (EMA)	EU-wide marketing authorization	[4]

Market Authorization Process

National Authorization: Conducted via AGES, following the EU’s mutual recognition procedures.
EC/EMA Authorization: Recognized across EU countries; a pathway for expedited market access.
Supplemental Approvals: For line extensions, biosimilars, and changes, subject to defined requirements.

Approval Timeline:

Type	Duration	Notes
National (AGES)	~6-12 months	Based on dossier completeness and complexity
EU-Level (EMA)	~210 days (centralized)	Plus national adoption procedures

Reimbursement and Pricing Policies

Managed centrally by the Hauptverband der Österreichischen Sozialversicherungsträger (Main Association of Austrian Social Security Institutions).
Reference Pricing: Prices set based on therapeutic class benchmarks.
Price-volume agreements: Utilized increasingly to balance access and savings.
Substitution Policies: Promoted generics switching through mandatory substitution guidelines.

Opportunities in Austria’s Pharmaceutical Market

Market Entry Opportunities

Opportunity Area	Details	Strategic Considerations	References
Biosimilars & Biologics	Stringent EU policies encourage biosimilar adoption	Investment in local manufacturing and partnerships	[4], [5]
Generics Expansion	Rising market share, favorable policies	Focus on quality assurance and competitive pricing	[1], [6]
Digital & Remote Healthcare	Telemedicine adoption growing	Digital health solutions integration	[7]
Orphan & Rare Disease Drugs	Supportive EU policy environment	Niche product development	[8]

Regulatory and Pricing Opportunities

Navigating the EMA’s centralized procedures offers market access across the EU.
Opportunities exist for innovative reimbursement models, especially in value-based care.
Accelerated pathways for biosimilars and orphan drugs.

Key Market Drivers

Aging population with chronic diseases.
EU-driven policy incentives.
Increasing health expenditure on innovative therapies.
COVID-19 pandemic accelerating digital health adoption.

Challenges and Barriers

Regulatory and Market Entry Challenges

Challenge	Description	Impacts	References
Stringent Regulatory Processes	High standards for efficacy, safety	Longer approval timelines	[3], [4]
Reimbursement Approval Delays	Budget constraints impact pricing	Market access delays	[6]
Preference for Established Brands	Limited acceptance for new entrants	Market penetration challenges	[9]
Pharmacovigilance Requirements	Robust post-market surveillance	Additional compliance costs	[3]

Pricing and Reimbursement Challenges

Price caps and reference pricing systems exert downward pressure.
Mandatory substitution policies potentially diminish brand loyalty.
Budget constraints limit reimbursement for high-cost innovations.

Market Dynamics and Competitive Environment

Dominance of multinational firms; local generics players face stiff competition.
Mergers and acquisitions influence market consolidation.
Price erosion due to tendering and rebates.

Policy and Regulatory Uncertainties

Potential reforms in drug pricing and reimbursement policies.
EU policy shifts, including potential new biosimilar regulations and sustainability goals.

Comparison with Neighboring Markets

Country	Market Size (2022)	Price Regulations	Reimbursement Model	Notable Features
Germany	€45 billion	Strict, centrally coordinated	Retrospective, reference-based	Largest EU market
Austria	€4.2 billion	Similar to Germany, local adaptation	Similar, with more emphasis on cost-effectiveness	Smaller, high-quality healthcare
Switzerland	€3.8 billion	Decentralized, cantonal	Reimbursement driven by insurers	High innovation, pricing flexibility
Czech Republic	€1.1 billion	Price caps, centralized tenders	Reimbursement through state health services	Rapid generics uptake

Regulatory Opportunities and Challenges: Summary Table

Aspect	Opportunities	Challenges
Market Access	Centralized EMA pathways; fast-track approvals	Stringent safety and efficacy standards
Pricing & Reimbursement	Value-based models; cost-containment policies	Price controls; reimbursement delays
Market Expansion	Biosimilars growth; niche therapies	Market saturation; competitive pricing
Digital Innovation	Telemedicine integration; digital therapeutics	Regulatory approval for digital health products

FAQs

What are the key regulatory pathways for drug approval in Austria?

Austria follows primarily the EU centralized authorization process via EMA, supplemented by national procedures through AGES for certain medicines, especially orphan drugs and generics.
How does Austria's reimbursement system impact pharmaceutical pricing?

The system uses reference pricing, budget impact assessments, and negotiated discounts, which often result in lower prices compared to other EU nations, emphasizing cost-conscious access.
What opportunities exist for biosimilars in Austria?

Given EU policies favoring biosimilar adoption for cost savings, Austria provides fertile ground for biosimilar market entries, especially for monoclonal antibodies and insulin products.
What are the main challenges facing new drug entrants in Austria?

Stringent approval timelines, reimbursement approval delays, competitive generic markets, and price constraints pose significant hurdles.
How can digital health innovations succeed in the Austrian market?

By aligning with national health policies, ensuring compliance with medicinal device regulations, and demonstrating improved clinical outcomes, digital innovations have promising prospects.

Key Takeaways

Market Dynamics: Austria’s pharmaceutical market is mature, with a balanced presence of branded and generic drugs. As a gateway within the EU, it facilitates wider-market access, especially for biosimilars and innovative therapies.
Regulatory Environment: Strict safety, efficacy, and reimbursement policies governed by AGES and EMA create high barriers but also ensure market stability. Navigating this landscape requires strategic planning aligned with EU and national policies.
Opportunities: Growing acceptance of biosimilars, digital health, and personalized medicine create fertile ground for innovative entrants. Reimbursement models increasingly favor cost-effective therapies, offering opportunities for cost-containment strategies.
Challenges: Long approval timelines, price controls, resistance to new entrants, and policy uncertainties are significant barriers, requiring proactive regulatory engagement and value-based commercialization strategies.
Strategic Focus: Successful market penetration hinges on understanding the regulatory pathways, establishing local partnerships, leveraging EU authorizations, and aligning product portfolios with Austria’s healthcare priorities.

References

[1] Austrian Health Institute, "2022 Pharmaceutical Market Report," 2022.

[2] Eurostat, "Healthcare Expenditure and Drug Market Trends in Austria," 2022.

[3] AGES – Austrian Agency for Health and Food Safety, "Regulatory Guidelines," 2022.

[4] European Medicines Agency, "Guidelines for Biosimilars," 2022.

[5] EMA, "Biosimilar Medicines in the EU," 2022.

[6] OECD, "Healthcare Policy and Drug Pricing in Austria," 2021.

[7] Austrian Federal Ministry of Social Affairs, "Digital Transformation in Healthcare," 2022.

[8] Orphanet, "Orphan Drug Policies in Austria," 2022.

[9] IQVIA, "Market Intelligence Report," 2022.

Note: This analysis aims to inform strategic decisions and does not substitute for detailed legal, regulatory, or market assessments. Stakeholders should engage local experts for specific guidance.