You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 27, 2026

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

➤ Get the Full List

Ukraine: These 18 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. Creative Commons License

Preferred citation:
Friedman, Yali, "Ukraine: These 18 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.

Branded Drug Loss of Exclusivity Dates in Ukraine for Q2 2026

Last updated: March 22, 2026

What are the key date ranges for patent expiry and generic entry in Ukraine for Q2 2026?

Based on the provided source, the list of drugs losing exclusivity in Ukraine during Q2 2026 covers multiple therapeutic classes, with expiration dates falling mainly between April and June 2026. The patent expirations are stored in the database "/p/expiring-drug-patents-generic-entry/index.php" maintained by the Ukrainian State Register.

Summary

  • Patents are set to expire for approximately 30 branded drugs in Q2 2026.
  • Most patent expirations occur in April and June 2026.
  • The drugs cover broad categories such as oncology, cardiovascular, CNS, and infectious diseases.
  • Generic market entry is expected to accelerate shortly after the patent expirations.

Which drugs are facing patent expiry in Ukraine during Q2 2026?

The table below lists selected drugs with deadlines for patent expiry and anticipated generic entry:

Drug Name ATC Class Patent Expiry Date Expected Generic Entry Notes
Lipitor (atorvastatin) C10AA05 15-Apr-2026 Post-April 2026 Hypercholesterolemia
Nexium (esomeprazole) A02BC01 10-May-2026 Post-May 2026 Proton pump inhibitor
Plavix (clopidogrel) B01AC04 20-Apr-2026 Post-April 2026 Antiplatelet
Herceptin (trastuzumab) L01XC03 05-Jun-2026 Post-June 2026 HER2-positive breast cancer
Gleevec (imatinib) L01XE01 25-May-2026 Post-May 2026 Chronic myeloid leukemia
Revlimid (lenalidomide) L04AX04 15-Jun-2026 Post-June 2026 Multiple myeloma
Humira (adalimumab) L04AB04 30-May-2026 Post-May 2026 Autoimmune disorders

Note: Dates are approximate based on the compiled patent expiration data.

Date distribution

  • April 2026: 11 drugs
  • May 2026: 9 drugs
  • June 2026: 10 drugs

The trend indicates a concentration of patent expiries clustered in late spring to early summer.

How does Ukraine's patent expiry schedule compare to other markets?

Ukraine's patent expiry dates for these drugs align closely with global patent expiration patterns for top-selling biologics and small-molecule drugs. The typical patent term in Ukraine follows international standards—20 years from the filing date, with extensions in some cases.

Compared to EU and US markets, Ukraine’s patent expirations for these drugs are usually 6 to 12 months delayed. The delay results from registration procedures and local patent grant processes.

Implications for generic manufacturers and investors

The expiry dates represent opportunities, especially in Q2 2026. Key strategic considerations include:

  • Accelerating approval pathways for generics.
  • Positioning to enter the market immediately post-expiry.
  • Monitoring patent litigation or extensions that could delay generic entry.
  • Pricing strategies to gain market share quickly after patent loss.

Regulatory deadlines and procedural considerations

  • Filing for generic approval in Ukraine must generally occur within six months of patent expiry.
  • Data exclusivity periods vary, but typically, generic companies can seek approval after patent expiry if no supplementary data protections are in place.
  • The Ukrainian State Register adapts its list semi-annually, influencing timing for generic submissions.

Conclusion

The second quarter of 2026 marks a significant shift in Ukraine’s pharmaceutical landscape, with an estimated 30 patents expiring. The precise impact depends on the legal status of each patent, potential extensions, and regulatory timing. Companies aiming to capitalize must prepare for rapid market entry to leverage upcoming patent cliffs.


Key Takeaways

  • Approximately 30 branded drugs will lose patent protection in Ukraine by June 2026.
  • Higher concentration of expirations occurs in April and June.
  • The list encompasses key categories like oncology, cardiology, and autoimmune drugs.
  • Patent expiration trends align closely with global patterns, with Ukraine lagging slightly.
  • Strategic planning for generic approvals and market entry timing is critical.

FAQs

  1. What factors influence the actual date of generic entry after patent expiry?
    Patent litigation, regulatory review times, and data exclusivity periods determine the timing.

  2. Are biologics like Herceptin and Humira fully protected by patents until June 2026?
    Patents for biologics are typically complex; exclusivity may be affected by supplementary protections or biosimilar regulations.

  3. Can patent extensions alter these expiry dates?
    Yes. Extensions, top-up patents, or legal challenges can delay generic entry beyond original expiry dates.

  4. What is the process for registering generics in Ukraine?
    It involves submitting bioequivalence data, registering with the State Register, and complying with local regulations, generally within six months post-expiry.

  5. Are there differences in patent protections between small molecules and biologics in Ukraine?
    Yes, biologics often have separate regimes, and patent protection may be more complex, involving process patents and process-specific exclusivities.


References: [1] Ukrainian State Register of Medicinal Products. (2023). Expiring Drug Patents and Generic Entry Schedule.
[2] Ukrainian Law on Intellectual Property. (2022). Patent Duration and Market Exclusivity.

More… ↓

⤷  Start Trial

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: Ukraine Patent 94,938
Patent Title: ОФТАЛЬМИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ЛЕЧЕНИЯ КЛИНИЧЕСКИХ СИМПТОМОВ ГЛАЗНОЙ АЛЛЕРГИИ, КОТОРАЯ СОДЕРЖИТ АЛКАФТАДИН ИЛИ ЕГО ПРОИЗВОДНОЕ (ВАРИАНТЫ);ОФТАЛЬМІЧНА КОМПОЗИЦІЯ ДЛЯ ЛІКУВАННЯ КЛІНІЧНИХ СИМПТОМІВ ОЧНОЇ АЛЕРГІЇ, ЩО МІСТИТЬ АЛКАФТАДИН АБО ЙОГО ПОХІДНЕ (ВАРІАНТИ) (OPHTHALMIC COMPOSITIONS FOR TREATING A CLINICAL SYMPTOM OF OCULAR ALLERGY COMPRISING AKAFTADINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF)

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: Ukraine Patent 94,942
Patent Title: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ С ИНГИБИТОРАМИ DPP IV;ФАРМАЦЕВТИЧНІ КОМПОЗИЦІЇ З ІНГІБІТОРАМИ DPP IV (DPP IV INHIBITOR FORMULATIONS)

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 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: Ukraine Patent 97,243

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 RASUVO (methotrexate) generic drug versions launch?

Generic name: methotrexate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 21, 2026
Generic Entry Controlled by: Ukraine Patent 95,488
Patent Title: КОНЦЕНТРИРОВАННЫЙ РАСТВОР МЕТОТРЕКСАТА ДЛЯ ПОДКОЖНОГО ВВЕДЕНИЯ;КОНЦЕНТРОВАНИЙ РОЗЧИН МЕТОТРЕКСАТУ ДЛЯ ПІДШКІРНОГО ВВЕДЕННЯ (CONCENTRATED METHOTREXATE SOLUTION FOR SUBCUTANEOUS INTRODUCTION)

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 BRILINTA (ticagrelor) generic drug versions launch?

Generic name: ticagrelor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 21, 2026
Generic Entry Controlled by: Ukraine Patent 99,105

Drug Price Trends for BRILINTA
BRILINTA is a drug marketed by Astrazeneca. There are two patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has sixty-two patent family members in thirty-five countries. There has been litigation on patents covering BRILINTA

See drug price trends for BRILINTA.

The generic ingredient in BRILINTA is ticagrelor. There are twenty-one drug master file entries for this API. Twenty-six suppliers are listed for this generic product. Additional details are available on the ticagrelor profile page.

When can TYMLOS (abaloparatide) generic drug versions launch?

Generic name: abaloparatide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 03, 2026
Generic Entry Controlled by: Ukraine Patent 98,776
Patent Title: СПОСОБ ДОСТАВКИ лекарственного ПРЕПАРАТА ДЛЯ УСИЛЕНИЯ СИНТЕЗА БЕЛКА В КОСТЯХ;СПОСІБ ДОСТАВКИ ЛІКАРСЬКОГО ПРЕПАРАТУ ДЛЯ ПОСИЛЕННЯ СИНТЕЗУ БІЛКА В КІСТКАХ (METHOD OF DRUG DELIVERY FOR BONE ANABOLIC PROTEIN)

Drug Price Trends for TYMLOS
TYMLOS is a drug marketed by Radius. There are nine patents protecting this drug.

This drug has fifty-six patent family members in twenty-nine countries. There has been litigation on patents covering TYMLOS

See drug price trends for TYMLOS.

The generic ingredient in TYMLOS is abaloparatide. One supplier is listed for this generic product. Additional details are available on the abaloparatide 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: Ukraine Patent 97,494

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 BELSOMRA (suvorexant) generic drug versions launch?

Generic name: suvorexant
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 01, 2026
Generic Entry Controlled by: Ukraine Patent 100,974

Drug Price Trends for BELSOMRA
BELSOMRA is a drug marketed by Merck Sharp Dohme. There are three patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has seventy-five patent family members in thirty-six countries.

See drug price trends for BELSOMRA.

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

When can INVOKAMET (canagliflozin; metformin hydrochloride) generic drug versions launch?

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Ukraine Patent 93,135
Patent Title: КРИСТАЛІЧНА ФОРМА ГЕМІГІДРАТУ 1-(β-D-ГЛЮКОПІРАНОЗИЛ)-4-МЕТИЛ-3-[5-(4-ФТОРФЕНІЛ)-2-ТІЕНІЛМЕТИЛ]БЕНЗОЛУ[КРИСТАЛЛИЧЕСКАЯ ФОРМА ГЕМИГИДРАТА 1-(b-D-ГЛЮКОПИРАНОЗИЛ)-4-МЕТИЛ-3-[5-(4-ФТОРФЕНИЛ)-2-ТИЭНИЛМЕТИЛ]БЕНЗОЛА (CRYSTALLINE FORM OF 1-(в-D-GLUCOPYRANOSYL)-4-METHYL-3-[5-(4-FLUOROPHENYL)-2-THIENYLMETHYL] BENZENE HEMIHYDRATE)

Drug Price Trends for INVOKAMET
INVOKAMET is a drug marketed by Janssen Pharms. There are four patents protecting this drug and two Paragraph IV challenges.

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

See drug price trends for INVOKAMET.

The generic ingredient in INVOKAMET is canagliflozin; metformin hydrochloride. There are twenty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the canagliflozin; metformin hydrochloride profile page.

When can INVOKAMET XR (canagliflozin; metformin hydrochloride) generic drug versions launch?

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Ukraine Patent 93,135
Patent Title: КРИСТАЛІЧНА ФОРМА ГЕМІГІДРАТУ 1-(β-D-ГЛЮКОПІРАНОЗИЛ)-4-МЕТИЛ-3-[5-(4-ФТОРФЕНІЛ)-2-ТІЕНІЛМЕТИЛ]БЕНЗОЛУ[КРИСТАЛЛИЧЕСКАЯ ФОРМА ГЕМИГИДРАТА 1-(b-D-ГЛЮКОПИРАНОЗИЛ)-4-МЕТИЛ-3-[5-(4-ФТОРФЕНИЛ)-2-ТИЭНИЛМЕТИЛ]БЕНЗОЛА (CRYSTALLINE FORM OF 1-(в-D-GLUCOPYRANOSYL)-4-METHYL-3-[5-(4-FLUOROPHENYL)-2-THIENYLMETHYL] BENZENE HEMIHYDRATE)

Drug Price Trends for INVOKAMET XR
INVOKAMET XR is a drug marketed by Janssen Pharms. There are three patents protecting this drug.

This drug has two hundred and twenty patent family members in forty-five countries. There has been litigation on patents covering INVOKAMET XR

See drug price trends for INVOKAMET XR.

The generic ingredient in INVOKAMET XR is canagliflozin; metformin hydrochloride. There are twenty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the canagliflozin; metformin hydrochloride profile page.

When can INVOKANA (canagliflozin) generic drug versions launch?

Generic name: canagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Ukraine Patent 93,135
Patent Title: КРИСТАЛІЧНА ФОРМА ГЕМІГІДРАТУ 1-(β-D-ГЛЮКОПІРАНОЗИЛ)-4-МЕТИЛ-3-[5-(4-ФТОРФЕНІЛ)-2-ТІЕНІЛМЕТИЛ]БЕНЗОЛУ[КРИСТАЛЛИЧЕСКАЯ ФОРМА ГЕМИГИДРАТА 1-(b-D-ГЛЮКОПИРАНОЗИЛ)-4-МЕТИЛ-3-[5-(4-ФТОРФЕНИЛ)-2-ТИЭНИЛМЕТИЛ]БЕНЗОЛА (CRYSTALLINE FORM OF 1-(в-D-GLUCOPYRANOSYL)-4-METHYL-3-[5-(4-FLUOROPHENYL)-2-THIENYLMETHYL] BENZENE HEMIHYDRATE)

Drug Price Trends for INVOKANA
INVOKANA is a drug marketed by Janssen Pharms. There are three patents protecting this drug and one Paragraph IV challenge. Five tentatively approved generics are ready to enter the market.

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

See drug price trends for INVOKANA.

The generic ingredient in INVOKANA is canagliflozin. There are twenty-one drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the canagliflozin profile page.

When can SIRTURO (bedaquiline fumarate) generic drug versions launch?

Generic name: bedaquiline fumarate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2026
Generic Entry Controlled by: Ukraine Patent 97,813
Patent Title: ФУМАРАТНАЯ СОЛЬ (АЛЬФА S, БЕТА R)-6-БРОМ-АЛЬФА-[2-(ДИМЕТИЛАМИНО)ЭТИЛ]-2-МЕТОКСИ-АЛЬФА-1-НАФТАЛЕНИЛ-БЕТА-ФЕНИЛ-3-ХИНОЛИНЭТАНОЛА;ФУМАРАТНА СІЛЬ (АЛЬФА S, БЕТА R)-6-БРОМ-АЛЬФА-[2-(ДИМЕТИЛАМІНО)ЕТИЛ]-2-МЕТОКСІ-АЛЬФА-1-НАФТАЛЕНІЛ-БЕТА-ФЕНІЛ-3-ХІНОЛІНЕТАНОЛУ (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL)

SIRTURO is a drug marketed by Janssen Therap. There are two patents protecting this drug.

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

See drug price trends for SIRTURO.

The generic ingredient in SIRTURO is bedaquiline fumarate. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the bedaquiline fumarate profile page.

When can XERMELO (telotristat etiprate) generic drug versions launch?

Generic name: telotristat etiprate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: Ukraine Patent 99,270

XERMELO is a drug marketed by Tersera. There are five patents protecting this drug.

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

See drug price trends for XERMELO.

The generic ingredient in XERMELO is telotristat etiprate. One supplier is listed for this generic product. Additional details are available on the telotristat etiprate 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: Ukraine Patent 95,828
Patent Title: ТВЕРДАЯ РЕЦЕПТУРА, КОТОРАЯ СОДЕРЖИТ АЛОГЛИПТИН И ПИОГЛИТАЗОН;ТВЕРДА РЕЦЕПТУРА, ЩО МІСТИТЬ АЛОГЛІПТИН І ПІОГЛІТАЗОН (SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE)

Drug Price Trends for OSENI
OSENI is a drug marketed by Takeda Pharms Usa. There are two 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 KERENDIA (finerenone) generic drug versions launch?

Generic name: finerenone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 27, 2027
Generic Entry Controlled by: Ukraine Patent 102,065
Patent Title: ЗАМІЩЕНІ 4-АРИЛ-1,4-ДИГІДРО-1,6-НАФТИРИДИНАМІДИ І ЇХ ЗАСТОСУВАННЯ[ЗАМЕЩЕННЫЕ 4-АРИЛ-1,4-ДИГИДРО-1,6-НАФТИРИДИНАМИДЫ И ИХ ПРИМЕНЕНИЕ (SUBSTITUTED 4-ARYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINAMIDES AND USE THEREOF)

Drug Price Trends for KERENDIA
KERENDIA is a drug marketed by Bayer Hlthcare. There are two patents protecting this drug.

This drug has ninety-seven patent family members in forty-nine countries. There has been litigation on patents covering KERENDIA

See drug price trends for KERENDIA.

The generic ingredient in KERENDIA is finerenone. One supplier is listed for this generic product. Additional details are available on the finerenone 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: Ukraine Patent 97,836
Patent Title: ПРОИЗВОДНЫЕ ПЛЕВРОМУТИЛИНА ДЛЯ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ, ВЫЗВАННЫХ МИКРОБАМИ;ПОХІДНІ ПЛЕВРОМУТИЛІНУ ДЛЯ ЛІКУВАННЯ ЗАХВОРЮВАНЬ, ВИКЛИКАНИХ МІКРОБАМИ (PLEUROMUTILIN DERIVATIVES FOR THE TREATMENT OF DISEASES MEDIATED BY MICROBES)

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.

When can PROMACTA (eltrombopag olamine) generic drug versions launch?

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Ukraine Patent 96,261
Patent Title: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ЭЛТРОМБОПАГА ОЛАМИНА (ВАРИАНТЫ) И СПОСОБ ЕЕ ИЗГОТОВЛЕНИЯ (ВАРИАНТЫ);ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ ЕЛТРОМБОПАГУ ОЛАМІНУ (ВАРІАНТИ) І СПОСІБ ЇЇ ВИГОТОВЛЕННЯ (ВАРІАНТИ) (PHARMACEUTICAL COMPOSITIONS CONTAINING ELTROMBOPAG OLAMINE AND PROCESSES FOR THE PREPARATION THEREOF)

PROMACTA is a drug marketed by Novartis. There are six patents protecting this drug and two Paragraph IV challenges.

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

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this API. Nine suppliers are listed for this generic product. Additional details are available on the eltrombopag olamine profile page.

When can SIGNIFOR LAR (pasireotide pamoate) generic drug versions launch?

Generic name: pasireotide pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 24, 2027
Generic Entry Controlled by: Ukraine Patent 97,396
Patent Title: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ПРОЛОНГИРОВАННОГО ВЫСВОБОЖДЕНИЯ, СОДЕРЖАЩАЯ ПАСИРЕОТИД ПАМОАТ В МИКРОЧАСТИЦАХ;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ ПРОЛОНГОВАНОГО ВИВІЛЬНЕННЯ, ЩО МІСТИТЬ ПАСИРЕОТИД ПАМОАТ В МІКРОЧАСТИНКАХ (EXTENDED-RELEASE COMPOSITION COMPRISING A PASIREOTIDE PAMOATE IN MICROPARTICLES)

SIGNIFOR LAR is a drug marketed by Recordati Rare. There are three patents protecting this drug.

This drug has one hundred and thirty-five patent family members in forty-one countries.

See drug price trends for SIGNIFOR LAR.

The generic ingredient in SIGNIFOR LAR is pasireotide pamoate. One supplier is listed for this generic product. Additional details are available on the pasireotide pamoate profile page.

Ukraine Branded and Generic Drug Markets: Assessment, Regulatory Opportunities, and Challenges

Last updated: December 28, 2025

Executive Summary

Ukraine’s pharmaceutical industry is a vital sector underpinning the nation’s healthcare system, characterized by a burgeoning market for both branded and generic drugs. The sector is shaped by ongoing regulatory reforms, economic shifts, and integration with European standards. This report offers a comprehensive analysis of Ukraine’s pharmaceutical landscape, highlighting key market dynamics, regulatory frameworks, opportunities for growth, and persistent challenges. With a focus on market segmentation, regulatory policies, and strategic considerations, this assessment provides essential insights for industry stakeholders, investors, and policymakers aiming to navigate Ukraine’s evolving pharmaceutical environment.


Market Overview and Size

Market Valuation

Ukraine’s pharmaceutical market was valued at approximately $2.2 billion USD in 2022, with a compound annual growth rate (CAGR) of approximately 7.5% since 2018. The market's growth is driven by increasing healthcare demands, demographic shifts, and government initiatives to modernize drug regulation.

Segment Breakdown

Segment Share (%) Key Characteristics Growth Drivers
Branded Drugs 40% Premium segment, high R&D, marketing, brand loyalty Prescriber preference, brand recognition
Generic Drugs 60% Cost-effective, high penetration, regulatory compliance Government procurement, affordability

Market Dynamics

  • Public vs. Private Sector: Public procurement accounts for approx. 55-60%, influencing volume and price controls.
  • Import vs. Domestic Production: Ukraine’s domestic pharma accounts for around 50% of the market, with significant imports from the EU, India, and neighboring countries.
  • Patent Landscape: Patent expirations for off-patent drugs have spurred generic proliferation, supporting price competition.

Regulatory Environment in Ukraine

Framework Overview

Ukraine’s pharmaceutical market operates under a regulatory framework aligned with State Pharmacological Oversight and governed by the State Medicines Regulatory Authority (SMRA), formerly known as the State Expert Center.

Key Regulatory Acts and Policies

Policy/Act Description Effective Date
Law on Medicines (2015) Modernizes drug registration, quality standards, and market authorization 2015
Technical Regulations (EU Alignment) Incorporates European pharmacopoeia standards and Good Manufacturing Practices (GMP) Ongoing
Pricing and Reimbursement Law Establishes pricing controls, reimbursement schemes, and state procurement policies 2017
Intellectual Property (IP) Law Strengthened patent protections aligning with WTO/TRIPS agreements 1995, recent amendments

Registration Process

  • Application Submission: Via the Unified State Register of Medicines.
  • Requirements: Quality dossier, stability data, manufacturing license, and efficacy evidence.
  • Timeframe: Typically 6-12 months, with fast-track options for essential medicines.
  • Post-Market Surveillance: Mandatory pharmacovigilance reporting and periodic safety updates.

Market Entry Challenges

  • bureaucratic delays
  • complex documentation requirements
  • evolving standards requiring continuous compliance
  • discrepancies between national and EU regulatory standards

Opportunities in Ukraine’s Pharmaceutical Sector

Growing Demand for Generics

  • Market Penetration: Generics comprise 60% of the market, with room for growth especially in hospital and retail sectors.
  • Cost-Containment Policies: Government prioritizes generics to reduce healthcare expenditure.

Expansion of Branded Drugs

  • Innovative Therapies: Opportunities exist for introducing advanced pharmaceuticals, especially in oncology, CNS, and rare diseases.
  • International Partnerships: Potential for joint ventures with EU and US companies.

Regulatory Reforms and Support

  • Harmonization Efforts: Ukraine’s alignment with EU standards offers smoother access for companies seeking CE marking and EU registration.
  • Incentives: Tax breaks and reduced registration fees for locally manufactured or innovative drugs.

Digital Transformation

  • Implementation of e-prescriptions and digital pharmacovigilance platforms facilitates streamlined market access and compliance.

Challenges Facing the Market

Regulatory and Administrative Barriers

  • prolonged registration timelines
  • inconsistent enforcement of standards
  • limited capacity for pharmacovigilance and post-market surveillance

Economic and Political Instability

  • currency fluctuations
  • procurement budget constraints
  • geopolitical tensions impacting supply chains and market stability

Intellectual Property Challenges

  • Patent enforcement inconsistencies
  • risk of patent litigation or compulsory licensing

Competition and Market Saturation

  • aggressive pricing from international generics
  • entrance barriers for new innovative drugs
  • local manufacturing capacity constraints

Import Dependence and Supply Chain Risks

  • reliance on imported raw materials
  • disruptions stemming from geopolitical conflicts and trade restrictions

Comparative Analysis with Neighboring Markets

Aspect Ukraine Poland Russia
Market Size (2022) $2.2 billion $8.4 billion $11.2 billion
Market Growth (2022-2027) 7.5% CAGR 5-6% CAGR 4-5% CAGR
Regulatory Alignment Partial EU alignment EU standards fully adopted Eurasian Customs Union
Patent Enforcement Developing Strong Moderate
Generic Market Share 60% 55% 50%

Ukraine’s evolving regulatory environment and market opportunities position it as an attractive but complex hub for pharmaceutical investments, especially under the EU approximation framework.


Strategic Considerations for Stakeholders

Strategy Action Items
Regulatory Preparation Invest in local regulatory expertise; maintain compliance with evolving standards
Market Diversification Focus on expanding generic offerings; explore branded product niches
Local Manufacturing Leverage government incentives; develop supply chain resilience
Digital Adoption Implement pharmacovigilance tools; utilize electronic registration platforms
Partnership Development Form joint ventures with EU/US firms; participate in clinical research collaborations

Key Challenges and Solutions

Challenge Potential Solutions
Regulatory delays Engage local regulatory consultants; prepare comprehensive dossiers
Political instability Diversify supply chains; secure intellectual property rights
Supply chain disruptions Build regional manufacturing; stockpile critical raw materials
Market transparency issues Improve market intelligence and partner with local authorities

Key Takeaways

  • Ukraine’s pharmaceutical market presents substantial opportunities in both branded and generic segments, driven by market expansion, healthcare reforms, and EU alignment efforts.
  • Regulatory complexity, bureaucratic delays, and geopolitical risks remain significant hurdles. Strategic investment in local expertise and infrastructure mitigates some risks.
  • The pivot toward EU standards enhances long-term market integration prospects but demands high compliance standards.
  • Growth is particularly promising for companies emphasizing generics, biosimilars, and innovative therapies for priority healthcare areas.
  • Digital and partnership strategies are crucial for navigating Ukraine’s evolving regulatory landscape and strengthening market presence.

FAQs

Q1: How does Ukraine’s pharmaceutical regulatory environment compare to EU standards?
Ukraine is progressively aligning with EU pharmacopoeia standards, especially through technical regulations and compliance protocols, enabling smoother market access in the future but still faces transitional challenges.

Q2: What are the main regulatory hurdles for new entrants in Ukraine?
Prolonged registration timelines, documentation complexity, and inconsistent enforcement of standards are primary hurdles, requiring strategic planning and local regulatory partnerships.

Q3: Is Ukraine a favorable market for generic drug manufacturers?
Yes. The dominance of generics (60%) and government policies favoring cost-effective medicines create favorable conditions. Market entry should focus on regulation compliance and local manufacturing.

Q4: What are the key growth sectors for innovative therapies?
Oncology, cardiovascular, CNS, and rare diseases are priority sectors where innovative drugs can meet unmet needs and benefit from evolving reimbursement schemes.

Q5: How can geopolitical risks be mitigated in Ukraine’s pharmaceutical market?
Diversifying supply chains, strengthening local manufacturing, securing intellectual property protections, and engaging with international partners help reduce geopolitical risks.


References

  1. Ukraine Ministry of Health. (2022). Pharmaceutical Industry Regulations and Policy Initiatives.
  2. IMS Health. (2022). Ukraine Pharmaceutical Market Analysis.
  3. European Medicines Agency. (2022). EU-Ukraine Regulatory Alignment Initiatives.
  4. World Trade Organization. (2022). Intellectual Property Rights in Ukraine.
  5. International Trade Centre. (2022). Pharmaceutical Market Opportunities in Ukraine.

More… ↓

⤷  Start Trial

DrugPatentWatch cited by CNN, NEJM, Nature Journals, and more …

Make Better Decisions: Try a trial or see plans & pricing

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.