Hikma Company Profile

What is the competitive landscape for HIKMA

HIKMA has six hundred and seventy-five approved drugs.

There are thirty-two US patents protecting HIKMA drugs. There are five tentative approvals on HIKMA drugs.

There are one hundred and twenty-seven patent family members on HIKMA drugs in thirty-five countries and six hundred and eighty-four supplementary protection certificates in seventeen countries.

Summary for Hikma

International Patents:	127
US Patents:	32
Tradenames:	435
Ingredients:	387
NDAs:	675
Patent Litigation for Hikma:	See patent lawsuits for Hikma
PTAB Cases with Hikma as petitioner:	See PTAB cases with Hikma as petitioner

Drugs and US Patents for Hikma

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200822-002	Jul 15, 2013		DISCN	No	No
Hikma	TYZAVAN	vancomycin hydrochloride	SOLUTION;INTRAVENOUS	211962-001	Feb 15, 2019		RX	Yes	Yes	10,039,804		Y
Hikma	TYZAVAN	vancomycin hydrochloride	SOLUTION;INTRAVENOUS	211962-003	Feb 15, 2019		RX	Yes	Yes	12,161,690		Y
Hikma	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	077187-001	Jun 30, 2008	AP	RX	No	No

Expired US Patents for Hikma

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999	5,362,755
Hikma	REGLAN	metoclopramide hydrochloride	INJECTABLE;INJECTION	017862-004	May 28, 1987	4,536,386
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999	5,362,555
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003	5,844,002

Paragraph IV (Patent) Challenges for HIKMA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Capsules	0.6 mg		2016-06-10
	Injection	1 mg/mL, 50 mL vials		2011-12-16
	Inhalation Solution	0.0103%, 0.021% and 0.042%		2005-06-20
	Inhalation Aerosol	0.045 mg/actuation		2012-02-27
	for Injection	200 mcg/vial		2015-05-01
	Injection	100 mg/mL, 2.5 mL vials		2007-09-24
	Tablets	1 mg		2009-08-14
	Inhalation Solution	0.0025		2006-05-23
	for Injection	100 mcg/vial and 500 mcg/vial		2015-04-14

International Patents for Hikma Drugs

Country	Patent Number	Estimated Expiration
Mexico	367209
South Korea	101900520
Philippines	12013500689
World Intellectual Property Organization (WIPO)	2016007245

Supplementary Protection Certificates for Hikma Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2022495	132021000000154	Italy		PRODUCT NAME: ICOSAPENT ETILE(VAZKEPA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1524, 20210329
3043773	301154	Netherlands		PRODUCT NAME: MOMETASON OF EEN ZOUT DAARVAN EN OLOPATADINE OF EEN ZOUT DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 126186 20211014; FIRST REGISTRATION: AT 140638 20210426
1761528	1490063-3	Sweden		PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REG. NO/DATE: EU/1/14/931 20140702
2822954	LUC00083	Luxembourg		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Hikma
• Hikma Farmaceutica
• Hikma Intl Pharms
• Hikma Pharm Co Ltd

Pharmaceutical Competitive Landscape Analysis: Hikma – Market Position, Strengths & Strategic Insights

Last updated: September 5, 2025

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Introduction

Hikma Pharmaceuticals PLC ranks as a prominent player within the global pharmaceutical industry, recognized for its focus on branded and generic medicines, APIs, and biosimilars. As markets evolve amidst increasing regulatory stringency, rising R&D costs, and patent cliffs, professionals must understand Hikma’s strategic positioning, competitive strengths, and future opportunities. This analysis delves into Hikma’s market position, core competencies, competitive landscape, and strategic pathways to sustain growth.

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Market Position and Business Overview

Founded in 1978 in Jordan, Hikma has transitioned from regional operations to a globally recognized pharmaceutical entity. As of 2022, the company generated approximately $2.4 billion in revenue, with a significant footprint across North America, MENA, and emerging markets. Hikma's diversified portfolio includes injectables, oral solids, biosimilars, and APIs, positioning it across multiple therapeutic areas such as oncology, respiratory, and cardiovascular.

Hikma's strategic focus revolves around two primary segments:

• Injectables and biosimilars, which account for roughly 55% of revenues, emphasizing differentiated formulations.
• Branded generics and over-the-counter (OTC) medicines, especially in MENA and North Africa.

The company's robust manufacturing footprint with multiple facilities across North America, Europe, and the Middle East enhances its supply chain resilience and capacity to meet global demand.

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Strengths and Competitive Advantages

1. Diversified Portfolio and Therapeutic Focus

Hikma’s broad spectrum of products reduces dependence on any single market or therapeutic area. Its emphasis on injectables—a high-margin, critical care segment—provides a competitive edge against oral generics, which face more intense pricing pressures.

2. Geographical and Market Diversification

With operations spanning North America, MENA, and Europe, Hikma mitigates country-specific risks such as regulatory changes or economic downturns. Its proprietary presence in high-growth markets like North Africa and the Middle East supports revenue stability and expansion potential.

3. Robust Manufacturing and R&D Capabilities

Hikma’s modern manufacturing facilities support complex formulations and biosimilars, aligning with industry shifts towards biologics. Strategic investments in R&D help develop advanced therapies, future-proofing against patent expirations in established markets.

4. Strategic Acquisitions and Partnerships

Hikma’s acquisition of companies like Jordan's Claris and the US-based Hospira injectables business has expanded its product offerings and market reach. Such strategic moves foster scale and access to new therapeutic pipelines.

5. Focus on Biosimilars and Specialized Therapies

Entering biosimilar markets aligns Hikma with the global push to reduce biologics costs, promising significant growth trajectories. Its investments in biosimilar development position it as a competitive alternative to innovator biologics.

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Competitive Landscape

Hikma operates within a competitive environment featuring several global and regional pharmaceutical giants, each vying for market share in generics, biosimilars, and injectables. Key competitors include:

• Teva Pharmaceutical Industries: A market leader in generics and biosimilars, renowned for its extensive portfolio.
• Sandoz (Novartis): Focused on biosimilars and complex generics, emphasizing innovation.
• Mylan (now part of Viatris): Recognized for its aggressive cost strategies and broad product lines.
• Pfizer and Johnson & Johnson: Prominent in branded and specialty medicines.
• Local and regional players: Particularly in Middle East and North Africa, such as Bio-Kenya or Pharco Pharmaceuticals.

While large players leverage scale and extensive pipelines, Hikma's niche focus on injectables and high-growth emerging markets enables it to amplify its differentiation. Its ability to navigate regulatory complexity and supply chain intricacies remains pivotal.

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Strategic Opportunities and Challenges

Opportunities

• Expansion in Biosimilars and Specialty Therapies: The rising prevalence of biologics necessitates cost-effective biosimilar alternatives, an area where Hikma’s R&D investments can accelerate growth.
• Emerging Market Penetration: Growing healthcare infrastructure in Africa, Asia, and the Middle East favors Hikma’s regional presence.
• Digital & Manufacturing Innovation: Adoption of Industry 4.0 technologies can enhance operational efficiency and compliance.

Challenges

• Regulatory Hurdles: Navigating complex approval pathways in multiple jurisdictions remains a barrier.
• Pricing Pressures and Market Access: Governments worldwide are implementing cost-containment measures affecting margins.
• Patent Cliffs: Loss of exclusivity on blockbuster drugs pressures revenue streams.
• Competitive Investment in R&D: Competing with larger firms with deeper pipelines demands sustained innovation.

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Growth Strategies and Recommendations

1. Pipeline Expansion through R&D and Collaborations
   Investing in innovative biologics and targeted therapies can diversify offerings and capitalize on personalized medicine trends.

2. Geographical Market Deepening
   Leveraging local partnerships and strengthening distribution networks across high-growth regions can enlarge market share.

3. Enhancement of Manufacturing for Biologics
   Scaling up biosimilar production capabilities provides leverage against patent expiry of leading biologics.

4. Strategic Acquisitions and Alliances
   Identifying complementary firms and technologies accelerates access to novel therapies and markets.

5. Digital Transformation
   Implementing integrated supply chain management systems and data analytics enhances operational agility and compliance.

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Key Takeaways

• Market Position: Hikma stands as a diversified, regionally strong pharmaceutical entity with a strategic focus on injectables and biosimilars, supporting stable growth prospects amidst global shifts.

• Strengths: Wide therapeutic and geographical portfolio, robust manufacturing, and strategic acquisitions underpin its competitive edge.

• Competitive Landscape: Dominated by large multinationals like Teva and Sandoz, with regional players intensifying competition, especially in emerging markets.

• Strategic Outlook: Investment in biosimilars, targeted R&D, and regional deepening are crucial for Hikma to sustain and enhance its market standing.

• Risks: Regulatory complexities, pricing pressures, and patent expiries necessitate agile strategies and continuous innovation.

Hikma’s future success hinges on its capacity to innovate within complex regulatory frameworks, deploy intelligent market expansion strategies, and leverage its manufacturing capabilities to capitalize on the burgeoning biologics and biosimilar markets globally.

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FAQs

1. How does Hikma differentiate itself from its competitors?
Hikma’s emphasis on high-margin injectables, strategic regional presence, and focused biosimilar development set it apart from larger generic giants heavily reliant on oral solids.

2. What are Hikma’s primary growth areas?
Biosimilars, specialty injectables, and expansion in high-growth emerging markets represent primary avenues for Hikma’s growth.

3. How is Hikma positioning itself in the biosimilars market?
Through targeted R&D investments and scaling manufacturing capacities, Hikma aims to become a competitive biosimilars manufacturer aligned with global cost-reduction trends.

4. What challenges does Hikma face in global markets?
Regulatory compliance, reimbursement policies, pricing pressures, and competition from larger players pose ongoing challenges.

5. What strategic moves can Hikma pursue to enhance its market share?
Strengthening its pipeline via acquisitions, investing in biologics, expanding in high-growth regions, and leveraging digital transformation are key strategies.

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References

[1] Hikma Pharmaceuticals PLC Annual Report, 2022.
[2] Evaluate Pharma: Global Biosimilars Market, 2023.
[3] IMS Health Data on Global Pharmaceutical Markets, 2022.
[4] Regulatory updates from the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA).
[5] Industry analysis reports from IQVIA and other market intelligence providers.