Hikma Company Profile

What is the competitive landscape for HIKMA

HIKMA has six hundred and eighty-seven approved drugs.

There are twenty-eight US patents protecting HIKMA drugs. There are four tentative approvals on HIKMA drugs.

There are one hundred and twenty-three patent family members on HIKMA drugs in thirty-five countries and six hundred and seventy-two supplementary protection certificates in seventeen countries.

Summary for Hikma

International Patents:	123
US Patents:	28
Tradenames:	432
Ingredients:	385
NDAs:	687
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	AMOXICILLIN	amoxicillin	TABLET;ORAL	065255-001	Mar 29, 2006	AB	RX	No	No
Hikma	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	215135-002	Mar 25, 2022		DISCN	No	No
Hikma	CODEINE SULFATE	codeine sulfate	TABLET;ORAL	022402-001	Jul 16, 2009	AB	RX	Yes	No
Hikma	DEXAMETHASONE INTENSOL	dexamethasone	CONCENTRATE;ORAL	088252-001	Sep 1, 1983		RX	No	Yes
Hikma	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	CAPSULE;ORAL	202827-004	Aug 25, 2023	AB	RX	No	No
Hikma	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	215827-001	Feb 2, 2023	AP	RX	No	No

Expired US Patents for Hikma

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-001	Sep 30, 1982	3,947,569
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-003	Sep 30, 1982	3,947,569
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-003	Jan 30, 2002	5,362,755
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003	5,362,755
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999	5,362,555
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999	5,760,090

Paragraph IV (Patent) Challenges for HIKMA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	Capsules	0.6 mg		2016-06-10
	Injection	1 mg/mL, 50 mL vials		2011-12-16

International Patents for Hikma Drugs

Country	Patent Number	Estimated Expiration
Canada	2955557
Colombia	2017005391
Denmark	3169307
Morocco	45995
Singapore	11201703568W
World Intellectual Property Organization (WIPO)	2016009067

Supplementary Protection Certificates for Hikma Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1744764	2018/042	Ireland		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180823
0413455	98C0040	Belgium		PRODUCT NAME: ALATROFLOXACIN; NAT. REGISTRATION NO/DATE: EU/1/98/060/001 19980327; FIRST REGISTRATION: CH 54484 19980327
0473687	99C0008	Belgium		PRODUCT NAME: FOSPHENYTOINUM DINATRICUM; REGISTRATION NO/DATE: 19 IS 102 F12 19980901; FIRST REGISTRATION: GB PL00019/1057 19980204
2768484	C201930069	Spain		PRODUCT NAME: COMBINACION DE DAUNORUBICINA Y CITARABINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1308; DATE OF AUTHORISATION: 20180823; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1308; DATE OF FIRST AUTHORISATION IN EEA: 20180823
0961612	CA 2009 00036	Denmark		PRODUCT NAME: PACLITAXELALBUMIN
1853250	PA2014022	Lithuania		PRODUCT NAME: PACLITAXELUM; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220

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
• Hikma Pharms

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

In the ever-evolving pharmaceutical industry, Hikma Pharmaceuticals has emerged as a significant player, carving out a unique position for itself. This article delves into Hikma's market position, strengths, and strategic insights, providing a comprehensive analysis of its competitive landscape.

Hikma's Market Position

Hikma Pharmaceuticals has established itself as a formidable force in the global pharmaceutical market. As of 2023, the company has become the second largest pharmaceutical company in the Middle East and North Africa (MENA) region by sales[2]. This achievement underscores Hikma's strong market presence and its ability to compete effectively in a challenging industry.

Global Reach and Diversification

Hikma's operations span across multiple regions, including the United States, Europe, and the MENA region. This geographical diversification has allowed the company to mitigate risks associated with market-specific challenges and capitalize on opportunities in different regions.

Product Portfolio

The company specializes in various therapeutic areas, including:

• Cardiovascular
• Diabetes
• Central Nervous System (CNS)
• Cancer
• Dermatology
• Genitourinary system
• Hormones
• Respiratory system[9]

This diverse product portfolio enables Hikma to cater to a wide range of medical needs, enhancing its market position and resilience.

Hikma's Key Strengths

1. Strong Financial Performance

Hikma has demonstrated consistent financial growth over the years. In 2023, the company reported strong performance across all its business segments:

"Hikma delivered strong growth and made significant progress in 2023. All three of our businesses grew, delivering double digit Group revenue and operating profit growth with an impressive core EBITDA margin of 28%."[2]

This financial robustness provides Hikma with the resources to invest in research and development, expand its operations, and pursue strategic acquisitions.

2. Manufacturing Capabilities

Hikma boasts world-class infrastructure for generics development and manufacturing[8]. The company's manufacturing flexibility allows it to handle fluctuating demand effectively, a crucial advantage in the pharmaceutical industry where market needs can change rapidly.

3. Innovation and R&D Focus

Hikma has been consistently investing in research and development to expand its product pipeline. The company is focusing on launching more complex and first-to-market products, demonstrating its commitment to innovation[10].

4. Strong Market Presence in MENA

As the second-largest pharmaceutical company in the MENA region, Hikma has a significant competitive advantage in this market. The company's deep understanding of local healthcare needs and regulatory environments positions it well for continued growth in the region.

Strategic Insights

1. Focus on Complex Generics

Hikma is strategically shifting its focus towards more complex generic products. This move is aimed at differentiating the company from competitors and potentially securing higher profit margins.

2. Expansion into New Markets

The company is actively seeking to expand its reach into new markets. Hikma's recent partnership with M42 to advance healthcare innovation in the UAE is a testament to this strategy[5].

3. Strategic Partnerships and Acquisitions

Hikma has been leveraging strategic partnerships and acquisitions to enhance its product portfolio and market reach. For instance, in January 2025, the company announced an exclusive commercial partnership with Emergent BioSolutions for KLOXXADO® (naloxone HCl) nasal spray[5].

4. Investment in Manufacturing Capacity

To support its growth strategy, Hikma is expanding its manufacturing capacity. This investment will enable the company to meet increasing demand and launch new products more efficiently.

Competitive Analysis

Strengths

1. Strong market position in MENA
2. Diverse product portfolio
3. Robust financial performance
4. World-class manufacturing capabilities
5. Focus on complex generics and innovation

Weaknesses

1. Limited presence in certain product categories
2. Dependence on a few key suppliers for raw materials[4]

Opportunities

1. Expanding into new markets
2. Growing demand for COVID-19 treatment drugs
3. Potential in biosimilars market[8]

Threats

1. Intense competition in the generics market
2. Regulatory challenges
3. Patent infringement litigation risks[8]

Future Outlook

Hikma's future looks promising, with the company well-positioned for sustainable growth. The focus on complex generics, expansion into new markets, and continued investment in R&D are likely to drive future success.

"Hikma has a resilient portfolio of diversified global businesses that are expanding to meet growing regional needs for a broad range of essential medicines."[2]

However, the company will need to navigate challenges such as intense competition and regulatory hurdles to maintain its growth trajectory.

Key Takeaways

1. Hikma is the second-largest pharmaceutical company in the MENA region, with a strong global presence.
2. The company's diverse product portfolio and focus on complex generics are key strengths.
3. Hikma's robust financial performance provides a solid foundation for future growth and investments.
4. Strategic partnerships and acquisitions play a crucial role in Hikma's expansion strategy.
5. The company's focus on innovation and R&D positions it well for future market challenges.
6. Hikma's manufacturing flexibility and capacity expansion efforts support its growth strategy.
7. While facing challenges such as intense competition and regulatory hurdles, Hikma's diversified business model provides resilience.

FAQs

1. What are Hikma's main therapeutic areas? Hikma specializes in areas including cardiovascular, diabetes, CNS, cancer, dermatology, genitourinary system, hormones, and respiratory system.

2. How is Hikma positioned in the MENA pharmaceutical market? As of 2023, Hikma is the second-largest pharmaceutical company in the MENA region by sales.

3. What is Hikma's strategy for future growth? Hikma is focusing on complex generics, expanding into new markets, forming strategic partnerships, and investing in manufacturing capacity and R&D.

4. How does Hikma's manufacturing capability contribute to its competitive advantage? Hikma's world-class infrastructure and manufacturing flexibility allow it to handle fluctuating demand effectively and support its growth strategy.

5. What recent partnerships has Hikma formed? In 2025, Hikma formed partnerships with M42 to advance healthcare innovation in the UAE and with Emergent BioSolutions for the commercialization of KLOXXADO® nasal spray.

Sources cited: [2] https://www.hikma.com/media/10ib0usi/2023-press-release-and-bfr-vfinal-combined.pdf [4] https://www.nativeassignmenthelp.co.uk/hikma-pharmaceuticals-business-strategy-and-competitive-analysis-case-study-23271 [5] https://www.hikma.com/who-we-are/ [8] https://www.swotandpestle.com/hikma-pharmaceuticals/ [9] https://www.globaldata.com/company-profile/hikma-pharmaceuticals-plc/ [10] https://www.hikma.com/news/hikma-has-strong-start-to-2024-with-continued-momentum-across-all-businesses-full-year-guidance-reiterated/