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	OLANZAPINE	olanzapine	TABLET;ORAL	204866-001	Jun 16, 2017		DISCN	No	No
Hikma	FUROSEMIDE	furosemide	TABLET;ORAL	070086-001	Jan 24, 1986	AB	RX	No	No
Hikma	METHADONE HYDROCHLORIDE	methadone hydrochloride	SOLUTION;ORAL	087393-001	Approved Prior to Jan 1, 1982	AA	RX	Yes	Yes
Hikma	CODEINE SULFATE	codeine sulfate	TABLET;ORAL	022402-003	Jul 16, 2009	AB	RX	Yes	Yes
Hikma	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065289-001	Jun 27, 2007	AP	RX	No	No
Hikma	CLARITHROMYCIN	clarithromycin	TABLET;ORAL	065178-002	May 25, 2004		DISCN	No	No
Hikma	PHENTOLAMINE MESYLATE	phentolamine mesylate	INJECTABLE;INJECTION	040235-001	Mar 11, 1998	AP	RX	No	Yes

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	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999	6,451,289
Hikma	REGLAN	metoclopramide hydrochloride	INJECTABLE;INJECTION	017862-001	Approved Prior to Jan 1, 1982	4,536,386
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-003	Sep 30, 1982	3,947,569
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-001	Sep 30, 1982	3,947,569
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999	5,547,994
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-003	Jan 30, 2002	6,083,993

Paragraph IV (Patent) Challenges for HIKMA drugs

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

International Patents for Hikma Drugs

Country	Patent Number	Estimated Expiration
China	111093625
Japan	7032488
Japan	2017533218
Eurasian Patent Organization	036212
Australia	2011324137
European Patent Office	4147710
Portugal	3169307

Supplementary Protection Certificates for Hikma Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2768484	SPC/GB19/067	United Kingdom		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTERED: UK EU/1/18/1308(FOR NI) 20180827; UK PLGB 31626/0004 20180827
0888289	C300376	Netherlands		PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829
1189916	2011C/004	Belgium		PRODUCT NAME: REGADENOSON; AUTHORISATION NUMBER AND DATE: EU/1/10/643/001 20100906
1519731	132013902182575	Italy		PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
0299602	SPC/GB96/040	United Kingdom		PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702
1856135	CA 2020 00018	Denmark		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
0196132	94C0008	Belgium		PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208

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/