You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 27, 2026

Hikma Company Profile


✉ Email this page to a colleague

« Back to Dashboard


Summary for Hikma
International Patents:127
US Patents:32
Tradenames:436
Ingredients:388
NDAs:677
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 CEFOTAXIME cefotaxime sodium INJECTABLE;INJECTION 065072-001 Nov 20, 2002 DISCN No No ⤷  Start Trial ⤷  Start Trial
Hikma COMBOGESIC IV acetaminophen; ibuprofen sodium SOLUTION;INTRAVENOUS 215320-001 Oct 17, 2023 RX Yes Yes 11,213,498 ⤷  Start Trial Y ⤷  Start Trial
Hikma MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075421-002 Jun 20, 2000 AP RX No No ⤷  Start Trial ⤷  Start Trial
Hikma LINEZOLID linezolid FOR SUSPENSION;ORAL 200068-001 Jun 3, 2015 AB RX No No ⤷  Start Trial ⤷  Start Trial
Hikma MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 090303-001 Oct 28, 2010 AP RX No No ⤷  Start Trial ⤷  Start Trial
Hikma Pharms PREDNISONE prednisone TABLET;ORAL 040890-001 Nov 1, 2010 DISCN No No ⤷  Start Trial ⤷  Start Trial
Hikma ATROPINE SULFATE atropine sulfate SOLUTION;INTRAVENOUS 217345-001 Oct 24, 2025 AP RX No No ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Hikma

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 6,451,289 ⤷  Start Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 6,451,289 ⤷  Start Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 6,083,993 ⤷  Start Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 5,547,994 ⤷  Start Trial
Hikma ATIVAN lorazepam INJECTABLE;INJECTION 018140-001 Approved Prior to Jan 1, 1982 4,017,616 ⤷  Start Trial
Hikma REGLAN metoclopramide hydrochloride INJECTABLE;INJECTION 017862-004 May 28, 1987 4,536,386 ⤷  Start Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-002 Mar 25, 1999 5,547,994 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for HIKMA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 2015-04-14
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24
➤ Subscribe Capsules 0.6 mg ➤ Subscribe 2016-06-10
➤ Subscribe Inhalation Solution 0.0025 ➤ Subscribe 2006-05-23
➤ Subscribe Inhalation Aerosol 0.045 mg/actuation ➤ Subscribe 2012-02-27
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe Tablets 1 mg ➤ Subscribe 2009-08-14
➤ Subscribe Inhalation Solution 0.0103%, 0.021% and 0.042% ➤ Subscribe 2005-06-20

Supplementary Protection Certificates for Hikma Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0260415 SPC/GB01/013 United Kingdom ⤷  Start Trial PRODUCT NAME: N,N'-BIS(2-CHLOROETHYL)-N-NITROSO-UREA (CARMUSTINE) COMBINED WITH A POLYANHYDRIDE HAVING A WEIGHT AVERAGE MOLECULAR WEIGHT OF GREATER THAN 20,000 PREPARED BY THE POLYCONDENSATION OF: (I) 4,4'-(TRIMETHYLENEDIOXY)-DIBENZOIC ACID; AND (II) SEBACIC ACID (POLI; REGISTERED: FR 561 907-5 19990105; UK PL 00012/0337 20000928
2334687 2018/028 Ireland ⤷  Start Trial PRODUCT NAME: ERTUGLIFLOZIN, OPTIONALLY AS A CRYSTAL FORM, PARTICULARLY AS A CO-CRYSTAL WITH L-PYROGLUTAMIC ACID, AND SPECIFICALLY AS ERTUGLIFLOZIN L-PYROGLUTAMIC ACID; REGISTRATION NO/DATE: EU/1/18/1267/001 EU/1/18/1267/012 20180321
1534313 76/2015 Austria ⤷  Start Trial PRODUCT NAME: PHENYLEPHRIN, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND KETOROLAC, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1018 (MITTEILUNG) 20150730
0502314 SPC/GB02/037 United Kingdom ⤷  Start Trial PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
1912999 2014/058 Ireland ⤷  Start Trial PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
2217577 7/2019 Austria ⤷  Start Trial PRODUCT NAME: ALLOPURINOL UND LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SALZE DAVON; REGISTRATION NO/DATE: EU/1/18/1300 20180827
0253738 C960002 Netherlands ⤷  Start Trial PRODUCT NAME: DOCETAXEL, DESGEWENST IN DE VORM VAN EEN TRIHYDRAAT; REGISTRATION NO/DATE: EU/1/95/002/001 - EU/1/95/002/002 19951127
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Hikma Pharmaceuticals: Market Position, Strengths, and Strategic Insights

Last updated: February 19, 2026

Hikma Pharmaceuticals maintains a significant presence in the global generic and branded generics pharmaceutical markets. The company's strategy centers on acquiring and developing a diversified portfolio of accessible medicines, primarily focusing on injectables and generic oral solid dosage forms. Hikma operates across three segments: Generics, Injectables, and Specialty.

What is Hikma's Current Market Position?

Hikma holds a strong position within its key markets, particularly in the United States and Europe.

Geographic Market Share Data

  • United States: Hikma is a top-tier generic pharmaceutical company, ranking among the leading suppliers of generic injectable products. It holds a significant share in the hospital and retail generic markets, driven by its extensive product catalog.
  • Europe: The company is a major player in several European markets, including the UK, Germany, and Portugal, where it competes in both the generics and branded generics sectors.
  • MENA (Middle East & North Africa): Hikma is a leading pharmaceutical manufacturer in the MENA region, with a strong brand recognition and a broad portfolio of both branded generics and established branded products.

Product Category Dominance

  • Injectables: Hikma is one of the largest suppliers of generic injectable medicines in the U.S. This segment is a core strength, providing a substantial portion of the company's revenue and profit.
  • Generic Oral Solid Doses: The company has a considerable presence in the generic oral solid dosage market, particularly in Europe and the U.S.

Key Competitors

Hikma competes with a broad spectrum of pharmaceutical companies, including:

  • Major Generic Manufacturers: Teva Pharmaceutical Industries, Viatris, Amneal Pharmaceuticals, Aurobindo Pharma, Cipla.
  • Injectable Specialists: Fresenius Kabi, Baxter International, Pfizer (through its Hospira acquisition).
  • Branded Generics Players (MENA): Local and regional pharmaceutical companies, as well as multinational corporations with established presence.

What are Hikma's Core Strengths?

Hikma's strengths lie in its diversified product portfolio, robust manufacturing capabilities, and strategic market access.

Product Portfolio Diversity

Hikma's portfolio encompasses a wide range of therapeutic areas, reducing reliance on any single product or disease state.

  • Therapeutic Areas: Cardiovascular, Central Nervous System (CNS), Oncology, Anti-infectives, Respiratory, Pain Management, and Diabetes.
  • Product Types:
    • Injectables: A significant portion of the portfolio, including anesthetics, analgesics, anti-infectives, and critical care medications.
    • Oral Solid Doses: Tablets and capsules across various therapeutic categories.
    • Branded Generics: Established brands with local market expertise, particularly in MENA.

Manufacturing and Supply Chain Excellence

The company possesses significant manufacturing infrastructure, enabling cost-effective production and reliable supply.

  • Manufacturing Sites: Hikma operates multiple manufacturing facilities across the U.S., Europe, and North Africa. These sites adhere to stringent regulatory standards (e.g., FDA, EMA).
  • Vertical Integration: Where applicable, Hikma benefits from backward integration, controlling key aspects of its supply chain to ensure quality and cost efficiency.
  • Regulatory Compliance: A strong track record of regulatory approvals and compliance across its global operations.

Strategic Acquisitions and Partnerships

Hikma has a history of leveraging strategic acquisitions to expand its product pipeline, geographic reach, and market share.

  • Acquisition of assets from Merck KGaA (2017): This acquisition significantly strengthened Hikma’s European generics business.
  • Acquisition of Portfolio of Injectable Products from Upsher-Smith Laboratories (2021): Expanded its U.S. injectables portfolio.
  • Ongoing pipeline development and in-licensing agreements.

Market Access and Commercial Infrastructure

Hikma has established strong relationships with key customers, including hospitals, wholesalers, and retail pharmacies.

  • U.S. Injectables Focus: Deep penetration into the U.S. hospital market, a key channel for injectable pharmaceuticals.
  • MENA Brand Recognition: Strong brand equity and established distribution networks in the Middle East and North Africa.

What are Hikma's Strategic Imperatives and Insights?

Hikma's strategy focuses on optimizing its existing business, expanding its product pipeline, and adapting to evolving market dynamics.

Focus on Injectables Growth

The company continues to prioritize its injectables business, recognizing its higher profitability and market demand.

  • Capacity Expansion: Investment in expanding manufacturing capacity for sterile injectables.
  • Pipeline Development: Focus on developing niche and complex injectable products.
  • Supply Chain Resilience: Ensuring a consistent supply of essential injectable medicines.

Navigating U.S. Market Dynamics

The U.S. market presents both opportunities and challenges, requiring strategic adjustments.

  • Addressing Price Erosion: Implementing strategies to mitigate the impact of price competition in the generics market.
  • Focus on Value-Added Products: Shifting towards more complex generics and differentiated products.
  • Long-Term Contracts: Securing stable revenue through contracts with major U.S. hospital groups and distributors.

European Market Optimization

Hikma aims to strengthen its position in European markets through organic growth and targeted expansion.

  • Portfolio Rationalization: Focusing on profitable product lines and exiting non-core segments.
  • Leveraging Existing Infrastructure: Maximizing the utilization of its European manufacturing and distribution networks.
  • Geographic Expansion: Exploring opportunities in underpenetrated European markets.

MENA Regional Leadership

Maintaining and enhancing its leadership position in the MENA region is a strategic priority.

  • Brand Strength: Continuing to leverage the equity of its established brands.
  • New Product Launches: Introducing new generics and branded generics to address local healthcare needs.
  • Digital Transformation: Investing in digital tools to enhance customer engagement and supply chain efficiency.

Research & Development (R&D) and Pipeline Management

Hikma's R&D efforts are critical for sustaining its competitive edge.

  • Targeted R&D: Focusing on the development of products with strong market potential and higher barriers to entry, particularly in injectables.
  • Lifecycle Management: Maximizing the value of existing products through formulation improvements and new indications.
  • Intellectual Property: Active management of its patent portfolio to protect market exclusivity.

Environmental, Social, and Governance (ESG) Integration

Increasingly, ESG considerations are influencing strategic decisions.

  • Sustainable Manufacturing: Reducing the environmental footprint of its operations.
  • Access to Medicines: Initiatives to improve the affordability and accessibility of its products globally.
  • Ethical Business Practices: Maintaining high standards of corporate governance and ethical conduct.

Key Takeaways

Hikma Pharmaceuticals is a significant global player in generic and branded generics, with particular strength in U.S. injectables and MENA markets. Its strategic advantages include a diversified portfolio, robust manufacturing, and established market access. Future success will depend on its ability to navigate pricing pressures in the U.S., optimize its European operations, continue to lead in MENA, and invest in R&D for complex products.

Frequently Asked Questions

  1. What are Hikma's primary revenue drivers? Hikma's primary revenue drivers are its Generics segment, particularly U.S. injectables, and its Injectables segment globally. The MENA region also contributes significantly through its branded generics and specialty products.

  2. How does Hikma differentiate itself from other generic drug manufacturers? Hikma differentiates itself through its strong focus and expertise in the complex injectable market, its diversified geographic presence, its robust manufacturing capabilities, and its history of strategic acquisitions that expand its product portfolio and market reach.

  3. What is Hikma's approach to R&D? Hikma's R&D approach is focused on developing complex generic products, particularly sterile injectables, with higher barriers to entry. It also engages in lifecycle management and the development of differentiated products to maintain market competitiveness.

  4. What are the main challenges Hikma faces in the U.S. market? The main challenges in the U.S. market include intense price competition among generic manufacturers, regulatory hurdles for new product approvals, and the need for robust supply chain management to ensure product availability.

  5. What is Hikma's growth strategy for the MENA region? In the MENA region, Hikma's growth strategy involves leveraging its strong brand recognition, expanding its portfolio of branded generics and specialty products to meet local healthcare needs, and optimizing its distribution networks.

Citations

[1] Hikma Pharmaceuticals Annual Report 2023. [2] Bloomberg Terminal data and analyst reports (various dates). [3] Company press releases and investor presentations (various dates).

More… ↓

⤷  Start Trial

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.