RANITIDINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for ranitidine hydrochloride and what is the scope of patent protection?

Ranitidine hydrochloride is the generic ingredient in seven branded drugs marketed by Ajanta Pharma Ltd, Appco, Aurobindo Pharma, Dr Reddys Labs Ltd, Norvium Bioscience, Novitium Pharma, Sandoz, Teva, Glaxosmithkline, Glaxo Grp Ltd, Bedford, Hikma, Mylan Labs Ltd, Zydus Pharms Usa Inc, Pai Holdings Pharm, Actavis Mid Atlantic, Amneal Pharms, Apotex Inc, Epic Pharma Llc, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Ranbaxy, Taro, Tolmar, Torrent, Wockhardt, Chattem Sanofi, Amneal Pharms Ny, Ani Pharms, Apotex, Boehringer Ingelheim, Contract Pharmacal, Dr Reddys Labs Inc, Endo Operations, Glenmark Pharms Inc, Granules, Heritage Pharma Avet, Mylan, Perrigo, Perrigo R And D, Strides Pharma, Sun Pharm Inds Ltd, Thinq Pharm-cro Pvt, Vkt Pharma, Watson Labs, and Wockhardt Ltd, and is included in eighty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for ranitidine hydrochloride. Twelve suppliers are listed for this compound.

Summary for RANITIDINE HYDROCHLORIDE

US Patents:	0
Tradenames:	7
Applicants:	47
NDAs:	84
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	169
Clinical Trials:	140
Patent Applications:	2,839
What excipients (inactive ingredients) are in RANITIDINE HYDROCHLORIDE?	RANITIDINE HYDROCHLORIDE excipients list
DailyMed Link:	RANITIDINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for RANITIDINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Kasr El Aini Hospital	N/A
Menoufia University	Phase 2/Phase 3
Cairo University	N/A

See all RANITIDINE HYDROCHLORIDE clinical trials

Pharmacology for RANITIDINE HYDROCHLORIDE

Drug Class	Histamine-2 Receptor Antagonist
Mechanism of Action	Histamine H2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for RANITIDINE HYDROCHLORIDE

A02BA	H2-receptor antagonists
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for RANITIDINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nostrum Labs Inc	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	203694-001	Nov 30, 2017		DISCN	No	No
Chattem Sanofi	ZANTAC 150	ranitidine hydrochloride	TABLET;ORAL	021698-001	Aug 31, 2004		DISCN	Yes	No
Norvium Bioscience	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	CAPSULE;ORAL	075564-002	Oct 27, 2000		DISCN	No	No

Expired US Patents for RANITIDINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	ZANTAC 75	ranitidine hydrochloride	TABLET;ORAL	020520-001	Dec 19, 1995	4,128,658
Chattem Sanofi	ZANTAC 150	ranitidine hydrochloride	TABLET;ORAL	021698-002	Mar 13, 2007	5,098,715
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	GRANULE, EFFERVESCENT;ORAL	020251-002	Mar 31, 1994	4,128,658

RANITIDINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ranitidine Hydrochloride

Introduction to Ranitidine Hydrochloride

Ranitidine hydrochloride, commonly known by the brand name Zantac, is a widely used antacid medication for treating various gastrointestinal disorders, including gastroesophageal reflux disease (GERD), stomach ulcers, and heartburn. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Growth and Forecast

The ranitidine market is projected to experience steady growth over the forecast period. According to Data Bridge Market Research, the global ranitidine market is expected to grow at a CAGR of 2.60% from 2021 to 2028, reaching a market value of USD 502.4 million by 2028[1].

Key factors driving this growth include the increasing prevalence of acidity and heartburn issues, changing food habits, and rising disposable incomes in emerging economies. The market is also bolstered by the growing incidence of gastroesophageal reflux disease (GERD) and other digestive disorders[1][4].

Market Segmentation

The ranitidine hydrochloride market is segmented based on several criteria:

• Indication: The market is segmented into intestinal and stomach ulcers, GERD, esophagitis, Zollinger-Ellison Syndrome, and other indications[1].
• Population Type: The market caters to both children and adults[1].
• Dosage Form: The drug is available in solid oral, liquid, and parenteral forms[1].
• Dosage Strength: It is available in various oral and parenteral strengths[1].
• Mode of Purchase: Ranitidine can be purchased over-the-counter (OTC) or by prescription[1].
• End User: The primary end users include hospitals, specialty clinics, and other healthcare facilities[1].
• Distribution Channel: The drug is distributed through hospital pharmacies, retail pharmacies, online pharmacies, and other channels[1].

Challenges and Restraints

Despite the growth prospects, the ranitidine hydrochloride market faces several challenges:

• NDMA Contamination: A significant setback came in 2019 when the FDA announced the presence of N-nitrosodimethylamine (NDMA), a carcinogenic substance, in ranitidine products. This led to widespread recalls and a significant decline in market trust[2].
• High R&D Costs: The high costs associated with research and development activities in the ranitidine hydrochloride market are a major restraint[4].
• Alternative Treatments: The availability of alternative treatments and the side effects associated with ranitidine also act as restraints to market growth[1].

Financial Impact of NDMA Contamination

The discovery of NDMA in ranitidine products has had a profound financial impact on the market. GlaxoSmithKline (GSK), one of the major manufacturers of Zantac, has reached settlement agreements to resolve a significant portion of the product liability cases in the U.S. GSK will pay up to $2.2 billion to settle approximately 80,000 state court cases and an additional $70 million to resolve a qui tam complaint. These settlements, while not admitting liability, reflect the substantial financial and legal repercussions of the NDMA contamination issue[5].

Historical Financial Performance

Ranitidine, introduced in 1981, was once the world's top-selling prescription drug, generating over $1 billion in sales. However, the recent controversies surrounding NDMA have significantly impacted its financial performance. Prior to the NDMA issue, the market was projected to reach $485.4 million by 2026[2].

Current Market Trends

• New Product Launches: Despite the challenges, there have been new product launches in the market. For example, Granules India Limited received FDA approval for its 150 mg Cool Mint OTC ranitidine tablets in August 2018[4].
• Strategic Collaborations: The market is expected to benefit from increased strategic collaborations and joint ventures among major pharmaceutical companies, as well as regulatory approvals from governing bodies[4].

Key Players

The ranitidine hydrochloride market is dominated by several key players, including:

• Sun Pharmaceutical Industries Limited
• Boehringer Ingelheim GmbH
• GlaxoSmithKline Plc
• Strides Pharma Science Limited (Strides Shasun)
• Merck KGaA
• Tocris Bioscience (R & D Systems)[4].

Regional Analysis

The market is analyzed across various regions, including North America, Europe, Asia-Pacific, and the Middle East and Africa. Each region presents unique opportunities and challenges, influenced by local healthcare policies, economic conditions, and the prevalence of gastrointestinal disorders[1][4].

Future Projections

Despite the current challenges, the ranitidine hydrochloride market is expected to recover and grow in the future. The increasing prevalence of digestive disorders and the need for effective treatments will drive market growth. However, the market will need to address the issues related to NDMA contamination and ensure the safety and efficacy of ranitidine products to regain consumer trust.

"Ranitidine market is expected to gain market growth in the forecast period of 2021 to 2028... Increasing in acidity/heartburn problems and changing food habits and increase gluten intake will assist in encouraging the growth of the market."[1]

Key Takeaways

• The ranitidine hydrochloride market is projected to grow at a CAGR of 2.60% from 2021 to 2028.
• The market is driven by increasing cases of acidity and heartburn, changing food habits, and rising disposable incomes.
• The NDMA contamination issue has significantly impacted the market, leading to recalls and legal settlements.
• Key players are focusing on new product launches and strategic collaborations to drive market growth.
• The market faces restraints such as high R&D costs and the availability of alternative treatments.

FAQs

1. What is the projected market value of the ranitidine hydrochloride market by 2028? The global ranitidine market is expected to reach USD 502.4 million by 2028[1].

2. What are the key factors driving the growth of the ranitidine hydrochloride market? Key factors include increasing cases of acidity and heartburn, changing food habits, and rising disposable incomes in emerging economies[1][4].

3. How has the NDMA contamination issue affected the ranitidine hydrochloride market? The NDMA contamination led to widespread recalls, legal settlements, and a significant decline in market trust. GSK has agreed to pay up to $2.2 billion to settle related product liability cases[2][5].

4. Who are the major players in the ranitidine hydrochloride market? Major players include Sun Pharmaceutical Industries Limited, Boehringer Ingelheim GmbH, GlaxoSmithKline Plc, Strides Pharma Science Limited, Merck KGaA, and Tocris Bioscience (R & D Systems)[4].

5. What are the future projections for the ranitidine hydrochloride market? Despite current challenges, the market is expected to recover and grow driven by the increasing prevalence of digestive disorders and the need for effective treatments[1][4].

Cited Sources:

1. Data Bridge Market Research - Global Ranitidine Market – Industry Trends and Forecast to 2028[1].
2. Napoli Law - Headaches Ahead For Zantac Labs | Pharmaceutical Litigation[2].
3. Cognitive Market Research - Global Ranitidine Hydrochloride for Injection Market Report 2024[3].
4. Allied Market Research - Ranitidine Hydrochloride Market Size | Segment Review- 2030[4].
5. GSK - Statement: Zantac (ranitidine) litigation – settlement agreements reached[5].