ZEGERID OTC Drug Patent Profile

Which patents cover Zegerid Otc, and when can generic versions of Zegerid Otc launch?

Zegerid Otc is a drug marketed by Riley Consumer and is included in two NDAs.

The generic ingredient in ZEGERID OTC is omeprazole; sodium bicarbonate. There are one hundred and thirty-one drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zegerid Otc

A generic version of ZEGERID OTC was approved as omeprazole; sodium bicarbonate by STRIDES PHARMA on April 19^th, 2013.

Summary for ZEGERID OTC

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	13
Patent Applications:	24
What excipients (inactive ingredients) are in ZEGERID OTC?	ZEGERID OTC excipients list
DailyMed Link:	ZEGERID OTC at DailyMed

Recent Clinical Trials for ZEGERID OTC

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

Sponsor	Phase
Syndax Pharmaceuticals	Phase 1
Population Health Research Institute	Phase 3
Norgine	Phase 3

See all ZEGERID OTC clinical trials

Pharmacology for ZEGERID OTC

Drug Class	Osmotic Laxative Proton Pump Inhibitor
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Osmotic Activity Proton Pump Inhibitors
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Paragraph IV (Patent) Challenges for ZEGERID OTC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZEGERID OTC	Capsules	omeprazole; sodium bicarbonate	20 mg/1100 mg	022281	1	2010-04-20

US Patents and Regulatory Information for ZEGERID OTC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009		OTC	Yes	Yes
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	022283-001	Jun 17, 2013		OTC	Yes	Yes

Expired US Patents for ZEGERID OTC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	022283-001	Jun 17, 2013	5,840,737
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009	6,489,346
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	022283-001	Jun 17, 2013	7,399,772
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	022283-001	Jun 17, 2013	6,780,882
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009	7,399,772

International Patents for ZEGERID OTC

See the table below for patents covering ZEGERID OTC around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2002121623
Germany	60123381
Canada	2396159	NOUVELLES FORMES POSOLOGIQUES DE BENZIMIDAZOLE SUBSTITUE (NOVEL SUBSTITUTED BENZIMIDAZOLE DOSAGE FORMS AND METHOD OF USING SAME)
Australia	3276701
Norway	20023313

Supplementary Protection Certificates for ZEGERID OTC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105

ZEGERID OTC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZEGERID OTC

Introduction to ZEGERID OTC

ZEGERID OTC, a proton pump inhibitor (PPI), is a significant player in the over-the-counter (OTC) market for treating frequent heartburn. It is distinguished by its patented dual-ingredient formula, combining omeprazole and sodium bicarbonate, which offers a unique mechanism of action compared to other OTC PPIs[4].

Market Entry and Approval

ZEGERID OTC received FDA approval in 2010, marking a significant milestone for Santarus, the original developer, and its partner Schering-Plough (later acquired by Merck & Co., Inc.). This approval allowed ZEGERID OTC to enter the competitive OTC market, posing strong competition to established brands like Prilosec OTC and Prevacid 24HR[3][4].

Unique Selling Proposition

The dual-ingredient formula of ZEGERID OTC, which includes omeprazole and sodium bicarbonate, provides immediate relief from heartburn without the need for an enteric coating. This design protects the omeprazole from stomach acid, enabling faster absorption and quicker relief from symptoms. This unique feature sets ZEGERID OTC apart from other OTC PPIs[4].

Clinical Efficacy

Clinical trials have demonstrated the efficacy of ZEGERID OTC in reducing acid levels and providing relief from heartburn. A head-to-head study showed that ZEGERID OTC reduced acid levels to clinically accepted gastric pH levels twice as fast as Prevacid 24HR[3].

Market Positioning

The entry of ZEGERID OTC into the market was expected to leverage the strong brand recognition of Zegerid in the prescription market. By expanding into the OTC segment, Santarus aimed to capture a share of the growing low-dosage PPI market. This move was anticipated to provide significant revenue opportunities, including a $20 million milestone payment and additional sales milestone payments and royalties[1][3].

Financial Performance

• Revenue Generation: The launch of ZEGERID OTC was expected to contribute significantly to Santarus's revenue. In 2010, Santarus reported total revenues exceeding $125 million, with a portion of this revenue attributed to the performance of ZEGERID and its OTC version[2].
• Milestone Payments: The agreement with Schering-Plough included an upfront fee of $15 million and potential additional milestone payments of up to $65 million, along with royalties on net sales[1].
• Royalties and Sales: ZEGERID OTC was projected to generate substantial royalties for Santarus, with the company also obligated to pay royalties to the University of Missouri on net sales of ZEGERID OTC[1].

Challenges and Competition

• Generic Competition: The prescription version of Zegerid faced generic competition starting in June 2010, which impacted its sales. In response, Santarus launched an authorized generic capsule product and restructured its operations to focus on other products like GLUMETZA[2].
• Market Competition: ZEGERID OTC competes in a crowded market with well-established brands. Despite its unique formulation, it must contend with consumer loyalty to other OTC PPIs like Prilosec OTC and Prevacid 24HR[3][4].

Strategic Alliances and Acquisitions

• Schering-Plough Agreement: The OTC license agreement with Schering-Plough was crucial for the commercialization of ZEGERID OTC. This partnership leveraged the consumer healthcare division of Schering-Plough, which included brands like CLARITIN and MiraLAX[4].
• Merck & Co., Inc.: Following the merger between Merck and Schering-Plough, Merck continued to promote and distribute ZEGERID OTC, further expanding its reach in the consumer healthcare market[4].
• Carlin Consumer Health: In 2024, Carlin Consumer Health, a platform backed by Hildred and The Emerson Group, acquired ZEGERID OTC. This acquisition is part of Carlin's strategy to build a preeminent consumer health business through investments in sales, marketing, and product development[5].

Future Outlook

The acquisition by Carlin Consumer Health indicates a continued commitment to the brand and its potential for growth. With market-leading consumer loyalty and significant potential for expansion, ZEGERID OTC is poised to remain a competitive force in the OTC PPI market.

Key Statistics and Milestones

• Revenue Projections: Peak annual sales for ZEGERID OTC were anticipated to be substantial, although exact figures varied based on market performance and competition.
• Clinical Trial Outcomes: ZEGERID OTC demonstrated faster acid reduction compared to Prevacid 24HR in clinical trials.
• Market Share: The entry of ZEGERID OTC into the OTC market was expected to capture a significant share of the low-dosage PPI segment.

Expert Insights

"ZEGERID OTC capsules do not need an enteric coating, because the sodium bicarbonate offers built-in protection against stomach acid, so the omeprazole can be absorbed by the body and get to work treating frequent heartburn," explained Dr. Michael Rahmin, a prominent gastroenterologist[4].

Key Takeaways

• Unique Formulation: ZEGERID OTC's dual-ingredient formula sets it apart in the OTC PPI market.
• Clinical Efficacy: The product has demonstrated faster and more effective relief from heartburn compared to competitors.
• Financial Performance: The launch of ZEGERID OTC contributed significantly to Santarus's revenue and is expected to continue generating revenue under new ownership.
• Market Positioning: ZEGERID OTC competes in a crowded market but has a strong brand presence and unique selling proposition.

FAQs

Q: What is the unique feature of ZEGERID OTC? A: ZEGERID OTC features a patented dual-ingredient formula combining omeprazole and sodium bicarbonate, which protects the omeprazole from stomach acid and allows for faster absorption.

Q: When did ZEGERID OTC receive FDA approval? A: ZEGERID OTC received FDA approval in 2010.

Q: How does ZEGERID OTC compare to other OTC PPIs in clinical trials? A: Clinical trials have shown that ZEGERID OTC reduces acid levels to clinically accepted gastric pH levels twice as fast as Prevacid 24HR.

Q: What was the impact of generic competition on the prescription version of Zegerid? A: The entry of generic competition in June 2010 led to a decline in sales, prompting Santarus to launch an authorized generic capsule product and restructure its operations.

Q: Who currently owns and promotes ZEGERID OTC? A: As of 2024, ZEGERID OTC is owned and promoted by Carlin Consumer Health, a platform backed by Hildred and The Emerson Group.

Cited Sources

1. Nasdaq: SNTS - JPMorgan Conference Final PDF
2. AnnualReports.com - Santarus 2010 Annual Report
3. ClinicalTrialsArena - Zegerid – Proton Pump Inhibitor for Treatment of Heartburn
4. BioSpace - Merck & Co., Inc.'s ZEGERID OTC(TM) Hits Store Shelves
5. Bourne-Partners - Carlin Consumer Health Acquisition of Zegerid