OSMOPREP Drug Patent Profile

Which patents cover Osmoprep, and what generic alternatives are available?

Osmoprep is a drug marketed by Salix Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-nine patent family members in eleven countries.

The generic ingredient in OSMOPREP is sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Additional details are available on the sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Osmoprep

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for OSMOPREP

International Patents:	29
US Patents:	1
Applicants:	1
NDAs:	1
Clinical Trials:	1
Drug Prices:	Drug price information for OSMOPREP
Drug Sales Revenues:	Drug sales revenues for OSMOPREP
What excipients (inactive ingredients) are in OSMOPREP?	OSMOPREP excipients list
DailyMed Link:	OSMOPREP at DailyMed

See drug prices for OSMOPREP

See drug sales revenues for OSMOPREP

Recent Clinical Trials for OSMOPREP

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

Sponsor	Phase
Valeant Pharmaceuticals International, Inc.	Phase 4
Bausch Health Americas, Inc.	Phase 4

See all OSMOPREP clinical trials

Paragraph IV (Patent) Challenges for OSMOPREP

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OSMOPREP	Tablets	sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate	1.102 g and 0.398 g	021892	1	2008-04-09

US Patents and Regulatory Information for OSMOPREP

OSMOPREP is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix Pharms	OSMOPREP	sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate	TABLET;ORAL	021892-001	Mar 16, 2006		DISCN	Yes	No			Y	Y

Expired US Patents for OSMOPREP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix Pharms	OSMOPREP	sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate	TABLET;ORAL	021892-001	Mar 16, 2006

International Patents for OSMOPREP

See the table below for patents covering OSMOPREP around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2015221520	COLONIC PURGATIVE COMPOSITION WITH SOLUBLE BINDING AGENT
Brazil	PI0416702	FORMULAÇÃO PURGATIVA COLÔNICA, KIT, MÉTODOS DE PURGAR O CÓLON DE UM PACIENTE, DE TRATAR UM PACIENTE COM, OU SUSCETÍVEL A, UM DISTÚRBIO GASTROINTESTINAL, E DE TRATAR UM PACIENTE SOFRENDO DE, OU SUSCETÍVEL À, CONSTIPAÇÃO, E, PROCESSO DE PRODUZIR A FORMULAÇÃO PURGATIVA COLÔNICA
Germany	69627170
Japan	2007512336

Supplementary Protection Certificates for OSMOPREP

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0579826	02C0041	France		PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
2932970	18C1043	France		PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
2203431	2015/009	Ireland		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204

Market Dynamics and Financial Trajectory for OsmoPrep

Introduction

OsmoPrep, an osmotic laxative, is used primarily for the cleansing of the colon as a preparation for colonoscopy in adults. Understanding its market dynamics and financial trajectory involves examining its usage, side effects, market competition, and the financial performance of the companies involved in its production and distribution.

Clinical Use and Side Effects

OsmoPrep is composed of sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous. It is supplied in tablet form and is known for its efficacy in bowel cleansing. However, it comes with several potential side effects, including bloating, nausea, abdominal pain, vomiting, and electrolyte abnormalities such as hyperphosphatemia, hypokalemia, and hypocalcemia[1][4].

Market Competition

The market for bowel preparation drugs is competitive, with several products available. OsmoPrep competes with other sodium phosphate-based products and alternative bowel cleansing agents. The competitive landscape is influenced by factors such as efficacy, safety profile, and patient compliance.

Financial Performance of Salix Pharmaceuticals

Salix Pharmaceuticals, the company behind OsmoPrep, has experienced significant financial fluctuations. In the first quarter of 2014, Salix reported total net product revenue of $384.4 million, a 90% increase from the previous year. However, the company also reported a GAAP net loss of $43.9 million due to various adjustments including amortization, depreciation, and transaction costs related to the acquisition of Santarus[2].

Quarterly and Annual Revenue

In the third quarter of 2014, Salix's total net product revenue was $354.7 million, with OsmoPrep contributing a relatively small portion compared to other products like XIFAXAN and UCERIS. The revenue from OsmoPrep was $1.2 million for the third quarter, which is a minor fraction of the total revenue[5].

EBITDA and Non-GAAP Net Income

Despite the GAAP net loss, Salix's EBITDA increased significantly, reaching $149.2 million in the first quarter of 2014 and $161.2 million in the third quarter of 2014. Non-GAAP net income also showed substantial growth, reflecting the company's operational performance after adjusting for various costs and expenses[2][5].

Factors Influencing Drug Pricing

The pricing of OsmoPrep, like other prescription drugs, is influenced by several factors beyond production costs. These include economic demand, patent protections, and the presence of health insurance, which can affect patient willingness to pay. The dynamic nature of drug markets, where prices can decrease with increased competition and the entry of generic versions, is also a critical factor[3].

Demand and Willingness to Pay

The demand for bowel preparation drugs is driven by the need for effective colon cleansing before procedures like colonoscopy. The willingness to pay is high due to the importance of these procedures in healthcare. However, as more competitors enter the market, prices are likely to decrease, making the drug more accessible[3].

Patent Protections and Competition

Patent protections play a crucial role in the pharmaceutical industry by providing temporary exclusivity, which incentivizes investment in research and development. As patents expire and generic versions of drugs enter the market, competition increases, leading to lower prices. This is evident in the market trajectory of other drugs, such as direct-acting antivirals for hepatitis C, where prices have significantly decreased over time due to increased competition[3].

Postmarketing Experience and Safety Concerns

OsmoPrep has been associated with several postmarketing adverse reactions, including hypersensitivity reactions, cardiovascular issues, and neurological abnormalities such as seizures. These safety concerns can impact market dynamics by influencing prescribing practices and patient compliance[1].

Geriatric Use and Special Populations

The use of OsmoPrep in geriatric populations and special patient groups, such as those with a history of seizures or electrolyte imbalances, requires careful consideration. This can affect the drug's market penetration and the company's revenue, as certain patient groups may be excluded or require special monitoring[1].

Conclusion

The market dynamics and financial trajectory of OsmoPrep are complex and influenced by multiple factors. While the drug is effective for bowel cleansing, its side effects and the competitive landscape of the pharmaceutical industry play significant roles. The financial performance of Salix Pharmaceuticals, now part of a larger pharmaceutical entity, reflects the challenges and opportunities in the market.

Key Takeaways

• Efficacy and Side Effects: OsmoPrep is effective but comes with significant side effects.
• Market Competition: The market is competitive, with multiple bowel preparation drugs available.
• Financial Performance: Salix Pharmaceuticals experienced significant revenue growth but also reported net losses due to various adjustments.
• Pricing Factors: Demand, patent protections, and competition influence drug pricing.
• Safety Concerns: Postmarketing adverse reactions can impact market dynamics.
• Special Populations: Careful consideration is needed for geriatric and special patient groups.

FAQs

Q1: What is OsmoPrep used for?

OsmoPrep is used for the cleansing of the colon as a preparation for colonoscopy in adults.

Q2: What are the common side effects of OsmoPrep?

Common side effects include bloating, nausea, abdominal pain, vomiting, and electrolyte abnormalities such as hyperphosphatemia and hypokalemia.

Q3: How has the financial performance of Salix Pharmaceuticals been with regards to OsmoPrep?

Salix Pharmaceuticals reported significant revenue growth but also net losses due to various adjustments. OsmoPrep contributed a relatively small portion to the total revenue.

Q4: What factors influence the pricing of OsmoPrep?

The pricing is influenced by economic demand, patent protections, health insurance, and competition in the market.

Q5: Are there any safety concerns associated with OsmoPrep?

Yes, OsmoPrep has been associated with several postmarketing adverse reactions, including hypersensitivity reactions, cardiovascular issues, and neurological abnormalities such as seizures.

Sources

1. RxList: OsmoPrep - RxList
2. Business Wire: Salix Pharmaceuticals Reports 1Q2014 Results
3. The American Journal of Managed Care: The Price of Progress: Understanding Innovation and Affordability of Prescription Drugs
4. Drugs.com: OsmoPrep: Package Insert / Prescribing Information
5. Fierce Pharma: Salix Pharmaceuticals Reports 3Q2014 Results