DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE Drug Patent Profile

Which patents cover Diphenoxylate Hydrochloride And Atropine Sulfate, and when can generic versions of Diphenoxylate Hydrochloride And Atropine Sulfate launch?

Diphenoxylate Hydrochloride And Atropine Sulfate is a drug marketed by Hikma, Able, Ani Pharms, Ascot, Bayshore Pharms Llc, Chartwell Rx, Dr Reddys Labs Sa, Fosun Pharma, Heather, Inwood Labs, Kv Pharm, Lannett, Leading, Lederle, Mylan, Parke Davis, Pvt Form, R And S Pharma, Roxane, Specgx Llc, Strides Pharma, Sun Pharm Industries, Upsher Smith Labs, Usl Pharma, Valeant Pharm Intl, Watson Labs, and Winder Labs Llc. and is included in twenty-eight NDAs.

The generic ingredient in DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE is atropine sulfate; diphenoxylate hydrochloride. There are twenty-three drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.

Summary for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

US Patents:	0
Applicants:	27
NDAs:	28
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	1
Patent Applications:	60
What excipients (inactive ingredients) are in DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE?	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE excipients list
DailyMed Link:	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE at DailyMed

Recent Clinical Trials for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

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

Sponsor	Phase
Puma Biotechnology, Inc.	Phase 2
Napo Pharmaceuticals, Inc.	Phase 2
University of California, San Francisco	Phase 2

See all DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE clinical trials

Pharmacology for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Drug Class	Anticholinergic Antidiarrheal Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

US Patents and Regulatory Information for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Winder Labs Llc	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	211362-001	Jan 27, 2021	AA	RX	No	No
Hikma	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	SOLUTION;ORAL	087708-001	May 3, 1982		RX	No	Yes
Pvt Form	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	085766-001	Approved Prior to Jan 1, 1982		DISCN	No	No

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diphenoxylate Hydrochloride and Atropine Sulfate

Introduction

Diphenoxylate hydrochloride and atropine sulfate, commonly known by the brand name Lomotil, is a medication used to manage diarrhea. This combination drug has been a staple in the pharmaceutical market for several decades, and its market dynamics and financial trajectory are influenced by various factors.

Market Size and Sales

As of 2018, the diphenoxylate hydrochloride and atropine sulfate tablet market in the U.S. had sales of approximately $64 million for the 12 months ending May 2018, according to IQVIA[1].

Generic Competition

The launch of generic versions of Lomotil, such as the one by Upsher-Smith Laboratories in 2018, has significantly impacted the market. Generic versions often reduce the market share of the branded product, leading to a more competitive pricing environment. Upsher-Smith's generic version, which is an AA-rated equivalent of Lomotil, competes directly with the branded product, potentially altering the financial trajectory of the original drug[1].

Indications and Usage

Diphenoxylate hydrochloride and atropine sulfate is indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older. This specific indication limits the market to a particular demographic, which can influence sales and revenue[2][4].

Pharmacological Mechanism

The drug's mechanism of action, involving the stimulation of mu opioid receptors in the gastrointestinal tract to decrease peristalsis and constrict sphincters, makes it effective for its intended use. However, this mechanism also introduces potential for misuse and addiction, which can affect market dynamics through regulatory and prescribing practices[3][4].

Regulatory Environment

The combination of diphenoxylate and atropine is classified as a Schedule V drug, which is less restrictive than Schedule II but still subject to certain regulations. Atropine is added to prevent misuse of diphenoxylate, which can impact patient compliance and prescribing rates[4].

Dosage Forms and Strengths

The drug is available in both tablet and liquid forms, with the liquid form being the only option for children. Each tablet contains 2.5 mg of diphenoxylate hydrochloride and 0.025 mg of atropine sulfate. The availability of different forms can influence market demand and patient preference[4][5].

Adverse Effects and Contraindications

The drug has several adverse effects, including anticholinergic symptoms, respiratory depression, and the potential for worsening dehydration and electrolyte imbalances. It is contraindicated in patients with certain types of infectious diarrhea and in pediatric patients under 6 years of age. These factors can affect prescribing rates and patient adherence, impacting the financial performance of the drug[2][4].

Competitive Landscape

The antidiarrheal market is competitive, with various other medications available for managing diarrhea. The presence of alternative treatments can erode market share for diphenoxylate hydrochloride and atropine sulfate, especially if those alternatives offer better safety profiles or greater efficacy.

Financial Impact of Generic Entry

The entry of generic versions significantly reduces the revenue of the branded product. Generic drugs are typically priced lower, which can lead to a substantial decrease in sales for the original manufacturer. For example, the launch of Upsher-Smith's generic version would likely capture a significant portion of the market share, reducing the financial trajectory of Lomotil[1].

Patient and Prescriber Preferences

Patient and prescriber preferences play a crucial role in the market dynamics. The addition of atropine to prevent misuse can be a deterrent for some patients due to its anticholinergic side effects. Prescribers may opt for alternative treatments with fewer side effects or less potential for abuse, further impacting the drug's financial performance[4].

Hepatic and Renal Impairment Considerations

The drug's use in patients with hepatic or renal impairment requires caution, which can limit its market. Patients with advanced hepatorenal disease are at risk of hepatic coma, and those with renal impairment may experience adverse effects more severely. These considerations can reduce the drug's prescribing rates in certain patient populations[2][4].

Pediatric Use and Safety

The safety and effectiveness of diphenoxylate hydrochloride and atropine sulfate have not been established in pediatric patients under 13 years of age, and it is contraindicated in those under 6 years due to the risk of severe respiratory depression. This limitation affects the drug's market size and financial potential[2][4].

Key Takeaways

• Market Size: The U.S. market for diphenoxylate hydrochloride and atropine sulfate tablets was approximately $64 million as of 2018.
• Generic Competition: The entry of generic versions significantly impacts the market, reducing the revenue of the branded product.
• Regulatory Environment: Classified as a Schedule V drug, with atropine added to prevent misuse.
• Adverse Effects: Includes anticholinergic symptoms, respiratory depression, and potential for worsening dehydration and electrolyte imbalances.
• Patient and Prescriber Preferences: Influenced by side effects and potential for abuse.
• Hepatic and Renal Impairment: Requires caution in patients with advanced hepatorenal disease.

FAQs

1. What is the primary indication for diphenoxylate hydrochloride and atropine sulfate?

   • The primary indication is as adjunctive therapy in the management of diarrhea in patients 13 years of age and older[2][4].

2. How does the addition of atropine affect the drug?

   • Atropine is added to prevent misuse of diphenoxylate by inducing unpleasant anticholinergic side effects at higher doses[4].

3. What are the common side effects of diphenoxylate hydrochloride and atropine sulfate?

   • Common side effects include anticholinergic symptoms, respiratory depression, and potential for worsening dehydration and electrolyte imbalances[2][4].

4. Can diphenoxylate hydrochloride and atropine sulfate be used in pediatric patients?

   • It is contraindicated in pediatric patients under 6 years of age and not established for safety and effectiveness in those under 13 years[2][4].

5. How does the drug's classification affect its market?

   • Classified as a Schedule V drug, it is subject to certain regulations but less restrictive than Schedule II, which can influence prescribing practices and patient compliance[4].

Cited Sources

1. Upsher-Smith Launches Generic Version of Lomotil... - PR Newswire
2. DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE... - DailyMed
3. Diphenoxylate: Uses, Interactions, Mechanism of Action - DrugBank
4. Diphenoxylate and Atropine - StatPearls - NCBI Bookshelf
5. Lomotil: Dosage, side effects, uses, and more - MedicalNewsToday