DICLEGIS Drug Patent Profile

When do Diclegis patents expire, and when can generic versions of Diclegis launch?

Diclegis is a drug marketed by Duchesnay and is included in one NDA.

The generic ingredient in DICLEGIS is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Diclegis

A generic version of DICLEGIS was approved as doxylamine succinate; pyridoxine hydrochloride by ACTAVIS LABS FL INC on August 19^th, 2016.

Summary for DICLEGIS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	2
Patent Applications:	5
Drug Prices:	Drug price information for DICLEGIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DICLEGIS
What excipients (inactive ingredients) are in DICLEGIS?	DICLEGIS excipients list
DailyMed Link:	DICLEGIS at DailyMed

See drug prices for DICLEGIS

See drug sales revenues for DICLEGIS

Recent Clinical Trials for DICLEGIS

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

Sponsor	Phase
Grünenthal GmbH	Phase 1
Grünenthal, S.A.	Phase 1
Premier Research Group plc	Phase 4

See all DICLEGIS clinical trials

Pharmacology for DICLEGIS

Ingredient-type	Analogs/Derivatives Vitamin B 6
Drug Class	Antihistamine Vitamin B6 Analog
Mechanism of Action	Histamine Receptor Antagonists

Paragraph IV (Patent) Challenges for DICLEGIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DICLEGIS	Delayed-release Tablets	doxylamine succinate; pyridoxine hydrochloride	10 mg/10 mg	021876	1	2013-08-01

US Patents and Regulatory Information for DICLEGIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013	AB	RX	Yes	Yes

Expired US Patents for DICLEGIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013

International Patents for DICLEGIS

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

Country	Patent Number	Title	Estimated Expiration
Denmark	200200947
Netherlands	1023797	Farmaceutische doseringsvorm die zwangerschapsvriendelijke onderscheidingstekens draagt.
France	2841783	FORME POSOLOGIQUE PHARMACEUTIQUE PORTANT UNE SIGNALISATION INDIQUANT UNE PARFAITE INNOCUITE EN CAS DE GROSSESSE
Italy	UD20030145	MODULO PER UN DOSAGGIO FARMACEUTICO, AVENTE SEGNI RASSERENANTI NEL CASO DI GRAVIDANZA.

DICLEGIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diclegis

Introduction

Diclegis, known as Diclectin in Canada, is a medication approved for the treatment of nausea and vomiting in pregnancy (NVP), a condition affecting 70% to 85% of pregnant women. Here, we delve into the market dynamics and financial trajectory of this drug.

Historical Context and Approval

Diclegis, a combination of doxylamine succinate and pyridoxine hydrochloride, has a complex history. Originally marketed as Bendectin, it was withdrawn from the U.S. market in 1983 due to lawsuits claiming birth defects, despite no evidence of such risks. In 2013, the FDA approved Diclegis, granting it Pregnancy Category A status, indicating no increased risk to the unborn baby[4].

Market Need and Demand

NVP is a prevalent condition, affecting a significant portion of pregnant women. The FDA approval of Diclegis marked the first new treatment for NVP in over 30 years, filling a critical gap in the market. The demand for effective treatments is high, given that NVP symptoms can range from mild to severe and can last throughout pregnancy[4].

Regulatory Endorsements

Diclegis has received strong regulatory endorsements. In Canada, an independent expert panel confirmed its positive benefit-risk profile, and Health Canada continues to support its use. In the U.S., the FDA's approval and categorization as a Pregnancy Category A drug underscore its safety and efficacy[1][4].

Prescription Trends

In Canada, Diclectin (the Canadian equivalent of Diclegis) sees stable prescription numbers, with approximately 180,000 new prescriptions per year. This stability indicates a consistent demand for the medication, reflecting its established position in the market[1].

Clinical Evidence and Guidelines

Clinical trials and observational studies have shown that Diclegis significantly improves nausea and vomiting in pregnant women without posing an increased risk to the fetus. The American Congress of Obstetricians and Gynecologists (ACOG) has recommended the active ingredients in Diclegis as a first-line pharmacotherapy for NVP for the last nine years[4].

Financial Performance

The financial performance of Diclegis is closely tied to its market acceptance and regulatory status. The approval and subsequent marketing of Diclegis have contributed to the revenue growth of its manufacturer, Duchesnay. While specific financial figures for Diclegis alone are not readily available, the overall revenue from prescription medications for NVP has seen significant growth since its approval.

Competitive Landscape

The market for NVP treatments is relatively niche but critical. Diclegis holds a dominant position due to its FDA approval and strong clinical evidence. However, other treatments and lifestyle modifications are also recommended, which can affect market dynamics. The lack of new competitors in this space over the past few decades has allowed Diclegis to maintain its market share[4].

Pricing and Reimbursement

The pricing of Diclegis is influenced by its prescription status and the costs associated with its development and marketing. In the U.S., the drug is covered by many insurance plans, which helps in maintaining its market presence. However, the impact of off-invoice discounts and rebates, common in the pharmaceutical industry, can affect the net revenue generated from Diclegis sales[3].

Future Outlook

The future outlook for Diclegis remains positive due to its established safety profile and efficacy. As the population grows, so does the number of pregnancies, which in turn increases the demand for effective NVP treatments. However, the pharmaceutical market is dynamic, and future competition or changes in regulatory environments could impact its financial trajectory.

Key Statistics

• Prescription Volume: Approximately 180,000 new prescriptions per year in Canada[1].
• Market Approval: FDA-approved in 2013, with Pregnancy Category A status[4].
• Clinical Trials: Studies have shown significant improvement in NVP symptoms without increased fetal risk[4].
• Revenue Impact: Contribution to revenue growth for Duchesnay, though specific figures are not detailed.

Industry Trends

The pharmaceutical industry is characterized by innovation, volume usage, and losses of exclusivity. Protected brands, including new products like Diclegis, drive significant spending growth. However, the impact of generic and biosimilar products, as well as off-invoice discounts and rebates, can offset list prices and affect net revenues[3].

Conclusion

Diclegis has established itself as a safe and effective treatment for NVP, supported by strong regulatory endorsements and clinical evidence. Its market dynamics are characterized by stable prescription volumes and a dominant market position. The financial trajectory of Diclegis is positive, driven by its critical role in addressing a prevalent condition in pregnancy.

Key Takeaways

• Regulatory Approval: FDA-approved with Pregnancy Category A status.
• Market Demand: High demand due to the prevalence of NVP.
• Clinical Evidence: Strong evidence supporting its safety and efficacy.
• Financial Performance: Contributes to revenue growth for its manufacturer.
• Future Outlook: Positive due to its established safety profile and market need.

FAQs

Q: What is Diclegis used for? Diclegis is used to treat nausea and vomiting in pregnancy (NVP), a condition affecting a significant portion of pregnant women.

Q: Why was Bendectin, the predecessor to Diclegis, removed from the market? Bendectin was removed from the market in 1983 due to lawsuits claiming birth defects, despite no evidence supporting these claims.

Q: What is the regulatory status of Diclegis? Diclegis has been approved by the FDA and is classified as a Pregnancy Category A drug, indicating no increased risk to the unborn baby.

Q: How is Diclegis prescribed? Diclegis is prescribed in a specific dosing regimen, starting with 2 tablets at bedtime and adjusting based on symptom persistence.

Q: Is Diclegis covered by insurance? Yes, Diclegis is covered by many insurance plans, which helps in maintaining its market presence.

Sources

1. Health Canada: Summary Safety Review - DICLECTIN (doxylamine and pyridoxine combination) - Safety in Pregnancy.
2. Alliance Pharmaceuticals: Interim Results for the six months ended 30 June 2016.
3. IQVIA: Drug Expenditure Dynamics 1995-2020: Understanding Medicine Spending in Context U.S Detail Appendix.
4. Drug Topics: FDA approves Diclegis for the treatment of morning sickness.
5. OTC Markets: MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.