ENTOCORT EC Drug Patent Profile

Which patents cover Entocort Ec, and what generic alternatives are available?

Entocort Ec is a drug marketed by Padagis Us and is included in one NDA.

The generic ingredient in ENTOCORT EC is budesonide. There are twenty-two drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the budesonide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Entocort Ec

A generic version of ENTOCORT EC was approved as budesonide by TEVA PHARMS on November 18^th, 2008.

Summary for ENTOCORT EC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	12
Drug Prices:	Drug price information for ENTOCORT EC
What excipients (inactive ingredients) are in ENTOCORT EC?	ENTOCORT EC excipients list
DailyMed Link:	ENTOCORT EC at DailyMed

See drug prices for ENTOCORT EC

Recent Clinical Trials for ENTOCORT EC

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

Sponsor	Phase
University of Calgary	Phase 2
Ferring Pharmaceuticals	Phase 2
Icahn School of Medicine at Mount Sinai	Phase 1

See all ENTOCORT EC clinical trials

Pharmacology for ENTOCORT EC

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for ENTOCORT EC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ENTOCORT EC	Enteric Coated Capsules	budesonide	3 mg	021324	1	2008-02-01

US Patents and Regulatory Information for ENTOCORT EC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Padagis Us	ENTOCORT EC	budesonide	CAPSULE, DELAYED RELEASE;ORAL	021324-001	Oct 2, 2001	AB	RX	Yes	Yes

Expired US Patents for ENTOCORT EC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Padagis Us	ENTOCORT EC	budesonide	CAPSULE, DELAYED RELEASE;ORAL	021324-001	Oct 2, 2001
Padagis Us	ENTOCORT EC	budesonide	CAPSULE, DELAYED RELEASE;ORAL	021324-001	Oct 2, 2001

EU/EMA Drug Approvals for ENTOCORT EC

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Dr. Falk Pharma GmbH	Jorveza	budesonide	EMEA/H/C/004655 Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).	Authorised	no	no	yes	2018-01-08
Stada Arzneimittel AG	Kinpeygo	budesonide	EMEA/H/C/005653 Kinpeygo is indicated for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.	Authorised	no	no	yes	2022-07-15

International Patents for ENTOCORT EC

See the table below for patents covering ENTOCORT EC around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	0502092
Finland	104949
Hong Kong	51897	Oral composition for the treatment of inflammatory bowel diseases
Lithuania	IP1751
Japan	H05501705
Finland	922325

Supplementary Protection Certificates for ENTOCORT EC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	132021000000095	Italy		PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210
2435024	SPC/GB21/029	United Kingdom		PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210
0613371	SPC/GB02/033	United Kingdom		PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
2435024	301102	Netherlands		PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024	21C1020	France		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024	2190014-7	Sweden		PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210

Market Dynamics and Financial Trajectory for Entocort EC

Introduction

Entocort EC, a formulation of budesonide, is a gastroenterology medicine used for the treatment and maintenance of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting key events, strategic moves, and financial impacts.

Market Position and Indications

Entocort EC is specifically indicated for the treatment of mild to moderate active Crohn’s disease and the maintenance of clinical remission for up to 3 months. The drug has shown efficacy in clinical trials, particularly in reducing the time to relapse and maintaining symptom control compared to placebo[4].

Historical Sales Performance

The sales performance of Entocort EC has been significant, especially after strategic marketing and diagnostic initiatives. When Prometheus Labs started detailing the drug, Entocort EC sales in the US grew by 59% annually, reaching $125 million annually. This growth was facilitated by a 170-person specialty sales force that helped identify patients who would benefit from the therapeutic agent, thereby improving its efficacy and justifying price increases[3].

Pricing Strategy

Prometheus Labs implemented a successful pricing strategy for Entocort EC. Upon acquiring the rights in 2005, the company raised the average wholesale price by 66%, followed by annual increases of 10%. This pricing strategy reflected the increased value to patients, physicians, and payers, resulting in a current price that is 120% of the original price when Prometheus started marketing it[3].

Divestment and Strategic Focus

AstraZeneca, the original developer of Entocort EC, divested the US rights to Perrigo Company plc in 2015. This move was part of AstraZeneca’s strategy to focus on three main therapy areas: Oncology, Cardiovascular, Renal & Metabolism (CVRM), and Respiratory & Immunology. The divestment included the rights to sell Entocort capsules and the authorized generic version, with Perrigo paying $380 million upon completion of the transaction[1].

Financial Impact of Divestment

The divestment of Entocort EC had a notable financial impact on AstraZeneca. The upfront payment of $380 million was reported in Other Operating Income in AstraZeneca’s financial statements. This transaction did not affect AstraZeneca’s 2015 Core Earnings Per Share guidance, which was maintained in the range of mid to high single-digit percentage increase versus the prior year at constant exchange rates[1].

Market Competition and Patient Access

The gastroenterology market, particularly for Crohn’s disease treatments, is competitive. However, Entocort EC has maintained its market presence due to its efficacy and the strategic efforts of its marketers. For instance, Prometheus Labs’ ability to work in both diagnostic and therapeutic areas helped in identifying the right patient subset, thereby improving the drug’s efficacy and market value[3].

Clinical Efficacy and Safety

Entocort EC has been evaluated in several clinical trials, demonstrating its efficacy in treating and maintaining remission in Crohn’s disease. The drug has shown better clinical improvement rates compared to placebo and has been found to have a favorable safety profile, particularly in maintaining normal plasma cortisol levels compared to prednisolone[4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pharmaceuticals. Entocort EC has been approved by the FDA for its specified indications, and any changes in regulatory policies or inclusion in national reimbursement drug lists can impact its market performance. For example, inclusion in such lists can initially affect pricing but may lead to increased volumes and overall market presence[5].

Global Market Perspective

While the focus here is on the US market, the global market for Entocort EC is also significant. AstraZeneca’s divestment of global rights outside the US to Tillotts Pharma AG in 2015 completed the global divestment of Entocort EC. This move allowed AstraZeneca to sharpen its focus on its core therapy areas while ensuring continued patient access to the drug worldwide[1].

Financial Statistics

• US Sales: Entocort EC sales in the US were $89 million in the year-to-date (nine months) of 2015[1].
• Annual Growth: Sales grew by 59% annually since Prometheus started detailing the drug, reaching $125 million annually[3].
• Pricing: The current pricing is 120% of the original price when Prometheus started marketing it[3].
• Divestment Payment: Perrigo paid $380 million to acquire the US rights to Entocort EC[1].

Key Takeaways

• Strategic Focus: AstraZeneca’s divestment of Entocort EC aligns with its strategic focus on core therapy areas.
• Market Growth: Entocort EC has shown significant sales growth, particularly after targeted marketing efforts.
• Pricing Strategy: Successful pricing strategies have increased the drug’s value and market presence.
• Clinical Efficacy: The drug has demonstrated efficacy in clinical trials and maintains a favorable safety profile.
• Regulatory Impact: Regulatory approvals and inclusion in reimbursement lists can significantly impact market performance.

FAQs

Q: What is Entocort EC used for? A: Entocort EC is used for the treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon and for the maintenance of clinical remission.

Q: Who acquired the US rights to Entocort EC from AstraZeneca? A: Perrigo Company plc acquired the US rights to Entocort EC from AstraZeneca in 2015.

Q: How much did Perrigo pay for the US rights to Entocort EC? A: Perrigo paid $380 million to acquire the US rights to Entocort EC.

Q: What was the impact of Prometheus Labs' marketing efforts on Entocort EC sales? A: Prometheus Labs' marketing efforts led to a 59% annual growth in Entocort EC sales in the US, reaching $125 million annually.

Q: How does Entocort EC compare to other treatments like prednisolone in clinical trials? A: Entocort EC has shown equal or comparable clinical improvement rates to prednisolone in some trials, with a better safety profile in maintaining normal plasma cortisol levels.

Sources

1. AstraZeneca Press Release: AstraZeneca enters into agreement with Perrigo for rights to Entocort in the US.
2. AbbVie Financial Results: AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results.
3. Pharmaceutical Executive: Overlooked Opportunities.
4. FDA Label: Entocort® EC.
5. AstraZeneca Full-Year 2020 Results: Full-year 2020 results announcement.

Last updated: 2024-12-19