ORTHO EVRA Drug Patent Profile

Which patents cover Ortho Evra, and when can generic versions of Ortho Evra launch?

Ortho Evra is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in ORTHO EVRA is ethinyl estradiol; norelgestromin. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norelgestromin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ortho Evra

A generic version of ORTHO EVRA was approved as ethinyl estradiol; norelgestromin by AMNEAL on February 25^th, 2021.

Summary for ORTHO EVRA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	48
Patent Applications:	130
DailyMed Link:	ORTHO EVRA at DailyMed

See drug sales revenues for ORTHO EVRA

Paragraph IV (Patent) Challenges for ORTHO EVRA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ORTHO EVRA	Transdermal System	ethinyl estradiol; norelgestromin	0.15 mg/0.02 mg per 24 hours	021180	1	2007-03-22

US Patents and Regulatory Information for ORTHO EVRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	ORTHO EVRA	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	021180-001	Nov 20, 2001		DISCN	Yes	No

Expired US Patents for ORTHO EVRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO EVRA	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	021180-001	Nov 20, 2001
Janssen Pharms	ORTHO EVRA	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	021180-001	Nov 20, 2001

EU/EMA Drug Approvals for ORTHO EVRA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gedeon Richter Plc.	Evra	norelgestromin, ethinyl estradiol	EMEA/H/C/000410 Female contraception.Evra is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years.	Authorised	no	no	no	2002-08-22

International Patents for ORTHO EVRA

See the table below for patents covering ORTHO EVRA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0836506	TIMBRE TRANSDERMIQUE POUR L'ADMINISTRATION DE 17-DEACETYL NORGESTIMATE EN COMBINAISON AVEC UN ESTROGENE (TRANSDERMAL PATCH FOR ADMINISTERING 17-DEACETYL NORGESTIMATE IN COMBINATION WITH AN ESTROGEN)
Canada	2222133	TIMBRE TRANSDERMIQUE ET PROCEDE D'ADMINISTRATION DE 17-DEACETYL NORGESTIMATE, SEUL OU EN COMBINAISON AVEC UN OESTROGENE (TRANSDERMAL PATCH AND METHOD FOR ADMINISTERING 17-DEACETYL NORGESTIMATE ALONE OR IN COMBINATION WITH AN ESTROGEN)
Hungary	228434	TRANSDERMAL MEDICAMENT FOR ADMINISTERING 17-DEACETYL NORGESTIMATE ALONE OR IN COMBINATION WITH AN ESTROGEN
Denmark	0836506
Japan	2004043510	PERCUTANEOUS PATCH FOR ADMINISTRATING 17-DEACETYLNORGESTIMATE ONLY OR IN COMBINATION WITH ESTROGEN, AND METHOD FOR ITS ADMINISTRATION
Norway	975586
Austria	229828

Supplementary Protection Certificates for ORTHO EVRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804

ORTHO EVRA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ortho Evra

Introduction

Ortho Evra, a transdermal contraceptive patch, has been a significant player in the contraceptive market since its introduction in 2002. This article delves into the market dynamics and financial trajectory of Ortho Evra, highlighting its performance, challenges, and future outlook.

Market Size and Growth

The U.S. contraceptive drugs market, which includes Ortho Evra, was valued at USD 6.25 billion in 2022 and is projected to grow at a CAGR of 6.8% from 2023 to 2030[1].

Product Overview

Ortho Evra is a once-weekly contraceptive patch that delivers norelgestromin and ethinyl estradiol (EE) through the skin. It maintains efficacious serum hormone concentrations under various conditions, including heat, humidity, and exercise[3][4].

Pharmacokinetics

The patch exhibits an excellent pharmacokinetic profile, with steady-state concentrations of norelgestromin and EE reached within 48 hours of application. These concentrations are maintained throughout the 7-day wear period, ensuring high contraceptive efficacy[3][4].

Market Trends

• Shift to Modern Contraceptive Methods: There is a significant trend towards modern contraceptive methods, including transdermal patches like Ortho Evra. This shift is driven by improved compliance and ease of use compared to traditional oral contraceptives[1].
• Distribution Channels: The retail pharmacy segment dominates the market, but online channels are expected to experience the fastest growth due to increasing customer preference for online purchases[1].

Regulatory Environment

The Affordable Care Act in the U.S. mandates private health plans to cover FDA-approved contraceptive methods, including Ortho Evra, which has positively impacted its adoption. However, the patch has faced regulatory scrutiny due to higher estrogen levels and associated risks of blood clots and strokes. The FDA has added warnings to the patch’s label highlighting these risks[1][2].

Safety Concerns and Litigation

Ortho Evra has been linked to serious side effects, including blood clots, heart attacks, and strokes. Johnson & Johnson has paid out over $68 million to settle lawsuits related to these adverse effects. Despite these issues, the company has defended the safety of the patch[2].

Competitive Landscape

The U.S. contraceptive drugs market is highly fragmented, with key players like Johnson & Johnson Services, Inc., Pfizer Inc., and AbbVie Inc. dominating the market. These companies have a strong focus on introducing new products and maintaining a wide portfolio, contributing to their market dominance[1].

Generic Versions

The original Ortho Evra patch has been discontinued, and generic versions have been approved. For instance, Amneal Pharmaceuticals received FDA approval for a generic version of Ortho Evra in 2021, which is expected to increase competition in the market[5].

Financial Impact of Litigation and Regulatory Issues

The financial impact of litigation and regulatory issues on Ortho Evra has been significant. The settlements and the need for continuous regulatory compliance have affected the financial trajectory of the product. However, the overall market growth and demand for contraceptive methods have helped mitigate some of these impacts[2].

Impact of COVID-19

The COVID-19 pandemic disrupted the supply chain and family planning services, affecting the market negatively. However, with the easing of lockdown restrictions, the market experienced strong growth in 2021, returning to pre-pandemic levels in 2022[1].

Future Outlook

Despite the challenges, Ortho Evra remains a viable option in the contraceptive market. The trend towards modern contraceptive methods and the convenience of transdermal patches are expected to drive demand. However, the market will continue to be influenced by regulatory scrutiny and the availability of generic versions[1][4].

Key Takeaways

• Market Growth: The U.S. contraceptive drugs market is projected to grow at a CAGR of 6.8% from 2023 to 2030.
• Regulatory Environment: Favorable reimbursement policies and FDA approvals are crucial for market growth.
• Safety Concerns: Ortho Evra faces ongoing regulatory scrutiny due to safety concerns.
• Generic Competition: The approval of generic versions is expected to increase market competition.
• COVID-19 Impact: The market recovered from pandemic disruptions, returning to pre-pandemic levels in 2022.

FAQs

Q: What is the current market size of the U.S. contraceptive drugs market? A: The U.S. contraceptive drugs market was valued at USD 6.25 billion in 2022[1].

Q: What is the projected growth rate of the U.S. contraceptive drugs market? A: The market is projected to grow at a CAGR of 6.8% from 2023 to 2030[1].

Q: What are the main distribution channels for Ortho Evra? A: The main distribution channels include retail pharmacy, public channels & NGOs, hospital pharmacy, online channels, and clinics[1].

Q: Why has Ortho Evra faced regulatory scrutiny? A: Ortho Evra has faced regulatory scrutiny due to higher estrogen levels and associated risks of blood clots and strokes[2].

Q: Has Johnson & Johnson settled lawsuits related to Ortho Evra? A: Yes, Johnson & Johnson has paid out over $68 million to settle lawsuits related to adverse effects of Ortho Evra[2].

Sources

1. Fortune Business Insights, U.S. Contraceptive Drugs Market Size, Growth | Report [2030].
2. PharmaTimes, J&J pays out $68.7 million to settle birth-control suits.
3. PubMed, Pharmacokinetic overview of Ortho Evra/Evra.
4. Grem Journal, Statement on transdermal contraception as an underused option for unmet needs in contraception.
5. Amneal Pharmaceuticals, Amneal Receives Approval for Generic Version of Ortho Evra.