ORTHO EVRA Drug Patent Profile

When do Ortho Evra patents expire, and what generic alternatives are available?

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

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

International Patents for ORTHO EVRA

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

Country	Patent Number	Title	Estimated Expiration
Austria	229828
Australia	6259796
Australia	703593

Supplementary Protection Certificates for ORTHO EVRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612

Investment Scenario and Fundamentals Analysis for ORTHO EVRA

Last updated: February 21, 2026

What is ORTHO EVRA?

ORTHO EVRA is a transdermal contraceptive patch approved by the U.S. Food and Drug Administration (FDA) in 2001. Marketed by Janssen Pharmaceuticals (a division of Johnson & Johnson), it delivers estrogen and progestin hormones through the skin to prevent pregnancy. The patch is replaced weekly over three weeks, with a patch-free week.

Market Overview

Global Market Size

• The global contraceptive market was valued at approximately $19 billion in 2022.
• The transdermal contraceptive segment accounts for roughly 15% of this market.
• Projected compound annual growth rate (CAGR): 5% from 2023 to 2028 [1].

Key Competitors

• Ortho Evra (Janssen/Johnson & Johnson)
• Xulane (generic version, Mylan/NantHealth)
• NuvaRing (Merck)
• Combined oral contraceptives (pill formulations)

Market Share

• ORTHO EVRA holds a significant portion of the transdermal market, estimated at 60-70% based on sales data.
• Competition from generic patches has increased since patent expiry in 2013.

Patent and Regulatory Landscape

Patent Status

• Original patents expired in 2013 in the U.S.
• Subsequent patents on formulations and delivery mechanisms may extend exclusivity periods until approximately 2025-2027.

Regulatory Environment

• Continual audits by FDA and similar agencies in other regions.
• No recent major regulatory hurdles reported; future approval of new formulations or delivery systems may impact the product lifecycle.

Sales and Revenue Analysis

Historical Sales Data (2020-2022)

Year	Sales (USD millions)	Market Share	Growth Rate
2020	350	65%	-5% (compared to 2019)
2021	340	60%	-2.8%
2022	330	55%	-2.9%

Revenue Drivers

• Steady decline in sales post-2013 patent expiry.
• Patent protections limited profitability; reliance on brand loyalty.
• Growing generic alternative market pressure.

R&D and Pipeline Outlook

• No publicly disclosed pipeline specifically for ORTHO EVRA.
• Johnson & Johnson focuses on new contraceptive technologies, including long-acting reversible contraceptives (LARCs), which may subdue future growth.

Pricing, Reimbursement, and Market Access

• Pricing in the U.S.: approximately USD 35-50 per cycle (four patches).
• Insurance coverage and reimbursement policies are stable; cost-effectiveness favors ORTHO EVRA over some oral contraceptives in certain markets.
• Price declines noted in markets with high generic penetration.

Strategic Risks and Opportunities

Risks

• Patent expiration and generic competition eroding market share.
• Potential safety concerns, such as increased risk of blood clots associated with hormonal patches.
• Regulatory changes impacting labeling or marketing.

Opportunities

• Expanding into emerging markets with increasing contraceptive demand.
• Innovation in patch formulations or delivery systems.
• Potential partnerships for new contraceptive products.

Investment Fundamentals

Metric	Data
Market Cap of Johnson & Johnson	USD 440 billion (as of 2023) [2]
Revenue from contraceptives	Significant but decline expected due to patent expiry
R&D expenditure	USD 14.7 billion (2022) [3]
Future patent protections	Expirations between 2025-2027

Financial Implications

• Revenue decline expected from ORTHO EVRA over next 2 years due to generic competition.
• The product is unlikely to generate significant new revenue streams without innovation.
• J&J’s diversified portfolio buffers negative impacts.

Key Takeaways

• ORTHO EVRA is a mature contraceptive patch with declining sales due to patent expiration and generic competition.
• The current patent landscape limits patent-based exclusivity until around 2025-2027.
• Market growth is driven largely by emerging markets and contraceptive demand expansion.
• Investment risks include steep sales decline and regulatory shifts; opportunities lie in product innovation and geographic expansion.
• J&J’s broader healthcare portfolio reduces reliance on this product for long-term growth.

FAQs

1. Will ORTHO EVRA recoup lost sales post-patent expiry?
   Likely not without product innovation or new formulations. Declining sales due to generics are expected to continue through 2025-2027.

2. Are there new formulations in development for hormonal contraceptives?
   No publicly disclosed new formulations specifically for ORTHO EVRA. Focus remains on developing alternative contraceptive technologies.

3. What is the competitive advantage of ORTHO EVRA?
   It offers convenience through weekly application, a key differentiator in the transdermal contraceptive segment. However, generics threaten its market share.

4. How does the patent expiry impact future revenues?
   Patents expiring in the mid-2020s will allow generics to enter, reducing brand-name sales. Patent protections on formulation innovations could delay this.

5. Should investors consider the contraceptive market for J&J?
   The market remains attractive, but product-specific risks for ORTHO EVRA suggest diversifying investments into other segments or products with stronger growth prospects.

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References

[1] Markets and Markets. (2023). Contraceptive market analysis. https://www.marketsandmarkets.com

[2] Johnson & Johnson. (2023). Annual Report 2022. https://investor.jnj.com

[3] Johnson & Johnson. (2022). Research & Development Report. https://jnj.com