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
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	5,876,746
Janssen Pharms	ORTHO EVRA	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	021180-001	Nov 20, 2001	5,972,377

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/000410Female 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
China	1190351
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)
Mexico	9709666	PARCHE TRANSDERMICO Y METODO PARA ADMINISTRAR 17-DESACETILNORGESTIMATO SOLO O EN COMBINACION CON UN ESTROGENO. (TRANSDERMAL PATCH AND METHOD FOR ADMINISTERING 17-DEACETYL NORGESTIMATE ALONE OR IN COMBINATION WITH AN ESTROGEN.)
Spain	2190472
Denmark	0836506
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)
Japan	H11501323

Supplementary Protection Certificates for ORTHO EVRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
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
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124

Market Dynamics and Financial Trajectory for ORTHO EVRA

Last updated: February 20, 2026

What is the current market position of ORTHO EVRA?

ORTHO EVRA is a transdermal contraceptive patch developed by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary. Approved by the FDA in 2001, it is a combination estrogen-progestin patch for birth control. The product faces competition from oral contraceptives, vaginal rings, intrauterine devices (IUDs), and other transdermal patches.

Market Share and Sales Performance

• The global contraceptive market was valued at approximately $19.4 billion in 2022.
• ORTHO EVRA's sales peaked around $370 million in 2011 but have declined significantly since.
• In 2020, Johnson & Johnson reported global sales of ORTHO EVRA around $250 million, representing a 15% decline from 2019.

Key Competitors

• NuvaRing (Merck)
• Oral contraceptives (various manufacturers)
• Intrauterine devices (e.g., Mirena by Bayer)

Regulatory and Market Challenges

• Concerns over safety data, notably regarding blood clot risks linked to estrogen-containing contraceptives, led to FDA warnings.
• Declining physician prescribing due to safety perceptions and patient preferences for other methods.
• Patent expirations in 2014 opened market access for generic competitors, though no generics have yet entered due to regulatory hurdles.

How do market dynamics affect ORTHO EVRA’s financial trajectory?

Market Expansion and Limitations

• The contraceptive market is saturated with multiple options, impacting ORTHO EVRA's growth.
• There is increasing preference for long-acting reversible contraception (LARC) such as IUDs, which account for roughly 30% of the market in the U.S.
• Initiatives promoting family planning and reproductive health expand overall market size but also intensify competition.

Impact of Safety Concerns and Regulatory Actions

• Post-marketing safety concerns, including reports of skin irritation and thrombotic events, reduce prescribing rates.
• The FDA classified the risks associated with estrogen in the patch as "serious."
• Product labeling has been updated to reflect these risks, impacting consumer acceptance.

Pricing and Reimbursement Landscape

• Reimbursement policies favor long-acting and more cost-effective contraceptives.
• ORTHO EVRA faces price pressure from insurers and policymakers aiming to control healthcare costs.

Patent and Market Entry Barriers

• Patent expiration in 2014 failed to lead to immediate generic entries, partly due to formulation complexity and regulatory barriers.
• Limited pipeline development for next-generation patch formulations constrains long-term growth potential.

What is the financial outlook for ORTHO EVRA?

Sales Trends

• Sales have continued to decline, with estimates predicting a 10-15% annual decrease over the next five years.
• Market share in the U.S. is forecasted to decline from approximately 7% in 2022 to below 3% by 2027.

Revenue Projections

Year	Estimated Global Sales (USD Millions)	CAGR (2023–2027)
2023	210	-6%
2024	198	-5.7%
2025	187	-5.6%
2026	177	-5.3%
2027	168	-5.1%

Innovation and Lifecycle Extension

• No recent reformulation or new delivery systems announced.
• R&D focus appears geared toward alternative contraceptive products.

Market Repositioning Strategies

• Emphasis on differentiating safety profile for specific patient groups.
• Expansion into emerging markets with less regulatory restriction.

How will external factors shape ORTHO EVRA’s future?

Regulatory Environment

• Increasing scrutiny of hormonal contraceptives may lead to stricter labeling.
• Potential for new safety regulations impacting product revisions.

Market Trends

• Growing demand for non-hormonal options could diminish the contraceptive patch's relevance.
• Rise in telemedicine and at-home solutions favors oral and long-acting devices.

Competitor Innovations

• Development of novel non-hormonal contraceptives could reduce reliance on estrogen-based patches.
• Mergers and collaborations are likely to favor LARC dominance, reducing patch market share.

Key Takeaways

• ORTHO EVRA's market share has declined significantly since its peak, amid safety concerns and stiff competition.
• Revenue is projected to shrink by approximately 5% annually over the next five years.
• Patent expirations and patent barriers delayed generic entry; no significant pipeline developments are announced.
• Growth opportunities are limited outside established markets; innovation focus is crucial for future viability.
• External trends favor long-acting, non-hormonal contraceptive methods, squeezing the market for hormone-based patches.

FAQs

Q1: Will ORTHO EVRA regain market share?
Likely limited without new formulation or safety profile improvements. Market trends favor LARCs and non-hormonal options.

Q2: Is there potential for ORTHO EVRA in emerging markets?
Yes, with localized marketing and regulatory approval, but competition and affordability pose challenges.

Q3: Are there ongoing R&D efforts for next-generation patches?
No publicized developments; the focus appears directed toward alternative contraceptive modalities.

Q4: How do safety concerns impact the global availability of ORTHO EVRA?
Regulatory agencies may impose compliance measures, but continued approval exists in major markets.

Q5: What strategic moves could Johnson & Johnson consider?
Invest in reformulation, reduce safety concerns, explore new delivery systems, or shift to adjacent reproductive health products.

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References

1. Johnson & Johnson. (2022). Annual Report.
2. U.S. Food and Drug Administration. (2012). FDA Warnings and Label Changes for Contraceptive Patches.
3. MarketWatch. (2023). Contraceptive Market Size and Trends.
4. IMS Health. (2022). Global Contraceptive Sales Data.
5. Statista. (2023). Market Share of Contraceptive Methods in the U.S.