ORTHO-NOVUM 7/7/7-28 Drug Patent Profile

Which patents cover Ortho-novum 7/7/7-28, and when can generic versions of Ortho-novum 7/7/7-28 launch?

Ortho-novum 7/7/7-28 is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in ORTHO-NOVUM 7/7/7-28 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

Summary for ORTHO-NOVUM 7/7/7-28

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ORTHO-NOVUM 7/7/7-28

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-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984		DISCN	Yes	No

International Patents for ORTHO-NOVUM 7/7/7-28

See the table below for patents covering ORTHO-NOVUM 7/7/7-28 around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1226221	ANTI-PROGRESTATIF TRIPHASE POUR ADMINISTRATION PAR VOIE ORALE (TRIPHASIC ORAL CONTRACEPTIVE)

Supplementary Protection Certificates for ORTHO-NOVUM 7/7/7-28

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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
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
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129

ORTHO-NOVUM 7/7/7-28 Market Analysis and Financial Projection

Last updated: February 4, 2026

What Is ORTHO-NOVUM 7/7/7-28?

ORTHO-NOVUM 7/7/7-28 is a combined oral contraceptive (COC) marketed by Janssen Pharmaceuticals. It contains 7 days of active estrogen and progestin pills, followed by 7 placebo days, then 7 days of active pills, and a final 7-day placebo phase. It is used for pregnancy prevention, menstrual regulation, and management of acne.

What Is the Market Size and Demand for Combined Oral Contraceptives?

Global contraceptive market topped approximately $18 billion in 2022, with an expected compound annual growth rate (CAGR) of 4% through 2027[1]. Oral contraceptives aproximadamente represent 50% of contraceptive sales, with the remainder split among intrauterine devices (IUDs), patches, rings, and injectables.

Key market drivers include:

• Growing awareness and acceptance of oral contraceptives.
• Increasing demand in emerging markets.
• Ongoing innovation in formulations and delivery methods.

What Are the Competitive Advantages and Challenges?

Advantages:

• Established efficacy and safety profile.
• Long-standing market presence with leading brands like Ortho-Novum and Lo/Ovral.
• Once-daily dosing enhances patient adherence.

Challenges:

• Market saturation due to multiple existing formulations.
• Risks associated with hormonal side effects (e.g., blood clots, mood changes).
• Regulatory scrutiny, especially concerning safety profiles.

What Are the Patent and Regulatory Landscapes?

Current patents for formulations similar to ORTHO-NOVUM 7/7/7-28 have started expiring, reducing market exclusivity. However, Janssen has pursued new formulations and delivery systems to extend patent protection.

Regulatory approval processes in key markets (U.S., Europe, Asia) remain robust but vary:

• The U.S. FDA approved ORTHO-NOVUM in the 1960s.
• Europe regulatory pathways focus on safety and efficacy, requiring ongoing post-market surveillance.
• Emerging markets may have less stringent regulations, creating opportunities for market entry and growth.

How Is the R&D Pipeline Structured?

Janssen and competitors explore:

• Fixed-dose combinations with lower hormone doses to reduce side effects.
• Extended-cycle and continuous-use formulations.
• Non-oral delivery systems, such as patches or intrauterine devices.

Innovations are primarily aimed at enhancing user compliance and minimizing adverse effects.

What Is the Investment Perspective?

Market Position:
As a mature product with decreased patent protection, ORTHO-NOVUM 7/7/7-28 faces generic competition. Market share may decline unless the company invests in reformulation or new delivery platforms.

R&D Focus:
Best positioned for investment in pipeline products targeting improved safety, reduced side effects, or alternative delivery methods.

Price and Profitability:
The generic landscape drives prices down; profit margins depend on manufacturing efficiencies and market share.

Regulatory Risks:
Changing safety standards could impact the product's lifecycle, especially if new safety concerns emerge.

Market Opportunities:

• Growing demand in developing countries.
• Increasing acceptance of oral contraceptives among teens and young adults.
• Potential expansion through OTC (over-the-counter) status in some markets.

Key Takeaways

• ORTHO-NOVUM 7/7/7-28 faces intense generic competition.
• Market growth is driven by rising contraceptive demand, especially in emerging markets.
• Innovation focus is shifting toward formulations with fewer hormones, alternative delivery systems, and improved safety profiles.
• Patent expiry limits long-term exclusivity, emphasizing the need for pipeline development.
• Investment viability depends on the company's ability to innovate and adapt to regulatory and market changes.

FAQs

1. What are the main competitors to ORTHO-NOVUM 7/7/7-28?
Brands like Yasmin, Loestrin, and Seasonique are key rivals, many of which are available as generics.

2. How does patent expiration affect the market?
Patent expiry leads to increased generic competition, pushing prices down and reducing margins for branded formulations.

3. Are there regulatory opportunities for reformulation?
Yes, reformulations with lower hormone doses or novel delivery systems can receive patent protection and regulatory approval.

4. What is the outlook for OTC availability?
Some markets are considering OTC status for oral contraceptives, which could expand access but pose regulatory and safety challenges.

5. How does the product fit into Janssen's broader portfolio?
ORTHO-NOVUM is a legacy product; strategic focus shifts toward innovative, patent-protected contraceptives and reproductive health solutions.

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References

[1] MarketWatch, "Contraceptive Market Outlook," 2022.