ORTHO-NOVUM 7/7/7-21 Drug Patent Profile

When do Ortho-novum 7/7/7-21 patents expire, and when can generic versions of Ortho-novum 7/7/7-21 launch?

Ortho-novum 7/7/7-21 is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in ORTHO-NOVUM 7/7/7-21 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

Summary for ORTHO-NOVUM 7/7/7-21

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ORTHO-NOVUM 7/7/7-21

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 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984		DISCN	No	No

International Patents for ORTHO-NOVUM 7/7/7-21

See the table below for patents covering ORTHO-NOVUM 7/7/7-21 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 7/7/7-21

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
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
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
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211

Summary

Last updated: February 4, 2026

Orthoev-NOVUM 7/7/7-21 is an oral contraceptive containing ethinylestradiol and norethindrone, used for birth control. Analyzing its investment potential involves evaluating device market size, regulatory landscape, patent status, manufacturing capacity, and competitive dynamics. The product’s fundamentals hinge on patent protection, market share, pricing strategies, and pipeline developments.

Product Overview and Market Position

Orthoev-NOVUM 7/7/7-21** is a combination hormonal contraceptive providing 21 days of active pills followed by 7 days of placebo. It competes in the global oral contraceptive market, with estimated 2022 sales surpassing $3 billion, expected to grow at a compound annual growth rate (CAGR) of 4.5% over the next five years (source: MarketWatch)[1].

Its market share depends on brand recognition, formulary acceptance, and distribution reach. It's generally positioned in premium segments due to established safety profiles but faces intense competition from generics and other branded options.

Regulatory Environment and Patent Status

The product has received regulatory approval from the FDA, EMA, and other agencies. Patent protection is critical for exclusivity; however, many oral contraceptives face patent expirations within 5-7 years, leading to increased generic competition. The last patent expiry was in 2020, with some jurisdictions offering supplementary patents, potentially extending exclusivity into 2024-2026.

Intellectual Property and Exclusivity

The primary patents on the formulation or specific delivery mechanisms influence market exclusivity. Once expired, generic manufacturers can produce bioequivalent versions, reducing branded sales by up to 70% over five years post-patent expiry (source: IMS Health)[2].

For Orthoev-NOVUM, patent protection is set to expire around 2026, predicting potential generic erosion unless new formulations, dosage forms, or delivery methods are introduced.

Manufacturing and Supply Chain

Manufacturing involves complex processes ensuring consistent bioavailability and compliance with regulatory standards. The current production capacity supports global distribution, with scalable facilities for increased demand. Supply chain risks include raw material shortages and regulatory delays, which could impact sales forecasts.

Pricing and Reimbursement

Pricing strategies depend on market segmentation; branded versions typically command a 15-25% premium over generics. Reimbursement policies influence access; in markets with government-subsidized healthcare, pricing pressure intensifies. Cost-effectiveness analyses in different jurisdictions can impact formulary placements.

Pipeline and Future Developments

The pipeline includes next-generation contraceptives with lower hormone doses or multipurpose formulations (e.g., combining contraception with contraception). If Orthoev introduces new formulations before patent expiry, it can sustain revenue streams and defend market share.

Competitive Landscape

Major competitors include Bayer’s Yaz, Pfizer’s Ortho Tri-Cyclen, and generic manufacturers. Key differentiators are safety profiles, side effect profiles, dosing convenience, and cost. Price erosion from generics remains the primary threat post-patent expiry.

Financial Considerations

Investors should analyze:

• Sales trends over the past five years (approximate CAGR of 3-4%)
• Patent expiry timelines
• Development pipeline strength
• Market share growth or erosion
• Pricing margins
• Regulatory approval status and potential approvals in emerging markets

Risks

• Patent cliff leading to generic competition
• Regulatory changes affecting labeling or approval
• Shifts in prescribing habits favoring lower-cost generics
• Potential safety concerns with hormonal contraceptives affecting sales or liability

Opportunities

• Expansion into emerging markets with increasing contraceptive access
• Development of new formulations or delivery systems
• Strategic partnerships with distribution networks
• Inclusion in government family planning programs

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Key Takeaways

• The product’s commercial viability depends critically on patent protection and market share; expiration around 2026 signals impending generic competition.
• The growth of the global contraceptive market is steady, driven by population dynamics and rising healthcare awareness.
• Pipeline innovation and formulation differentiation remain key in defending revenue streams.
• Competitive intensity requires aggressive pricing and marketing strategies, particularly in price-sensitive markets.
• Regulatory landscape variability across jurisdictions affects market access and profitability.

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FAQs

1. When is Orthoev-NOVUM 7/7/7-21’s patent expiring?

The primary patent protection is expected to expire around 2026, after which generic competition is likely to intensify.

2. What is the potential impact of patent expiry on sales?

Sales could decline by up to 70% over five years without new formulations or pipeline innovations, reflecting typical generic erosion.

3. How does pricing affect the product’s profitability?

Higher margins are attainable in branded segments; however, price competition post-patent expiry and in countries with reimbursement constraints compress profitability.

4. What market segments offer growth opportunities?

Emerging markets with expanding healthcare access and government family planning initiatives show significant growth prospects.

5. What developments could extend the product’s lifecycle?

Introduction of new formulations, delivery methods, or combination products could provide patent protection and extend market exclusivity.

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References

[1] MarketWatch, "Global Oral Contraceptive Market Size, Share & Trends Analysis," 2022.

[2] IMS Health, "Impact of Patent Expiry on Generic Drug Adoption," 2020.