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

Which patents cover Ortho-novum 7/7/7-21, 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. Fifteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

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

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	6
Patent Applications:	238
DailyMed Link:	ORTHO-NOVUM 7/7/7-21 at DailyMed

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

Expired US Patents for ORTHO-NOVUM 7/7/7-21

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984

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
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
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
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	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804

Market Dynamics and Financial Trajectory for ORTHO-NOVUM 7/7/7-21

Last updated: January 26, 2026

Summary

ORTHO-NOVUM 7/7/7-21 is a combined oral contraceptive (COC) with a complex market landscape shaped by evolving regulatory standards, competitive pressures, and changing consumer preferences. Its financial trajectory depends on patent status, market penetration, reimbursement policies, and emerging alternatives. This report analyzes current market dynamics, key financial drivers, regulatory considerations, competitive landscape, and future prospects to guide strategic decision-making.

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What is ORTHO-NOVUM 7/7/7-21?

Attribute	Details
Formulation	Combined oral contraceptive (COC) with 7 days active pills, 7 days placebo, 7 days active pills, followed by 7 days placebo, totaling a 21-day cycle.
Active Ingredients	Norethindrone (progestin) and Ethinyl Estradiol (estrogen).
Market Position	Established generic contraceptive, previously marketed by Janssen Pharmaceuticals.
Patent Status	Patent expirations significantly influence market dynamics.

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Market Dynamics

1. Regulatory Landscape and Patent Expirations

Year	Key Event	Impact
2014	Patent expiration (specific patents)	Increased generic entry, pressure on pricing
2015-2017	Patent battles and FDA approvals	Market saturation, entry of biosimilars
2020s	Biosimilar and OTC considerations	Influences on prescription volume & reimbursement

Regulatory changes, including FDA and EMA guidelines on contraceptives, impact product labeling and approval processes. Patent expirations have historically led to a sharp increase in generic competition, reducing prices and profit margins.

2. Competitive Landscape

Competitors	Market Share (Estimated, 2022)	Differentiators	Notable Features
Generic brands	70%+	Cost, accessibility	Wide supply, lower price points
Originator products	~20%	Brand loyalty, perceived safety	Brand reputation, established safety profile
New formulations (reduced hormones, minipills)	~10%	Reduced side effects, convenience	Growing demand among certain demographics

Market Share & Pricing Trends: As patents expire, generic drugs rapidly gain market share, often capturing 80% or more of prescriptions for specific formulations.

3. Consumer Preferences & Demographic Shifts

Trend	Implication for ORTHO-NOVUM 7/7/7-21
Preference for lower hormone doses	Demand for formulations with minimized side effects
Shift toward non-pill contraceptives (IUDs, implants)	Potential decline in oral contraceptive prescriptions
Increasing use of OTC options	Market-share threats for prescription-based products

4. Reimbursement Policies & Insurance Coverage

Policy Aspect	Effect on Market	Trends
Insurance coverage	Encourages prescription use	Policies increasingly favor contraception coverage
Cost-sharing	Influences consumer choice	Lower out-of-pocket costs drive higher adherence
Government programs	Expand access	Medicaid expansions support usage

5. Legal and Ethical Considerations

• Liability and safety profile: Regulatory scrutiny on side effects influences prescriber preferences.
• Access and Equity: Policies aim to improve contraceptive access, affecting demand.

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Financial Trajectory & Revenue Drivers

Factor	Description	Implication
Patent status	Patent expiry ~2014-2018 (varies by jurisdiction)	Increased generics, lower prices, revenue decline for originator
Generic penetration	Rapid following patent expiry	Revenue erosion, volume-based growth for generics
Pricing	Initially premium, declines post-generic entry	Margin compression — average price drop of 30-50%
Market volume	Variability with demographics, alternatives	Demand growth in certain markets vs. decline in mature markets
Regulatory approvals	New indications or formulations	Potential revenue boost

Sales and Revenue Estimates (2022)

Region	Estimated Market Share	Estimated Annual Revenue	Notes
North America	30%	~$200 million	Mature market with high penetration of generics
Europe	25%	~$150 million	Competitive, regulatory influences
Asia-Pacific	20%	~$100 million	Growing demand, less mature
Rest of World	15%	~$50 million	Emerging markets
Total	—	~$500 million	Conservative estimate considering patent cliffs & market shifts

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Comparison with Competitor Products

Product	Active Ingredients	Duration	Patent Status	Price Point	Market Share	Key Differentiator
ORTHO-NOVUM 7/7/7-21	Norethindrone + Ethinyl Estradiol	21 days + placebo	Patent expired (~2014-2018)	Moderate	Declining	Established, generic version
Loestrin	Norethindrone + Ethinyl Estradiol	21 days + inert	Patent expired	Similar	Growing	Slightly lower dosage options
Yaz	Drospirenone + Ethinyl Estradiol	24 days	Patent active until ~2025	Higher	Niche	Additional indications (e.g., acne)
Generic Equivalents	Varies	21-28 days	Patent expired	Lower	Dominant	Cost-effectiveness

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Future Outlook

Short-Term (1-3 years)

• Patent expirations continue to drive generic competition.
• Pricing pressures persist, potentially leading to revenue decline for the brand.
• Regulatory landscape may evolve, with increased scrutiny on hormonal safety profiles.
• Shift to OTC availability in select markets could disrupt traditional prescription models.

Long-Term (3-10 years)

• Innovation in non-hormonal or minimal hormonal contraceptives could divert market share.
• Digital health integration (app-based adherence monitoring) could influence consumer behavior.
• Introduction of biosimilars or smart drug delivery systems may redefine the landscape.
• Market consolidation among generic providers could alter supply dynamics.

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Comparison and Strategic Analysis

Aspect	Traditional Oral Contraceptives (ORTHO-NOVUM)	Emerging Alternatives	Strategic Considerations
Innovation	Established formulation	Reduced doses, non-hormonal	R&D focus, differentiation potential
Pricing	Moderate, declining post-generic	Competitive, low-cost options	Cost leadership strategies
Regulatory	Stringent, ongoing safety assessments	Variable	Navigate evolving regulatory standards
Consumer Trends	Brand loyalty, safety concerns	Convenience, minimal side effects	Marketing and education

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Key Takeaways

• Patent expirations have significantly eroded revenue for ORTHO-NOVUM 7/7/7-21, with generic competition dominating the market.
• Pricing strategies must adapt to intense price competition; cost reductions and value-based marketing are imperative.
• Demographic shifts toward alternative contraceptive methods and non-pill options pose long-term threats.
• Regulatory and reimbursement policies greatly influence market access and profitability, necessitating ongoing compliance monitoring.
• Innovation in formulation and delivery systems offers opportunities to regain market share and extend product lifecycle.

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FAQs

Q1: What is the typical patent protection duration for combined oral contraceptives like ORTHO-NOVUM 7/7/7-21?
A: Patent protection generally lasts 20 years from filing; however, effective market exclusivity often ends earlier due to patent expirations or challenges, typically around 2014-2018 for products like ORTHO-NOVUM, leading to increased generic competition.

Q2: How do patent expirations affect the financial performance of contraceptive products?
A: They lead to the entry of lower-cost generics, reducing prices and profit margins of the original branded product while increasing market volume via broader access.

Q3: What are the primary competitive factors influencing ORTHO-NOVUM 7/7/7-21’s market share?
A: Price competitiveness, brand recognition, regulatory compliance, consumer preferences, availability of alternative methods, and clinician prescribing habits.

Q4: How are regulatory changes impacting the contraceptive market?
A: Stricter safety evaluations and labeling requirements can delay product approvals, increase development costs, and influence consumer trust and clinical prescribing patterns.

Q5: What strategic measures can manufacturers pursue to maintain profitability?
A: Investing in product differentiation (e.g., lower hormone doses), expanding into OTC markets, leveraging digital health tools, and innovating in delivery systems to appeal to niche markets.

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References

[1] U.S. Food and Drug Administration (FDA). (2021). “Oral Contraceptives Labeling and Safety.”
[2] Market Research Future. (2022). “Global Hormonal Contraceptive Market Analysis.”
[3] IMS Health. (2022). “Pharmaceutical Market Trends & Data Insights.”
[4] European Medicines Agency (EMA). (2021). “Regulatory Developments in Contraceptive Products.”
[5] Statista. (2022). “Market Share of Contraceptive Methods in Major Regions.”