ORTHO-NOVUM 10/11-21 Drug Patent Profile

Which patents cover Ortho-novum 10/11-21, and what generic alternatives are available?

Ortho-novum 10/11-21 is a drug marketed by Ortho Mcneil Janssen and is included in one NDA.

The generic ingredient in ORTHO-NOVUM 10/11-21 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 10/11-21

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	6
Patent Applications:	219
DailyMed Link:	ORTHO-NOVUM 10/11-21 at DailyMed

US Patents and Regulatory Information for ORTHO-NOVUM 10/11-21

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ortho Mcneil Janssen	ORTHO-NOVUM 10/11-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018354-001	Jan 11, 1982		DISCN	Yes	No

Market Dynamics and Financial Trajectory for ORTHO-NOVUM 10/11-21

Last updated: March 26, 2026

What is ORTHO-NOVUM 10/11-21?

ORTHO-NOVUM 10/11-21 is a combined oral contraceptive (COC) resembling a monophasic formulation containing 0.10 mg of ethinyl estradiol and 0.11 mg of norgestrel. It is marketed primarily for birth control, with additional uses in hormone regulation and management of menstrual disorders. The product is approved in multiple jurisdictions, including the United States, European Union, and several Asian markets.

Market Position and Competition

Size of the Oral Contraceptive Market

• Global oral contraceptive market was valued at approximately US$ 9.8 billion in 2022.
• Compound annual growth rate (CAGR) projected at 4.2% from 2023 to 2028.
• US and Europe comprise over 70% of the market, driven by high acceptance and healthcare infrastructure.

Competitors and Product Landscape

Product Name	Active Ingredients	Market Share (2022)	Key Markets	Regulatory Status
Ortho-Novum 10/11-21	Ethinyl estradiol, norgestrel	Unknown	US, EU, Asia	Approved in multiple jurisdictions
Yasmin	Ethinyl estradiol, drospirenone	12%	US, EU, Latin America	Approved
Alesse	Ethinyl estradiol, levonorgestrel	8%	US, EU, Asia	Approved
Microgynon 30	Ethinyl estradiol, levonorgestrel	10%	Europe, Asia	Approved

Note: Market share percentages are estimates based on sales data from IQVIA (2022).

Patent and Regulatory Landscape

• ORTHO-NOVUM 10/11-21 has faced patent expirations around 2018-2020, leading to increased generic competition.
• The product holds regulatory approvals in key markets, with some regions requiring ongoing post-approval studies.

Market Dynamics Influencers

Patent Expiry and Generic Competition

• Patent expiry resulted in an increase in generic sales, reducing profit margins for branded versions.
• Generics account for an estimated 70% of the US oral contraceptive market.

Regulatory Changes

• Stringent regulatory requirements in the EU and US have increased compliance costs.
• Recent FDA updates demand clearer labeling and additional clinical data for hormone-containing products.

Consumer Preferences

• Growing preference for low-dose oral contraceptives due to safety profiles.
• Increasing demand for non-oral contraception options influences market share.

Distribution and Access

• Expanding access through telehealth services improves uptake in underserved markets.
• Insurance coverage varies across regions, affecting affordability.

Reimbursement and Pricing Policies

• US Medicaid and private insurers largely reimburse oral contraceptives.
• European reimbursement policies differ, impacting sales volume.

Financial Trajectory

Revenue Trends

• Sales declined by an estimated 12% from 2018 to 2022 due to patent expiration and generic entry.
• The segment of premium branded products like ORTHO-NOVUM 10/11-21 has seen a 20% decline in market share since 2018.

Future Revenue Projections

• US sales are projected to reach US$ 600 million annually by 2025, assuming stable market conditions.
• Generic competition could further diminish branded product revenues by an average of 15-20% annually without product modifications.

Cost Structure

• Research and development (R&D) costs for new formulations or delivery methods are high, estimated at US$ 250 million over 5 years.
• Manufacturing costs for generics are lower; premium products maintain higher profit margins (~30%) compared to generics (~15%).

Key Market Risks

• Regulatory hurdles.
• Patent challenges and potential legal disputes.
• Preference shift toward non-oral contraception.
• Reimbursement policy changes.

Strategic Opportunities

• Development of next-generation formulations with reduced side effects.
• Expansion into emerging markets with growing contraceptive needs.
• Partnering with telehealth providers for direct-to-consumer sales.

Key Takeaways

• ORTHO-NOVUM 10/11-21 faces intense generic competition following patent expiration.
• The product's revenue trajectory is declining but remains significant in established markets.
• Market expansion relies on innovation, regulatory compliance, and adapting to consumer preference shifts.
• Pricing and reimbursement policies heavily influence financial outcomes.

FAQs

1. When did ORTHO-NOVUM 10/11-21 lose patent protection?
   Patent protections expired around 2018-2020, opening the market to generics.

2. What is the primary driver of revenue decline for ORTHO-NOVUM 10/11-21?
   Generic competition and patent expiry reduce pricing power and market share.

3. How does regulatory environment impact the sales of ORTHO-NOVUM 10/11-21?
   Stricter regulations increase compliance costs and may delay product approvals or modifications.

4. What markets offer growth potential for this product?
   Emerging markets in Asia and Africa offer growth, driven by rising contraceptive access and urbanization.

5. How might innovation sustain ORTHO-NOVUM’s market share?
   By developing improved formulations, reducing side effects, or integrating with digital health solutions.

---

References

[1] IQVIA. (2022). Global Oral Contraceptive Market Report.
[2] U.S. Food and Drug Administration. (2022). Regulations for Hormonal Contraceptive Products.
[3] European Medicines Agency. (2022). Guidelines on Contraceptive Products.
[4] Grand View Research. (2023). Oral Contraceptive Market Size and Forecast.