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

When do Ortho-novum 7/7/7-28 patents expire, and what generic alternatives are available?

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
Raw Ingredient (Bulk) Api Vendors:	7
Patent Applications:	131
DailyMed Link:	ORTHO-NOVUM 7/7/7-28 at DailyMed

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

Expired US Patents for ORTHO-NOVUM 7/7/7-28

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984
Janssen Pharms	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984
Janssen Pharms	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984
Janssen Pharms	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984

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	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 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
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
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

Market Dynamics and Financial Trajectory for ORTHO-NOVUM 7/7/7-28

Introduction

ORTHO-NOVUM 7/7/7-28 is a combined oral contraceptive (COC) containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol. This product is widely used for the prevention of pregnancy and has been a staple in the contraceptive market for decades.

Market Overview

The contraceptive market is a significant segment within the pharmaceutical industry, driven by the ongoing need for effective and reliable birth control methods. ORTHO-NOVUM 7/7/7-28, with its established brand and efficacy, holds a substantial market share.

Competitive Landscape

The contraceptive market is highly competitive, with numerous brands and generic alternatives available. However, ORTHO-NOVUM 7/7/7-28 benefits from its long-standing reputation and the trust of healthcare providers and patients. The market competition is further intensified by the presence of other contraceptive methods such as intrauterine devices (IUDs), implants, and emergency contraceptives[1][4].

Financial Performance

The financial performance of ORTHO-NOVUM 7/7/7-28 is closely tied to the overall performance of its manufacturer and the broader pharmaceutical industry.

Revenue Streams

The revenue generated by ORTHO-NOVUM 7/7/7-28 comes primarily from prescription sales. The product's sales are influenced by factors such as market demand, pricing strategies, and competition from other contraceptive methods.

Growth Trends

Historically, the sales of ORTHO-NOVUM 7/7/7-28 have been stable, with occasional fluctuations based on market conditions and regulatory changes. For instance, the formulation business, which includes oral contraceptives, has seen growth driven by new product launches and increased volume in various markets[2].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics and financial trajectory of ORTHO-NOVUM 7/7/7-28.

Approvals and Indications

ORTHO-NOVUM 7/7/7-28 is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. It has not been studied or indicated for use in emergency contraception[1][4].

Contraindications and Warnings

The product comes with several contraindications and warnings, including cardiovascular risks associated with smoking, thromboembolic disorders, and certain medical conditions. These factors can impact its marketability and usage rates[1].

Technological and Market Trends

The pharmaceutical industry is undergoing significant changes driven by technological advancements and shifting market trends.

Impact of AI and Gene Editing

While AI and gene editing are primarily transforming the drug development process for new therapies, they also influence the broader pharmaceutical landscape. These technologies can lead to more personalized and effective treatments, potentially impacting the demand for traditional contraceptives like ORTHO-NOVUM 7/7/7-28[3].

Digital Health and Connected Care

The integration of digital tools in healthcare is making patient care more connected and personalized. This trend could influence how contraceptives are prescribed and used, potentially affecting the market dynamics of ORTHO-NOVUM 7/7/7-28[3].

Patient and Healthcare Provider Perspectives

The perspectives of patients and healthcare providers are critical in determining the market success of ORTHO-NOVUM 7/7/7-28.

Patient Preferences

Patients increasingly seek convenient, effective, and safe contraceptive methods. ORTHO-NOVUM 7/7/7-28, with its established efficacy and ease of use, remains a preferred choice for many. However, patient preferences can shift towards newer, more innovative methods as they become available[1].

Healthcare Provider Recommendations

Healthcare providers play a significant role in recommending contraceptive methods. Their trust in ORTHO-NOVUM 7/7/7-28, based on its long history and clinical data, is a key factor in its market performance[1].

Challenges and Opportunities

The market for ORTHO-NOVUM 7/7/7-28 faces several challenges and opportunities.

Challenges

• Competition: The presence of numerous contraceptive options and the continuous introduction of new methods pose a significant challenge.
• Regulatory Changes: Stricter regulations and changing healthcare policies can impact the product's marketability.
• Patient Safety Concerns: The product's contraindications and warnings, particularly related to cardiovascular risks, need to be carefully managed[1].

Opportunities

• Expanding Markets: Growing demand in emerging markets and the increasing awareness of contraceptive options present opportunities for growth.
• Innovative Packaging and Delivery: Enhancements in packaging and delivery systems can make the product more appealing and convenient for users.
• Educational Campaigns: Educational initiatives to raise awareness about the benefits and proper use of ORTHO-NOVUM 7/7/7-28 can help maintain market share[2][3].

Key Takeaways

• Established Market Presence: ORTHO-NOVUM 7/7/7-28 has a long-standing reputation and significant market share in the contraceptive market.
• Regulatory Compliance: The product must adhere to strict regulatory guidelines and contraindications.
• Technological Impact: Advances in AI, gene editing, and digital health are shaping the broader pharmaceutical landscape and could influence the demand for traditional contraceptives.
• Patient and Provider Trust: The trust of patients and healthcare providers is crucial for the product's continued success.

Frequently Asked Questions (FAQs)

Q: What are the active ingredients in ORTHO-NOVUM 7/7/7-28? A: The active ingredients are norethindrone and ethinyl estradiol[1][4].

Q: What are the contraindications for using ORTHO-NOVUM 7/7/7-28? A: Contraindications include thrombophlebitis or thromboembolic disorders, certain cardiovascular conditions, and known or suspected carcinoma of the breast, among others[1].

Q: How does the use of ORTHO-NOVUM 7/7/7-28 affect cardiovascular health? A: Cigarette smoking increases the risk of serious cardiovascular events associated with the use of combination oral contraceptives like ORTHO-NOVUM 7/7/7-28, particularly in women over 35 years of age[1].

Q: Can ORTHO-NOVUM 7/7/7-28 be used for emergency contraception? A: No, ORTHO-NOVUM 7/7/7-28 has not been studied or indicated for use in emergency contraception[1][4].

Q: How is the market for ORTHO-NOVUM 7/7/7-28 likely to be affected by technological advancements in the pharmaceutical industry? A: Technological advancements such as AI and gene editing could lead to more personalized and effective treatments, potentially influencing the demand for traditional contraceptives like ORTHO-NOVUM 7/7/7-28[3].

Cited Sources:

1. FDA Label for ORTHO-NOVUM Tablets - accessdata.fda.gov
2. Earnings Release for Q3 FY16-17 - stockdiscovery.s3.amazonaws.com
3. The Future of Pharma: 2025's Key Trends To Know - laboratoriosrubio.com
4. Ortho-Novum and Modicon Label - accessdata.fda.gov