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:	7
Patent Applications:	131
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	4,616,006
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984	4,628,051
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984	4,530,839
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984	4,544,554

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
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
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211

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

Introduction

ORTHO-NOVUM 7/7/7 is a combined oral contraceptive (COC) that has been on the market since its approval by the FDA in 1984. This article will delve into the market dynamics and financial trajectory of this drug, including its user reviews, medical indications, contraindications, generic availability, and legal implications.

User Reviews and Satisfaction

ORTHO-NOVUM 7/7/7 has received mixed reviews from users. On Drugs.com, it has an average rating of 6.8 out of 10 from 17 reviews, with 65% of reviewers reporting a positive experience and 29% reporting a negative one[1].

Positive Experiences

Many users have reported favorable outcomes, such as lighter and more regular periods, minimal to no cramping, and stable birth control with no spotting. For example, one user noted that the pill was "wonderful" and recommended it to others, highlighting its effectiveness in preventing pregnancy and managing menstrual symptoms[1].

Negative Experiences

However, some users have experienced adverse effects, including mood swings, depression, irritability, and hair loss. One user stopped taking the pill due to significant hair loss, while another experienced severe mood swings and bloating[1].

Medical Indications and Mechanism of Action

ORTHO-NOVUM 7/7/7 is indicated for the prevention of pregnancy in women who choose this method of contraception. It contains norethindrone and ethinyl estradiol, which work by suppressing gonadotropins, inhibiting ovulation, and altering cervical mucus and the endometrium to prevent sperm entry and implantation[2].

Contraindications and Warnings

The use of ORTHO-NOVUM 7/7/7 is contraindicated in women with certain medical conditions, such as thrombophlebitis, thromboembolic disorders, cerebral vascular or coronary artery disease, and known or suspected carcinoma of the breast or endometrium. Additionally, it is advised against for women over 35 years old who smoke due to increased cardiovascular risks[2].

Generic Availability

ORTHO-NOVUM 7/7/7 is no longer available in its original brand form, as all its formulations have been discontinued. However, generic versions of ethinyl estradiol and norethindrone combinations are available. It is crucial to purchase medications from reputable sources to avoid counterfeit products[3].

Market Competition

ORTHO-NOVUM 7/7/7 competes with other contraceptive methods, including other oral contraceptives, intrauterine devices (IUDs), and subdermal implants. For instance, Mirena (levonorgestrel) and Nexplanon (etonogestrel) are popular alternatives, each with their own set of user reviews and ratings[4].

Financial Trajectory

The financial performance of ORTHO-NOVUM 7/7/7 has been influenced by several factors, including its market share, competition, and the availability of generic alternatives.

Historical Sales

During its peak, ORTHO-NOVUM 7/7/7 was a significant player in the oral contraceptive market. However, with the discontinuation of its brand formulations and the rise of generic alternatives, its sales have declined.

Generic Impact

The availability of generic versions has reduced the market share and revenue of the brand name product. Generic drugs are generally cheaper, making them more attractive to consumers and insurers, which has further eroded the financial standing of the original brand[3].

Legal and Regulatory Implications

ORTHO-NOVUM 7/7/7 has been involved in legal cases related to its safety and efficacy. For example, a notable case involved a user who attributed her acute kidney failure to the use of the drug, leading to a significant judgment against the manufacturer. Such cases can impact the drug's reputation and financial performance[5].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of any pharmaceutical product. ORTHO-NOVUM 7/7/7 must comply with FDA regulations, including labeling and warning requirements. Non-compliance can lead to legal and financial repercussions[2].

Consumer and Market Trends

Consumer preferences and market trends also influence the financial trajectory of ORTHO-NOVUM 7/7/7. With increasing awareness of health and wellness, consumers are more likely to opt for products with fewer side effects and more convenient administration methods. This has led to a shift towards other contraceptive options like IUDs and implants[4].

Conclusion

ORTHO-NOVUM 7/7/7 has had a complex market and financial trajectory. While it has been effective for many users, it has also faced significant challenges, including adverse user experiences, contraindications, and the impact of generic alternatives. The discontinuation of its brand formulations and legal issues have further affected its financial performance.

Key Takeaways

• User Satisfaction: Mixed reviews with both positive and negative experiences.
• Medical Indications: Effective for preventing pregnancy but with specific contraindications.
• Generic Availability: Original brand formulations discontinued, but generic alternatives available.
• Market Competition: Faces competition from other oral contraceptives and non-oral methods.
• Financial Trajectory: Declined due to generic competition and legal issues.
• Regulatory Environment: Must comply with FDA regulations to avoid legal and financial repercussions.

FAQs

Q: What are the common side effects of ORTHO-NOVUM 7/7/7?

A: Common side effects include mood swings, bloating, hair loss, and changes in menstrual flow.

Q: Why is ORTHO-NOVUM 7/7/7 contraindicated in certain women?

A: It is contraindicated in women with conditions like thrombophlebitis, thromboembolic disorders, and certain types of cancer.

Q: Is ORTHO-NOVUM 7/7/7 still available in its original brand form?

A: No, all original brand formulations of ORTHO-NOVUM 7/7/7 have been discontinued.

Q: What are some alternatives to ORTHO-NOVUM 7/7/7?

A: Alternatives include other oral contraceptives, Mirena (levonorgestrel), and Nexplanon (etonogestrel).

Q: How has the availability of generic alternatives affected the market for ORTHO-NOVUM 7/7/7?

A: The availability of generic alternatives has significantly reduced the market share and revenue of the original brand.

Sources

1. Drugs.com - Ortho-Novum 7/7/7 Reviews & Ratings
2. FDA - ORTHO-NOVUM Tablets (norethindrone/ethinyl estradiol) Label
3. Drugs.com - Generic Ortho-Novum 7/7/7 Availability
4. Drugs.com - Ortho-Novum 7/7/7 Alternatives Compared
5. Justia Law - Ortho Pharmaceutical Corp. v. Heath