ORTHO TRI-CYCLEN Drug Patent Profile

When do Ortho Tri-cyclen patents expire, and what generic alternatives are available?

Ortho Tri-cyclen is a drug marketed by Janssen Pharms and is included in two NDAs.

The generic ingredient in ORTHO TRI-CYCLEN is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.

Summary for ORTHO TRI-CYCLEN

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	20
Patent Applications:	8
Drug Prices:	Drug price information for ORTHO TRI-CYCLEN
DailyMed Link:	ORTHO TRI-CYCLEN at DailyMed

See drug prices for ORTHO TRI-CYCLEN

Recent Clinical Trials for ORTHO TRI-CYCLEN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Gilead Sciences	Phase 1
Lexicon Pharmaceuticals	Phase 1
Aegerion Pharmaceuticals, Inc.	Phase 1

See all ORTHO TRI-CYCLEN clinical trials

US Patents and Regulatory Information for ORTHO TRI-CYCLEN

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 TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-28	019697-001	Jul 3, 1992		DISCN	Yes	No
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-21	019697-002	Jul 3, 1992		DISCN	No	No
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002		DISCN	Yes	No

Expired US Patents for ORTHO TRI-CYCLEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-28	019697-001	Jul 3, 1992	4,616,006*PED
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-21	019697-002	Jul 3, 1992	4,027,019
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-21	019697-002	Jul 3, 1992	4,628,051
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-28	019697-001	Jul 3, 1992	4,544,554*PED
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-28	019697-001	Jul 3, 1992	4,027,019
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-28	019697-001	Jul 3, 1992	4,530,839*PED
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-28	019697-001	Jul 3, 1992	4,628,051*PED

International Patents for ORTHO TRI-CYCLEN

See the table below for patents covering ORTHO TRI-CYCLEN around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	501808
Croatia	P940806
France	2318645
Ireland	43581	3-OXIMES AND D-NORGESTREL ESTERS AND METHOD FOR THE PREPARATION THEREOF
Japan	S624400
Norway	143350
Portugal	65402	3-OXIMES OF D-17ALPHA-ETHYNYL-19-NORTESTOSTERONE ESTERS AND METHOD

Supplementary Protection Certificates for ORTHO TRI-CYCLEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211

Market Dynamics and Financial Trajectory for ORTHO TRI-CYCLEN

Introduction

ORTHO TRI-CYCLEN, a combination oral contraceptive, is widely used for pregnancy prevention and the treatment of moderate acne vulgaris in females. To understand its market dynamics and financial trajectory, it is essential to delve into its clinical efficacy, market competition, and the financial performance of its manufacturer.

Clinical Efficacy and Indications

ORTHO TRI-CYCLEN is indicated for the prevention of pregnancy and the treatment of moderate acne vulgaris in females at least 15 years of age who have achieved menarche and have no known contraindications to oral contraceptive therapy[1][3][4].

Pregnancy Prevention

The drug has been shown to be highly effective in preventing pregnancy, with a use-efficacy pregnancy rate of approximately 1 pregnancy per 100 women-years. This rate includes patients who did not take the drug correctly[1][3].

Acne Treatment

In clinical trials, ORTHO TRI-CYCLEN demonstrated a statistically significant improvement in total lesions compared to placebo. The treatment resulted in a 42% reduction in total lesions over six months, compared to a 27% reduction in the placebo group[1][3].

Market Competition

The market for oral contraceptives is highly competitive, with numerous brands and generic alternatives available.

Generic Competition

Generic versions of ORTHO TRI-CYCLEN have been approved and are marketed by various companies, which can impact the sales and revenue of the branded product. Several generic companies have filed Abbreviated New Drug Applications (ANDAs) seeking approval to market generic versions of ORTHO TRI-CYCLEN LO[2].

Brand Loyalty and Prescription Trends

Despite the presence of generics, brand loyalty and prescription preferences can influence market dynamics. Healthcare providers often prescribe well-known and trusted brands, which can help maintain market share for ORTHO TRI-CYCLEN.

Financial Trajectory of the Manufacturer

Johnson & Johnson, the manufacturer of ORTHO TRI-CYCLEN, is a multinational healthcare company with a diverse portfolio of products.

Revenue and Profitability

Johnson & Johnson's pharmaceutical segment, which includes ORTHO TRI-CYCLEN, has experienced fluctuations in revenue and profitability. In the fiscal first quarter of 2013, the pharmaceutical segment saw a decline of 6.5% in revenue compared to the previous year, partly due to litigation expenses and integration costs related to other acquisitions[2].

Geographic Sales Performance

The company's sales performance varies by geographic region. For example, in the fiscal first quarter of 2013, Johnson & Johnson reported an 11.2% increase in sales in the United States and a 6.8% increase in Europe. These regional performances can impact the overall financial trajectory of the company and its products, including ORTHO TRI-CYCLEN[2].

Impact of Acquisitions and Divestitures

Johnson & Johnson's financial performance is also influenced by its strategic acquisitions and divestitures. For instance, the acquisition of Synthes, Inc., a global developer and manufacturer of orthopedic devices, had significant financial implications, including integration costs and positive currency adjustments[2].

Litigation and Regulatory Factors

Litigation expenses and regulatory changes can significantly affect the financial trajectory of pharmaceutical products. Johnson & Johnson incurred substantial litigation expenses in the fiscal first quarter of 2013, which impacted its overall profitability[2].

Consumer and Market Trends

Consumer preferences and market trends play a crucial role in the sales and revenue of ORTHO TRI-CYCLEN.

Smoking and Cardiovascular Risks

The warning that cigarette smoking increases the risk of serious cardiovascular events associated with combination oral contraceptive use can influence consumer choice and prescribing practices. This warning is particularly relevant for women over 35 years of age who smoke[1].

Awareness and Education

Patient education and awareness campaigns can impact the adoption and retention of ORTHO TRI-CYCLEN. Healthcare providers must counsel patients about the benefits and risks of the medication, including its effectiveness in preventing pregnancy and treating acne, as well as its contraindications[1][3].

Financial Performance Metrics

To gauge the financial performance of ORTHO TRI-CYCLEN, several metrics are crucial:

Sales Revenue

The sales revenue of ORTHO TRI-CYCLEN is a key indicator of its market performance. This revenue is influenced by prescription rates, generic competition, and pricing strategies.

Operating Profit

The operating profit margin of the pharmaceutical segment of Johnson & Johnson provides insight into the profitability of ORTHO TRI-CYCLEN after accounting for operating expenses.

Cash Flow

The cash flow generated from the sales of ORTHO TRI-CYCLEN contributes to Johnson & Johnson's overall financial health and ability to invest in research and development, marketing, and other business activities[2].

Conclusion

The market dynamics and financial trajectory of ORTHO TRI-CYCLEN are influenced by a combination of clinical efficacy, market competition, and the broader financial performance of its manufacturer, Johnson & Johnson. Despite the presence of generic competition, ORTHO TRI-CYCLEN remains a significant player in the oral contraceptive market due to its proven efficacy and brand recognition.

Key Takeaways

• Clinical Efficacy: ORTHO TRI-CYCLEN is highly effective in preventing pregnancy and treating moderate acne vulgaris.
• Market Competition: The presence of generic versions and other oral contraceptives impacts its market share.
• Financial Performance: Johnson & Johnson's overall financial health, influenced by acquisitions, litigation, and regional sales performance, affects the product's financial trajectory.
• Consumer Trends: Patient education and awareness about the benefits and risks of the medication are crucial for its adoption and retention.

FAQs

Q: What are the primary indications for ORTHO TRI-CYCLEN?

A: ORTHO TRI-CYCLEN is indicated for the prevention of pregnancy and the treatment of moderate acne vulgaris in females at least 15 years of age.

Q: How effective is ORTHO TRI-CYCLEN in preventing pregnancy?

A: ORTHO TRI-CYCLEN has a use-efficacy pregnancy rate of approximately 1 pregnancy per 100 women-years, including patients who did not take the drug correctly.

Q: What are the potential cardiovascular risks associated with ORTHO TRI-CYCLEN?

A: Cigarette smoking increases the risk of serious cardiovascular events associated with combination oral contraceptive use, particularly in women over 35 years of age.

Q: How does generic competition affect the market for ORTHO TRI-CYCLEN?

A: Generic versions of ORTHO TRI-CYCLEN can reduce the market share and revenue of the branded product, although brand loyalty and prescription preferences can mitigate this impact.

Q: What are some key financial metrics to evaluate the performance of ORTHO TRI-CYCLEN?

A: Key metrics include sales revenue, operating profit margin, and cash flow generated from the sales of the product.

Sources

1. FDA Label for ORTHO TRI-CYCLEN: Accessdata.fda.gov
2. Johnson & Johnson Form 10-Q: Q4cdn.com
3. FDA Label for ORTHO-CYCLEN: Accessdata.fda.gov
4. Ortho Tri-Cyclen Package Insert: Drugs.com