ORTHO TRI-CYCLEN LO Drug Patent Profile

Which patents cover Ortho Tri-cyclen Lo, and when can generic versions of Ortho Tri-cyclen Lo launch?

Ortho Tri-cyclen Lo is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in ORTHO TRI-CYCLEN LO 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 LO

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	20
Patent Applications:	8
Drug Prices:	Drug price information for ORTHO TRI-CYCLEN LO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ORTHO TRI-CYCLEN LO
DailyMed Link:	ORTHO TRI-CYCLEN LO at DailyMed

See drug prices for ORTHO TRI-CYCLEN LO

See drug sales revenues for ORTHO TRI-CYCLEN LO

Recent Clinical Trials for ORTHO TRI-CYCLEN LO

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 LO clinical trials

US Patents and Regulatory Information for ORTHO TRI-CYCLEN LO

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 LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002		DISCN	Yes	No

Expired US Patents for ORTHO TRI-CYCLEN LO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002

International Patents for ORTHO TRI-CYCLEN LO

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

Country	Patent Number	Title	Estimated Expiration
Canada	2356747	CONTRACEPTIF ORAL TRIPHASE (TRIPHASIC ORAL CONTRACEPTIVE)
Czech Republic	302568	Trífázový orální antikoncepcní prostredek (Triphasic oral contraceptive composition)
New Zealand	512404	Triphasic oral contraceptive comprising an estrogen and a progestogen administrated over 21 days
Norway	20013144
Taiwan	589311

Supplementary Protection Certificates for ORTHO TRI-CYCLEN LO

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	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON

Market Dynamics and Financial Trajectory for Ortho Tri-Cyclen Lo

Introduction

Ortho Tri-Cyclen Lo, a combination oral contraceptive containing norgestimate and ethinyl estradiol, has been a significant player in the contraceptive market since its approval by the FDA in 2002. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Position and Approval

Ortho Tri-Cyclen Lo is manufactured by Janssen Pharmaceuticals Inc. and was approved by the FDA on August 22, 2002. It is indicated for the prevention of pregnancy in women who elect to use oral contraceptives[4].

Sales Performance

Prior to the introduction of generic versions, Ortho Tri-Cyclen Lo had substantial sales. As of September 2015, the product had US sales of $488.4 million, highlighting its market dominance in the oral contraceptive segment[1].

Generic Competition

The market dynamics for Ortho Tri-Cyclen Lo changed significantly with the introduction of generic versions. Lupin Limited, for example, launched its generic equivalent, Tri-Lo-Marzia™ Tablets, after receiving FDA approval. This generic version is AB-rated, meaning it is bioequivalent to the brand-name product, and it marked Lupin's 16th oral contraceptive launch in the US[1].

Impact of Generic Entry

The entry of generic competitors has typically led to a decline in sales for the brand-name product. Generic versions often offer significant cost savings, making them more attractive to consumers and healthcare providers. This shift can erode the market share and revenue of the original brand-name drug.

Financial Trajectory

Pre-Generic Era

Before the introduction of generics, Ortho Tri-Cyclen Lo was a high-revenue product for Janssen Pharmaceuticals. The sales figure of $488.4 million as of September 2015 indicates its strong market presence and financial performance during this period[1].

Post-Generic Era

With the launch of generic equivalents, the financial trajectory for Ortho Tri-Cyclen Lo has likely experienced a decline. Generic competition often leads to reduced prices and market share for the brand-name product. This can result in lower revenues and profitability for Janssen Pharmaceuticals.

Market Share and Competition

The oral contraceptive market is highly competitive, with multiple brands and generics available. The introduction of generics like Tri-Lo-Marzia™ Tablets has increased competition, making it challenging for Ortho Tri-Cyclen Lo to maintain its market share. Lupin's significant presence in the generics market, particularly in the US, further intensifies the competition[1].

Pharmaceutical Company Performance

Janssen Pharmaceuticals, as part of Johnson & Johnson, has a diversified portfolio that helps mitigate the impact of generic competition on individual products. However, the decline in sales of a major product like Ortho Tri-Cyclen Lo can still affect the company's overall financial performance. For instance, Johnson & Johnson's pharmaceutical segment has experienced fluctuations due to various market and competitive factors[2].

Consumer and Prescriber Preferences

Consumer and prescriber preferences play a crucial role in the market dynamics of pharmaceutical products. The availability of generic versions can influence prescribing habits, with many healthcare providers opting for the more cost-effective generic alternatives. This shift can further reduce the market share and sales of the brand-name product.

Regulatory and Safety Considerations

Regulatory oversight and safety considerations are essential in the pharmaceutical industry. Ortho Tri-Cyclen Lo, like other oral contraceptives, must comply with FDA regulations. Any safety concerns or regulatory changes can impact the product's market performance. For example, fraudulent online pharmacies attempting to sell counterfeit versions of the drug can undermine consumer trust and affect legitimate sales[3].

Pharmacokinetics and Efficacy

The efficacy and pharmacokinetics of Ortho Tri-Cyclen Lo have been well-documented. The product has a high efficacy rate in preventing pregnancy, with a typical user efficacy rate of 2.36 per 100 women-years of use. However, these factors, while important for clinical use, do not directly influence the financial trajectory but can impact market perception and prescriber confidence[4].

Conclusion

The market dynamics and financial trajectory of Ortho Tri-Cyclen Lo have been significantly influenced by the introduction of generic competitors. While the product was once a high-revenue generator for Janssen Pharmaceuticals, the entry of generics has led to a decline in its market share and sales. The competitive landscape of the oral contraceptive market, combined with regulatory and safety considerations, continues to shape the financial performance of this and similar products.

Key Takeaways

• Market Dominance: Ortho Tri-Cyclen Lo was a dominant player in the oral contraceptive market before the introduction of generics.
• Generic Competition: The launch of generic equivalents has significantly impacted the product's sales and market share.
• Financial Impact: The financial trajectory has declined post-generic entry, affecting Janssen Pharmaceuticals' revenue and profitability.
• Regulatory and Safety: Compliance with FDA regulations and safety considerations remain crucial for market performance.
• Consumer and Prescriber Preferences: Cost-effectiveness of generics influences prescribing habits and consumer preferences.

FAQs

Q: What is Ortho Tri-Cyclen Lo used for?

A: Ortho Tri-Cyclen Lo is used for the prevention of pregnancy in women who elect to use oral contraceptives.

Q: When was Ortho Tri-Cyclen Lo approved by the FDA?

A: Ortho Tri-Cyclen Lo was approved by the FDA on August 22, 2002.

Q: What are the active ingredients in Ortho Tri-Cyclen Lo?

A: The active ingredients are norgestimate and ethinyl estradiol.

Q: How has the introduction of generics affected Ortho Tri-Cyclen Lo's market performance?

A: The introduction of generics has led to a decline in sales and market share for Ortho Tri-Cyclen Lo.

Q: Who are some of the generic manufacturers of Ortho Tri-Cyclen Lo?

A: One notable generic manufacturer is Lupin Limited, which launched Tri-Lo-Marzia™ Tablets.

Sources

1. Lupin Launches Generic Ortho Tri-Cyclen Lo Tablets in the US - PR Newswire
2. Form 10-Q for Johnson Johnson filed 05/03/2013 - Johnson & Johnson
3. Generic Ortho Tri-Cyclen Lo Availability - Drugs.com
4. Ortho Tri-Cyclen Lo Tablets - FDA
5. Ethinyl estradiol and norgestimate (oral route) - Mayo Clinic