LYBREL Drug Patent Profile

Which patents cover Lybrel, and when can generic versions of Lybrel launch?

Lybrel is a drug marketed by Wyeth Pharms Inc and is included in one NDA.

The generic ingredient in LYBREL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for LYBREL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	2
Patent Applications:	277
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LYBREL
DailyMed Link:	LYBREL at DailyMed

Recent Clinical Trials for LYBREL

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

Sponsor	Phase
Pfizer
Boston Collaborative Drug Surveillance Program
Oregon Health and Science University	N/A

See all LYBREL clinical trials

Paragraph IV (Patent) Challenges for LYBREL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LYBREL	Tablets	ethinyl estradiol; levonorgestrel	0.09 mg/0.02 mg	021864	1	2007-10-05

US Patents and Regulatory Information for LYBREL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms Inc	LYBREL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021864-001	May 22, 2007		DISCN	Yes	No

Expired US Patents for LYBREL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	LYBREL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021864-001	May 22, 2007	6,500,814

International Patents for LYBREL

See the table below for patents covering LYBREL around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2200384
European Patent Office	1935423
Germany	59808545
Austria	241361
European Patent Office	1011682	MOYEN DE CONTRACEPTION HORMONALE (HORMONAL CONTRACEPTIVE)

Supplementary Protection Certificates for LYBREL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
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
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129

LYBREL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LYBREL

Introduction

LYBREL, a non-cyclic oral contraceptive, was introduced to the market as a innovative option for women seeking continuous hormonal contraception. Here, we will delve into the market dynamics and financial trajectory of LYBREL, highlighting its launch, market reception, and the financial implications for its manufacturer.

Market Context

The hormonal contraceptive market has been a significant segment within the pharmaceutical industry. In the early 2000s, this market was dominated by oral formulations and injectable contraceptives, with other methods like the contraceptive patch and devices holding smaller market shares[4].

Launch and Approval

LYBREL, developed by Wyeth (now part of Pfizer), received FDA approval in 2007. The drug was designed to provide a continuous regimen of 90 mcg levonorgestrel and 20 mcg ethinyl estradiol, differing from traditional cyclic oral contraceptives by extending the hormonal exposure period[3].

Market Reception

Upon its introduction, LYBREL was expected to capture a significant share of the growing hormonal contraceptive market. However, the drug faced challenges in gaining widespread acceptance. A post-marketing observational study aimed to evaluate the risk of venous thromboembolism associated with LYBREL, but it was discontinued due to low accrual of users and the product's eventual withdrawal from the market[1].

Efficacy and Safety

The primary efficacy and safety study for LYBREL involved 2,134 subjects in North America. The study reported a Pearl Index of 2.38, indicating a relatively low pregnancy rate among users. However, the study also highlighted a higher incidence of venous thromboembolism compared to cyclic oral contraceptives, which contributed to concerns about its safety profile[1].

Market Performance

Despite initial expectations, LYBREL did not achieve the anticipated market success. The drug's continuous regimen, while innovative, did not resonate with enough users to sustain its presence in the market. The hormonal contraceptive market continued to grow, but LYBREL's share remained limited. By 2007, the global hormonal contraceptive market was projected to reach $7.89 billion by 2008, but LYBREL's contribution to this growth was minimal[4].

Financial Implications

The financial performance of LYBREL was closely tied to its market reception. Wyeth, the manufacturer, invested significantly in the development and marketing of LYBREL. However, the drug's poor market performance likely resulted in substantial financial losses. While specific financial data for LYBREL is not readily available, the overall financial health of Wyeth during this period would have been impacted by the drug's underperformance.

Comparison with Other Contraceptives

Other hormonal contraceptives, such as Ortho Evra (the combined hormonal patch) and NuvaRing (the vaginal ring), gained more significant market traction during the same period. These products offered alternative delivery systems that appealed more to consumers, further marginalizing LYBREL's market position[4].

Discontinuation

Due to low usage and the aforementioned safety concerns, LYBREL was eventually discontinued from the market. This decision was likely driven by a combination of factors, including the high incidence of venous thromboembolism and the lack of significant market adoption[1].

Key Takeaways

• Innovative but Limited Adoption: LYBREL introduced a continuous hormonal regimen but failed to gain significant market traction.
• Safety Concerns: Higher incidence of venous thromboembolism compared to cyclic oral contraceptives.
• Financial Impact: Poor market performance likely resulted in financial losses for the manufacturer.
• Market Competition: Other hormonal contraceptives with alternative delivery systems captured more market share.

FAQs

What is LYBREL and how does it differ from other oral contraceptives?

LYBREL is a non-cyclic oral contraceptive that provides a continuous regimen of 90 mcg levonorgestrel and 20 mcg ethinyl estradiol, extending the hormonal exposure period compared to traditional cyclic oral contraceptives.

Why was LYBREL discontinued from the market?

LYBREL was discontinued due to low usage and safety concerns, particularly a higher incidence of venous thromboembolism compared to cyclic oral contraceptives.

How did LYBREL's market performance impact its manufacturer financially?

The poor market performance of LYBREL likely resulted in significant financial losses for Wyeth, although specific financial data for the drug is not available.

What other hormonal contraceptives were more successful during the same period?

Other hormonal contraceptives like Ortho Evra (the combined hormonal patch) and NuvaRing (the vaginal ring) gained more significant market traction during the same period.

What were the key findings of the efficacy and safety studies for LYBREL?

The primary efficacy and safety study reported a Pearl Index of 2.38, indicating a relatively low pregnancy rate, but also highlighted a higher incidence of venous thromboembolism compared to cyclic oral contraceptives.

Sources

1. FDA Label for LYBREL: Accessdata.fda.gov
2. Biospace - Lyra Therapeutics Financial Results: Biospace.com
3. FDA Label for LYBREL (2007): Accessdata.fda.gov
4. PharmaVoice - The Birth of a New Market: Pharmavoice.com
5. Biospace - Lyra Therapeutics First Quarter 2024 Financial Results: Biospace.com