Understanding the Scope and Claims of United States Patent 8,747,888
Introduction to Agile Therapeutics and Patent 8,747,888
Agile Therapeutics, a women’s health specialty pharmaceutical company, has been at the forefront of developing innovative contraceptive products. One of their key patents is United States Patent 8,747,888, which is crucial for their lead product candidate, Twirla.
Overview of Twirla
Twirla is a transdermal contraceptive patch that combines ethinyl estradiol and levonorgestrel. This patch is designed to provide women with a convenient and compliant method of contraception, leveraging Agile Therapeutics' Skinfusion technology[2].
Patent Details: 8,747,888
Abstract and Invention Description
The patent 8,747,888 pertains to a transdermal drug delivery device. This invention includes an active ingredient (AI) layer with a skin-contacting surface and a backing layer. The AI layer contains the contraceptive hormones ethinyl estradiol and levonorgestrel, which are delivered through the skin to achieve contraceptive efficacy[5].
Claims
The patent includes several claims that define the scope of the invention. Here are some key claims:
- Claim 1: A transdermal drug delivery device comprising an active ingredient layer having a skin-contacting surface and a backing layer.
- Claim 2: The device of claim 1, where the active ingredient layer includes ethinyl estradiol and levonorgestrel.
- Claim 3: The device of claim 1, where the backing layer is impermeable to the active ingredients.
- Claim 4: The device of claim 1, where the active ingredient layer is adhered to the skin-contacting surface of the backing layer[5].
Patent Landscape and Exclusivity
Orange Book Listing
Patent 8,747,888 is one of the eight U.S. patents that Agile Therapeutics intends to list in the FDA’s Orange Book. The Orange Book lists drug products approved by the FDA, along with related patent and exclusivity information. This listing creates a significant barrier for potential competitors seeking to market generic versions of Twirla, as they must provide a patent certification addressing the listed patents[2][4].
Patent Expiration
The patents covering Twirla, including 8,747,888, expire between 2021 and 2028. This extended period of exclusivity provides Agile Therapeutics with a substantial market advantage and protection against generic competition[2][4].
Intellectual Property Strategy
Additional Patents and Applications
Agile Therapeutics continues to prosecute additional patent applications related to Twirla and other product candidates. This strategy ensures comprehensive protection of their intellectual property and further solidifies their market position. The company has a robust portfolio of patents, with no royalties or payments owed to third parties for their Skinfusion technology or product candidates[1][2].
Progestin-Only Patch R&D
The company also holds patents relevant to their progestin-only patch R&D program, such as US Patent 9,364,487, which covers the formulation of a progestin-only transdermal patch containing levonorgestrel. This patent is expected to expire in 2032 and supports their ongoing research and development in hormonal contraceptives[2].
Regulatory and Clinical Context
FDA Approval and CRL
The FDA's Complete Response Letter (CRL) in 2017 highlighted several issues that needed to be addressed before Twirla could be approved. These included the adhesion properties demonstrated in the SECURE clinical trial and subject patch compliance. However, the CRL did not identify any safety issues with Twirla. Agile Therapeutics has since submitted amendments and responses to the FDA's observations, which are expected to address the CRL's concerns[1].
Clinical Trials and Compliance
The success of Twirla is also dependent on the outcomes of clinical trials and the compliance of trial subjects. The company has been working to address the implications of clinical trial subject patch compliance and withdrawal rates, which are critical for regulatory approval and market acceptance[1].
Market Impact and Future Developments
Market Acceptance
The acceptance of Twirla by the market will be influenced by its convenience, efficacy, and compliance rates. Agile Therapeutics aims to provide women with contraceptive options that are easier to use and more compliant, which could significantly impact market dynamics[2].
Pipeline Products
In addition to Twirla, Agile Therapeutics is developing a pipeline of other new transdermal contraceptive products. These include AG200-ER, AG200-SP, AG200-ER (SmP), and AG890, which cater to different needs and preferences of women. These products are expected to further expand the company's market presence and offerings[1].
Key Takeaways
- Patent Protection: Patent 8,747,888 is part of a robust patent portfolio that protects Twirla and other Agile Therapeutics products.
- Orange Book Listing: The patent is listed in the FDA’s Orange Book, creating a barrier for generic competitors.
- Exclusivity Period: The patents covering Twirla expire between 2021 and 2028, providing extended market exclusivity.
- Clinical and Regulatory Compliance: Addressing FDA concerns and ensuring high compliance rates in clinical trials are crucial for the success of Twirla.
- Market Impact: Twirla and other Agile Therapeutics products aim to revolutionize the contraceptive market with their convenience and compliance features.
FAQs
Q: What is the main product covered by United States Patent 8,747,888?
A: The main product covered is Twirla, a transdermal contraceptive patch containing ethinyl estradiol and levonorgestrel.
Q: Why is the Orange Book listing important for Agile Therapeutics?
A: The Orange Book listing creates a barrier for generic competitors by requiring them to address the listed patents in their applications.
Q: What is the expiration date range for the patents covering Twirla?
A: The patents covering Twirla expire between 2021 and 2028.
Q: What other contraceptive products is Agile Therapeutics developing?
A: Agile Therapeutics is developing products like AG200-ER, AG200-SP, AG200-ER (SmP), and AG890, which offer different contraceptive regimens.
Q: How does the FDA’s CRL impact the approval of Twirla?
A: The FDA’s CRL highlighted issues such as adhesion properties and subject compliance that need to be addressed before Twirla can be approved.
Sources
- 2017 Annual Report - Annual Reports
- Agile Therapeutics, Inc. Announces Issuance Of Patent For Progestin Patch Designs
- Patent Claims Research Dataset - USPTO
- UNITED STATES SECURITIES AND EXCHANGE COMMISSION ...
- Pharmaceutical drugs covered by patent 8,747,888. Claims ...
