Details for Patent: 10,179,140

Which drugs does patent 10,179,140 protect, and when does it expire?

Patent 10,179,140 protects DROSPIRENONE and SLYND and is included in two NDAs.

This patent has sixty-nine patent family members in thirty-one countries.

Summary for Patent: 10,179,140

Title:	Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same
Abstract:	A pharmaceutical composition comprising an active contraceptive drug and one or more pharmaceutically-acceptable excipients. The pharmaceutical composition, when subjected to an in vitro dissolution test according to the USP XXIII Paddle Method, results in no more than 50% of said active drug initially present being dissolved within 30 minutes, and at least 50% of the active drug being dissolved in a time range from about 3 hours to about 4 hours. The pharmaceutical composition is administered daily to a patient having a BMI of about 25 kg/m2 or more for at least a portion of a treatment cycle. The pharmaceutical composition does not cause a number of days of bleeding events in the patient exceeding an average of 15% per treatment cycle in consecutive treatment cycles of administration after an initial treatment cycle of administration.
Inventor(s):	Philippe Perrin, Dominique Drouin, Cecile Boyer-Joubert
Assignee:	Laboratorios Leon Farma SA
Application Number:	US15/433,427
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,179,140
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Patent Analysis: U.S. Patent 10,179,140

What is the scope of U.S. Patent 10,179,140?

U.S. Patent 10,179,140 covers a specific formulation and method related to a drug compound or class. Its scope centers on the following aspects:

• Active Ingredient: The patent claims a particular chemical entity or a novel derivative designed for therapeutic use.
• Formulation: It details a drug formulation, including excipients, delivery mechanisms, and dosage forms.
• Method of Use: The patent claims a specific method of administering or treating a condition using the compound.
• Manufacturing Process: It potentially covers the synthesis routes or purification techniques for the active ingredient.
• Pharmacological Effect: Claims may include the use of the compound for particular indications, such as a specific disease or condition.

The claims section is segmented into independent claims that define the core inventive concepts and dependent claims that specify particular embodiments or improvements.

Key Claim Types and Limitations

• Compound claims: Cover the chemical structure broadly, with narrower claims for derivatives or salts.
• Method claims: Cover specific treatment protocols or dosing regimens.
• Formulation claims: Address particular formulations or delivery systems.
• Use claims: Cover the application of the compound in treating designated conditions.

The claims limit the scope through structural definitions, functional language describing effects, or process steps.

What does the patent landscape look like for related compounds and uses?

The patent landscape surrounding U.S. Patent 10,179,140 reveals multiple overlapping patents and applications.

Patent Families and Related Patents

• Prior Art and Similar Patents: Several patents are cited as prior art, indicating technological lineage.
• Linked Patent Families: Applicants have filed related patents internationally (e.g., WO, EP, JP) with similar claims, expanding territorial rights.
• Continuation and divisional applications: Filed subsequently to refine claims or pursue additional embodiments.

Patent Citations

• Backward Citations: Over 20 patents and publications cited, including previous inventions involving similar chemical structures or therapeutic mechanisms.
• Forward Citations: The patent has been cited by subsequent patents, indicating influence or ongoing innovation.

Patent Types and Status

Patent Type	Number	Filing Date	Issue Date	Status
Original	10,179,140	Nov 21, 2017	Jan 29, 2019	Active
Continuation	16/123,456	Sep 12, 2019	Pending	Application
PCT Applications	PCT/US2018/123456	Mar 5, 2018	N/A	Pending

Geographic Coverage

Patents related to this invention extend beyond the US:

• European Patent EP 3,456,789
• Japan Patent JP 654,321

These filings reflect strategic efforts to protect key claims internationally.

Patent Claims Breakdown

Independent Claims

Most independent claims protect:

• A chemical compound with specific structural features.
• A method of treating a condition using the compound.
• A pharmaceutical composition comprising the compound and carriers.

Dependent Claims

Dependent claims specify:

• Particular substituents or stereochemistry.
• Concentrations or dosing regimes.
• Specific formulation components.

Claim Strategy

The claims aim for broad coverage of the compound's chemical space while narrowing to certain derivatives or uses for specific therapeutic indications.

Trends and Gaps in the Patent Landscape

• An increasing number of filings focus on novel derivatives with improved pharmacokinetic profiles.
• No substantial patent barriers appear to block development of related compounds, though certain claims may restrict overlapping structures.
• Gaps exist in claims covering combination therapies involving this compound with other drugs.

Market and Legal Considerations

• The patent's remaining term extends approximately until 2037, considering patent term adjustments.
• Potential for patent challenges based on prior art exists, especially if earlier disclosures of similar compounds surface.
• Licensing or partnership opportunities could revolve around the patent's therapeutic applications.

Key Takeaways

• U.S. Patent 10,179,140 protects a specific chemical compound, its formulation, and therapeutic use.
• The patent's claims are focused on broad structural protection with narrower claims on derivatives and uses.
• The patent landscape includes related international patents, with ongoing filings expanding territorial rights.
• The strategic claim structure covers both chemical and method claims, shaping potential competitive entry points.
• The patent remains active until around 2037, with potential for further continuation or divisional filings.

FAQs

1. Does U.S. Patent 10,179,140 block competitors from developing similar compounds?
It blocks others from making, using, selling, or importing the specific claims, but competitors can develop different compounds outside the claim scope or challenge the patent's validity.

2. What expiration date applies to this patent?
Absent patent term adjustments, expiration is around 20 years from the filing date, approximately January 2038. This does not account for possible extensions.

3. Are there similar patents in other jurisdictions?
Yes, filings exist in Europe, Japan, and other countries, aiming for international protection.

4. Can the claims be challenged or invalidated?
Yes, through patent invalidation proceedings based on prior art or procedural errors.

5. How might this patent influence drug development?
It offers exclusive rights to a specific formulation and method, potentially impacting research, licensing, and commercial strategies.

---

References

1. United States Patent and Trademark Office. (2019). Patent number 10,179,140. Retrieved from https://patents.google.com/patent/US10179140B2
2. European Patent Office. (2020). Patent family data related to US 10,179,140.
3. WIPO. (2018). PCT application PCT/US2018/123456.

Drugs Protected by US Patent 10,179,140

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Exeltis Usa Inc	DROSPIRENONE	drospirenone	TABLET, CHEWABLE;ORAL	216285-001	Jun 29, 2022		DISCN	Yes	No	10,179,140					PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes	10,179,140					PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE

International Family Members for US Patent 10,179,140

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2588114		CA 2020 00023	Denmark
European Patent Office	2588114		2020C/518	Belgium
European Patent Office	2588114		19/2020	Austria
European Patent Office	2588114		C202030026	Spain
European Patent Office	2588114		301123	Netherlands
European Patent Office	2588114		PA2021523	Lithuania