MIUDELLA Drug Patent Profile

Name: MIUDELLA Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

« Back to Dashboard

When do Miudella patents expire, and what generic alternatives are available?

Miudella is a drug marketed by Sebela Womens Hlth and is included in one NDA. There are fourteen patents protecting this drug.

The generic ingredient in MIUDELLA is copper. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the copper profile page.

DrugPatentWatch^® Generic Entry Outlook for Miudella

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 16, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

< Available with Subscription >

Start Trial

AI Deep Research

Questions you can ask:

What is the 5 year forecast for MIUDELLA?
What are the global sales for MIUDELLA?
What is Average Wholesale Price for MIUDELLA?

Summary for MIUDELLA

US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in MIUDELLA?	MIUDELLA excipients list
DailyMed Link:	MIUDELLA at DailyMed

Drug patent expirations by year for MIUDELLA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MIUDELLA

Generic Entry Date for MIUDELLA^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: 11,207,209 NDA: 218201 Dosage: SYSTEM;INTRAUTERINE

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for MIUDELLA

Drug Class	Copper-containing Intrauterine Device
Physiological Effect	Decreased Embryonic Implantation Decreased Sperm Motility Inhibit Ovum Fertilization

US Patents and Regulatory Information for MIUDELLA

MIUDELLA is protected by fourteen US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of MIUDELLA is ⤷ Start Trial.

This potential generic entry date is based on patent 11,207,209.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sebela Womens Hlth	MIUDELLA	copper	SYSTEM;INTRAUTERINE	218201-001	Feb 24, 2025		RX	Yes	Yes	10,398,588	⤷ Start Trial	Y			⤷ Start Trial
Sebela Womens Hlth	MIUDELLA	copper	SYSTEM;INTRAUTERINE	218201-001	Feb 24, 2025		RX	Yes	Yes	10,188,546	⤷ Start Trial	Y			⤷ Start Trial
Sebela Womens Hlth	MIUDELLA	copper	SYSTEM;INTRAUTERINE	218201-001	Feb 24, 2025		RX	Yes	Yes	9,427,351	⤷ Start Trial	Y			⤷ Start Trial
Sebela Womens Hlth	MIUDELLA	copper	SYSTEM;INTRAUTERINE	218201-001	Feb 24, 2025		RX	Yes	Yes	9,180,040	⤷ Start Trial	Y			⤷ Start Trial
Sebela Womens Hlth	MIUDELLA	copper	SYSTEM;INTRAUTERINE	218201-001	Feb 24, 2025		RX	Yes	Yes	11,207,209	⤷ Start Trial	Y			⤷ Start Trial
Sebela Womens Hlth	MIUDELLA	copper	SYSTEM;INTRAUTERINE	218201-001	Feb 24, 2025		RX	Yes	Yes	12,138,199	⤷ Start Trial	Y			⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for MIUDELLA

When does loss-of-exclusivity occur for MIUDELLA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 14334816
Patent: Intrauterine device with retrieval thread
Estimated Expiration: ⤷ Start Trial

Patent: 19200369
Patent: Intrauterine device with retrieval thread
Estimated Expiration: ⤷ Start Trial

Brazil

Patent: 2016008594
Patent: Sistema contraceptivo intrauterino
Estimated Expiration: ⤷ Start Trial

Canada

Patent: 26933
Patent: DISPOSITIF INTRA-UTERIN AVEC FIL D'EXTRACTION (INTRAUTERINE DEVICE WITH RETRIEVAL THREAD)
Estimated Expiration: ⤷ Start Trial

European Patent Office

Patent: 57546
Patent: DISPOSITIF INTRA-UTÉRIN AVEC FIL D'EXTRACTION (INTRAUTERINE DEVICE WITH RETRIEVAL THREAD)
Estimated Expiration: ⤷ Start Trial

Mexico

Patent: 4834
Patent: DISPOSITIVO INTRAUTERINO CON HILO DE RECUPERACION. (INTRAUTERINE DEVICE WITH RETRIEVAL THREAD)
Estimated Expiration: ⤷ Start Trial

Patent: 16004857
Patent: DISPOSITIVO INTRAUTERINO CON HILO DE RECUPERACION. (INTRAUTERINE DEVICE WITH RETRIEVAL THREAD.)
Estimated Expiration: ⤷ Start Trial

Spain

Patent: 85294
Estimated Expiration: ⤷ Start Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering MIUDELLA around the world.

Subscribe to access the full database, or Start Trial
Country	Patent Number	Title	Estimated Expiration
Australia	2014334816	Intrauterine device with retrieval thread	⤷ Start Trial
Australia	2019200369	Intrauterine device with retrieval thread	⤷ Start Trial
Brazil	112016008594	Sistema contraceptivo intrauterino	⤷ Start Trial
Canada	2926933	DISPOSITIF INTRA-UTERIN AVEC FIL D'EXTRACTION (INTRAUTERINE DEVICE WITH RETRIEVAL THREAD)	⤷ Start Trial
European Patent Office	3057546	DISPOSITIF INTRA-UTÉRIN AVEC FIL D'EXTRACTION (INTRAUTERINE DEVICE WITH RETRIEVAL THREAD)	⤷ Start Trial
Spain	2685294		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration