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Orange Book drug · Brand (NDA)

Miudella

Copper

RLDNDA 218201 Sebela Womens Hlth
Approved
Feb 24, 2025
Strengths
1
Listed patents
14

What does the FDA Orange Book show for Miudella?

Miudella contains Copper and is the new drug FDA Orange Book record for NDA 218201. The application has 1 presentation with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 218201

New drug application identity from the Orange Book snapshot.

Application holder
Sebela Womens Health Inc

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
1

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
14

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
1

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
001N/ASYSTEMINTRAUTERINEPrescriptionNone posted
RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Sebela Womens Health Inc

The Orange Book identifies this organization as the applicant responsible for NDA 218201.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

1 presentation listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

14 listed patent expirations and 1 exclusivity date remain on or after Jul 26, 2026

The latest future date recorded across those files is Jan 23, 2037. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 3 other NDAs found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 218201 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-218201

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Product detail

NDA 218201
RLDRS
Strength
N/A
Dosage form
SYSTEM
Route
INTRAUTERINE
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    1 yr 5 mo ago

  2. Today

  3. Exclusivity ends · NP

    New product exclusivity (3 years)

    in 1 yr 7 mo

  4. Patent 10159596 expires

    Listed drug product patent expiration.

    in 6 yr 2 mo

  5. Patent 10188546 expires

    Listed drug product patent expiration.

    in 6 yr 2 mo

  6. Patent 11850181 expires

    Listed drug product patent expiration.

    in 6 yr 2 mo

  7. Patent 9427351 expires

    Listed drug product patent expiration.

    in 6 yr 2 mo

  8. Patent 9089418 expires

    Listed drug product patent expiration.

    in 6 yr 10 mo

  9. Patent 12138199 expires

    Listed drug product patent expiration.

    in 7 yr 4 mo

  10. Patent 10398588 expires

    Listed drug product patent expiration.

    in 7 yr 8 mo

  11. Patent 9610191 expires

    Listed method-of-use patent (U-4155) expiration.

    in 7 yr 8 mo

  12. Patent 10022264 expires

    Listed drug product patent expiration.

    in 7 yr 9 mo

  13. Patent 9180040 expires

    Listed drug product patent expiration.

    in 7 yr 9 mo

  14. Patent 9265652 expires

    Listed method-of-use patent (U-4155) expiration.

    in 7 yr 10 mo

  15. Patent 10166141 expires

    Listed drug product patent expiration.

    in 8 yr

  16. Patent 11207209 expires

    Listed drug product patent expiration.

    in 8 yr 2 mo

  17. Patent 10918516 expires

    Listed drug product patent expiration.

    in 10 yr 8 mo

Patent & exclusivity timeline

Protection horizon
2026202820302032203420362038TodayExclusivity NP: 2028-02-24Exclusivity NPPatent 10159596: 2032-08-14Patent 10159596Patent 10188546: 2032-08-14Patent 10188546Patent 11850181: 2032-08-14Patent 11850181Patent 9427351: 2032-08-14Patent 9427351Patent 9089418: 2033-04-09Patent 9089418Patent 12138199: 2033-10-18Patent 12138199Patent 10398588: 2034-02-24Patent 10398588Patent 9610191: 2034-02-24Patent 9610191Patent 10022264: 2034-03-22Patent 10022264Patent 9180040: 2034-03-22Patent 9180040Patent 9265652: 2034-04-28Patent 9265652Patent 10166141: 2034-06-13Patent 10166141Patent 11207209: 2034-08-16Patent 11207209Patent 10918516: 2037-01-23Patent 10918516
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

COPPER

Strength

N/A

Dosage form

SYSTEM

Route

INTRAUTERINE

TE code

Not listed

Application

NDA 218201

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • NPNew product exclusivity (3 years)

    in 1 yr 7 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10159596in 6 yr 2 mo
Product
10188546in 6 yr 2 mo
Product
11850181in 6 yr 2 mo
Product
9427351in 6 yr 2 mo
Product
9089418in 6 yr 10 mo
Product
12138199in 7 yr 4 mo
Product
10398588in 7 yr 8 mo
ProductU-4155
9610191in 7 yr 8 mo
U-4155
10022264in 7 yr 9 mo
Product
9180040in 7 yr 9 mo
Product
9265652in 7 yr 10 mo
U-4155
10166141in 8 yr
Product
11207209in 8 yr 2 mo
Product
10918516in 10 yr 8 mo
Product

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Copper family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Miudella: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 218201 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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