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Orange Book drug · Brand (NDA)

Mycapssa

Octreotide Acetate

RLDNDA 208232 Chiesi
Approved
Jun 26, 2020
Strengths
1
Listed patents
16

What does the FDA Orange Book show for Mycapssa?

Mycapssa contains Octreotide Acetate and is the new drug FDA Orange Book record for NDA 208232. 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 208232

New drug application identity from the Orange Book snapshot.

Application holder
Chiesi Farmaceutici Spa

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
16

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
001EQ 20MG BASECAPSULE, DELAYED RELEASEORALPrescriptionNone 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

Chiesi Farmaceutici Spa

The Orange Book identifies this organization as the applicant responsible for NDA 208232.

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

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

The latest future date recorded across those files is Dec 28, 2040. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

23 other ANDAs and 3 other NDAs found

15 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 208232 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Capsule, Delayed Release · Oral

Octreotide Acetate

1 application
Product rows
1
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-208232

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 208232
RLDRS
Strength
EQ 20MG BASE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    6 yr 2 mo ago

  2. Today

  3. Exclusivity ends · ODE-474

    Orphan-drug exclusivity (7 years)

    in 11 mo

  4. Patent 11969471 expires

    Listed drug product patent expiration.

    in 3 yr 2 mo

  5. Patent 11986529 expires

    Listed method-of-use patent (U-2857) expiration.

    in 3 yr 2 mo

  6. Patent 8329198 expires

    Listed drug product patent expiration.

    in 3 yr 2 mo

  7. Patent 8535695 expires

    Listed method-of-use patent (U-2857) expiration.

    in 3 yr 2 mo

  8. Patent 9265812 expires

    Listed drug product patent expiration.

    in 3 yr 2 mo

  9. Patent 9566246 expires

    Listed drug product patent expiration.

    in 3 yr 2 mo

  10. Patent 10238709 expires

    Listed method-of-use patent (U-2857) expiration.

    in 9 yr 8 mo

  11. Patent 10695397 expires

    Listed method-of-use patent (U-2857) expiration.

    in 9 yr 8 mo

  12. Patent 11052126 expires

    Listed method-of-use patent (U-2857) expiration.

    in 9 yr 8 mo

  13. Patent 11338011 expires

    Listed method-of-use patent (U-2857) expiration.

    in 9 yr 8 mo

  14. Patent 11510963 expires

    Listed method-of-use patent (U-2857) expiration.

    in 9 yr 8 mo

  15. Patent 11857595 expires

    Listed method-of-use patent (U-3784) expiration.

    in 9 yr 8 mo

  16. Patent 12246054 expires

    Listed method-of-use patent (U-2857) expiration.

    in 9 yr 8 mo

  17. Patent 12251418 expires

    Listed method-of-use patent (U-2857) expiration.

    in 9 yr 8 mo

  18. Patent 11141457 expires

    Listed method-of-use patent (U-3232) expiration.

    in 14 yr 8 mo

  19. Patent 11890316 expires

    Listed method-of-use patent (U-3232) expiration.

    in 14 yr 8 mo

Patent & exclusivity timeline

Protection horizon
20262028203020322034203620382040TodayExclusivity ODE-474: 2027-06-26Exclusivity ODE-474Patent 11969471: 2029-09-17Patent 11969471Patent 11986529: 2029-09-17Patent 11986529Patent 8329198: 2029-09-17Patent 8329198Patent 8535695: 2029-09-17Patent 8535695Patent 9265812: 2029-09-17Patent 9265812Patent 9566246: 2029-09-17Patent 9566246Patent 10238709: 2036-02-03Patent 10238709Patent 10695397: 2036-02-03Patent 10695397Patent 11052126: 2036-02-03Patent 11052126Patent 11338011: 2036-02-03Patent 11338011Patent 11510963: 2036-02-03Patent 11510963Patent 11857595: 2036-02-03Patent 11857595Patent 12246054: 2036-02-03Patent 12246054Patent 12251418: 2036-02-03Patent 12251418Patent 11141457: 2040-12-28Patent 11141457Patent 11890316: 2040-12-28Patent 11890316
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

OCTREOTIDE ACETATE

Strength

EQ 20MG BASE

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 208232

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • ODE-474Orphan-drug exclusivity (7 years)

    in 11 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11969471in 3 yr 2 mo
Product
11986529in 3 yr 2 mo
U-2857
8329198in 3 yr 2 mo
Product
8535695in 3 yr 2 mo
U-2857
9265812in 3 yr 2 mo
Product
9566246in 3 yr 2 mo
Product
10238709in 9 yr 8 mo
U-2857
10695397in 9 yr 8 mo
U-2857
11052126in 9 yr 8 mo
U-2857
11338011in 9 yr 8 mo
U-2857
11510963in 9 yr 8 mo
U-2857
11857595in 9 yr 8 mo
U-3784
12246054in 9 yr 8 mo
U-2857
12251418in 9 yr 8 mo
U-2857
11141457in 14 yr 8 mo
U-3232
11890316in 14 yr 8 mo
U-3232

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 Octreotide Acetate 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.

Mycapssa: 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 208232 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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