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Orange Book drug · Brand (NDA)

Zohydro ER

Hydrocodone Bitartrate

DiscontinuedRLDNDA 202880 6 strengths Recro Gainesville
Approved
Oct 25, 2013
Strengths
6
Listed patents
16

What does the FDA Orange Book show for Zohydro ER?

Zohydro ER contains Hydrocodone Bitartrate and is the new drug FDA Orange Book record for NDA 202880. The application has 6 presentations 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 202880

New drug application identity from the Orange Book snapshot.

Application holder
Recro Gainesville LLC

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

Product presentations
6

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

Marketing categories
Discontinued

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

Reference roles
RLD

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
0

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
00110MGCAPSULE, EXTENDED RELEASEORALDiscontinuedNone posted
RLD
00215MGCAPSULE, EXTENDED RELEASEORALDiscontinuedNone posted
RLD
00320MGCAPSULE, EXTENDED RELEASEORALDiscontinuedNone posted
RLD
00430MGCAPSULE, EXTENDED RELEASEORALDiscontinuedNone posted
RLD
00540MGCAPSULE, EXTENDED RELEASEORALDiscontinuedNone posted
RLD
00650MGCAPSULE, EXTENDED RELEASEORALDiscontinuedNone posted
RLD

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

Recro Gainesville LLC

The Orange Book identifies this organization as the applicant responsible for NDA 202880.

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

6 presentations listed as on the Discontinued Drug Product List

A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.

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 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Sep 12, 2034. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

2 other ANDAs and 2 other NDAs found

2 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 202880 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-202880

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.

Strengths & dosage forms

6 approved presentations · NDA 202880
RLDDiscontinued
Strength
10MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing status
Discontinued

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    12 yr 11 mo ago

  2. Today

  3. Patent 10028946 expires

    Listed method-of-use patent (U-1810) expiration.

    in 7 yr 1 mo

  4. Patent 10322120 expires

    Listed drug product patent expiration.

    in 7 yr 1 mo

  5. Patent 10456393 expires

    Listed method-of-use patent (U-1810) expiration.

    in 7 yr 1 mo

  6. Patent 10722511 expires

    Listed method-of-use patent (U-1810) expiration.

    in 7 yr 1 mo

  7. Patent 9265760 expires

    Listed method-of-use patent (U-1810) expiration.

    in 7 yr 1 mo

  8. Patent 9326982 expires

    Listed method-of-use patent (U-1810) expiration.

    in 7 yr 1 mo

  9. Patent 9333201 expires

    Listed method-of-use patent (U-1810) expiration.

    in 7 yr 1 mo

  10. Patent 9339499 expires

    Listed method-of-use patent (U-1810) expiration.

    in 7 yr 1 mo

  11. Patent 9421200 expires

    Listed method-of-use patent (U-1810) expiration.

    in 7 yr 1 mo

  12. Patent 9433619 expires

    Listed method-of-use patent (U-1810) expiration.

    in 7 yr 1 mo

  13. Patent 9610286 expires

    Listed method-of-use patent (U-1810) expiration.

    in 7 yr 1 mo

  14. Patent 10092559 expires

    Listed method-of-use patent (U-55) expiration.

    in 8 yr 3 mo

  15. Patent 9132096 expires

    Listed drug product patent expiration.

    in 8 yr 3 mo

  16. Patent 9452163 expires

    Listed method-of-use patent (U-55) expiration.

    in 8 yr 3 mo

  17. Patent 9486451 expires

    Listed method-of-use patent (U-55) expiration.

    in 8 yr 3 mo

  18. Patent 9713611 expires

    Listed drug product patent expiration.

    in 8 yr 3 mo

Patent & exclusivity timeline

Protection horizon
2026202720282029203020312032203320342035TodayPatent 10028946: 2033-07-25Patent 10028946Patent 10322120: 2033-07-25Patent 10322120Patent 10456393: 2033-07-25Patent 10456393Patent 10722511: 2033-07-25Patent 10722511Patent 9265760: 2033-07-25Patent 9265760Patent 9326982: 2033-07-25Patent 9326982Patent 9333201: 2033-07-25Patent 9333201Patent 9339499: 2033-07-25Patent 9339499Patent 9421200: 2033-07-25Patent 9421200Patent 9433619: 2033-07-25Patent 9433619Patent 9610286: 2033-07-25Patent 9610286Patent 10092559: 2034-09-12Patent 10092559Patent 9132096: 2034-09-12Patent 9132096Patent 9452163: 2034-09-12Patent 9452163Patent 9486451: 2034-09-12Patent 9486451Patent 9713611: 2034-09-12Patent 9713611
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

HYDROCODONE BITARTRATE

Strength

10MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 202880

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10028946in 7 yr 1 mo
U-1810
10322120in 7 yr 1 mo
Product
10456393in 7 yr 1 mo
U-1810
10722511in 7 yr 1 mo
U-1810
9265760in 7 yr 1 mo
U-1810
9326982in 7 yr 1 mo
U-1810
9333201in 7 yr 1 mo
U-1810
9339499in 7 yr 1 mo
U-1810
9421200in 7 yr 1 mo
U-1810
9433619in 7 yr 1 mo
U-1810
9610286in 7 yr 1 mo
U-1810
10092559in 8 yr 3 mo
U-55
9132096in 8 yr 3 mo
Product
9452163in 8 yr 3 mo
U-55
9486451in 8 yr 3 mo
U-55
9713611in 8 yr 3 mo
ProductU-55

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 Hydrocodone Bitartrate 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.

Zohydro ER: 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 202880 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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