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Orange Book drug · Brand (NDA)

Hysingla ER

Hydrocodone Bitartrate

RLDNDA 206627 7 strengths Knoa Pharma
Approved
Nov 20, 2014
Strengths
7
Listed patents
19

What does the FDA Orange Book show for Hysingla ER?

Hysingla ER contains Hydrocodone Bitartrate and is the new drug FDA Orange Book record for NDA 206627. The application has 7 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 206627

New drug application identity from the Orange Book snapshot.

Application holder
Knoa Pharma LLC

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

Product presentations
7

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

Marketing categories
Prescription and Discontinued

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
AB

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

Listed patents
19

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
00120MGTABLET, EXTENDED RELEASEORALPrescriptionAB
RLDRS
00230MGTABLET, EXTENDED RELEASEORALPrescriptionAB
RLD
00340MGTABLET, EXTENDED RELEASEORALPrescriptionAB
RLD
00460MGTABLET, EXTENDED RELEASEORALPrescriptionAB
RLD
00580MGTABLET, EXTENDED RELEASEORALPrescriptionAB
RLD
006100MGTABLET, EXTENDED RELEASEORALPrescriptionAB
RLD
007120MGTABLET, 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

Knoa Pharma LLC

The Orange Book identifies this organization as the applicant responsible for NDA 206627.

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

Status varies by presentation: 6 prescription and 1 on the Discontinued Drug Product List

Orange Book status is assigned at the product-presentation level, so one strength can remain listed as prescription or OTC while another appears on the discontinued list.

Therapeutic equivalence

TE code AB across rated presentations

An AB code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group. 1 presentation in the application has no posted TE code.

Patent & exclusivity record

19 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Dec 21, 2031. 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 206627 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-206627

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

7 approved presentations · NDA 206627
TE ABRLDRS
Strength
20MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    11 yr 10 mo ago

  2. Today

  3. Patent 11304908 expires

    Listed drug product patent expiration.

    in 1 yr 1 mo

  4. Patent 11304909 expires

    Listed method-of-use patent (U-1556) expiration.

    in 1 yr 1 mo

  5. Patent 9084816 expires

    Listed drug product patent expiration.

    in 1 yr 1 mo

  6. Patent 9095614 expires

    Listed method-of-use patent (U-1556) expiration.

    in 1 yr 1 mo

  7. Patent 9095615 expires

    Listed drug product patent expiration.

    in 1 yr 1 mo

  8. Patent 9486412 expires

    Listed drug product patent expiration.

    in 1 yr 1 mo

  9. Patent 9486413 expires

    Listed drug product patent expiration.

    in 1 yr 1 mo

  10. Patent 9492389 expires

    Listed drug product patent expiration.

    in 1 yr 1 mo

  11. Patent 9492390 expires

    Listed method-of-use patent (U-1556) expiration.

    in 1 yr 1 mo

  12. Patent 9492391 expires

    Listed method-of-use patent (U-1556) expiration.

    in 1 yr 1 mo

  13. Patent 9545380 expires

    Listed method-of-use patent (U-1556) expiration.

    in 1 yr 1 mo

  14. Patent 9763933 expires

    Listed drug product patent expiration.

    in 1 yr 1 mo

  15. Patent 9770416 expires

    Listed drug product patent expiration.

    in 1 yr 1 mo

  16. Patent 9775809 expires

    Listed drug product patent expiration.

    in 1 yr 1 mo

  17. Patent 8808740 expires

    Listed drug product patent expiration.

    in 5 yr 6 mo

  18. Patent 9572779 expires

    Listed drug product patent expiration.

    in 5 yr 6 mo

  19. Patent 9750703 expires

    Listed drug product patent expiration.

    in 5 yr 6 mo

  20. Patent 9861584 expires

    Listed drug product patent expiration.

    in 5 yr 6 mo

  21. Patent 9872837 expires

    Listed drug product patent expiration.

    in 5 yr 6 mo

Patent & exclusivity timeline

Protection horizon
2026202720282029203020312032TodayPatent 11304908: 2027-08-24Patent 11304908Patent 11304909: 2027-08-24Patent 11304909Patent 9084816: 2027-08-24Patent 9084816Patent 9095614: 2027-08-24Patent 9095614Patent 9095615: 2027-08-24Patent 9095615Patent 9486412: 2027-08-24Patent 9486412Patent 9486413: 2027-08-24Patent 9486413Patent 9492389: 2027-08-24Patent 9492389Patent 9492390: 2027-08-24Patent 9492390Patent 9492391: 2027-08-24Patent 9492391Patent 9545380: 2027-08-24Patent 9545380Patent 9763933: 2027-08-24Patent 9763933Patent 9770416: 2027-08-24Patent 9770416Patent 9775809: 2027-08-24Patent 9775809Patent 8808740: 2031-12-21Patent 8808740Patent 9572779: 2031-12-21Patent 9572779Patent 9750703: 2031-12-21Patent 9750703Patent 9861584: 2031-12-21Patent 9861584Patent 9872837: 2031-12-21Patent 9872837
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

HYDROCODONE BITARTRATE

Strength

20MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

AB

Application

NDA 206627

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11304908in 1 yr 1 mo
Product
11304909in 1 yr 1 mo
U-1556
9084816in 1 yr 1 mo
Product
9095614in 1 yr 1 mo
U-1556
9095615in 1 yr 1 mo
Product
9486412in 1 yr 1 mo
Product
9486413in 1 yr 1 mo
Product
9492389in 1 yr 1 mo
Product
9492390in 1 yr 1 mo
U-1556
9492391in 1 yr 1 mo
U-1556
9545380in 1 yr 1 mo
U-1556
9763933in 1 yr 1 mo
Product
9770416in 1 yr 1 mo
Product
9775809in 1 yr 1 mo
Product
8808740in 5 yr 6 mo
ProductU-1556
9572779in 5 yr 6 mo
Product
9750703in 5 yr 6 mo
Product
9861584in 5 yr 6 mo
Product
9872837in 5 yr 6 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 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.

Hysingla 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 206627 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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