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Orange Book drug · Brand (NDA)

Nuzyra

Omadacycline Tosylate

RLDNDA 209816 Paratek Pharms
Approved
Oct 02, 2018
Strengths
1
Listed patents
8
Applications
2

What does the FDA Orange Book show for Nuzyra?

Nuzyra contains Omadacycline Tosylate and appears in 2 FDA Orange Book applications. NDA 209816 is the lead filing, with 1 presentation shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.

FDA applications
2; lead NDA 209816

Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.

Lead application holder
Paratek Pharmaceuticals 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
8

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

Exclusivity records
2

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 150MG BASETABLETORALPrescriptionNone 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

Paratek Pharmaceuticals Inc

The Orange Book identifies this organization as the applicant responsible for NDA 209816.

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

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

The latest future date recorded across those files is Oct 31, 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 0 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 209816 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Tablet · Oral

Omadacycline Tosylate

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-209816

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 209816
RLDRS
Strength
EQ 150MG BASE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    7 yr 11 mo ago

  2. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    2 yr 10 mo ago

  3. Today

  4. Exclusivity ends · GAIN

    Qualified infectious disease product exclusivity (adds 5 years)

    in 2 yr 3 mo

  5. Patent 10124014 expires

    Listed method-of-use patent (U-2449) expiration.

    in 2 yr 8 mo

  6. Patent 9724358 expires

    Listed method-of-use patent (U-1569) expiration.

    in 2 yr 8 mo

  7. Patent 8383610 expires

    Listed drug substance patent expiration.

    in 4 yr 3 mo

  8. Patent 9265740 expires

    Listed drug product patent expiration.

    in 4 yr 4 mo

  9. Patent 9314475 expires

    Listed drug product patent expiration.

    in 4 yr 9 mo

  10. Patent 10111890 expires

    Listed method-of-use patent (U-2444) expiration.

    in 11 yr 2 mo

  11. Patent 10383884 expires

    Listed method-of-use patent (U-2576) expiration.

    in 11 yr 5 mo

  12. Patent 10835542 expires

    Listed method-of-use patent (U-2576) expiration.

    in 11 yr 5 mo

Patent & exclusivity timeline

Protection horizon
20232025202720292031203320352037TodayExclusivity NCE: 2023-10-02Exclusivity NCEExclusivity GAIN: 2028-10-02Exclusivity GAINPatent 10124014: 2029-03-05Patent 10124014Patent 9724358: 2029-03-05Patent 9724358Patent 8383610: 2030-09-23Patent 8383610Patent 9265740: 2030-10-24Patent 9265740Patent 9314475: 2031-03-18Patent 9314475Patent 10111890: 2037-08-03Patent 10111890Patent 10383884: 2037-10-31Patent 10383884Patent 10835542: 2037-10-31Patent 10835542
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

OMADACYCLINE TOSYLATE

Strength

EQ 150MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 209816

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • NCENew chemical entity exclusivity (5 years)

    2 yr 10 mo ago

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    in 2 yr 3 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10124014in 2 yr 8 mo
U-2449
9724358in 2 yr 8 mo
U-1569
8383610in 4 yr 3 mo
Substance
9265740in 4 yr 4 mo
ProductU-1569
9314475in 4 yr 9 mo
Product
10111890in 11 yr 2 mo
U-2444
10383884in 11 yr 5 mo
U-2576
10835542in 11 yr 5 mo
U-2576

Other FDA applications for Nuzyra

1 additional filing

The FDA has approved 2 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Nuzyra, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
NDA 209817Paratek PharmsOct 02, 20181—Prescription

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.

No other applications share this active ingredient.

View full Omadacycline Tosylate 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.

Nuzyra: 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 209816 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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