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Orange Book drug · Brand (NDA)

Onpattro

Patisiran Sodium

RLDNDA 210922 Alnylam Pharms Inc
Approved
Aug 10, 2018
Strengths
1
Listed patents
13

What does the FDA Orange Book show for Onpattro?

Onpattro contains Patisiran Sodium and is the new drug FDA Orange Book record for NDA 210922. 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 210922

New drug application identity from the Orange Book snapshot.

Application holder
Alnylam 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
13

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 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTIONINTRAVENOUSPrescriptionNone 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

Alnylam Pharmaceuticals Inc

The Orange Book identifies this organization as the applicant responsible for NDA 210922.

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

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

The latest future date recorded across those files is Aug 27, 2035. 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 210922 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Solution · Intravenous

Patisiran Sodium

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-210922

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 210922
RLDRS
Strength
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    8 yr 1 mo ago

  2. Exclusivity ends · M-270

    New use / labeling-change exclusivity (3 years)

    6 mo ago

  3. Today

  4. Patent 8642076 expires

    Listed drug product patent expiration.

    in 1 yr 2 mo

  5. Patent 11141378 expires

    Listed drug product patent expiration.

    in 2 yr 9 mo

  6. Patent 8058069 expires

    Listed drug product patent expiration.

    in 2 yr 9 mo

  7. Patent 8492359 expires

    Listed drug product patent expiration.

    in 2 yr 9 mo

  8. Patent 8822668 expires

    Listed drug product patent expiration.

    in 2 yr 9 mo

  9. Patent 9364435 expires

    Listed drug product patent expiration.

    in 2 yr 9 mo

  10. Patent 10240152 expires

    Listed drug substance patent expiration.

    in 3 yr 3 mo

  11. Patent 8741866 expires

    Listed method-of-use patent (U-2378) expiration.

    in 3 yr 3 mo

  12. Patent 9234196 expires

    Listed drug product patent expiration.

    in 3 yr 3 mo

  13. Patent 8802644 expires

    Listed drug product patent expiration.

    in 4 yr 4 mo

  14. Patent 8158601 expires

    Listed drug product patent expiration.

    in 4 yr 4 mo

  15. Patent 8168775 expires

    Listed drug substance patent expiration.

    in 6 yr 2 mo

  16. Patent 11079379 expires

    Listed drug substance patent expiration.

    in 9 yr 3 mo

Patent & exclusivity timeline

Protection horizon
20262027202820292030203120322033203420352036TodayExclusivity M-270: 2026-01-13Exclusivity M-270Patent 8642076: 2027-10-03Patent 8642076Patent 11141378: 2029-04-15Patent 11141378Patent 8058069: 2029-04-15Patent 8058069Patent 8492359: 2029-04-15Patent 8492359Patent 8822668: 2029-04-15Patent 8822668Patent 9364435: 2029-04-15Patent 9364435Patent 10240152: 2029-10-20Patent 10240152Patent 8741866: 2029-10-20Patent 8741866Patent 9234196: 2029-10-20Patent 9234196Patent 8802644: 2030-10-21Patent 8802644Patent 8158601: 2030-11-10Patent 8158601Patent 8168775: 2032-08-10Patent 8168775Patent 11079379: 2035-08-27Patent 11079379
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

PATISIRAN SODIUM

Strength

EQ 10MG BASE/5ML (EQ 2MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 210922

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • M-270New use / labeling-change exclusivity (3 years)

    6 mo ago

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8642076in 1 yr 2 mo
Product
11141378in 2 yr 9 mo
Product
8058069in 2 yr 9 mo
Product
8492359in 2 yr 9 mo
Product
8822668in 2 yr 9 mo
ProductU-2378
9364435in 2 yr 9 mo
ProductU-2378
10240152in 3 yr 3 mo
SubstanceProductU-2378
8741866in 3 yr 3 mo
U-2378
9234196in 3 yr 3 mo
ProductU-2378
8802644in 4 yr 4 mo
ProductU-2378
8158601in 4 yr 4 mo
ProductU-2378
8168775in 6 yr 2 mo
SubstanceProductU-2378
11079379in 9 yr 3 mo
SubstanceProductU-2378

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 Patisiran Sodium 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.

Onpattro: 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 210922 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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