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Orange Book drug · Brand (NDA)

Viekira Pak (copackaged)

Dasabuvir Sodium; Ombitasvir, Paritaprevir, Ritonavir

DiscontinuedRLDNDA 206619 Abbvie
Approved
Dec 19, 2014
Strengths
1
Listed patents
15

What does the FDA Orange Book show for Viekira Pak (copackaged)?

Viekira Pak (copackaged) contains Dasabuvir Sodium; Ombitasvir, Paritaprevir, Ritonavir and is the new drug FDA Orange Book record for NDA 206619. 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 206619

New drug application identity from the Orange Book snapshot.

Application holder
Abbvie 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
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
15

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
001EQ 250MG BASE;12.5MG, 75MG, 50MGTABLETORALDiscontinuedNone 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

Abbvie Inc

The Orange Book identifies this organization as the applicant responsible for NDA 206619.

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 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

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

The latest future date recorded across those files is Oct 18, 2033. 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 206619 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

Dasabuvir Sodium; Ombitasvir, Paritaprevir, Ritonavir

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

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-206619

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 206619
RLDDiscontinued
Strength
EQ 250MG BASE;12.5MG, 75MG, 50MG
Dosage form
TABLET
Route
ORAL
Marketing status
Discontinued

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    11 yr 9 mo ago

  2. Today

  3. Patent 9139536 expires

    Listed method-of-use patent (U-1753) expiration.

    in 2 yr 4 mo

  4. Patent 8501238 expires

    Listed drug substance patent expiration.

    in 2 yr 5 mo

  5. Patent 8188104 expires

    Listed drug substance patent expiration.

    in 2 yr 10 mo

  6. Patent 8642538 expires

    Listed drug substance patent expiration.

    in 3 yr 2 mo

  7. Patent 9006387 expires

    Listed method-of-use patent (U-1687) expiration.

    in 3 yr 11 mo

  8. Patent 8420596 expires

    Listed drug substance patent expiration.

    in 4 yr 9 mo

  9. Patent 9044480 expires

    Listed method-of-use patent (U-1638) expiration.

    in 4 yr 9 mo

  10. Patent 8686026 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  11. Patent 8691938 expires

    Listed drug substance patent expiration.

    in 5 yr 10 mo

  12. Patent 8466159 expires

    Listed method-of-use patent (U-1637) expiration.

    in 6 yr 2 mo

  13. Patent 8492386 expires

    Listed method-of-use patent (U-1840) expiration.

    in 6 yr 2 mo

  14. Patent 8680106 expires

    Listed method-of-use patent (U-1637) expiration.

    in 6 yr 2 mo

  15. Patent 8685984 expires

    Listed method-of-use patent (U-1840) expiration.

    in 6 yr 2 mo

  16. Patent 10201542 expires

    Listed drug product patent expiration.

    in 7 yr 4 mo

  17. Patent 9629841 expires

    Listed drug product patent expiration.

    in 7 yr 4 mo

Patent & exclusivity timeline

Protection horizon
202620272028202920302031203220332034TodayPatent 9139536: 2028-11-09Patent 9139536Patent 8501238: 2028-12-19Patent 8501238Patent 8188104: 2029-05-17Patent 8188104Patent 8642538: 2029-09-10Patent 8642538Patent 9006387: 2030-06-10Patent 9006387Patent 8420596: 2031-04-10Patent 8420596Patent 9044480: 2031-04-10Patent 9044480Patent 8686026: 2031-06-09Patent 8686026Patent 8691938: 2032-04-13Patent 8691938Patent 8466159: 2032-09-04Patent 8466159Patent 8492386: 2032-09-04Patent 8492386Patent 8680106: 2032-09-04Patent 8680106Patent 8685984: 2032-09-04Patent 8685984Patent 10201542: 2033-10-18Patent 10201542Patent 9629841: 2033-10-18Patent 9629841
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR

Strength

EQ 250MG BASE;12.5MG, 75MG, 50MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 206619

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
9139536in 2 yr 4 mo
U-1753
8501238in 2 yr 5 mo
SubstanceProductU-1636
8188104in 2 yr 10 mo
SubstanceProductU-1636
8642538in 3 yr 2 mo
SubstanceProductU-1638
9006387in 3 yr 11 mo
U-1687
8420596in 4 yr 9 mo
SubstanceProduct
9044480in 4 yr 9 mo
U-1638
8686026in 4 yr 11 mo
Product
8691938in 5 yr 10 mo
SubstanceProduct
8466159in 6 yr 2 mo
U-1637
8492386in 6 yr 2 mo
U-1840
8680106in 6 yr 2 mo
U-1637
8685984in 6 yr 2 mo
U-1840
10201542in 7 yr 4 mo
ProductU-1753
9629841in 7 yr 4 mo
ProductU-1753

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 Dasabuvir Sodium; Ombitasvir, Paritaprevir, Ritonavir 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.

Viekira Pak (copackaged): 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 206619 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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