# VIEKIRA XR — FDA application NDA208624

Informational only - not investment advice.

Application NDA208624 · type NDA · FDA status: approved · original approval 2016-07-22

Listed sponsor: ABBVIE · [ABBV company profile](/company/ABBV/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | VIEKIRA XR | DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR | TABLET, EXTENDED RELEASE | ORAL | EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 8501238, product 001; listed patent expiry date: 2028-09-17.
- Patent 9139536, product 001; listed patent expiry date: 2028-11-09.
- Patent 8188104, product 001; listed patent expiry date: 2029-05-17.
- Patent 8642538, product 001; listed patent expiry date: 2029-09-10.
- Patent 9006387, product 001; listed patent expiry date: 2030-06-10.
- Patent 8420596, product 001; listed patent expiry date: 2031-04-10.
- Patent 9044480, product 001; listed patent expiry date: 2031-04-10.
- Patent 8686026, product 001; listed patent expiry date: 2031-06-09.
- Patent 8691938, product 001; listed patent expiry date: 2032-04-13.
- Patent 10201541, product 001; listed patent expiry date: 2032-05-17.
- Patent 10201584, product 001; listed patent expiry date: 2032-05-17.
- Patent 8466159, product 001; listed patent expiry date: 2032-09-04.
- Patent 8492386, product 001; listed patent expiry date: 2032-09-04.
- Patent 8680106, product 001; listed patent expiry date: 2032-09-04.
- Patent 8685984, product 001; listed patent expiry date: 2032-09-04.
- Patent 10105365, product 001; listed patent expiry date: 2035-01-02.
- Patent 9333204, product 001; listed patent expiry date: 2035-01-02.
- Patent 9744170, product 001; listed patent expiry date: 2035-01-02.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR · UNII not resolved · no lmmol compound match

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/ABBV/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA208624. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.