INSULIN ASPART RECOMBINANT | B020986 | NOVO NORDISK INC
No 12-year reference-product exclusivity is listed in the Purple Book.
Marketing-entry ceiling (litigation risk)
No listed or discovered patents.
Disclaimer: Identifying an available carve-out is not a prediction that FDA will approve the particular carved label, nor that marketing it is free of infringement risk. For biologics, availability turns on exclusivities, not patents: FDA licenses a biosimilar (full or carved label) without adjudicating any patent, and patent disputes run through the § 262(l) patent dance and ordinary litigation, outside this availability view.
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lachman Consultant Services Inc FDA-2015-P-2867 · 6 docket documents Lachman Consultant Services Inc. filed this petition on behalf of a client requesting that the FDA declare Capecitabine Tablets, 300 mg suitable for submission as an abbreviated new drug application under Section 505(j)(2)(C), with Xeloda (capecitabine) Tablets, 500 mg as the reference listed drug. | Other | 2015-08-11 | Withdrawn | Lachman Consultant Services Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.