secwatch.observer — SEC 8-K summary
======================================

Issuer:     HERON THERAPEUTICS, INC. /DE/ (HRTX)
CIK:        0000818033
Form:       8-K
Filed at:   2023-12-22T23:59:59+00:00
Accession:  0001193125-23-302150
Event type: regulatory
Sentiment:  negative
Materiality: 0.70
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Mylan files ANDA for generic APONVIE; Heron to defend 10 patents
----------------------------------------------------------------

- Mylan filed paragraph IV certification notice for generic version of APONVIE (aprepitant).
- Heron will file patent infringement lawsuit within 45 days of December 18, 2023 notice.
- 10 Orange Book-listed patents expiring September 18, 2035 are challenged as invalid or not infringed.
- FDA approval of Mylan's ANDA stayed for 7.5 years if suit is timely filed, absent court ruling.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/818033/000119312523302150/0001193125-23-302150-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/818033/000119312523302150/d668785d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-302150

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer