NOLVADEX (tamoxifen) — Competitive Intelligence Brief

NOLVADEX (tamoxifen) (NOLVADEX (tamoxifen)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Selective estrogen receptor modulator (SERM). Area: Oncology.

phase 3 Selective estrogen receptor modulator (SERM) Estrogen receptor alpha (ERα) Oncology Small molecule

Target snapshot

NOLVADEX (tamoxifen) (NOLVADEX (tamoxifen)) — AstraZeneca. Tamoxifen is a selective estrogen receptor modulator (SERM) that blocks estrogen signaling in breast tissue by competitively binding to estrogen receptors.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
NOLVADEX (tamoxifen) TARGET	NOLVADEX (tamoxifen)	AstraZeneca	phase 3	Selective estrogen receptor modulator (SERM)	Estrogen receptor alpha (ERα)
Clomifene Citrate	Clomifene Citrate	Fundació Privada Eugin	marketed	Selective estrogen receptor modulator (SERM)	Estrogen receptor (ER-α and ER-β)
High Dose Clomiphencitrat	High Dose Clomiphencitrat	University Hospital, Basel, Switzerland	marketed	Selective estrogen receptor modulator (SERM)	Estrogen receptor (ER-α and ER-β)
Low Dose Clomiphencitrat	Low Dose Clomiphencitrat	University Hospital, Basel, Switzerland	marketed	Selective estrogen receptor modulator (SERM)	Estrogen receptor (ER-α and ER-β)
fenofibrate and tibolone	fenofibrate and tibolone	Keogh Institute for Medical Research	marketed	Fibrate + Selective Estrogen Receptor Modulator (SERM)	PPAR-α (fenofibrate); Estrogen receptor, progesterone receptor, androgen receptor (tibolone)
Tamoxifen (open label)	Tamoxifen (open label)	Oregon Health and Science University	marketed	Selective estrogen receptor modulator (SERM)	Estrogen receptor alpha (ERα)
Metformin plus clomiphene citrate	Metformin plus clomiphene citrate	University Magna Graecia	marketed	Combination therapy: biguanide + selective estrogen receptor modulator (SERM)	Insulin signaling pathway (metformin); estrogen receptor (clomiphene citrate)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Selective estrogen receptor modulator (SERM) class)

1. University Hospital, Basel, Switzerland · 2 drugs in this class
2. AstraZeneca · 2 drugs in this class
3. Estetra · 1 drug in this class
4. Fundació Privada Eugin · 1 drug in this class
5. H. Lee Moffitt Cancer Center and Research Institute · 1 drug in this class
6. National Taiwan University Hospital · 1 drug in this class
7. Oregon Health and Science University · 1 drug in this class
8. Samsung Medical Center · 1 drug in this class
9. Shandong Suncadia Medicine Co., Ltd. · 1 drug in this class
10. Sheba Medical Center · 1 drug in this class