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estradiol; progesterone · Mayne Pharma · NDA 210132

Bijuva

Earliest generic entry, as listed · earliest of 2 marketed strengths
21 Nov 2032

Blocked by patent: US 10052386, US 10206932, US 10639375, US 10675288, US 10806740, US 11033626, US 11103513, US 11103516, US 11110099, US 11166963, US 11529360, US 11793819, US 11865179, US 8633178, US 8846648, US 8846649, US 8933059, US 8987237, US 8993548, US 8993549, US 9006222, US 9114145, US 9114146, US 9301920.

Listed patents · 24 unexpired

PatentClaimsExpires
US 10052386product21 Nov 2032
US 10206932use U-243921 Nov 2032
US 10639375product21 Nov 2032
US 10675288use U-243921 Nov 2032
US 10806740product, use U-243921 Nov 2032
US 11033626product, use U-243921 Nov 2032
US 11103513use U-243921 Nov 2032
US 11103516product21 Nov 2032
US 11110099product21 Nov 2032
US 11166963product21 Nov 2032
US 11529360product21 Nov 2032
US 11793819use U-243921 Nov 2032
US 11865179substance, product21 Nov 2032
US 8633178product21 Nov 2032
US 8846648use U-243921 Nov 2032
US 8846649product, use U-243921 Nov 2032
US 8933059product, use U-243921 Nov 2032
US 8987237product21 Nov 2032
US 8993548product21 Nov 2032
US 8993549product21 Nov 2032
US 9006222product, use U-243921 Nov 2032
US 9114145use U-243921 Nov 2032
US 9114146product, use U-243921 Nov 2032
US 9301920product, use U-243921 Nov 2032

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 2

NDA · productFormStrengthListed expiry
210132 · 001 · RLDcapsule, oral1MG;100MG21 Nov 2032
210132 · 002 · RLDcapsule, oral0.5MG;100MG21 Nov 2032