Assyro AI

Orange Book product · Brand (NDA)

IMVEXXY

ESTRADIOL

Brand (NDA)NDA 208564TE ABRX MAYNE PHARMA
View ESTRADIOL familyOpen on FDA Orange Book

At a glance

May 29, 2018

Approved

Brand (NDA)

Application

AB

TE code

32

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 29, 2018

    8 yr 2 mo ago

  2. Today

  3. Patent 10258630 expires

    Listed method-of-use patent (U-2316) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  4. Patent 10258630 expires

    Listed method-of-use patent (U-2317) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  5. Patent 10398708 expires

    Listed method-of-use patent (U-2317) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  6. Patent 10398708 expires

    Listed method-of-use patent (U-2614) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  7. Patent 10471072 expires

    Listed method-of-use patent (U-2317) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  8. Patent 10471072 expires

    Listed method-of-use patent (U-2316) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  9. Patent 10537581 expires

    Listed drug product patent expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  10. Patent 10537581 expires

    Listed drug product patent expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  11. Patent 10568891 expires

    Listed method-of-use patent (U-2316) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  12. Patent 10568891 expires

    Listed method-of-use patent (U-2317) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  13. Patent 10668082 expires

    Listed method-of-use patent (U-2317) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  14. Patent 10668082 expires

    Listed method-of-use patent (U-2316) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  15. Patent 10806697 expires

    Listed drug product patent expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  16. Patent 10835487 expires

    Listed method-of-use patent (U-2316) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  17. Patent 10835487 expires

    Listed method-of-use patent (U-2317) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  18. Patent 10888516 expires

    Listed method-of-use patent (U-2316) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  19. Patent 10888516 expires

    Listed method-of-use patent (U-2317) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  20. Patent 11065197 expires

    Listed drug product patent expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  21. Patent 11116717 expires

    Listed drug product patent expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  22. Patent 11123283 expires

    Listed drug product patent expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  23. Patent 11241445 expires

    Listed method-of-use patent (U-2316) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  24. Patent 11241445 expires

    Listed method-of-use patent (U-2317) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  25. Patent 11246875 expires

    Listed method-of-use patent (U-2316) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  26. Patent 11246875 expires

    Listed method-of-use patent (U-2317) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  27. Patent 11304959 expires

    Listed drug product patent expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  28. Patent 11351182 expires

    Listed method-of-use patent (U-2316) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  29. Patent 11351182 expires

    Listed method-of-use patent (U-2317) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  30. Patent 9180091 expires

    Listed drug product patent expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  31. Patent 9180091 expires

    Listed drug product patent expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  32. Patent 9289382 expires

    Listed drug product patent expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  33. Patent 11266661 expires

    Listed method-of-use patent (U-2316) expiration.

    Feb 02, 2034

    in 7 yr 9 mo

  34. Patent 11266661 expires

    Listed method-of-use patent (U-2317) expiration.

    Feb 02, 2034

    in 7 yr 9 mo

Pharmaceutical detail

Active ingredient

ESTRADIOL

Strength

0.004MG

Dosage form

INSERT

Route

VAGINAL

TE code

AB

Application

NDA 208564

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (32)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10258630Nov 21, 2032in 6 yr 6 mo
U-2316
10258630Nov 21, 2032in 6 yr 6 mo
U-2317
10398708Nov 21, 2032in 6 yr 6 mo
U-2317
10398708Nov 21, 2032in 6 yr 6 mo
U-2614
10471072Nov 21, 2032in 6 yr 6 mo
U-2317
10471072Nov 21, 2032in 6 yr 6 mo
U-2316
10537581Nov 21, 2032in 6 yr 6 mo
ProductU-2316
10537581Nov 21, 2032in 6 yr 6 mo
ProductU-2317
10568891Nov 21, 2032in 6 yr 6 mo
U-2316
10568891Nov 21, 2032in 6 yr 6 mo
U-2317
10668082Nov 21, 2032in 6 yr 6 mo
U-2317
10668082Nov 21, 2032in 6 yr 6 mo
U-2316
10806697Nov 21, 2032in 6 yr 6 mo
Product
10835487Nov 21, 2032in 6 yr 6 mo
U-2316
10835487Nov 21, 2032in 6 yr 6 mo
U-2317
10888516Nov 21, 2032in 6 yr 6 mo
U-2316
10888516Nov 21, 2032in 6 yr 6 mo
U-2317
11065197Nov 21, 2032in 6 yr 6 mo
Product
11116717Nov 21, 2032in 6 yr 6 mo
Product
11123283Nov 21, 2032in 6 yr 6 mo
Product
11241445Nov 21, 2032in 6 yr 6 mo
U-2316
11241445Nov 21, 2032in 6 yr 6 mo
U-2317
11246875Nov 21, 2032in 6 yr 6 mo
U-2316
11246875Nov 21, 2032in 6 yr 6 mo
U-2317
11304959Nov 21, 2032in 6 yr 6 mo
Product
11351182Nov 21, 2032in 6 yr 6 mo
U-2316
11351182Nov 21, 2032in 6 yr 6 mo
U-2317
9180091Nov 21, 2032in 6 yr 6 mo
ProductU-2317
9180091Nov 21, 2032in 6 yr 6 mo
ProductU-2316
9289382Nov 21, 2032in 6 yr 6 mo
Product
11266661Feb 02, 2034in 7 yr 9 mo
U-2316
11266661Feb 02, 2034in 7 yr 9 mo
U-2317
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