Assyro AI

Orange Book product · Brand (NDA)

JORNAY PM

METHYLPHENIDATE HYDROCHLORIDE

Brand (NDA)NDA 209311RX IRONSHORE PHARMS
View METHYLPHENIDATE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Aug 08, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

16

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 08, 2018

    8 yr ago

  2. Today

  3. Patent 10182995 expires

    Listed drug product patent expiration.

    Mar 23, 2032

    in 5 yr 10 mo

  4. Patent 10292937 expires

    Listed method-of-use patent (U-2357) expiration.

    Mar 23, 2032

    in 5 yr 10 mo

  5. Patent 10617651 expires

    Listed method-of-use patent (U-2357) expiration.

    Mar 23, 2032

    in 5 yr 10 mo

  6. Patent 10881618 expires

    Listed method-of-use patent (U-2357) expiration.

    Mar 23, 2032

    in 5 yr 10 mo

  7. Patent 10905652 expires

    Listed drug product patent expiration.

    Mar 23, 2032

    in 5 yr 10 mo

  8. Patent 11241391 expires

    Listed method-of-use patent (U-2357) expiration.

    Mar 23, 2032

    in 5 yr 10 mo

  9. Patent 11241392 expires

    Listed drug product patent expiration.

    Mar 23, 2032

    in 5 yr 10 mo

  10. Patent 11911518 expires

    Listed method-of-use patent (U-2357) expiration.

    Mar 23, 2032

    in 5 yr 10 mo

  11. Patent 8916588 expires

    Listed method-of-use patent (U-2357) expiration.

    Mar 23, 2032

    in 5 yr 10 mo

  12. Patent 8927010 expires

    Listed drug product patent expiration.

    Mar 23, 2032

    in 5 yr 10 mo

  13. Patent 9023389 expires

    Listed drug product patent expiration.

    Mar 23, 2032

    in 5 yr 10 mo

  14. Patent 9028868 expires

    Listed method-of-use patent (U-2357) expiration.

    Mar 23, 2032

    in 5 yr 10 mo

  15. Patent 9034902 expires

    Listed method-of-use patent (U-2357) expiration.

    Mar 23, 2032

    in 5 yr 10 mo

  16. Patent 9283214 expires

    Listed drug product patent expiration.

    Mar 23, 2032

    in 5 yr 10 mo

  17. Patent 9498447 expires

    Listed drug product patent expiration.

    Mar 23, 2032

    in 5 yr 10 mo

  18. Patent 9603809 expires

    Listed method-of-use patent (U-2357) expiration.

    Mar 23, 2032

    in 5 yr 10 mo

Pharmaceutical detail

Active ingredient

METHYLPHENIDATE HYDROCHLORIDE

Strength

40MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 209311

Product number

002

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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 (16)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10182995Mar 23, 2032in 5 yr 10 mo
Product
10292937Mar 23, 2032in 5 yr 10 mo
U-2357
10617651Mar 23, 2032in 5 yr 10 mo
U-2357
10881618Mar 23, 2032in 5 yr 10 mo
U-2357
10905652Mar 23, 2032in 5 yr 10 mo
Product
11241391Mar 23, 2032in 5 yr 10 mo
U-2357
11241392Mar 23, 2032in 5 yr 10 mo
Product
11911518Mar 23, 2032in 5 yr 10 mo
U-2357
8916588Mar 23, 2032in 5 yr 10 mo
U-2357
8927010Mar 23, 2032in 5 yr 10 mo
Product
9023389Mar 23, 2032in 5 yr 10 mo
Product
9028868Mar 23, 2032in 5 yr 10 mo
U-2357
9034902Mar 23, 2032in 5 yr 10 mo
U-2357
9283214Mar 23, 2032in 5 yr 10 mo
Product
9498447Mar 23, 2032in 5 yr 10 mo
Product
9603809Mar 23, 2032in 5 yr 10 mo
U-2357
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