FDA Orange Book · active-ingredient family
Bromocriptine mesylate
Bromocriptine mesylate: 2 brands, 6 generics; first approved Mar 01, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
6
Listed patents
13
Next patent expiry
Jun 07, 2030
in 3 yr 10 mo
Brand (NDA) products
Originator applications
- VEROSCIENCENDA 0208662009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.8MG BASE TABLET ORAL Rx — - PARLODELRLDESJAY PHARMANDA 01796219822 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2.5MG BASE TABLET ORAL Rx AB EQ 5MG BASE CAPSULE ORAL Rx AB
Generic (ANDA) products (6)
Abbreviated applications
- BROMOCRIPTINE MESYLATERSPADAGIS USANDA 0776462008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2.5MG BASE TABLET ORAL Rx AB - BROMOCRIPTINE MESYLATEZYDUS PHARMS USA INCANDA 0788992008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE CAPSULE ORAL Rx AB - BROMOCRIPTINE MESYLATERSMYLANANDA 0772262005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE CAPSULE ORAL Rx AB - BROMOCRIPTINE MESYLATEAUROBINDO PHARMA USAANDA 0769622004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2.5MG BASE TABLET ORAL Discontinued — - BROMOCRIPTINE MESYLATELEK PHARMANDA 0751001998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE CAPSULE ORAL Discontinued — - BROMOCRIPTINE MESYLATESANDOZANDA 0746311998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2.5MG BASE TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8877708 | in 3 yr 10 mo | ProductU-1706 | |
| 9352025 | in 3 yr 10 mo | U-2111 | |
| 9895422 | in 3 yr 10 mo | U-2285 | |
| 10688155 | in 3 yr 10 mo | U-2898 | |
| 8431155 | in 5 yr 9 mo | ProductU-976 | |
| 9700555 | in 5 yr 9 mo | ProductU-2190 | |
| 9993474 | in 5 yr 9 mo | U-2393 | |
| 9192576 | in 5 yr 9 mo | ProductU-976 | |
| 9522117 | in 5 yr 9 mo | ProductU-1939 | |
| 10688094 | in 5 yr 9 mo | U-2871 | |
| 11000522 | in 5 yr 9 mo | U-3119 | |
| 8613947 | in 5 yr 9 mo | ProductU-976 | |
| 11666567 | in 5 yr 9 mo | U-4015 |
Approval history
FDA approval span
First approval
45 yr 1 mo ago
Most recent approval
17 yr 6 mo ago
Approvals span 1982–2009 across 8 FDA applications.
Brand (NDA) 225%
Generic (ANDA) 675%
Bromocriptine mesylate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
