Ethinyl estradiol; norgestimate - Generic Drug Details
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What are the generic sources for ethinyl estradiol; norgestimate and what is the scope of patent protection?
Ethinyl estradiol; norgestimate
is the generic ingredient in nineteen branded drugs marketed by Janssen Pharms, Xiromed, Aurobindo Pharma Ltd, Novast Labs Ltd, Amneal Pharms, Glenmark Generics, Glenmark Pharms, Lupin Ltd, Lupin Pharms, Mylan, Mylan Labs Ltd, Naari Pte Ltd, Watson Labs, Vintage Pharms Llc, Barr, Barr Labs Inc, Novast Labs, and Aurobindo Pharma, and is included in thirty-four NDAs. Additional information is available in the individual branded drug profile pages.Twenty suppliers are listed for this compound.
Summary for ethinyl estradiol; norgestimate
US Patents: | 0 |
Tradenames: | 19 |
Applicants: | 18 |
NDAs: | 34 |
Finished Product Suppliers / Packagers: | 20 |
Clinical Trials: | 29 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ethinyl estradiol; norgestimate |
DailyMed Link: | ethinyl estradiol; norgestimate at DailyMed |
Recent Clinical Trials for ethinyl estradiol; norgestimate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Benha University | Phase 2/Phase 3 |
Amgen | Phase 1 |
Gilead Sciences | Phase 1 |
US Patents and Regulatory Information for ethinyl estradiol; norgestimate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Xiromed | TRI-LO-ESTARYLLA | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 091232-001 | Jun 29, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Vintage Pharms Llc | PREVIFEM | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 076334-001 | Jan 9, 2004 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Lupin Ltd | NORGESTIMATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 205630-001 | Oct 27, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ethinyl estradiol; norgestimate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Pharms | ORTHO TRI-CYCLEN | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 019697-001 | Jul 3, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | ORTHO TRI-CYCLEN | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 019697-001 | Jul 3, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | ORTHO TRI-CYCLEN | ethinyl estradiol; norgestimate | TABLET;ORAL-21 | 019697-002 | Jul 3, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |