Ethinyl estradiol; norgestimate - Generic Drug Details
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What are the generic drug sources for ethinyl estradiol; norgestimate and what is the scope of freedom to operate?
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 Pharms Ltd, Glenmark Speclt, Lupin Ltd, Lupin Pharms, Mylan, Naari Pte Ltd, Watson Labs, Endo Operations, 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-two suppliers are listed for this compound.
Summary for ethinyl estradiol; norgestimate
| US Patents: | 0 |
| Tradenames: | 19 |
| Applicants: | 17 |
| NDAs: | 34 |
| Finished Product Suppliers / Packagers: | 22 |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for ethinyl estradiol; norgestimate
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glenmark Speclt | NORGESTIMATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 204057-001 | Feb 23, 2016 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Xiromed | TRI-ESTARYLLA | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 090793-001 | Jan 30, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Barr Labs Inc | TRI LO SPRINTEC | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 076784-001 | Jun 29, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 LO | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 021241-001 | Aug 22, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | ORTHO TRI-CYCLEN LO | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 021241-001 | Aug 22, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | ORTHO TRI-CYCLEN | ethinyl estradiol; norgestimate | TABLET;ORAL-21 | 019697-002 | Jul 3, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
