DESOGESTREL; ETHINYL ESTRADIOL - Generic Drug Details
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What are the generic drug sources for desogestrel; ethinyl estradiol and what is the scope of patent protection?
Desogestrel; ethinyl estradiol
is the generic ingredient in seventeen branded drugs marketed by Organon Usa Inc, Duramed Pharms Barr, Janssen Pharms, Lupin Ltd, Aspen Global Inc, Dr Reddys Labs Sa, Naari Pte Ltd, Novast Labs, Watson Labs, Xiromed, Endo Operations, Aurobindo Pharma, Barr, Teva Branded Pharm, and Glenmark Pharms Ltd, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.Sixteen suppliers are listed for this compound.
Summary for DESOGESTREL; ETHINYL ESTRADIOL
| US Patents: | 0 |
| Tradenames: | 17 |
| Applicants: | 15 |
| NDAs: | 25 |
| Finished Product Suppliers / Packagers: | 16 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Clinical Trials: | 7 |
| Patent Applications: | 869 |
| DailyMed Link: | DESOGESTREL; ETHINYL ESTRADIOL at DailyMed |
Recent Clinical Trials for DESOGESTREL; ETHINYL ESTRADIOL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Laboratorios Andromaco S.A. | Phase 1 |
| National Institutes of Health (NIH) | Phase 3 |
| University of Pennsylvania | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for DESOGESTREL; ETHINYL ESTRADIOL
US Patents and Regulatory Information for DESOGESTREL; ETHINYL ESTRADIOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Naari Pte Ltd | DESOGESTREL AND ETHINYL ESTRADIOL | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 207067-001 | Sep 13, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Xiromed | VOLNEA | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 202689-001 | Sep 9, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Glenmark Pharms Ltd | VIORELE | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 091346-001 | Apr 2, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lupin Ltd | ENSKYCE | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 201887-001 | Mar 7, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Xiromed | ISIBLOOM | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 202789-001 | Aug 12, 2015 | 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 DESOGESTREL; ETHINYL ESTRADIOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Organon Usa Inc | DESOGEN | desogestrel; ethinyl estradiol | TABLET;ORAL-21 | 020071-001 | Dec 10, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| Aspen Global Inc | CYCLESSA | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 021090-001 | Dec 20, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Aspen Global Inc | CYCLESSA | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 021090-001 | Dec 20, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Branded Pharm | MIRCETTE | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 020713-001 | Apr 22, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Branded Pharm | MIRCETTE | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 020713-001 | Apr 22, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
