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 freedom to operate?
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, Mayne Pharma, Mylan Labs Ltd, Naari Pte Ltd, Novast Labs, Watson Labs, Vintage Pharms Llc, Xiromed, Aurobindo Pharma Ltd, Barr, Vintage Pharms, Teva Branded Pharm, and Glenmark Generics, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.Fifteen suppliers are listed for this compound.
Summary for desogestrel; ethinyl estradiol
| US Patents: | 0 |
| Tradenames: | 17 |
| Applicants: | 17 |
| NDAs: | 25 |
| Finished Product Suppliers / Packagers: | 15 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Clinical Trials: | 7 |
| Patent Applications: | 1,129 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Pharms | ORTHO-CEPT | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 020301-002 | Dec 14, 1992 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Aurobindo Pharma Ltd | SIMLIYA | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 206853-001 | Mar 22, 2017 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Aurobindo Pharma Ltd | KALLIGA | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 207081-001 | May 17, 2017 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Mayne Pharma | DESOGESTREL AND ETHINYL ESTRADIOL | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 076916-001 | Dec 29, 2008 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Lupin Ltd | ENSKYCE | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 201887-001 | Mar 7, 2013 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| >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 |
|---|---|---|---|---|---|---|---|
| Aspen Global Inc | CYCLESSA | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 021090-001 | Dec 20, 2000 | See Plans and Pricing | See Plans and Pricing |
| Organon Usa Inc | DESOGEN | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 020071-002 | Dec 10, 1992 | See Plans and Pricing | See Plans and Pricing |
| Organon Usa Inc | DESOGEN | desogestrel; ethinyl estradiol | TABLET;ORAL-21 | 020071-001 | Dec 10, 1992 | See Plans and Pricing | See Plans and Pricing |
| Aspen Global Inc | CYCLESSA | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 021090-001 | Dec 20, 2000 | See Plans and Pricing | See Plans and Pricing |
| Teva Branded Pharm | MIRCETTE | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 020713-001 | Apr 22, 1998 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
