By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
DrugPatentWatch Database Preview
Desogestrel; ethinyl estradiol - Generic Drug Details
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.There are eight drug master file entries for desogestrel; ethinyl estradiol. Fifteen suppliers are listed for this compound.
Summary for desogestrel; ethinyl estradiol
| US Patents: | 0 |
| Tradenames: | 17 |
| Applicants: | 17 |
| NDAs: | 25 |
| Drug Master File Entries: | 8 |
| Finished Product Suppliers / Packagers: | 15 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Clinical Trials: | 8 |
| Patent Applications: | 8 |
| 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 |
| Milton S. Hershey Medical Center | Phase 3 |
| National Institutes of Health (NIH) | Phase 3 |
ATC Classes for desogestrel; ethinyl estradiol
Paragraph IV (Patent) Challenges for DESOGESTREL; ETHINYL ESTRADIOL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| MIRCETTE | TABLET;ORAL-28 | desogestrel; ethinyl estradiol | 020713 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Xiromed | VOLNEA | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 202689-001 | Sep 9, 2016 | AB | RX | No | No | Get Started Free | Get Started Free | Get Started Free | |||
| Glenmark Generics | VIORELE | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 091346-001 | Apr 2, 2012 | AB | RX | No | No | Get Started Free | Get Started Free | Get Started Free | |||
| Duramed Pharms Barr | VELIVET | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 076455-001 | Feb 24, 2004 | AB | RX | No | No | Get Started Free | Get Started Free | Get Started Free | |||
| >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 | Get Started Free | Get Started Free |
| Organon Usa Inc | DESOGEN | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 020071-002 | Dec 10, 1992 | Get Started Free | Get Started Free |
| Aspen Global Inc | CYCLESSA | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 021090-001 | Dec 20, 2000 | Get Started Free | Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
