NORGESTREL - Generic Drug Details
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What are the generic sources for norgestrel and what is the scope of freedom to operate?
Norgestrel
is the generic ingredient in one branded drug marketed by Laboratoire Hra and is included in one NDA. Additional information is available in the individual branded drug profile pages.There are twenty-five drug master file entries for norgestrel. One supplier is listed for this compound.
Summary for NORGESTREL
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 25 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 104 |
| Clinical Trials: | 13 |
| Patent Applications: | 6,238 |
| What excipients (inactive ingredients) are in NORGESTREL? | NORGESTREL excipients list |
| DailyMed Link: | NORGESTREL at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NORGESTREL
Generic Entry Date for NORGESTREL*:
Constraining patent/regulatory exclusivity:
RX TO OTC SWITCH OR OTC USE Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for NORGESTREL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sohag University | Early Phase 1 |
| Health Decisions | Phase 2 |
| HRA Pharma | Phase 2 |
Medical Subject Heading (MeSH) Categories for NORGESTREL
US Patents and Regulatory Information for NORGESTREL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Laboratoire Hra | OPILL | norgestrel | TABLET;ORAL | 017031-001 | Approved Prior to Jan 1, 1982 | OTC | Yes | Yes | ⤷ 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 NORGESTREL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Laboratoire Hra | OPILL | norgestrel | TABLET;ORAL | 017031-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Laboratoire Hra | OPILL | norgestrel | TABLET;ORAL | 017031-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Laboratoire Hra | OPILL | norgestrel | TABLET;ORAL | 017031-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
