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Last Updated: November 4, 2024

Norgestrel - Generic Drug Details


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What are the generic sources for norgestrel and what is the scope of patent protection?

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

SponsorPhase
Sohag UniversityEarly Phase 1
Health DecisionsPhase 2
HRA PharmaPhase 2

See all norgestrel clinical trials

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

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