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Last Updated: March 19, 2026

ORTHO-NOVUM 1 Drug Patent Profile

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Which patents cover Ortho-novum 1, and when can generic versions of Ortho-novum 1 launch?

Ortho-novum 1 is a drug marketed by Ortho Mcneil Pharm, Janssen Pharms, and Ortho Mcneil Janssen. and is included in six NDAs.

The generic ingredient in ORTHO-NOVUM 1 is mestranol; norethindrone. There are eleven drug master file entries for this compound. Additional details are available on the mestranol; norethindrone profile page.

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Summary for ORTHO-NOVUM 1

US Patents:	0
Applicants:	3
NDAs:	6

US Patents and Regulatory Information for ORTHO-NOVUM 1

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ortho Mcneil Pharm	ORTHO-NOVUM 1/35-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	017489-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
Ortho Mcneil Pharm	ORTHO-NOVUM 10-21	mestranol; norethindrone	TABLET;ORAL-21	012728-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
Ortho Mcneil Janssen	ORTHO-NOVUM 1/50 28	mestranol; norethindrone	TABLET;ORAL-28	016709-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
Ortho Mcneil Janssen	ORTHO-NOVUM 10/11-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018354-001	Jan 11, 1982		DISCN	Yes	No	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
Janssen Pharms	ORTHO-NOVUM 1/35-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	017919-002	Approved Prior to Jan 1, 1982		DISCN	Yes	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

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