TRI-NORINYL 21-DAY Drug Patent Profile

Which patents cover Tri-norinyl 21-day, and what generic alternatives are available?

Tri-norinyl 21-day is a drug marketed by Dr Reddys Labs Sa and is included in one NDA.

The generic ingredient in TRI-NORINYL 21-DAY is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

Summary for TRI-NORINYL 21-DAY

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for TRI-NORINYL 21-DAY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Sa	TRI-NORINYL 21-DAY	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018977-001	Apr 13, 1984		DISCN	No	No

International Patents for TRI-NORINYL 21-DAY

See the table below for patents covering TRI-NORINYL 21-DAY around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2104779	METHOD OF CONTRACEPTION AND PHARMACEUTICAL PACKAGE THEREFOR
New Zealand	201539	PROCESS FOR THE PRODUCTION OF A CONTRACEPTIVE COMPOSITION
Singapore	93686
Malaysia	8700596	METHOD OF CONTRACEPTION AND PHARMACEUTICAL PACKAGE THEREFOR
Australia	8697682
Canada	1198057	METHODE DE CONTRACEPTION PAR ADMINISTRATION DE PROGESTOGENE (METHOD OF CONTRACEPTION USING PEAK PROGESTOGEN DOSAGE)
Germany	3229612

Supplementary Protection Certificates for TRI-NORINYL 21-DAY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211

Last updated: April 28, 2026

TRI-NORINYL 21-DAY: Investment Scenario and Fundamentals Analysis

What is TRI-NORINYL 21-DAY in identifiable, investable terms?

No actionable fundamentals can be produced because “TRI-NORINYL 21-DAY” does not map to a uniquely identifiable marketed drug, INN/USAN name, labeled active ingredient, or an unambiguous patent-protected product in the public regulatory and patent record based on the information provided. Without a deterministic mapping from the name to (1) active ingredient, (2) route of administration, (3) dosage form/strength, and (4) jurisdictional marketing authorization, an investment scenario cannot be constructed with patent status, exclusivity, competitive landscape, pricing, or manufacturing implications.

What is the patent and exclusivity posture?

No patent or regulatory exclusivity posture can be established from the provided string. A patent fundamentals analysis requires at minimum: the active ingredient identity and the specific product form (drug-device combination, formulation, dosing regimen, or depot/sustained-release platform) tied to published patent families and regulatory filings. “21-DAY” could indicate a dosing interval, but it does not identify the underlying molecular entity or the controlling claim set.

What are the commercial fundamentals (demand, pricing, reimbursement, uptake)?

No demand or pricing fundamentals can be computed because the product’s market and therapeutic area are not identified. “Tri-nor” naming patterns can be used in multiple contexts across products, but the dossier cannot be anchored to a specific indication, comparator set, or payer environment.

What is the competitive landscape and positioning?

A competitive landscape requires the treated indication, mechanism-of-action class, and geography. Without drug identity, it is impossible to determine:

• nearest substitutable therapies (same MoA and dosing interval)
• expected competitive entry timing (biosimilar/generic/line-extension)
• differentiation drivers (PK/PD, adherence, safety, immunogenicity if applicable)

What are the manufacturing and supply-chain risks?

No investable manufacturing conclusions can be drawn. Risks differ sharply by formulation type (oral solid vs injectable depot), sterility requirements, controlled substances handling, and scale-up constraints. “21-DAY” suggests long-interval dosing, but the delivery system is not identified.

What is the investable thesis and key diligence checklist?

A complete diligence checklist is not available without product identity. A defensible thesis for a pharmaceutical investment hinges on:

• regulatory status (approved indications and label scope)
• patent expiry dates (composition-of-matter, method-of-use, and formulation)
• exclusivity layers (data exclusivity, pediatric exclusivity, orphan exclusivity, patents listed in Orange Book equivalents)
• competitor pipeline and launch likelihood
• reimbursement and channel strategy

Key Takeaways

• TRI-NORINYL 21-DAY cannot be translated into investable drug fundamentals (patent status, exclusivity, competitive mapping, pricing, demand) from the information provided.
• A patent-and-exclusivity-driven investment scenario requires an unambiguous mapping to the underlying active ingredient and specific authorized product attributes.
• Without that mapping, any asserted investment thesis would be non-actionable.

FAQs

1. Can you analyze patent expiry and exclusivity for TRI-NORINYL 21-DAY?
   Not from the provided product identifier alone; no deterministic linkage to a specific patent family and regulatory product record is possible.

2. Is “21-DAY” enough to model demand and competitive threat?
   No. Dosing interval does not identify therapeutic indication, mechanism, delivery system, or the relevant comparator set.

3. What inputs are necessary to build an investment scenario?
   A uniquely identified drug product (active ingredient, dosage form, route, strength) plus geography and indication to map to patent and regulatory records.

4. Do you consider formulation-only patents and method-of-use patents?
   Yes, but only when the underlying product identity and claim scope can be mapped to published patent documents and regulatory listings.

5. Can you estimate revenue and pricing without regulatory approval details?
   No. Revenue and pricing models require the label, payer environment, and comparable products by indication and geography.

References

[1] No sources were used because TRI-NORINYL 21-DAY could not be uniquely identified to a public regulatory or patent record from the provided information.