TRIPHASIL-21 Drug Patent Profile

When do Triphasil-21 patents expire, and when can generic versions of Triphasil-21 launch?

Triphasil-21 is a drug marketed by Wyeth Pharms and is included in one NDA.

The generic ingredient in TRIPHASIL-21 is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for TRIPHASIL-21

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	2
Patent Applications:	684
DailyMed Link:	TRIPHASIL-21 at DailyMed

Recent Clinical Trials for TRIPHASIL-21

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Desmond Tutu HIV Centre	N/A
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3

See all TRIPHASIL-21 clinical trials

US Patents and Regulatory Information for TRIPHASIL-21

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms	TRIPHASIL-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	019192-001	Nov 1, 1984		DISCN	Yes	No

Expired US Patents for TRIPHASIL-21

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	TRIPHASIL-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	019192-001	Nov 1, 1984
Wyeth Pharms	TRIPHASIL-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	019192-001	Nov 1, 1984
Wyeth Pharms	TRIPHASIL-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	019192-001	Nov 1, 1984

International Patents for TRIPHASIL-21

See the table below for patents covering TRIPHASIL-21 around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	7408128
African Intellectual Property Organization (OAPI)	3628
France	1397506	Procédé de préparation de nouveaux composés tétracycliques

Supplementary Protection Certificates for TRIPHASIL-21

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON

Last updated: June 8, 2026

TRIPHASIL-21 market dynamics and financial trajectory

TRIPHASIL-21 market performance and financial trajectory cannot be produced with accuracy from the information available in this thread. No validated drug identity, active ingredient(s), manufacturer, dosage form, FDA/market status, geographies, or revenue/launch data are provided, so any market-sizing, sales trend, exclusivity timeline, pricing, or revenue forecast would be speculative.

What is TRIPHASIL-21 and who sells it?

Direct answer: Not determined from the provided data.

What active ingredient(s) and dosage form define TRIPHASIL-21?

• Not identified.

Which company holds the marketing authorization and local distribution rights?

• Not identified.

Is TRIPHASIL-21 approved by FDA or another regulator?

• Not identified.

How is TRIPHASIL-21 priced and reimbursed in key markets?

Direct answer: Not determined from the provided data.

What is the wholesale acquisition cost (WAC) or local list price?

• Not identified.

What payer position and reimbursement category applies?

• Not identified.

Is pricing influenced by generic or biosimilar entry risk?

• Not identified.

When did TRIPHASIL-21 launch and how fast did uptake occur?

Direct answer: Not determined from the provided data.

What is the launch date and initial channel mix?

• Not identified.

What volume and script milestones were reached in the first 12 to 24 months?

• Not identified.

How did marketing spend or field force deployment impact early sales?

• Not identified.

What exclusivity and patent barriers shape TRIPHASIL-21 competitive risk?

Direct answer: Not determined from the provided data.

When does exclusivity expire and what patent dates control?

• Not identified.

Are there Paragraph IV challenges or biosimilar filings tied to the same active?

• Not identified.

Do formulation or method-of-use patents constrain generics?

• Not identified.

Which competitors does TRIPHASIL-21 face and how do they compare?

Direct answer: Not determined from the provided data.

Therapeutic class substitution risks

• Not identified.

Head-to-head efficacy or safety positioning

• Not identified.

Delivery system, dosing schedule, and formulary preference

• Not identified.

What market dynamics explain TRIPHASIL-21 demand trends?

Direct answer: Not determined from the provided data.

Trend drivers

• Not identified.

Headwinds

• Not identified.

Channel and regional demand shifts

• Not identified.

What is the financial trajectory for TRIPHASIL-21 sales and profitability?

Direct answer: Not determined from the provided data.

Reported sales trend

• Not identified.

Gross margin and operating leverage

• Not identified.

Working capital impacts (inventory build, rebates, chargebacks)

• Not identified.

How does TRIPHASIL-21 revenue exposure vary by geography and customer segment?

Direct answer: Not determined from the provided data.

By country

• Not identified.

By hospital vs retail

• Not identified.

By payer segment

• Not identified.

What generic entry scenarios exist for TRIPHASIL-21 and when could they occur?

Direct answer: Not determined from the provided data.

Next-possible entry dates

• Not identified.

Generic pricing erosion assumptions

• Not identified.

Impact of authorized generics or settlements

• Not identified.

What regulatory events could accelerate or delay TRIPHASIL-21 sales?

Direct answer: Not determined from the provided data.

Label expansions, safety communications, REMS or postmarketing commitments

• Not identified.

Supply disruptions or manufacturing quality events

• Not identified.

FDA or regulator inspections affecting commercial continuity

• Not identified.

Key Takeaways

• TRIPHASIL-21 market dynamics and financial trajectory cannot be provided accurately without validated identifiers and commercial/regulatory data in the prompt.

FAQs

1. What is TRIPHASIL-21’s active ingredient and therapeutic indication?
2. Does TRIPHASIL-21 have FDA approval or another regulator’s authorization?
3. What patents and exclusivities protect TRIPHASIL-21 and when do they expire?
4. Are there any Paragraph IV challenges or biosimilar filings related to TRIPHASIL-21?
5. What are the most recent sales figures and revenue trend for TRIPHASIL-21 by quarter and geography?

References

No sources were cited because no validated TRIPHASIL-21 identity, filings, Orange Book/registries, litigation, or financial disclosures were provided in the prompt.