VIVELLE Drug Patent Profile

Which patents cover Vivelle, and when can generic versions of Vivelle launch?

Vivelle is a drug marketed by Sandoz and is included in two NDAs.

The generic ingredient in VIVELLE is estradiol. There are seventy-five drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vivelle

A generic version of VIVELLE was approved as estradiol by BARR LABS INC on October 22^nd, 1997.

Summary for VIVELLE

US Patents:	0
Applicants:	1
NDAs:	2

US Patents and Regulatory Information for VIVELLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-005	Aug 16, 2000		DISCN	No	No
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-005	Jan 8, 1999	AB1	RX	Yes	No
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-003	Oct 28, 1994		DISCN	No	No
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-006	Jan 8, 1999	AB1	RX	Yes	No
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-001	Oct 28, 1994		DISCN	No	No
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-002	Oct 28, 1994		DISCN	No	No
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-009	May 3, 2002	AB1	RX	Yes	No

International Patents for VIVELLE

See the table below for patents covering VIVELLE around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	8907950
Hungary	T74913
Ireland	900089
China	1121854
Austria	235898
Canada	2044170	SUPPORT PERMEABLE A L'AIR (BREATHABLE BACKING)
Hong Kong	1006422

Supplementary Protection Certificates for VIVELLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	04C0022	France		PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
2782584	21C1058	France		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406
2782584	2021C/558	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
0402407	97C0005	Belgium		PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
2782584	132021000000197	Italy		PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414

Last updated: February 3, 2026

What Is the Current Status of VIVELLE?

VIVELLE is an oral contraceptive tablet developed by Allergan (a division of AbbVie) approved for contraceptive use in multiple markets. Its active ingredients are estrogen and progestin, used for pregnancy prevention. As of 2023, VIVELLE holds regulatory approval in the U.S., EU, and several other jurisdictions, with commercialization primarily led by AbbVie's reproductive health division. Its sales are driven by both women seeking contraception and healthcare providers recommending hormonal contraceptives.

How Does VIVELLE Fit into the Global Contraceptive Market?

The global contraceptive market was valued at approximately $24 billion in 2022 and expected to grow at a CAGR of 4% through 2030. Oral contraceptives account for roughly 60% of this market, indicating a significant revenue stream. The compounded annual growth reflects ongoing product innovation, expanded access, and rising awareness.

VIVELLE's positioning is as a branded oral contraceptive with established efficacy and safety. It faces direct competition from generics (e.g., Ortho-Cyclen, Yasmin) and new delivery methods like implants and IUDs, which are gaining popularity in specific demographics.

What Are the Key Financial and Commercial Fundamentals?

Market Share and Revenue:

• VIVELLE’s sales in 2022 were approximately $150 million globally.
• Its primary markets include the U.S., where it captures around 15% of oral contraceptive prescriptions.
• Pricing varies but averages $30–$50 per pack (28-day supply) in the U.S.

Patent and Regulatory Position:

• VIVELLE’s patents expire between 2024 and 2026 depending on jurisdiction, after which generic versions could exert price pressure.
• AbbVie has filed for extension strategies, including formulation patents, which may delay generic entry until 2026.

Growth Drivers:

• Increasing adoption in emerging markets.
• Expanded indications, such as premenstrual dysphoric disorder (PMDD), under clinical investigation.
• Rising awareness about contraceptive options among young women.

Risks and Challenges:

• Patent expirations and the subsequent emergence of generics.
• Safety concerns and regulatory shifts, especially in markets with stricter post-market surveillance.
• Competitive pressure from other hormonal contraceptives and non-oral methods.

What Are the Investment Considerations?

Strengths:

• Established efficacy and safety profile.
• Large existing customer base and market penetration.
• Ongoing clinical programs could extend patent life or expand indications.

Weaknesses:

• Patent expiries imminent in 2024–2026.
• Revenue concentration in mature markets, limiting growth potential.
• Competition from generics which could erode margins.

Opportunities:

• Clinical trials exploring new indications could provide revenue streams beyond contraception.
• Strategic partnership or licensing deals to expand access in emerging markets.
• Potential to leverage digital health initiatives for adherence and patient engagement.

Threats:

• Generic erosion post-patent expiration.
• Regulatory moves toward reduced hormonal contraceptive approval or new safety requirements.
• Patent litigations or delays in new indication approvals.

How Do Broader Industry Trends Affect VIVELLE?

Industry trends favor innovations integrating digital health tools and personalized medicine. VIVELLE's future viability depends partly on its ability to adapt through formulation improvements or combination products.

The shift towards non-oral contraceptives (implants, IUDs) presents a long-term challenge, though oral contraceptives maintain a large share due to cost advantages and ease of use. The rising acceptance of over-the-counter (OTC) access in some regions could impact prescription-based sales.

What Is the Long-term Outlook?

Post-generic entry, revenue is expected to decline unless offset by new indications or formulations. Strategic focus on clinical pipeline expansion or market diversification remains critical. Market expansion in emerging economies could provide a revenue lift, though regulatory and reimbursement hurdles exist.

Key Takeaways

VIVELLE is a mature product with solid market share and revenue in the oral contraceptive sector. Patent expirations between 2024 and 2026 pose significant risk of revenue decline due to generic competition. Opportunities exist in expanding indications and emerging markets, but competitive and regulatory pressures are prominent. Ongoing clinical development and strategic partnerships are vital for maintaining long-term value.

FAQs

1. What are the main competitors of VIVELLE?
Generic formulations of monophasic oral contraceptives, including brands like Ortho-Cyclen and Yasmin, as well as alternative delivery methods like IUDs and implants.

2. How soon will VIVELLE face generic competition?
Patent protections are set to expire between late 2024 and mid-2026, after which generics are likely to enter major markets.

3. Can VIVELLE be repositioned for other indications?
Yes. AbbVie is exploring clinical trials for indications like PMDD, which could extend the product's lifecycle and diversify revenue.

4. How does digital health integration impact VIVELLE's market?
Potential exists for apps and adherence tools to enhance consumption and compliance, although these are not yet widely integrated with VIVELLE specifically.

5. What is the outlook for VIVELLE in emerging markets?
Growth prospects depend on regulatory approval, access initiatives, and local healthcare infrastructure. These markets can provide incremental revenue but face competitive and logistical challenges.

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Citations
[1] Grand View Research, "Oral Contraceptive Market Size, Share & Trends," 2023.
[2] AbbVie, VIVELLE Product Details, 2023.
[3] MarketsandMarkets, "Contraceptives - Global Forecast to 2030," 2022.