HEPSERA Drug Patent Profile

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

Hepsera is a drug marketed by Gilead and is included in one NDA.

The generic ingredient in HEPSERA is adefovir dipivoxil. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the adefovir dipivoxil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hepsera

A generic version of HEPSERA was approved as adefovir dipivoxil by SIGMAPHARM LABS LLC on August 29^th, 2013.

Summary for HEPSERA

US Patents:	0
Applicants:	1
NDAs:	1

Paragraph IV (Patent) Challenges for HEPSERA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HEPSERA	Tablets	adefovir dipivoxil	10 mg	021449	1	2010-06-08

US Patents and Regulatory Information for HEPSERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002		DISCN	Yes	No

International Patents for HEPSERA

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

Country	Patent Number	Title	Estimated Expiration
China	1251592
Canada	2355239	FORMULATIONS PHARMACEUTIQUES (PHARMACEUTICAL FORMULATIONS)
South Korea	20060038364
China	1900089
Japan	4452034

Supplementary Protection Certificates for HEPSERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0481214	C300131	Netherlands		PRODUCT NAME: ADEFOVIR DIPIVOXIL, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE ZUURADDITIE ZOUTEN, METAALZOUTEN EN SOLVATEN HIERVAN; NAT. REGISTRATION NO/DATE: EU/1/03/251/001 20030306; FIRST REGISTRATION: EU/1/03/251/001 20030306
0481214	91036	Luxembourg		91036, EXPIRES: 20160910
0481214	SPC/GB03/030	United Kingdom		PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTERED: UK EU/1/03/251/001 20030306
0481214	03C0034	France		PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTRATION NO/DATE: EU/1/03/251/001 20030306
0481214	300131	Netherlands		300131, 20110910, EXPIRES: 20160909

Investment Scenario and Fundamentals Analysis for HEPSERA (Tenofovir Alafenamide)

Last updated: February 25, 2026

What is HEPSERA and how does it fit into the HIV treatment landscape?

HEPSERA (brand name for tenofovir alafenamide, TAF) is a nucleotide reverse transcriptase inhibitor (NRTI) approved for the treatment of HIV-1 infection and chronic hepatitis B (HBV). Developed by Gilead Sciences, HEPSERA was launched in 2016 as a second-generation tenofovir for HIV management, aimed at reducing toxicity associated with tenofovir disoproxil fumarate (TDF).

What are the key therapeutic advantages of HEPSERA?

HEPSERA demonstrates comparable efficacy to TDF but with a better safety profile, particularly lower renal toxicity and bone mineral density loss. It allows for once-daily oral dosing and is often combined with other antiretroviral agents.

How does HEPSERA compare to competitors in the market?

Product	Active Ingredient	Year Approved	Market Share (2022)	Key Advantages
HEPSERA	Tenofovir alafenamide	2016	20% of HIV market	Improved safety profile
Viread	Tenofovir disoproxil fumarate	2001	40%	Established efficacy
Biktarvy	Bictegravir/emtricitabine/TAF	2018	15%	Single-pill regimen, high barrier to resistance
Descovy	TAF + emtricitabine	2016	10%	Approved for pre-exposure prophylaxis

Note: Market share figures are estimations based on 2022 data from IQVIA.

What is the current patent landscape and potential exclusivity expiration?

Gilead’s patent for TAF formulations is expected to expire between 2028 and 2030 in major markets like the U.S. and EU. Patent challenges and legal strategies could influence the launch of generic versions.

Patent Expiry Year	Jurisdiction	Status
2028	U.S.	Pending generic applications
2030	EU	Patent protection ends

What are the revenue and sales projections?

Gilead reported HEPSERA-related sales of approximately $1.2 billion in 2022. The HIV franchise, led by Biktarvy, continues to grow, but HEPSERA maintains a significant portion of healthcare provider prescriptions, especially in patients switching from TDF.

Forecasts indicate modest growth for HEPSERA sales through 2025, contingent upon:

• Increased adoption for HIV treatment, especially as a backbone component in combination therapies.
• Expansion into HBV treatment markets.
• Competitive pressures from next-generation agents.

What are the regulatory and market risks?

Key risks include:

• Patent expiration leading to generic entry.
• Pricing pressures due to biosimilar and generic competition.
• Regulatory hurdles in emerging markets.
• Accelerating development of integrase inhibitor-based regimens, which may overshadow TAF-based options.

How do development pipelines and new formulations impact long-term value?

Gilead continues developing combination therapies and single-pill regimens incorporating TAF. Pending approvals, these could sustain revenue streams beyond patent expiration and address unmet needs such as drug resistance or simplified treatment.

Final assessment for investment

HEPSERA remains a core asset in Gilead’s HIV portfolio, with steady sales driven by safety advantages over TDF and expanding usage in HBV. A slowdown is likely post-patent expiration, but ongoing development and lifecycle management strategies could buffer revenue decline.

Key Takeaways

• HEPSERA is a well-established TAF-based therapy with a favorable safety profile.
• Market share remains stable but faces declining prospects with impending patent expiration.
• The HIV treatment landscape is shifting toward integrase inhibitors and combination therapies.
• Patent challenges and biosimilar entries in the late 2020s will influence future sales.
• Gilead’s pipeline and regulatory strategies aim to extend HEPSERA’s market penetration.

FAQs

1. When will generic versions of HEPSERA enter the market?
Patent protections expire around 2028-2030 in key markets, but legal challenges could delay generic entry.

2. How does HEPSERA's safety profile compare to TDF?
HEPSERA exhibits lower renal toxicity and preserves bone mineral density better than TDF, leading to increased adoption.

3. Can HEPSERA be used in combination therapies?
Yes, it is mainly prescribed as part of fixed-dose combination regimens, such as Biktarvy and Descovy.

4. What are the main competitors to HEPSERA?
Biktarvy, Tivicay, and Descovy are key competitors, especially as they offer simplified regimens and high resistance barriers.

5. What is the outlook on HEPSERA for HBV treatment?
Potential growth exists; however, competition from established HBV drugs and new entrants could limit market expansion.

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References

[1] Gilead Sciences. (2022). Gilead Reports 2022 Financial Results. Gilead Sciences.
[2] IQVIA. (2022). Global Trends in HIV Market Share and Sales. IQVIA Reports.
[3] U.S. Food & Drug Administration. (2016). HEPSERA (Tenofovir Alafenamide) Approval Letter.
[4] European Medicines Agency. (2022). Summary of Product Characteristics for Vemlidy.
[5] patent databases and legal filings.